FDA’s Authority, the NDI Process, and CBD
March 23, 2021
Daniel S. Fabricant, Ph.D.
Across the country, things are beginning to feel like they are getting back to normal. It certainly feels like business as usual in Washington, DC, especially for the multi-billion-dollar CBD marketplace and the Food and Drug Administration’s (FDA) failure to create a regulatory pathway for it.
For more than four years, the Natural Products Association (NPA) has been asking the FDA to set a safe level of daily consumption for CBD products. Instead of taking real substantive action, the FDA has slapped a few companies on the wrist for making false claims, while leaving the bulk of the regulatory work to the states, with 24 states introducing proposals to regulate the CBD industry’s manufacturing, testing, and labeling of products at the state level.
While many states have stepped up where the feds have fallen short, that has not stopped proposals in Congress from moving forward that would do more harm than good when it comes to safely regulating CBD.
One proposal supported by some industry groups, including the Council for Responsible Nutrition (CRN) would play right into the hands of critics who wrongfully claim that the dietary supplement industry is unregulated.
While CRN claims to be moving CBD legislation, the truth is that this bill lacks the support of House and Senate leaders who are concerned about undermining the authority of DSHEA and FDA.
The proposal, called the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (HR 841) would create an end-run around DSHEA and the new dietary ingredient notification process – basically the entire regulatory framework of the nutritional supplement industry – while doing nothing to ensure that we have a science-based regulatory process for consumers and the industry alike, and that’s not responsible.
CRN has also inaccurately argued the FDA lacks the authority to set a safe level of consumption for CBD, claiming the agency:
“doesn’t get to decide in advance of a product coming to market what is safe level of use. That’s one of the fundamental tenets of DSHEA.”
Factually, this is completely wrong. This ignores the NDI process, a fundamental statutory tenet of DSHEA that specifies that data has to be provided to FDA on safety of a new dietary ingredient 75 days prior to going to market. For those unfamiliar with the law, it can be viewed here.
More interesting is that CRN recently submitted a citizen’s petition asking the FDA to set a safe level of daily consumption. CRN’s citizen petition states that:
“its own assessment of the publicly available scientific literature and, based on a conservative view of the literature available, proposed a safe amount of up to 40 mg CBD per day.”
It’s not responsible and likely hypocritical for an organization to state it’s not about a safe level to then submit what they believe a safe level is to the regulator? Also, if they were so against efforts to distinguish a daily amount for foods and dietary supplements, why did they provide FDA their own? Additionally, what if a company has specific safety data supporting a level of 100 mg a day, how does this level they established take that into consideration, as there is no apparent data call incorporated into that citizen’s petition.
We, as an industry have to be responsible, scientifically and factually regarding CBD. The fact of the matter is until a CBD bill addresses safety, it will never be taken seriously. FDA said as much when they provided technical assistance on the bill when it was introduced, and subsequently wasn’t advanced in the last congress.
NPA will stick to our core values and principles as it pertains to CBD, being factually accurate and scientifically sound. NPA continues to lead the way on CBD from having the first amendment to pass the House on setting a safe level for CBD to playing a role in the more than 24 state bills on establishing a safe threshold for CBD. It’s bigger than CBD, in the past year NPA was responsible for making sure the industry was deemed essential and stayed open, through our work the industry was listed in the CISA guidelines as essential, we secured legislation from Senator Cramer to expand access to supplements through Health Savings Accounts, ensured supplements are accurately labeled through our work with the Coalition for Accurate Product Labeling, defeated misguided state proposals and supported state proposals exempting supplements from sales and use tax.
The State of California vs Natural Products (Again)
February 23, 2021
Daniel S. Fabricant, Ph.D.
California just became the latest state to introduce legislation that would restrict access to dietary supplements. That makes them the third state this year to propose this sort of action either requiring them to be placed under lock and key or put behind the counter, like cigarettes.
Every day it seems as if another significant industry is leaving California, which is probably part of the reason why the state is facing depleted tax revenues and a $54 billion budget deficit, and we won’t even bring up Prop 65. Our industry has a massive presence in the state providing over 50,000 jobs and over half-a-billion in state tax revenue. Californians’ know and trust our products to be apart of their daily health routines.
Yet, despite this and lawmakers in Washington exploring ways to expand access to supplements, whether through expansion of Health Savings Accounts (HSAs) to include supplements, by members of congress recognizing the benefits of vitamin D intake and encouraging the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to issue guidance on vitamin D intake for elderly and immunocompromised individuals during the ongoing pandemic, the California state legislature is looking to punish responsible retailers and manufacturers. In fact, their proposal is so extreme the penalties are more severe than selling cigarettes or alcohol to a child.
Let me say that again, the proposed fines would be $1,000 dollars for failing to restrict access to a supplement, compared with a $200 and $250 dollar fines respectively for selling alcohol or cigarettes to minors. Selling dietary supplements shouldn’t be a crime.
We know some people don’t want their business to be involved with politics, however, politics (like it, or not) is ALWAYS involved in your business. This is why if you’re not a member of NPA, there has never been a more critical time to join the industry’s oldest and largest trade association. Joining NPA provides you with the opportunity and resources necessary to defeat out-of-touch proposals and be a part of the preventative health care solution. For instance, our members have worked tirelessly with our team to provide broader access to supplements through social programs like SNAP and WIC and tax-savings accounts like a Health Savings Account over the last year.
When you join a trade organization, you expect them to provide you with services that elevate your voice within the industry and elevate the industry’s voice with regulators, lawmakers across all levels of government, and the media. Keeping businesses open and thriving, that’s the best return on investment.
Speaking for Natural starts with us. In 2020, NPA members sent over 20,000 personal messages to federal, state, and local officials in support of the natural products industry. Their support of the industry helped defeat dangerous proposals that like this one. The result has been congressional action and recognition by leaders in Congress that natural products play a significant role in our everyday lives to stay healthy. It’s time to join a team that has and will continue to be the voice of the industry, it’s time you explored membership opportunities with NPA. Thank you to those of you who are members, together we will continue advocating for a more accessible marketplace.
Please go to this link for more information about membership benefits and joining NPA.
Strengthening State CBD Laws Amid FDA Purgatory
February 4, 2021
Daniel S. Fabricant, Ph.D.
CBD is everywhere; even industry giants like Molson Coors are looking to cash in on the craze. Yet, the regulatory environment has remained murky. To date, CBD remains illegal as a dietary ingredient. Despite the illegality, the Food and Drug Administration’s enforcement has been tied to companies selling products claiming to treat medical conditions.
The lack of enforcement from the FDA has left industry in a purgatory. Left waiting are the companies who have established integrity by providing their consumers with safe and reliable products. All while consumers canvas the CBD market trