April 1, 2021
NPA’s Fabricant on CBD, NDI-related import alerts, and banned stimulants
Nutra Ingredients
Efforts to move the needle on hemp-CBD at the Federal level are slow, and upcoming exits of key personnel at FDA are unlikely to affect progress much, says NPA’s Dr Daniel Fabricant. “In some ways I think FDA likes the status quo,” he tells NutraIngredients-USA.
March 18, 2021
Why one FDA import alert on higenamine could increase NDI compliance industry-wide for all dietary supplements
Nutritional Outlook
The FDA import alert, issued to two foreign companies over stimulant ingredient higenamine, could have widescale repercussions in the dietary supplements industry by finally getting more firms to file New Dietary Ingredient notifications.
March 15, 2021
FDA publishes import alert for NDIs in supplements
Natural Products Insider
Based on a recently issued import alert by FDA, two Chinese-based companies and an NDI present in sports supplements are subject to detention without physical examination.
October 28, 2020
NPA asks FDA to help curb lawsuits over caloric values of BCAAs
Nutra Ingredients
The Natural Products Association has asked FDA to clarify that the minor amount of calories contributed by certain amino acids do not need to be reported on labels.
October 19, 2020
NPA Big Natural Virtual Event Planned
WholeFoods Magazine
The Natural Products Association (NPA) announced that its annual conference, The Big Natural, will take place virtually on November 30-December 1.
May 8, 2020
Texas Proposes CBD, Hemp Legislation
WholeFoods Magazine
Texas has proposed new rules for hemp and cannabidiol (CBD) products, according to a press release from the Natural Products Association (NPA).
May 6, 2020
NPA’s Fabricant: ‘It’s a global pandemic. We need to speak a global language when it comes to the science around vitamin D and zinc’
Nutra Ingredients
Every week, new studies are emerging that highlight the important roles that nutrients like vitamin D and zinc play for our immune systems, but the dietary supplements industry cannot talk about much of it.
April 28, 2020
AFT Requests Deferred Duties and Fees in Letter to Pres. Trump
WholeFoods Magazine
Americans for Free Trade has written a letter to President Trump, requesting that he delay due dates for all duties and fees and that the program be extended to cover imports made during May and June. The Natural Products Association has signed the letter.
April 21, 2020
NPA Survey: Natural Products Businesses Hit Hard
WholeFoods Magazine
A new survey conducted by the Natural Products Association (NPA) provides insight into the hardships businesses in the natural products industry are facing as the COVID-19 public health crisis continues to impact the economy.
April 21, 2020
Virginia to Pass Law Regulating CBD As Food
happi.com
NPA reaches out to Virginia’s governor to discuss regulations.
April 16, 2020
Health food stores, supplement manufacturers add more jobs, NPA launches job board
Nutritional Outlook
As millions of Americans face unemployment and economic hardship during the COVID-19 crisis, the Natural Products Association (NPA; Washington, D.C.) launched a new job board offering employment opportunities in the natural products industry. The U.S. Department of Homeland Security (DHS) recently declared that supplement retailers and manufacturers are essential businesses.
April 8, 2020
NPA: Supplements Should Be Covered Under FSA and HSA
WholeFoods Magazine
The Natural Products Association (NPA) called for allowing nutritional and dietary supplements to be covered under Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) as Congress and the IRS consider relaxing rules and expanding coverage during the pandemic, according to a press release.
March 3, 2020
NPA Expresses Continued Support for the Accurate Labels Act
WholeFoods Magazine
The Natural Products Association (NPA) has expressed its continued support for the Accurate Labels Act (ALA), which would establish a federal standard for labeling and ingredient disclosure requirements that is risk-based and substantiated by sound science.
December 17, 2019
Congress doesn’t solve CBD conundrum in 2019
Natural Products INSIDER
Despite lobbying from several industry groups, a bill to fund some federal agencies—including FDA—and avert a shutdown does not include language that would create a legal pathway for hemp-based CBD in dietary supplements.
December 17, 2019
Congress Fails to Pass CBD Legislation
WholeFoods Magazine
Congress yesterday failed to pass legislation that would appropriate $100,000 for FDA to perform a Health Hazard Evaluation on cannabidiol (CBD), instead creating a conference report that directs funding for research, policy evaluation, market surveillance, and enforcement discretion related to CBD and hemp. However, a conference report does not have the force of law, unlike legislation, notes a press release from the Natural Products Association (NPA).
December 13, 2019
NPA review of 2019: CBD Goes Mainstream
Nutra Ingredients
CBD regulation has been a top priority for NPA this year and we are the only trade association to have secured legislation on the issue. We worked with Congressman McNerney (D-CA) on an amendment that passed the House of Representatives’ Agriculture Appropriations Committee and would appropriate $100,000 for the FDA to perform a Health Hazard Evaluation (HHE) and set a safe level of consumption for CBD. We believe this approach – passing clear legislation that would provide for the FDA to set a safe level – puts consumer safety first.
December 4, 2019
CBD industry hit with nearly half dozen class action lawsuits
Natural Products INSIDER
Daniel Fabricant, president and CEO of the Natural Products Association (NPA), suggested the plaintiff’s bar would continue to lean on a page from FDA’s playbook—that CBD cannot be lawfully marketed in a dietary supplement.
“This page says that these products aren’t legal, and yet you’ve been on the market for … X amount of time making X amount of dollars,” he said in an interview.
December 4, 2019
NPA Asks for Defined Standards for Cosmetics
WholeFoods Magazine
The Natural Products Association (NPA) submitted comments to the House Energy and Commerce Committee (ECC) regarding Good Manufacturing Practices (GMPs) for cosmetic products, according to a press release. The comments note that in the past, NPA has asked for amendments to the Federal Food, Drug and Cosmetic Act (FDCA) introducing measures to regulate ingredients, monitor adverse reactions to cosmetics, and establish good manufacturing practices.
November 26, 2019
FDA Issues CBD Warning Letters; Comments on GRAS
WholeFoods Magazine
The U.S. Food and Drug Administration (FDA) announced that warning letters were issued to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
November 21, 2019
WholeFoods Magazine’s 2019 Person of the Year: Senator Mitch McConnell
WholeFoods Magazine
Dr. Daniel Fabricant, President and CEO of the Natural Products Association (NPA), told WholeFoods: “The Natural Products Association has welcomed our work with Senator McConnell and leaders in Congress to press FDA to set standards for the growing CBD and hemp markets…”
November 13, 2019
NPA’s Fabricant talks DSHEA 2.0, mandatory product listing, user fees, and CBD
NutraIngredients-usa.com
Introducing user fees for the food industry – of which dietary supplements are a subset – is a tough proposition, says Dan Fabricant, Ph.D., president and CEO of the Natural Products Association.
November 13, 2019
New Jersey Senate introduces resolution urging Congress to set safe level for CBD consumption
Nutritional Outlook
The New Jersey State Senate has introduced a resolution urging the President of the United States and Congress to issue legislation that establishes a safe daily level of consumption for cannabidiol (CBD).
November 12, 2019
NJ Senate: Congress Needs to Legislate Safe Level of CBD Consumption
WholeFoods Magazine
The New Jersey Senate has introduced a resolution calling on Congress and the President to “establish a safe daily level of consumption of cannabidiol through legislation,” according to a press release from NPA.
November 8, 2019
NPA Granted Observer Status by Codex Alimentarius
WholeFoods Magazine
The Natural Products Association (NPA) has been granted observer status by Codex Alimentarius Commission, according to a press release.
October 18, 2019
NPA Poll: 51% of Americans Don’t Know CBD is Illegal
WholeFoods Magazine
A new poll shows that 44% of Americans are less likely to use cannabidiol (CBD) products after learning that the FDA has no standards in place to protect consumers, including 30% who say they would be far less likely to use the products, according to NPA.
September 26, 2019
House Passes CBD Banking Bill
Nutraingredients-usa.com
A bill that will allow companies selling CBD products to access banking services has been approved by the US House of Representatives.
September 25, 2019
US House to Vote Today on Hemp/CBD Banking Measure
Nutraingredients-usa.com
The US House of Representatives is expected to vote today on a bill that would clear the way for full banking services for companies dealing in hemp/CBD products.
September 18, 2019
Senate Committee excludes language in appropriations bill that funds health hazard evaluation for CBD
Nutritional Outlook
NPA reports that the U.S. Senate Agriculture Appropriations Committee failed to include legislation passed the House of Representatives that would have appropriated $100,000 for the FDA to perform a health hazard evaluation on CBD.
September 17, 2019
With vaping in the crosshairs, is CBD next? NPA thinks so
Nutritional Outlook
As the Centers for Disease Control continues its investigation into vaping-related illnesses, and several states consider banning the sale of flavored vape products, NPA is warning Congress that this public health crisis may inevitably extend to cannabidiol (CBD) products, some of which can also be vaped.
September 4, 2019
NPA’s Big Natural to Begin with Remarks from NFL Hall of Famer John Riggins
WholeFoods Magazine
The Natural Products Association’s annual conference, The Big Natural, will kick off with remarks from NFL runningback and hall of famer John Riggins, according to a press release.
August 9, 2019
NPA Releases Agenda for The Big Natural
WholeFoods Magazine
NPA released the agenda for The Big Natural, which takes place September 11-12, right after their lobbying Day on the Hill on the 10th.
August 2, 2019
White House announces broad new tariffs, catching many supplement ingredients in the net
Nutraingredients-usa.com
President Trump has announced new 10% tariffs on an additional $300 billion world of Chinese goods. The move unveiled yesterday means tariffs will now likely apply to most dietary supplements whose ingredients come from China, sparking questions of what it will mean for the industry.
July 25, 2019
Counterfeit Supplement Concerns at Amazon; NPA Points to SSCI to Protect Consumers
WholeFoods Magazine
NPA announced that it has offered to be a resource for Amazon after concerns emerged about counterfeit nutritional supplements.
July 23, 2019
Trade groups weigh path forward for CBD in dietary supplements
Natural Products Insider
Some industry trade groups in the nation’s capital differ on the appropriate path forward in FDA establishing a framework authorizing CBD in dietary supplements.
July 22, 2019
NPA Submits Comments to FDA on NDIs and CBD
WholeFoods Magazine
NPA has filed comments with FDA regarding its review of “Responsible Innovation in Dietary Supplements.” NPA said these new comments reinforce points made during the Association’s presentation at FDA’s May 16 meeting on the same topic.
July 18, 2019
NPA asks that FDA utilize existing tools for comprehensive NDI enforcement
Nutritional Outlook
Expanding upon statements made to FDA during the public meeting, “Responsible Innovation in Dietary Supplements,” Daniel Fabricant, president and CEO of the Natural Products Associations (NPA; Washington, D.C.) submitted comments to the agency on July 15, 2019.
July 18, 2019
Groups urge FDA to regulate plant-derived CBD, not synthetic, as dietary supplements and food, to issue final rule, and to exercise enforcement
Nutritional Outlook
Advocacy groups are urging FDA to issue an interim final rule that would permit the lawful use of the hemp-derived cannabinoid cannabidiol (CBD) in dietary supplement and food products.
July 2, 2019
After the FDA’s Public Hearing on CBD, Industry Efforts Turn Towards Congress
Lexology
FDA’s public hearing at the end of May presented the cannabis industry with an opportunity to encourage the agency to take a serious look at cannabis-derived products, particularly those that contain cannabidiol (“CBD”). While industry may not have fully agreed on how FDA should regulate CBD products, almost everyone asked FDA to take action and implement a regulatory framework for the legal marketing of these products (i.e., as foods, dietary supplements, or other consumer products).
June 27, 2019
Congress Urges FDA To Move Forward With CBD Legalization
WholeFoods Magazine
Senator Ron Wyden (D-OR) urged FDA to promptly issue guidance that ensures the regulatory pathway Congress intended for the lawful use of CBD as a food additive and a dietary supplement, according to a statement on Senator Wyden’s website.
June 26, 2019
House passes appropriations package that includes funding for a health hazard evaluation of CBD
Nutritional Outlook
“This is a promising new product that Americans are excited about, but science and public health concerns must always come first,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, D.C.), in a press release.
June 21, 2019
CBD earmark advocated by NPA makes it into final House version of budget bill
Nutraingredients-usa.com
An amendment advocated by the Natural Products Association that would earmark funds for CBD regulation was including in the final version of the 2019 appropriations bill passed by the US House of Representatives.
June 21, 2019
The House approved amendment in appropriations bill to fund health hazard evaluation of CBD
Nutritional Outlook
NPA reports that an amendment filed by Representative Jerry McNerney of California’s 9th congressional district to modify the House Agriculture appropriations bill “to include critical funds that would enable FDA to undertake the appropriate processes and set a safe level of CBD for consumers to use each day,” has been approved by the House of Representatives.
June 18, 2019
Congressman filed amendment to ensure funds for CBD regulation in appropriations bill, reports NPA
Nutritional Outlook
NPA announced today that as a result of its work with congress to encourage FDA to establish a safe use level for dietary supplements and conventional foods containing CBD, Representative Jerry McNerney of California’s 9th congressional district filed an amendment last week to modify the House Agriculture appropriations bill “to include critical funds that would enable FDA to undertake the appropriate processes and set a safe level of CBD for consumers to use each day.”
June 10, 2019
FDA Warns Women Against Vinpocetine; NPA Alleges “Red Herring”
WholeFoods Magazine
NPA, following the release of FDA’s more recent statement, sent out a press release in which Daniel Fabricant, Ph.D., president and CEO of NPA, said: “This is a red herring for the FDA to ban vinpocetine. This latest report has nothing to do with the FDA’s 2016 notice that it reached a tentative conclusion that vinpocetine is not a dietary ingredient. The FDA is grasping at straws in an attempt to ban this safe and legal product.”
June 6, 2019
‘You don’t apply statistical analysis to hearsay’: AER expert slams new Harvard analysis
Nutraingredients-usa.com
A new analysis of FDA adverse event data that calls for reduced access to dietary supplements for children, adolescents, and young adults has been slammed by a leading expert in adverse event reporting.
June 5, 2019
FDA warns childbearing women against using vinpocetine, NPA takes issue with the tactic
Nutritional Outlook
NPA has taken issue with this latest move and consumer warning from FDA, which the group says could have major implications for new dietary ingredient notifications and have an adverse impact on consumers and manufacturers of dietary supplements.
May 31, 2019
NPA Announces Sports Nutrition Speakers for The Big Natural
WholeFoods Magazine
The sports nutrition speakers at the Natural Products Association’s (NPA) “The Big Natural” conference will be Nyree Dardarian, director of Drexel University’s Center for Nutrition and Performance, and Jonathan Scheiman, CEO of FitBiomics, according to a press release. The Big Natural will take place at the MGM National Harbor on September 11-12, coinciding with the 22nd Annual Natural Products Day, NPA’s lobby event on Capital Hill, which takes place on September 10.
May 24, 2019
NPA: Opening of Exclusion Process for Tariffs on Dietary Ingredients a Major Victory
WholeFoods Magazine
The Natural Products Association (NPA) announced a “major victory” for the natural products industry: The Office of the United States Trade Representative (USTR) is opening an exclusion process for List 3 China 301 tariffs, which includes many ingredients used in natural products.
May 24, 2019
Trump administration opens exclusion process for List 3 China 301 tariffs
Nutritional Outlook
The Trump Administration and U.S. Trade Representative (USTR) have opened an exclusion process for List 3 China 301 tariffs, which encompass many ingredients used in the natural products industry.
May 22, 2019
SSCI Praised Across Industry Summits
WholeFoods Magazine
New benchmarking standards for nutritional supplements were praised during the American National Standards Institute’s (ANSI) Dietary Supplements Standardization Coordination Meeting on May 13, according to a press release from NPA.
May 15, 2019
CHPA and CRN join chorus of support for SSCI’s draft technical standards
Nutraingredients-usa.com
New benchmarking standards developed by the Supplement Safety and Compliance Initiative (SSCI) are being widely welcomed by dietary supplements stakeholders, with the initiative coming up for discussion this week during a key ANSI meeting.
May 10, 2019
U.S. Raises China Tariffs, Threatens to Impose More
WholeFoods Magazine
Washington, D.C., and Beijing, China—President Donald Trump has raised existing tariffs on $200 billion of Chinese imports to 25%, effective on all goods that shipped out of China after 12:01 Friday morning. Goods that shipped prior to midnight will be charged the previous 10% rate.
April 25, 2019
Consumer advocacy group presses FDA to take enforcement against smoking-cessation drugs sold as supplements
Nutraingredients-usa.com
The Center for Science in the Public Interest (CSPI) sent a letter to the FDA yesterday, asking the agency to take enforcement action against 15 companies selling products as dietary supplements to help smokers quit.
April 24, 2019
FDA’s thinking on GMPs
Natural Products Insider
FDA offers resources on its thinking regarding GMP (good manufacturing practice) to help supplement brands ensure compliance.
April 18, 2019
The Vitamin Shoppe to carry CBD following FDA’s move to exercise ‘enforcement discretion’
Natural Products Insider
Industry attorneys point to FDA’s announcement to exercise “enforcement discretion” related to foods and supplements containing CBD as a factor driving mass-market retailer activity in the category, including The Vitamin Shoppe’s recent move to carry CBD supplements.
April 16, 2019
FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements
Natural Products Insider
Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients.
April 15, 2019
Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’
Nutraingredients-usa.com
As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant.
April 10, 2019
Experts take issue with researchers’ conclusion that supplements don’t prevent death
Nutraingredients-usa.com
Multivitamins don’t extend lifespan, according to the conclusion of a recent population based study. Industry experts countered that the many confounders in the data make that result tentative at best.
April 3, 2019
SSCI Offers Benchmarks As Gatekeepers For Supplements To Reach Retail Shelves
HBW Insight
FDA’s GMP final rule set uniform standards to ensure quality throughout manufacturing, packaging, labeling and holding of supplements, but Supplement Safety and Compliance Initiative says manufacturing practices continue to vary widely across the industry and the agency cannot inspect every facility. “FDA can’t solve all our problems. I don’t know if FDA knows the number of facilities it needs to inspect to ensure consumer confidence,” says Daniel Fabricant, president of SSCI member NPA.
April 2, 2019
NPA on Benefits of Medical Foods for Pain Management
WholeFoods Magazine
Medical foods can play a beneficial role in the management of acute and chronic pain and should be the subject of more research, the Natural Products Association (NPA) said in comments to the U.S. Department of Health and Human Services Pain Management Task Force.
April 2, 2019
Comment period opens on SSCI standards
Nutraingredients-usa.com
The new Supplement Safety and Compliance Initiative standards were formally unveiled by late last week at a meeting hosted by Walmart. The standards now go into a 30-day comment period.
April 2, 2019
FDA schedules public hearing on cannabis
Natural Products Insider
Over the last decade, state and federal lawmakers have increasingly embraced a plant that was long denounced: cannabis. FDA’s challenge is figuring out whether and how to regulate cannabis-containing products–including dietary supplements that contain CBD.
March 29, 2019
FDA, supplement industry eye ways to foster compliance with ingredient notification system
Natural Products Insider
FDA is looking at ways to foster the submission of new dietary ingredient notifications. The notification system, established by law in 1994, may be in need of changes to ensure U.S. regulators have an opportunity to review the safety of new ingredients before they are marketed in supplements.
March 28, 2019
SSCI releases benchmarking guidance documents and opens public comment period
Nutritional Outlook
The Supplement Safety and Compliance Initiative (SSCI) released its new general and technical benchmarking guidance documents today, and opened up a 30-day public comment period for the documents. Retailers that are participating in SSCI and expecting supplements sold in their stores to comply with these guidelines, include Walmart and GNC.
March 21, 2019
NAI trumpets its patent victory as crucial precedent for IP protection in supplements industry
Nutraingredients-usa.com
A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry.
March 15, 2019
Final defendant pleads guilty in Hawaii liver injuries case
Nutraingredients-usa.com
The final defendant in a criminal case arising from a spate of liver injuries in Hawaii has pleaded guilty, according to Reuters.
March 5, 2019
‘Gottlieb’s FDA tenure marked by tremendous progress’: Industry reacts to resignation
www.foodnavigator-usa.com
Stakeholders from the dietary supplements and food industries have been reacting to the resignation of Scott Gottlieb, MD, with many pushing for the Agency to follow through on the key initiatives started during his leadership.
March 5, 2019
FDA Commissioner Scott Gottlieb resigns, dietary supplement industry responds
Nutritional Outlook
FDA Commissioner Scott Gottlieb is resigning from the agency, effective in a month. At the time this story went to press, FDA had not yet released a public statement on Gottlieb’s resignation; however, FDA’s Twitter account posted a snapshot of a memo the Commissioner sent to his FDA colleagues noting that he wants to spend more time with family. Gottlieb has served as FDA Commissioner since May 2017.
February 28, 2019
NPA says ‘arbitrary’ new FDA protein definition could have implications for industry
Nutraingredients-usa.com
NPA has filed a comment on a proposed FDA rule that would define protein in what the organization calls an arbitrary way.
February 4, 2019
Dietary supplement trade groups asks federal appeals court to rehear false advertising case
Natural Products Insider
A controversy before the U.S. Court of Appeals for the Ninth Circuit raises questions as to how judges should apply a fundamental legal principle—”summary judgment”—in false advertising cases.
January 29, 2019
Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts
Natural Products Insider
State Rep. Kay Kahn refiled her earlier bill aimed at forcing retailers to put diet and sports products behind lock and key.
January 29, 2019
NPA: National Standard Needed for Plant-Based Food Labeling
WholeFoods Magazine
NPA has issued comments to the Food and Drug Administration (FDA) urging the agency to adopt a policy of enforcement discretion on standards of identity for products that use dairy names to describe plant-based products.
January 28, 2019
NPA calls for action on state bill that would restrict access to and post health warning on muscle building supplements
Nutraingredients-usa.com
NPA is calling for a grassroots response to oppose a bill in Massachusetts that would put sports nutrition and weight management products behind the counter and mandate the posting of a comprehensive health warning.
January 25, 2019
NPA files amicus brief in Schwabe and Nature’s Way lawsuit to prevent “dangerous precedent” in claims substantiation standards
Nutritional Outlook
NPA filed an amicus brief in the legal case Sonner vs. Schwabe North America, Inc. and Nature’s Way Product LLC being heard by the U.S. Court of Appeals for the 9th Circuit in California.
January 21, 2019
Dumb rules: NPA accuses US FDA of ‘regulatory mission creep’
Naturalproductsglobal.com
Tensions between NPA and FDA continue as the trade group this month accuses the regulator of – once again – actions at odds with the Trump Administration’s stated commitment to cut business red tape.
January 16, 2019
NPA objects to FDA’s proposed data collection for inclusion on export lists
Nutraingredients-usa.com
The Natural Products Association has objected to a proposal by the US Food and Drug Administration that NPA says will result in an expanded sharing of information on US firms with foreign governments. NPA said the proposal lacks transparency and runs counter to stated goals of the current administration with regard to paring back regulation.
January 15, 2019
NPA Submits Comments to FDA Requesting Transparency
WholeFoods Magazine
NPA said in a press release that it submitted comments to the FDA regarding a new proposal to share data collected from U.S. companies with foreign governments. NPA noted that the proposal lacks transparency and is out of step with the Trump Administration’s goals to streamline regulations.
January 11, 2019
Shutdown presents opportunity for industry to highlight self regulatory efforts
Nutraingredients-usa.com
The supplement industry has an opportunity to make a powerful case about its self regulatory capabilities during the interregnum of federal regulatory authority imposed by the budget impasse.
January 5, 2019
NPA Questions FDA’s Lack of Guidance for Dietary Supplements
WholeFoods Magazine
In comments made to the FDA, the Natural Products Association (NPA) questioned why the Agency’s draft guidance for food labeling serving sizes does not provide examples for dietary supplements, according to a press release. The NPA took issue with the fact that no examples were provided for dietary supplements carrying Supplement Facts labels, whether in pill form, liquid form or chewing gum form.
January 4, 2019
FDA supplement industry functions on hold during shutdown; backlog foreseen
Nutraingredients-usa.com
The federal government shutdown has thrown a wrench into the works of the Food and Drug Administration. While food safety might not have been compromised, many of the agency’s more routine assignments are on hold and it may take months to catch up.
January 2, 2019
Arizona proposal to register supplements as non-prescription drugs axed, thanks to efforts of trade organizations
Nutritional Outlook
“Natural products and supplements are safe and under strict regulation by the federal government, and because of that the U.S. enjoys the safest food supply in the world,” said Daniel Fabricant, president and CEO of NPA, in a press release. “Supplements are not drugs and should not be regulated like drugs, because it would raise costs and block access to the products consumers want. We commend the Arizona Board of Pharmacy and other officials for working with us to help Arizonans.”
December 24, 2018
NPA Submits Comments to FDA Regarding GMPs for Cosmetic Products
WholeFoods Magazine
The Natural Products Association (NPA) submitted comments to the FDA outlining a framework for developing Good Manufacturing Practices (GMPs) for cosmetic products, according to a press release.
December 20, 2018
Arizona pharmacy board backs down on plan to regulate supplements like OTC drugs
Nutraingredients-usa.com
A proposal by an Arizona governmental branch to regulate supplements like drugs has been successfully opposed by the American Herbal Products Association and the Natural Products Association.
December 14, 2018
New FDA Dietary Supplement Working Group to examine how effective agency’s existing authority is for regulating supplement industry
Nutritional Outlook
FDA has created a new Dietary Supplement Working Group whose goal is “to take a hard look at what more the FDA can be doing with our existing authorities” to regulate dietary supplements, said FDA Commissioner Scott Gottlieb, MD, this week. Gottlieb made the announcement during a speech he gave on December 12 at the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference hosted in Washington, DC, by the nonprofit organization the Food and Drug Law Institute.
December 12, 2018
NPA Asks to Join Dietary Supplement Working Group
WholeFoods Magazine
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the NPA’s press release that, “While we share the commissioner’s concerns and hope FDA gets serious about bad actors who illegally sell drugs under a dietary supplement label or make false claims, we disagree with his suggestion that more or different rules are needed or that the industry’s outstanding safety record has changed. We’ve urged FDA to get tougher on bad actors and we hope they do that, but in the meantime, they should also lead the discussion on new areas like cannabidiol and other promising natural products, not playing catch-up.”
December 6, 2018
Nutritional Outlook’s 2018 Best of the Industry Awards, Industry Leader: Supplement Safety Compliance InitiativeNew Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutritional Outlook
In recent years, self-regulation has become a key dietary supplement industry priority. While many manufacturers have incredible reputations because of their long history of ensuring quality and safety, it has become clear that the most effective way to earn respect as an industry is to come together as one. That is why Nutritional Outlook is recognizing two self-regulatory initiatives: The Supplement Safety Compliance Initiative (SSCI) and the Global Retailer and Manufacturer Alliance (GRMA).
November 16, 2018
NPA CEO on CBD: ‘Folks need to take the front door with FDA’
Nutraingredients-usa.com
The Natural Products Association’s stance on CBD is to take FDA’s word on the controversial ingredient, until someone takes the front door with the Agency and files an NDI or a GRAS notification with the FDA for CBD.
November 1, 2018
FDA still finding same cGMP deficiencies at dietary supplement facilities
Natural Products Insider
FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.
October 25, 2018
As Chinese import tariffs hit natural products supply chain, retail-level impact looms
New Hope
The latest round of implemented tariffs include many dietary ingredients, leaving the industry seeking exclusions and new non-China sources.
October 18, 2018
NPA expresses support for FDA’s Nutrition Innovation Strategy in public comments
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) has submitted comments to FDA regarding the agency’s “Multi-Year Nutrition Innovation Strategy” released in January 2018. With its new innovation strategy, the agency aims to provide the public with more information that will help consumers make healthier nutrition and lifestyle choices and reduce their incidence of morbidity and mortality. The agency held a public meeting on the topic on July 26, 2018, and extended the public comment period to October 11, 2018.
October 16, 2018
From the Ground Up: Standardization, Regulation, Innovation
WholeFoods Magazine
It’s time to go back to the beginning, all the way to the raw materials. First, there’s the all-consuming issue of tariffs, of what happened, how the industry fought back, and what to do now that the tariffs have passed. From there, we move on to how manufacturers offer all-important transparency, how technology is helping them do it, and the certifications to look for when research fails you. Labeling issues keep popping up, so we’ll go into why your products are—or aren’t—marked the way they are. And then experts will talk about what kind of innovation they see in the near future.
September 27, 2018
SSCI progress includes pilot audits to test standardized tools, redesigned app for farmers
Nutraingredients-usa.com
Progress on the Supplement Safety & Compliance Initiative has included pilot audits and a revamped mobile app for farmers, an executive with one of the groups behind the initiative has said.
September 27, 2018
FDA ups ante in plant ‘milk’ debate: ‘We’re on a fast track to take a fresh look at labeling’
Foodnavigator-usa.com
The FDA has upped the ante in the ongoing debate over the use of terms such as ‘almondmilk’ and ‘vegan cheese,’ with a public request for information to help inform the development of draft guidance to “provide greater clarity on appropriate labeling of plant-based alternatives.”
September 25, 2018
Tariffs Have Been Implemented. What Next?
WholeFoods Magazine
Dr. Daniel Fabricant, president of the Natural Products Association, says that now that the tariffs have passed, the NPA is hoping to get an exclusion process. The first two lists of tariffs had one, but the third list, which affects the industry the most, does not. And while glucosamine and sucralose were removed from the list, it’s still full of items that are vital to all aspects of the natural products industry
September 23, 2018
US hearing: Trump’s tariff plan disrupts companies’ supply chains and hurts consumers
CGTN
As the Office of the US Trade Representative holds a six-day hearing which began Monday on the proposed tariffs on 200 billion US dollars of Chinese goods, dozens of companies voiced concerns that the tariffs are disrupting American companies’ supply chains by raising the costs of raw materials they import.
September 20, 2018
CV Sciences ventures into food space following CBD safety assessment
Natural Products Insider
CV Sciences, a public company, has received self-affirmed GRAS status, demonstrating the safety of its “hemp-derived CBD gold extract.” But FDA could disagree with the assessment, and many regulatory hurdles remain to marketing CBD in foods and supplements, lawyers said.
September 18, 2018
Prepare for the Worst: China-U.S. Trade War Is On
WholeFoods Magazine
The trade war is on. President Trump announced he is ordering 10% tariffs beginning Sept. 24 on the $200 billion worth of Chinese imports on a list released July 10, NPR reports.
The list included a variety of items the American Herbal Products Association (AHPA) and the National Products Association (NPA) listed as necessary for the natural products industry, ranging from amino acids to dried fruits.
August 22, 2018
NPA testifies in tariff hearing, Trump seeks even higher duties
Natural Products Insider
Dan Fabricant of the Natural Products Association told the U.S. Trade Representative tariffs proposed by the Trump administration would have major negative effects on the U.S. natural products and dietary supplement industry.
August 22, 2018
Should FDA create a mandatory product registry for dietary supplements?
Nutritional Outlook
If FDA had a comprehensive, mandatory, industry-wide database of every single dietary supplement product on the market, would such information help regulators as well as industry better police the dietary supplement market? Also, how could FDA create such a registry? These questions are being debated more often as the dietary supplement industry faces more public scrutiny and ongoing discussion about whether the existing regulatory framework for supplements is effective.
August 8, 2018
BASF Awarded NPA Novel Ingredient and Science Award
Global Cosmetics News
BASF has been recognized by the Natural Products Association (NPA) for its naturals portfolio. At the certifying body’s 25th Annual Awards in Las Vegas, BASF picked up the Novel Ingredient and Science Award.
August 3, 2018
Proposed Tariffs Threaten Ingredient Supply Chain For US Supplement Firms
HBW Insight
NPA sounds alarm on Trump administration tariffs on $200bn in Chinese goods scheduled for October. In letter US Trade Representative, NPA President and CEO Daniel Fabricant asks the agency to exempt 57 items from the Harmonized Tariff Schedule that would impact hundreds of dietary ingredients.
August 3, 2018
New Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutraingredients-usa.com
The Chinese government has retaliated in the latest escalation of President Trump’s trade war by releasing lists of new tariffs on US products, the highest of which will reach 25%. Experts worry that the fallout could affect the supplement industry.
July 31st, 2018
NPA to testify against ‘burdensome’ Trump tariffs at hearing in August
Nutraingredients-usa.com
The most recent tariffs proposed by the Trump Administration will place significant burdens on small businesses in the dietary supplement industry, according to the Natural Products Association.
July 31st, 2018
Trump tariffs on natural ingredients hurt small business, consumers, NPA says
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) is urging the Trump administration not to impose tariffs on many of the ingredients used to create natural products and dietary supplements.
July 30th, 2018
Trump Tariffs Will Impose Financial Burden on Supplement Industry, NPA Warns
Vitamin Retailer
The Trump Administration’s proposal to impose tariffs on key ingredients for nutritional supplements and vitamins will cause disproportionate economic harm to U.S. interests and increase costs for small businesses and consumers, the Natural Products Association (NPA) said in a letter to United States Trade Representative Robert E. Lighthizer.
July 25th, 2018
Dietary Ingredients Ensnared in U.S.-China Trade War
Natural Products Insider
“You can go through the exemption process, but there is a backlog there,” said Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), who noted some 2,000 such applications have already been filed. “The government might have to hire more people just to deal with these applications.”
July 24th, 2018
Probiotic and prebiotic studies lack safety data, says review
Nutritional Outlook
A systematic review in the Annals of Internal Medicine says that hundreds of published probiotic and prebiotic studies failed to report important safety data. Industry leaders are expressing disagreement with the findings or at least what they imply.
July 19th, 2018
Trade group advocates to keep skip lot testing option in dietary supplements GMPs
Nutraingredients-usa.com
The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice.
July 6th, 2018
Former FDA Supplement Chief Describes Retailers’ ‘Gatekeeper’ Role
Natural Products Insider
In the last of three short video segments, Daniel Fabricant of the Natural Products Association highlights the “gatekeeper” role of U.S. retailers selling dietary supplements.
June 26th, 2018
FDA says Gottlieb statement does not signal CBD enforcement shift, but some questions unanswered, observers say
Nutraingredients-usa.com
A statement by FDA Commissioner Dr. Scott Gottlieb on the approval of a CBD drug has left some industry stakeholders wondering what the exact implications are for the many CBD products being marketed as dietary supplements.
June 22, 2018
Farm Bill passes House, includes language for vitamin and mineral supplements purchase using SNAP
Nutraingredients-usa.com
Industry celebrates inclusion of vitamin and mineral supplements language in the House’s recently updated and passed Farm Bill. One industry expert said that more work still needs to be done to get similar provisions in the Senate version of the Bill.
June 21st, 2018
Supplements Are Important for Vast Majority of Americans Who Do Not Receive Recommended Nutrients From Diet Alone
Life Extension
Supplements are important for vast majority of Americans, especially children in low-income households, who may not receive the recommended daily nutrients from diet alone. Former FDA official Daniel Fabricant is available for comment following a new report in the journal JAMA Pediatrics.
June 13th, 2018
NPA Joins Group Seeking to Amend Nationwide Labeling Regulations to Eliminate the Prevalence of Various “Unfounded” and “Unwarranted” State-Specific Warning Labels
Nutritional Outlook
Fabricant stated that NPA chose to join the Coalition because “consumers have a right to know what is in the products they use each and every day, especially when it comes to making decisions about taking products to support their health.”
June 5th, 2018
NPA CEO Discusses Regulatory Status of Kratom
Natural Products Insider
In this short video, former FDA official Daniel Fabricant, Ph.D., weighs in on kratom, the popular and controversial botanical.
May 30th, 2018
Meta-analysis finds vitamins, minerals don’t lessen CVD risk
Nutraingredients-usa.com
“It’s well documented, NPA said, that Americans fall short in many key nutrients. It should not be extrapolated that from the narrow analysis of this one study that these ingredients have no health benefits at all.”
May 4th, 2018
NPA CEO Weights in on CBD, Regulatory Risks
Natural Products Insider
“Daniel Fabricant, Ph.D. of the Natural Products Association weighs in on some of the risks associated with selling CBD in dietary supplements.”
April 25th, 2018
A Natural Products Day takeaway: The industry needs to be more active in D.C.
New Hope Network
“Supplements and labeling policies were at the top of the agenda at NPA’s annual Natural Products Day in Washington, D.C.”
April 25th, 2018
2018 Natural Products Day: Keeping Up Appearances at the Capitol
WholeFoods Magazine
“On April 18th, the Natural Products Association (NPA) held its annual Natural Products Day, during which NPA members lobby their representatives and senators on behalf of the natural products industry.”
April 4th, 2018
FDA Orders Recall of Salmonella-Tainted Kratom
Everyday Health
“The salmonella contamination reflects ‘a perfect example of a firm that doesn’t follow regulatory processes,’ says Dr. Fabricant… ‘If a firm doesn’t follow regulatory processes, it’s likely they are going to have quality-control problems.'”
March 22nd, 2018
FDA’s evidence not compelling enough to revoke soy protein heart-health claim, trade groups say
Nutraingredients-usa.com
“‘The FDA is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease ont he label or in the labeling of foods but has failed to perform its own meta-analysis,’ according to a statement made by the NPA.”
March 22nd, 2018
Unsettled political outlook boosts interest in lobby day, NPA says
Nutraingredients-usa.com
“An unsettled national political environment is one rife with opportunity. That’s one reason the Natural Products Association has cited for the strong turnout anticipated for its lobby day, which is set for mid-April.”
July 18, 2019
Groups urge FDA to regulate plant-derived CBD, not synthetic, as dietary supplements and food, to issue final rule, and to exercise enforcement
Nutritional Outlook
Advocacy groups are urging FDA to issue an interim final rule that would permit the lawful use of the hemp-derived cannabinoid cannabidiol (CBD) in dietary supplement and food products.
July 2, 2019
After the FDA’s Public Hearing on CBD, Industry Efforts Turn Towards Congress
Lexology
FDA’s public hearing at the end of May presented the cannabis industry with an opportunity to encourage the agency to take a serious look at cannabis-derived products, particularly those that contain cannabidiol (“CBD”). While industry may not have fully agreed on how FDA should regulate CBD products, almost everyone asked FDA to take action and implement a regulatory framework for the legal marketing of these products (i.e., as foods, dietary supplements, or other consumer products).
June 27, 2019
Congress Urges FDA To Move Forward With CBD Legalization
WholeFoods Magazine
Senator Ron Wyden (D-OR) urged FDA to promptly issue guidance that ensures the regulatory pathway Congress intended for the lawful use of CBD as a food additive and a dietary supplement, according to a statement on Senator Wyden’s website.
June 26, 2019
House passes appropriations package that includes funding for a health hazard evaluation of CBD
Nutritional Outlook
“This is a promising new product that Americans are excited about, but science and public health concerns must always come first,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, D.C.), in a press release.
June 21, 2019
CBD earmark advocated by NPA makes it into final House version of budget bill
Nutraingredients-usa.com
An amendment advocated by the Natural Products Association that would earmark funds for CBD regulation was including in the final version of the 2019 appropriations bill passed by the US House of Representatives.
June 21, 2019
The House approved amendment in appropriations bill to fund health hazard evaluation of CBD
Nutritional Outlook
NPA reports that an amendment filed by Representative Jerry McNerney of California’s 9th congressional district to modify the House Agriculture appropriations bill “to include critical funds that would enable FDA to undertake the appropriate processes and set a safe level of CBD for consumers to use each day,” has been approved by the House of Representatives.
June 18, 2019
Congressman filed amendment to ensure funds for CBD regulation in appropriations bill, reports NPA
Nutritional Outlook
NPA announced today that as a result of its work with congress to encourage FDA to establish a safe use level for dietary supplements and conventional foods containing CBD, Representative Jerry McNerney of California’s 9th congressional district filed an amendment last week to modify the House Agriculture appropriations bill “to include critical funds that would enable FDA to undertake the appropriate processes and set a safe level of CBD for consumers to use each day.”
June 10, 2019
FDA Warns Women Against Vinpocetine; NPA Alleges “Red Herring”
WholeFoods Magazine
NPA, following the release of FDA’s more recent statement, sent out a press release in which Daniel Fabricant, Ph.D., president and CEO of NPA, said: “This is a red herring for the FDA to ban vinpocetine. This latest report has nothing to do with the FDA’s 2016 notice that it reached a tentative conclusion that vinpocetine is not a dietary ingredient. The FDA is grasping at straws in an attempt to ban this safe and legal product.”
June 6, 2019
‘You don’t apply statistical analysis to hearsay’: AER expert slams new Harvard analysis
Nutraingredients-usa.com
A new analysis of FDA adverse event data that calls for reduced access to dietary supplements for children, adolescents, and young adults has been slammed by a leading expert in adverse event reporting.
June 5, 2019
FDA warns childbearing women against using vinpocetine, NPA takes issue with the tactic
Nutritional Outlook
NPA has taken issue with this latest move and consumer warning from FDA, which the group says could have major implications for new dietary ingredient notifications and have an adverse impact on consumers and manufacturers of dietary supplements.
May 31, 2019
NPA Announces Sports Nutrition Speakers for The Big Natural
WholeFoods Magazine
The sports nutrition speakers at the Natural Products Association’s (NPA) “The Big Natural” conference will be Nyree Dardarian, director of Drexel University’s Center for Nutrition and Performance, and Jonathan Scheiman, CEO of FitBiomics, according to a press release. The Big Natural will take place at the MGM National Harbor on September 11-12, coinciding with the 22nd Annual Natural Products Day, NPA’s lobby event on Capital Hill, which takes place on September 10.
May 24, 2019
NPA: Opening of Exclusion Process for Tariffs on Dietary Ingredients a Major Victory
WholeFoods Magazine
The Natural Products Association (NPA) announced a “major victory” for the natural products industry: The Office of the United States Trade Representative (USTR) is opening an exclusion process for List 3 China 301 tariffs, which includes many ingredients used in natural products.
May 24, 2019
Trump administration opens exclusion process for List 3 China 301 tariffs
Nutritional Outlook
The Trump Administration and U.S. Trade Representative (USTR) have opened an exclusion process for List 3 China 301 tariffs, which encompass many ingredients used in the natural products industry.
May 22, 2019
SSCI Praised Across Industry Summits
WholeFoods Magazine
New benchmarking standards for nutritional supplements were praised during the American National Standards Institute’s (ANSI) Dietary Supplements Standardization Coordination Meeting on May 13, according to a press release from NPA.
May 15, 2019
CHPA and CRN join chorus of support for SSCI’s draft technical standards
Nutraingredients-usa.com
New benchmarking standards developed by the Supplement Safety and Compliance Initiative (SSCI) are being widely welcomed by dietary supplements stakeholders, with the initiative coming up for discussion this week during a key ANSI meeting.
May 10, 2019
U.S. Raises China Tariffs, Threatens to Impose More
WholeFoods Magazine
Washington, D.C., and Beijing, China—President Donald Trump has raised existing tariffs on $200 billion of Chinese imports to 25%, effective on all goods that shipped out of China after 12:01 Friday morning. Goods that shipped prior to midnight will be charged the previous 10% rate.
April 25, 2019
Consumer advocacy group presses FDA to take enforcement against smoking-cessation drugs sold as supplements
Nutraingredients-usa.com
The Center for Science in the Public Interest (CSPI) sent a letter to the FDA yesterday, asking the agency to take enforcement action against 15 companies selling products as dietary supplements to help smokers quit.
April 24, 2019
FDA’s thinking on GMPs
Natural Products Insider
FDA offers resources on its thinking regarding GMP (good manufacturing practice) to help supplement brands ensure compliance.
April 18, 2019
The Vitamin Shoppe to carry CBD following FDA’s move to exercise ‘enforcement discretion’
Natural Products Insider
Industry attorneys point to FDA’s announcement to exercise “enforcement discretion” related to foods and supplements containing CBD as a factor driving mass-market retailer activity in the category, including The Vitamin Shoppe’s recent move to carry CBD supplements.
April 16, 2019
FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements
Natural Products Insider
Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients.
April 15, 2019
Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’
Nutraingredients-usa.com
As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant.
April 10, 2019
Experts take issue with researchers’ conclusion that supplements don’t prevent death
Nutraingredients-usa.com
Multivitamins don’t extend lifespan, according to the conclusion of a recent population based study. Industry experts countered that the many confounders in the data make that result tentative at best.
April 3, 2019
SSCI Offers Benchmarks As Gatekeepers For Supplements To Reach Retail Shelves
HBW Insight
FDA’s GMP final rule set uniform standards to ensure quality throughout manufacturing, packaging, labeling and holding of supplements, but Supplement Safety and Compliance Initiative says manufacturing practices continue to vary widely across the industry and the agency cannot inspect every facility. “FDA can’t solve all our problems. I don’t know if FDA knows the number of facilities it needs to inspect to ensure consumer confidence,” says Daniel Fabricant, president of SSCI member NPA.
April 2, 2019
NPA on Benefits of Medical Foods for Pain Management
WholeFoods Magazine
Medical foods can play a beneficial role in the management of acute and chronic pain and should be the subject of more research, the Natural Products Association (NPA) said in comments to the U.S. Department of Health and Human Services Pain Management Task Force.
April 2, 2019
Comment period opens on SSCI standards
Nutraingredients-usa.com
The new Supplement Safety and Compliance Initiative standards were formally unveiled by late last week at a meeting hosted by Walmart. The standards now go into a 30-day comment period.
April 2, 2019
FDA schedules public hearing on cannabis
Natural Products Insider
Over the last decade, state and federal lawmakers have increasingly embraced a plant that was long denounced: cannabis. FDA’s challenge is figuring out whether and how to regulate cannabis-containing products–including dietary supplements that contain CBD.
March 29, 2019
FDA, supplement industry eye ways to foster compliance with ingredient notification system
Natural Products Insider
FDA is looking at ways to foster the submission of new dietary ingredient notifications. The notification system, established by law in 1994, may be in need of changes to ensure U.S. regulators have an opportunity to review the safety of new ingredients before they are marketed in supplements.
March 28, 2019
SSCI releases benchmarking guidance documents and opens public comment period
Nutritional Outlook
The Supplement Safety and Compliance Initiative (SSCI) released its new general and technical benchmarking guidance documents today, and opened up a 30-day public comment period for the documents. Retailers that are participating in SSCI and expecting supplements sold in their stores to comply with these guidelines, include Walmart and GNC.
March 21, 2019
NAI trumpets its patent victory as crucial precedent for IP protection in supplements industry
Nutraingredients-usa.com
A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry.
March 15, 2019
Final defendant pleads guilty in Hawaii liver injuries case
Nutraingredients-usa.com
The final defendant in a criminal case arising from a spate of liver injuries in Hawaii has pleaded guilty, according to Reuters.
March 5, 2019
‘Gottlieb’s FDA tenure marked by tremendous progress’: Industry reacts to resignation
www.foodnavigator-usa.com
Stakeholders from the dietary supplements and food industries have been reacting to the resignation of Scott Gottlieb, MD, with many pushing for the Agency to follow through on the key initiatives started during his leadership.
March 5, 2019
FDA Commissioner Scott Gottlieb resigns, dietary supplement industry responds
Nutritional Outlook
FDA Commissioner Scott Gottlieb is resigning from the agency, effective in a month. At the time this story went to press, FDA had not yet released a public statement on Gottlieb’s resignation; however, FDA’s Twitter account posted a snapshot of a memo the Commissioner sent to his FDA colleagues noting that he wants to spend more time with family. Gottlieb has served as FDA Commissioner since May 2017.
February 28, 2019
NPA says ‘arbitrary’ new FDA protein definition could have implications for industry
Nutraingredients-usa.com
NPA has filed a comment on a proposed FDA rule that would define protein in what the organization calls an arbitrary way.
February 4, 2019
Dietary supplement trade groups asks federal appeals court to rehear false advertising case
Natural Products Insider
A controversy before the U.S. Court of Appeals for the Ninth Circuit raises questions as to how judges should apply a fundamental legal principle—”summary judgment”—in false advertising cases.
January 29, 2019
Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts
Natural Products Insider
State Rep. Kay Kahn refiled her earlier bill aimed at forcing retailers to put diet and sports products behind lock and key.
January 29, 2019
NPA: National Standard Needed for Plant-Based Food Labeling
WholeFoods Magazine
NPA has issued comments to the Food and Drug Administration (FDA) urging the agency to adopt a policy of enforcement discretion on standards of identity for products that use dairy names to describe plant-based products.
January 28, 2019
NPA calls for action on state bill that would restrict access to and post health warning on muscle building supplements
Nutraingredients-usa.com
NPA is calling for a grassroots response to oppose a bill in Massachusetts that would put sports nutrition and weight management products behind the counter and mandate the posting of a comprehensive health warning.
January 25, 2019
NPA files amicus brief in Schwabe and Nature’s Way lawsuit to prevent “dangerous precedent” in claims substantiation standards
Nutritional Outlook
NPA filed an amicus brief in the legal case Sonner vs. Schwabe North America, Inc. and Nature’s Way Product LLC being heard by the U.S. Court of Appeals for the 9th Circuit in California.
January 21, 2019
Dumb rules: NPA accuses US FDA of ‘regulatory mission creep’
Naturalproductsglobal.com
Tensions between NPA and FDA continue as the trade group this month accuses the regulator of – once again – actions at odds with the Trump Administration’s stated commitment to cut business red tape.
January 16, 2019
NPA objects to FDA’s proposed data collection for inclusion on export lists
Nutraingredients-usa.com
The Natural Products Association has objected to a proposal by the US Food and Drug Administration that NPA says will result in an expanded sharing of information on US firms with foreign governments. NPA said the proposal lacks transparency and runs counter to stated goals of the current administration with regard to paring back regulation.
January 15, 2019
NPA Submits Comments to FDA Requesting Transparency
WholeFoods Magazine
NPA said in a press release that it submitted comments to the FDA regarding a new proposal to share data collected from U.S. companies with foreign governments. NPA noted that the proposal lacks transparency and is out of step with the Trump Administration’s goals to streamline regulations.
January 11, 2019
Shutdown presents opportunity for industry to highlight self regulatory efforts
Nutraingredients-usa.com
The supplement industry has an opportunity to make a powerful case about its self regulatory capabilities during the interregnum of federal regulatory authority imposed by the budget impasse.
January 5, 2019
NPA Questions FDA’s Lack of Guidance for Dietary Supplements
WholeFoods Magazine
In comments made to the FDA, the Natural Products Association (NPA) questioned why the Agency’s draft guidance for food labeling serving sizes does not provide examples for dietary supplements, according to a press release. The NPA took issue with the fact that no examples were provided for dietary supplements carrying Supplement Facts labels, whether in pill form, liquid form or chewing gum form.
January 4, 2019
FDA supplement industry functions on hold during shutdown; backlog foreseen
Nutraingredients-usa.com
The federal government shutdown has thrown a wrench into the works of the Food and Drug Administration. While food safety might not have been compromised, many of the agency’s more routine assignments are on hold and it may take months to catch up.
January 2, 2019
Arizona proposal to register supplements as non-prescription drugs axed, thanks to efforts of trade organizations
Nutritional Outlook
“Natural products and supplements are safe and under strict regulation by the federal government, and because of that the U.S. enjoys the safest food supply in the world,” said Daniel Fabricant, president and CEO of NPA, in a press release. “Supplements are not drugs and should not be regulated like drugs, because it would raise costs and block access to the products consumers want. We commend the Arizona Board of Pharmacy and other officials for working with us to help Arizonans.”
December 24, 2018
NPA Submits Comments to FDA Regarding GMPs for Cosmetic Products
WholeFoods Magazine
The Natural Products Association (NPA) submitted comments to the FDA outlining a framework for developing Good Manufacturing Practices (GMPs) for cosmetic products, according to a press release.
December 20, 2018
Arizona pharmacy board backs down on plan to regulate supplements like OTC drugs
Nutraingredients-usa.com
A proposal by an Arizona governmental branch to regulate supplements like drugs has been successfully opposed by the American Herbal Products Association and the Natural Products Association.
December 14, 2018
New FDA Dietary Supplement Working Group to examine how effective agency’s existing authority is for regulating supplement industry
Nutritional Outlook
FDA has created a new Dietary Supplement Working Group whose goal is “to take a hard look at what more the FDA can be doing with our existing authorities” to regulate dietary supplements, said FDA Commissioner Scott Gottlieb, MD, this week. Gottlieb made the announcement during a speech he gave on December 12 at the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference hosted in Washington, DC, by the nonprofit organization the Food and Drug Law Institute.
December 12, 2018
NPA Asks to Join Dietary Supplement Working Group
WholeFoods Magazine
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the NPA’s press release that, “While we share the commissioner’s concerns and hope FDA gets serious about bad actors who illegally sell drugs under a dietary supplement label or make false claims, we disagree with his suggestion that more or different rules are needed or that the industry’s outstanding safety record has changed. We’ve urged FDA to get tougher on bad actors and we hope they do that, but in the meantime, they should also lead the discussion on new areas like cannabidiol and other promising natural products, not playing catch-up.”
December 6, 2018
Nutritional Outlook’s 2018 Best of the Industry Awards, Industry Leader: Supplement Safety Compliance InitiativeNew Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutritional Outlook
In recent years, self-regulation has become a key dietary supplement industry priority. While many manufacturers have incredible reputations because of their long history of ensuring quality and safety, it has become clear that the most effective way to earn respect as an industry is to come together as one. That is why Nutritional Outlook is recognizing two self-regulatory initiatives: The Supplement Safety Compliance Initiative (SSCI) and the Global Retailer and Manufacturer Alliance (GRMA).
November 16, 2018
NPA CEO on CBD: ‘Folks need to take the front door with FDA’
Nutraingredients-usa.com
The Natural Products Association’s stance on CBD is to take FDA’s word on the controversial ingredient, until someone takes the front door with the Agency and files an NDI or a GRAS notification with the FDA for CBD.
November 1, 2018
FDA still finding same cGMP deficiencies at dietary supplement facilities
Natural Products Insider
FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.
October 25, 2018
As Chinese import tariffs hit natural products supply chain, retail-level impact looms
New Hope
The latest round of implemented tariffs include many dietary ingredients, leaving the industry seeking exclusions and new non-China sources.
October 18, 2018
NPA expresses support for FDA’s Nutrition Innovation Strategy in public comments
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) has submitted comments to FDA regarding the agency’s “Multi-Year Nutrition Innovation Strategy” released in January 2018. With its new innovation strategy, the agency aims to provide the public with more information that will help consumers make healthier nutrition and lifestyle choices and reduce their incidence of morbidity and mortality. The agency held a public meeting on the topic on July 26, 2018, and extended the public comment period to October 11, 2018.
October 16, 2018
From the Ground Up: Standardization, Regulation, Innovation
WholeFoods Magazine
It’s time to go back to the beginning, all the way to the raw materials. First, there’s the all-consuming issue of tariffs, of what happened, how the industry fought back, and what to do now that the tariffs have passed. From there, we move on to how manufacturers offer all-important transparency, how technology is helping them do it, and the certifications to look for when research fails you. Labeling issues keep popping up, so we’ll go into why your products are—or aren’t—marked the way they are. And then experts will talk about what kind of innovation they see in the near future.
September 27, 2018
SSCI progress includes pilot audits to test standardized tools, redesigned app for farmers
Nutraingredients-usa.com
Progress on the Supplement Safety & Compliance Initiative has included pilot audits and a revamped mobile app for farmers, an executive with one of the groups behind the initiative has said.
September 27, 2018
FDA ups ante in plant ‘milk’ debate: ‘We’re on a fast track to take a fresh look at labeling’
Foodnavigator-usa.com
The FDA has upped the ante in the ongoing debate over the use of terms such as ‘almondmilk’ and ‘vegan cheese,’ with a public request for information to help inform the development of draft guidance to “provide greater clarity on appropriate labeling of plant-based alternatives.”
September 25, 2018
Tariffs Have Been Implemented. What Next?
WholeFoods Magazine
Dr. Daniel Fabricant, president of the Natural Products Association, says that now that the tariffs have passed, the NPA is hoping to get an exclusion process. The first two lists of tariffs had one, but the third list, which affects the industry the most, does not. And while glucosamine and sucralose were removed from the list, it’s still full of items that are vital to all aspects of the natural products industry
September 23, 2018
US hearing: Trump’s tariff plan disrupts companies’ supply chains and hurts consumers
CGTN
As the Office of the US Trade Representative holds a six-day hearing which began Monday on the proposed tariffs on 200 billion US dollars of Chinese goods, dozens of companies voiced concerns that the tariffs are disrupting American companies’ supply chains by raising the costs of raw materials they import.
September 20, 2018
CV Sciences ventures into food space following CBD safety assessment
Natural Products Insider
CV Sciences, a public company, has received self-affirmed GRAS status, demonstrating the safety of its “hemp-derived CBD gold extract.” But FDA could disagree with the assessment, and many regulatory hurdles remain to marketing CBD in foods and supplements, lawyers said.
September 18, 2018
Prepare for the Worst: China-U.S. Trade War Is On
WholeFoods Magazine
The trade war is on. President Trump announced he is ordering 10% tariffs beginning Sept. 24 on the $200 billion worth of Chinese imports on a list released July 10, NPR reports.
The list included a variety of items the American Herbal Products Association (AHPA) and the National Products Association (NPA) listed as necessary for the natural products industry, ranging from amino acids to dried fruits.
August 22, 2018
NPA testifies in tariff hearing, Trump seeks even higher duties
Natural Products Insider
Dan Fabricant of the Natural Products Association told the U.S. Trade Representative tariffs proposed by the Trump administration would have major negative effects on the U.S. natural products and dietary supplement industry.
August 22, 2018
Should FDA create a mandatory product registry for dietary supplements?
Nutritional Outlook
If FDA had a comprehensive, mandatory, industry-wide database of every single dietary supplement product on the market, would such information help regulators as well as industry better police the dietary supplement market? Also, how could FDA create such a registry? These questions are being debated more often as the dietary supplement industry faces more public scrutiny and ongoing discussion about whether the existing regulatory framework for supplements is effective.
August 8, 2018
BASF Awarded NPA Novel Ingredient and Science Award
Global Cosmetics News
BASF has been recognized by the Natural Products Association (NPA) for its naturals portfolio. At the certifying body’s 25th Annual Awards in Las Vegas, BASF picked up the Novel Ingredient and Science Award.
August 3, 2018
Proposed Tariffs Threaten Ingredient Supply Chain For US Supplement Firms
HBW Insight
NPA sounds alarm on Trump administration tariffs on $200bn in Chinese goods scheduled for October. In letter US Trade Representative, NPA President and CEO Daniel Fabricant asks the agency to exempt 57 items from the Harmonized Tariff Schedule that would impact hundreds of dietary ingredients.
August 3, 2018
New Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutraingredients-usa.com
The Chinese government has retaliated in the latest escalation of President Trump’s trade war by releasing lists of new tariffs on US products, the highest of which will reach 25%. Experts worry that the fallout could affect the supplement industry.
July 31st, 2018
NPA to testify against ‘burdensome’ Trump tariffs at hearing in August
Nutraingredients-usa.com
The most recent tariffs proposed by the Trump Administration will place significant burdens on small businesses in the dietary supplement industry, according to the Natural Products Association.
July 31st, 2018
Trump tariffs on natural ingredients hurt small business, consumers, NPA says
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) is urging the Trump administration not to impose tariffs on many of the ingredients used to create natural products and dietary supplements.
July 30th, 2018
Trump Tariffs Will Impose Financial Burden on Supplement Industry, NPA Warns
Vitamin Retailer
The Trump Administration’s proposal to impose tariffs on key ingredients for nutritional supplements and vitamins will cause disproportionate economic harm to U.S. interests and increase costs for small businesses and consumers, the Natural Products Association (NPA) said in a letter to United States Trade Representative Robert E. Lighthizer.
July 25th, 2018
Dietary Ingredients Ensnared in U.S.-China Trade War
Natural Products Insider
“You can go through the exemption process, but there is a backlog there,” said Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), who noted some 2,000 such applications have already been filed. “The government might have to hire more people just to deal with these applications.”
July 24th, 2018
Probiotic and prebiotic studies lack safety data, says review
Nutritional Outlook
A systematic review in the Annals of Internal Medicine says that hundreds of published probiotic and prebiotic studies failed to report important safety data. Industry leaders are expressing disagreement with the findings or at least what they imply.
July 19th, 2018
Trade group advocates to keep skip lot testing option in dietary supplements GMPs
Nutraingredients-usa.com
The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice.
July 6th, 2018
Former FDA Supplement Chief Describes Retailers’ ‘Gatekeeper’ Role
Natural Products Insider
In the last of three short video segments, Daniel Fabricant of the Natural Products Association highlights the “gatekeeper” role of U.S. retailers selling dietary supplements.
June 26th, 2018
FDA says Gottlieb statement does not signal CBD enforcement shift, but some questions unanswered, observers say
Nutraingredients-usa.com
A statement by FDA Commissioner Dr. Scott Gottlieb on the approval of a CBD drug has left some industry stakeholders wondering what the exact implications are for the many CBD products being marketed as dietary supplements.
June 22, 2018
Farm Bill passes House, includes language for vitamin and mineral supplements purchase using SNAP
Nutraingredients-usa.com
Industry celebrates inclusion of vitamin and mineral supplements language in the House’s recently updated and passed Farm Bill. One industry expert said that more work still needs to be done to get similar provisions in the Senate version of the Bill.
June 21st, 2018
Supplements Are Important for Vast Majority of Americans Who Do Not Receive Recommended Nutrients From Diet Alone
Life Extension
Supplements are important for vast majority of Americans, especially children in low-income households, who may not receive the recommended daily nutrients from diet alone. Former FDA official Daniel Fabricant is available for comment following a new report in the journal JAMA Pediatrics.
June 13th, 2018
NPA Joins Group Seeking to Amend Nationwide Labeling Regulations to Eliminate the Prevalence of Various “Unfounded” and “Unwarranted” State-Specific Warning Labels
Nutritional Outlook
Fabricant stated that NPA chose to join the Coalition because “consumers have a right to know what is in the products they use each and every day, especially when it comes to making decisions about taking products to support their health.”
June 5th, 2018
NPA CEO Discusses Regulatory Status of Kratom
Natural Products Insider
In this short video, former FDA official Daniel Fabricant, Ph.D., weighs in on kratom, the popular and controversial botanical.
May 30th, 2018
Meta-analysis finds vitamins, minerals don’t lessen CVD risk
Nutraingredients-usa.com
“It’s well documented, NPA said, that Americans fall short in many key nutrients. It should not be extrapolated that from the narrow analysis of this one study that these ingredients have no health benefits at all.”
May 4th, 2018
NPA CEO Weights in on CBD, Regulatory Risks
Natural Products Insider
“Daniel Fabricant, Ph.D. of the Natural Products Association weighs in on some of the risks associated with selling CBD in dietary supplements.”
April 25th, 2018
A Natural Products Day takeaway: The industry needs to be more active in D.C.
New Hope Network
“Supplements and labeling policies were at the top of the agenda at NPA’s annual Natural Products Day in Washington, D.C.”
April 25th, 2018
2018 Natural Products Day: Keeping Up Appearances at the Capitol
WholeFoods Magazine
“On April 18th, the Natural Products Association (NPA) held its annual Natural Products Day, during which NPA members lobby their representatives and senators on behalf of the natural products industry.”
April 4th, 2018
FDA Orders Recall of Salmonella-Tainted Kratom
Everyday Health
“The salmonella contamination reflects ‘a perfect example of a firm that doesn’t follow regulatory processes,’ says Dr. Fabricant… ‘If a firm doesn’t follow regulatory processes, it’s likely they are going to have quality-control problems.'”
March 22nd, 2018
FDA’s evidence not compelling enough to revoke soy protein heart-health claim, trade groups say
Nutraingredients-usa.com
“‘The FDA is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease ont he label or in the labeling of foods but has failed to perform its own meta-analysis,’ according to a statement made by the NPA.”
March 22nd, 2018
Unsettled political outlook boosts interest in lobby day, NPA says
Nutraingredients-usa.com
“An unsettled national political environment is one rife with opportunity. That’s one reason the Natural Products Association has cited for the strong turnout anticipated for its lobby day, which is set for mid-April.”
April 16, 2019
FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements
Natural Products Insider
Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients.
April 15, 2019
Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’
Nutraingredients-usa.com
As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant.
April 10, 2019
Experts take issue with researchers’ conclusion that supplements don’t prevent death
Nutraingredients-usa.com
Multivitamins don’t extend lifespan, according to the conclusion of a recent population based study. Industry experts countered that the many confounders in the data make that result tentative at best.
April 3, 2019
SSCI Offers Benchmarks As Gatekeepers For Supplements To Reach Retail Shelves
HBW Insight
FDA’s GMP final rule set uniform standards to ensure quality throughout manufacturing, packaging, labeling and holding of supplements, but Supplement Safety and Compliance Initiative says manufacturing practices continue to vary widely across the industry and the agency cannot inspect every facility. “FDA can’t solve all our problems. I don’t know if FDA knows the number of facilities it needs to inspect to ensure consumer confidence,” says Daniel Fabricant, president of SSCI member NPA.
April 2, 2019
NPA on Benefits of Medical Foods for Pain Management
WholeFoods Magazine
Medical foods can play a beneficial role in the management of acute and chronic pain and should be the subject of more research, the Natural Products Association (NPA) said in comments to the U.S. Department of Health and Human Services Pain Management Task Force.
April 2, 2019
Comment period opens on SSCI standards
Nutraingredients-usa.com
The new Supplement Safety and Compliance Initiative standards were formally unveiled by late last week at a meeting hosted by Walmart. The standards now go into a 30-day comment period.
April 2, 2019
FDA schedules public hearing on cannabis
Natural Products Insider
Over the last decade, state and federal lawmakers have increasingly embraced a plant that was long denounced: cannabis. FDA’s challenge is figuring out whether and how to regulate cannabis-containing products–including dietary supplements that contain CBD.
March 29, 2019
FDA, supplement industry eye ways to foster compliance with ingredient notification system
Natural Products Insider
FDA is looking at ways to foster the submission of new dietary ingredient notifications. The notification system, established by law in 1994, may be in need of changes to ensure U.S. regulators have an opportunity to review the safety of new ingredients before they are marketed in supplements.
March 28, 2019
SSCI releases benchmarking guidance documents and opens public comment period
Nutritional Outlook
The Supplement Safety and Compliance Initiative (SSCI) released its new general and technical benchmarking guidance documents today, and opened up a 30-day public comment period for the documents. Retailers that are participating in SSCI and expecting supplements sold in their stores to comply with these guidelines, include Walmart and GNC.
March 21, 2019
NAI trumpets its patent victory as crucial precedent for IP protection in supplements industry
Nutraingredients-usa.com
A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry.
March 15, 2019
Final defendant pleads guilty in Hawaii liver injuries case
Nutraingredients-usa.com
The final defendant in a criminal case arising from a spate of liver injuries in Hawaii has pleaded guilty, according to Reuters.
March 5, 2019
‘Gottlieb’s FDA tenure marked by tremendous progress’: Industry reacts to resignation
www.foodnavigator-usa.com
Stakeholders from the dietary supplements and food industries have been reacting to the resignation of Scott Gottlieb, MD, with many pushing for the Agency to follow through on the key initiatives started during his leadership.
March 5, 2019
FDA Commissioner Scott Gottlieb resigns, dietary supplement industry responds
Nutritional Outlook
FDA Commissioner Scott Gottlieb is resigning from the agency, effective in a month. At the time this story went to press, FDA had not yet released a public statement on Gottlieb’s resignation; however, FDA’s Twitter account posted a snapshot of a memo the Commissioner sent to his FDA colleagues noting that he wants to spend more time with family. Gottlieb has served as FDA Commissioner since May 2017.
February 28, 2019
NPA says ‘arbitrary’ new FDA protein definition could have implications for industry
Nutraingredients-usa.com
NPA has filed a comment on a proposed FDA rule that would define protein in what the organization calls an arbitrary way.
February 4, 2019
Dietary supplement trade groups asks federal appeals court to rehear false advertising case
Natural Products Insider
A controversy before the U.S. Court of Appeals for the Ninth Circuit raises questions as to how judges should apply a fundamental legal principle—”summary judgment”—in false advertising cases.
January 29, 2019
Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts
Natural Products Insider
State Rep. Kay Kahn refiled her earlier bill aimed at forcing retailers to put diet and sports products behind lock and key.
January 29, 2019
NPA: National Standard Needed for Plant-Based Food Labeling
WholeFoods Magazine
NPA has issued comments to the Food and Drug Administration (FDA) urging the agency to adopt a policy of enforcement discretion on standards of identity for products that use dairy names to describe plant-based products.
January 28, 2019
NPA calls for action on state bill that would restrict access to and post health warning on muscle building supplements
Nutraingredients-usa.com
NPA is calling for a grassroots response to oppose a bill in Massachusetts that would put sports nutrition and weight management products behind the counter and mandate the posting of a comprehensive health warning.
January 25, 2019
NPA files amicus brief in Schwabe and Nature’s Way lawsuit to prevent “dangerous precedent” in claims substantiation standards
Nutritional Outlook
NPA filed an amicus brief in the legal case Sonner vs. Schwabe North America, Inc. and Nature’s Way Product LLC being heard by the U.S. Court of Appeals for the 9th Circuit in California.
January 21, 2019
Dumb rules: NPA accuses US FDA of ‘regulatory mission creep’
Naturalproductsglobal.com
Tensions between NPA and FDA continue as the trade group this month accuses the regulator of – once again – actions at odds with the Trump Administration’s stated commitment to cut business red tape.
January 16, 2019
NPA objects to FDA’s proposed data collection for inclusion on export lists
Nutraingredients-usa.com
The Natural Products Association has objected to a proposal by the US Food and Drug Administration that NPA says will result in an expanded sharing of information on US firms with foreign governments. NPA said the proposal lacks transparency and runs counter to stated goals of the current administration with regard to paring back regulation.
January 15, 2019
NPA Submits Comments to FDA Requesting Transparency
WholeFoods Magazine
NPA said in a press release that it submitted comments to the FDA regarding a new proposal to share data collected from U.S. companies with foreign governments. NPA noted that the proposal lacks transparency and is out of step with the Trump Administration’s goals to streamline regulations.
January 11, 2019
Shutdown presents opportunity for industry to highlight self regulatory efforts
Nutraingredients-usa.com
The supplement industry has an opportunity to make a powerful case about its self regulatory capabilities during the interregnum of federal regulatory authority imposed by the budget impasse.
January 5, 2019
NPA Questions FDA’s Lack of Guidance for Dietary Supplements
WholeFoods Magazine
In comments made to the FDA, the Natural Products Association (NPA) questioned why the Agency’s draft guidance for food labeling serving sizes does not provide examples for dietary supplements, according to a press release. The NPA took issue with the fact that no examples were provided for dietary supplements carrying Supplement Facts labels, whether in pill form, liquid form or chewing gum form.
January 4, 2019
FDA supplement industry functions on hold during shutdown; backlog foreseen
Nutraingredients-usa.com
The federal government shutdown has thrown a wrench into the works of the Food and Drug Administration. While food safety might not have been compromised, many of the agency’s more routine assignments are on hold and it may take months to catch up.
January 2, 2019
Arizona proposal to register supplements as non-prescription drugs axed, thanks to efforts of trade organizations
Nutritional Outlook
“Natural products and supplements are safe and under strict regulation by the federal government, and because of that the U.S. enjoys the safest food supply in the world,” said Daniel Fabricant, president and CEO of NPA, in a press release. “Supplements are not drugs and should not be regulated like drugs, because it would raise costs and block access to the products consumers want. We commend the Arizona Board of Pharmacy and other officials for working with us to help Arizonans.”
December 24, 2018
NPA Submits Comments to FDA Regarding GMPs for Cosmetic Products
WholeFoods Magazine
The Natural Products Association (NPA) submitted comments to the FDA outlining a framework for developing Good Manufacturing Practices (GMPs) for cosmetic products, according to a press release.
December 20, 2018
Arizona pharmacy board backs down on plan to regulate supplements like OTC drugs
Nutraingredients-usa.com
A proposal by an Arizona governmental branch to regulate supplements like drugs has been successfully opposed by the American Herbal Products Association and the Natural Products Association.
December 14, 2018
New FDA Dietary Supplement Working Group to examine how effective agency’s existing authority is for regulating supplement industry
Nutritional Outlook
FDA has created a new Dietary Supplement Working Group whose goal is “to take a hard look at what more the FDA can be doing with our existing authorities” to regulate dietary supplements, said FDA Commissioner Scott Gottlieb, MD, this week. Gottlieb made the announcement during a speech he gave on December 12 at the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference hosted in Washington, DC, by the nonprofit organization the Food and Drug Law Institute.
December 12, 2018
NPA Asks to Join Dietary Supplement Working Group
WholeFoods Magazine
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the NPA’s press release that, “While we share the commissioner’s concerns and hope FDA gets serious about bad actors who illegally sell drugs under a dietary supplement label or make false claims, we disagree with his suggestion that more or different rules are needed or that the industry’s outstanding safety record has changed. We’ve urged FDA to get tougher on bad actors and we hope they do that, but in the meantime, they should also lead the discussion on new areas like cannabidiol and other promising natural products, not playing catch-up.”
December 6, 2018
Nutritional Outlook’s 2018 Best of the Industry Awards, Industry Leader: Supplement Safety Compliance InitiativeNew Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutritional Outlook
In recent years, self-regulation has become a key dietary supplement industry priority. While many manufacturers have incredible reputations because of their long history of ensuring quality and safety, it has become clear that the most effective way to earn respect as an industry is to come together as one. That is why Nutritional Outlook is recognizing two self-regulatory initiatives: The Supplement Safety Compliance Initiative (SSCI) and the Global Retailer and Manufacturer Alliance (GRMA).
November 16, 2018
NPA CEO on CBD: ‘Folks need to take the front door with FDA’
Nutraingredients-usa.com
The Natural Products Association’s stance on CBD is to take FDA’s word on the controversial ingredient, until someone takes the front door with the Agency and files an NDI or a GRAS notification with the FDA for CBD.
November 1, 2018
FDA still finding same cGMP deficiencies at dietary supplement facilities
Natural Products Insider
FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.
October 25, 2018
As Chinese import tariffs hit natural products supply chain, retail-level impact looms
New Hope
The latest round of implemented tariffs include many dietary ingredients, leaving the industry seeking exclusions and new non-China sources.
October 18, 2018
NPA expresses support for FDA’s Nutrition Innovation Strategy in public comments
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) has submitted comments to FDA regarding the agency’s “Multi-Year Nutrition Innovation Strategy” released in January 2018. With its new innovation strategy, the agency aims to provide the public with more information that will help consumers make healthier nutrition and lifestyle choices and reduce their incidence of morbidity and mortality. The agency held a public meeting on the topic on July 26, 2018, and extended the public comment period to October 11, 2018.
October 16, 2018
From the Ground Up: Standardization, Regulation, Innovation
WholeFoods Magazine
It’s time to go back to the beginning, all the way to the raw materials. First, there’s the all-consuming issue of tariffs, of what happened, how the industry fought back, and what to do now that the tariffs have passed. From there, we move on to how manufacturers offer all-important transparency, how technology is helping them do it, and the certifications to look for when research fails you. Labeling issues keep popping up, so we’ll go into why your products are—or aren’t—marked the way they are. And then experts will talk about what kind of innovation they see in the near future.
September 27, 2018
SSCI progress includes pilot audits to test standardized tools, redesigned app for farmers
Nutraingredients-usa.com
Progress on the Supplement Safety & Compliance Initiative has included pilot audits and a revamped mobile app for farmers, an executive with one of the groups behind the initiative has said.
September 27, 2018
FDA ups ante in plant ‘milk’ debate: ‘We’re on a fast track to take a fresh look at labeling’
Foodnavigator-usa.com
The FDA has upped the ante in the ongoing debate over the use of terms such as ‘almondmilk’ and ‘vegan cheese,’ with a public request for information to help inform the development of draft guidance to “provide greater clarity on appropriate labeling of plant-based alternatives.”
September 25, 2018
Tariffs Have Been Implemented. What Next?
WholeFoods Magazine
Dr. Daniel Fabricant, president of the Natural Products Association, says that now that the tariffs have passed, the NPA is hoping to get an exclusion process. The first two lists of tariffs had one, but the third list, which affects the industry the most, does not. And while glucosamine and sucralose were removed from the list, it’s still full of items that are vital to all aspects of the natural products industry
September 23, 2018
US hearing: Trump’s tariff plan disrupts companies’ supply chains and hurts consumers
CGTN
As the Office of the US Trade Representative holds a six-day hearing which began Monday on the proposed tariffs on 200 billion US dollars of Chinese goods, dozens of companies voiced concerns that the tariffs are disrupting American companies’ supply chains by raising the costs of raw materials they import.
September 20, 2018
CV Sciences ventures into food space following CBD safety assessment
Natural Products Insider
CV Sciences, a public company, has received self-affirmed GRAS status, demonstrating the safety of its “hemp-derived CBD gold extract.” But FDA could disagree with the assessment, and many regulatory hurdles remain to marketing CBD in foods and supplements, lawyers said.
September 18, 2018
Prepare for the Worst: China-U.S. Trade War Is On
WholeFoods Magazine
The trade war is on. President Trump announced he is ordering 10% tariffs beginning Sept. 24 on the $200 billion worth of Chinese imports on a list released July 10, NPR reports.
The list included a variety of items the American Herbal Products Association (AHPA) and the National Products Association (NPA) listed as necessary for the natural products industry, ranging from amino acids to dried fruits.
August 22, 2018
NPA testifies in tariff hearing, Trump seeks even higher duties
Natural Products Insider
Dan Fabricant of the Natural Products Association told the U.S. Trade Representative tariffs proposed by the Trump administration would have major negative effects on the U.S. natural products and dietary supplement industry.
August 22, 2018
Should FDA create a mandatory product registry for dietary supplements?
Nutritional Outlook
If FDA had a comprehensive, mandatory, industry-wide database of every single dietary supplement product on the market, would such information help regulators as well as industry better police the dietary supplement market? Also, how could FDA create such a registry? These questions are being debated more often as the dietary supplement industry faces more public scrutiny and ongoing discussion about whether the existing regulatory framework for supplements is effective.
August 8, 2018
BASF Awarded NPA Novel Ingredient and Science Award
Global Cosmetics News
BASF has been recognized by the Natural Products Association (NPA) for its naturals portfolio. At the certifying body’s 25th Annual Awards in Las Vegas, BASF picked up the Novel Ingredient and Science Award.
August 3, 2018
Proposed Tariffs Threaten Ingredient Supply Chain For US Supplement Firms
HBW Insight
NPA sounds alarm on Trump administration tariffs on $200bn in Chinese goods scheduled for October. In letter US Trade Representative, NPA President and CEO Daniel Fabricant asks the agency to exempt 57 items from the Harmonized Tariff Schedule that would impact hundreds of dietary ingredients.
August 3, 2018
New Chinese tariffs target $60 billion in US trade; supplements escape for now
Nutraingredients-usa.com
The Chinese government has retaliated in the latest escalation of President Trump’s trade war by releasing lists of new tariffs on US products, the highest of which will reach 25%. Experts worry that the fallout could affect the supplement industry.
July 31st, 2018
NPA to testify against ‘burdensome’ Trump tariffs at hearing in August
Nutraingredients-usa.com
The most recent tariffs proposed by the Trump Administration will place significant burdens on small businesses in the dietary supplement industry, according to the Natural Products Association.
July 31st, 2018
Trump tariffs on natural ingredients hurt small business, consumers, NPA says
Nutritional Outlook
The Natural Products Association (NPA; Washington, DC) is urging the Trump administration not to impose tariffs on many of the ingredients used to create natural products and dietary supplements.
July 30th, 2018
Trump Tariffs Will Impose Financial Burden on Supplement Industry, NPA Warns
Vitamin Retailer
The Trump Administration’s proposal to impose tariffs on key ingredients for nutritional supplements and vitamins will cause disproportionate economic harm to U.S. interests and increase costs for small businesses and consumers, the Natural Products Association (NPA) said in a letter to United States Trade Representative Robert E. Lighthizer.
July 25th, 2018
Dietary Ingredients Ensnared in U.S.-China Trade War
Natural Products Insider
“You can go through the exemption process, but there is a backlog there,” said Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), who noted some 2,000 such applications have already been filed. “The government might have to hire more people just to deal with these applications.”
July 24th, 2018
Probiotic and prebiotic studies lack safety data, says review
Nutritional Outlook
A systematic review in the Annals of Internal Medicine says that hundreds of published probiotic and prebiotic studies failed to report important safety data. Industry leaders are expressing disagreement with the findings or at least what they imply.
July 19th, 2018
Trade group advocates to keep skip lot testing option in dietary supplements GMPs
Nutraingredients-usa.com
The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice.
July 6th, 2018
Former FDA Supplement Chief Describes Retailers’ ‘Gatekeeper’ Role
Natural Products Insider
In the last of three short video segments, Daniel Fabricant of the Natural Products Association highlights the “gatekeeper” role of U.S. retailers selling dietary supplements.
June 26th, 2018
FDA says Gottlieb statement does not signal CBD enforcement shift, but some questions unanswered, observers say
Nutraingredients-usa.com
A statement by FDA Commissioner Dr. Scott Gottlieb on the approval of a CBD drug has left some industry stakeholders wondering what the exact implications are for the many CBD products being marketed as dietary supplements.
June 22, 2018
Farm Bill passes House, includes language for vitamin and mineral supplements purchase using SNAP
Nutraingredients-usa.com
Industry celebrates inclusion of vitamin and mineral supplements language in the House’s recently updated and passed Farm Bill. One industry expert said that more work still needs to be done to get similar provisions in the Senate version of the Bill.
June 21st, 2018
Supplements Are Important for Vast Majority of Americans Who Do Not Receive Recommended Nutrients From Diet Alone
Life Extension
Supplements are important for vast majority of Americans, especially children in low-income households, who may not receive the recommended daily nutrients from diet alone. Former FDA official Daniel Fabricant is available for comment following a new report in the journal JAMA Pediatrics.
June 13th, 2018
NPA Joins Group Seeking to Amend Nationwide Labeling Regulations to Eliminate the Prevalence of Various “Unfounded” and “Unwarranted” State-Specific Warning Labels
Nutritional Outlook
Fabricant stated that NPA chose to join the Coalition because “consumers have a right to know what is in the products they use each and every day, especially when it comes to making decisions about taking products to support their health.”
June 5th, 2018
NPA CEO Discusses Regulatory Status of Kratom
Natural Products Insider
In this short video, former FDA official Daniel Fabricant, Ph.D., weighs in on kratom, the popular and controversial botanical.
May 30th, 2018
Meta-analysis finds vitamins, minerals don’t lessen CVD risk
Nutraingredients-usa.com
“It’s well documented, NPA said, that Americans fall short in many key nutrients. It should not be extrapolated that from the narrow analysis of this one study that these ingredients have no health benefits at all.”
May 4th, 2018
NPA CEO Weights in on CBD, Regulatory Risks
Natural Products Insider
“Daniel Fabricant, Ph.D. of the Natural Products Association weighs in on some of the risks associated with selling CBD in dietary supplements.”
April 25th, 2018
A Natural Products Day takeaway: The industry needs to be more active in D.C.
New Hope Network
“Supplements and labeling policies were at the top of the agenda at NPA’s annual Natural Products Day in Washington, D.C.”
April 25th, 2018
2018 Natural Products Day: Keeping Up Appearances at the Capitol
WholeFoods Magazine
“On April 18th, the Natural Products Association (NPA) held its annual Natural Products Day, during which NPA members lobby their representatives and senators on behalf of the natural products industry.”
April 4th, 2018
FDA Orders Recall of Salmonella-Tainted Kratom
Everyday Health
“The salmonella contamination reflects ‘a perfect example of a firm that doesn’t follow regulatory processes,’ says Dr. Fabricant… ‘If a firm doesn’t follow regulatory processes, it’s likely they are going to have quality-control problems.'”
March 22nd, 2018
FDA’s evidence not compelling enough to revoke soy protein heart-health claim, trade groups say
Nutraingredients-usa.com
“‘The FDA is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease ont he label or in the labeling of foods but has failed to perform its own meta-analysis,’ according to a statement made by the NPA.”
March 22nd, 2018
Unsettled political outlook boosts interest in lobby day, NPA says
Nutraingredients-usa.com
“An unsettled national political environment is one rife with opportunity. That’s one reason the Natural Products Association has cited for the strong turnout anticipated for its lobby day, which is set for mid-April.”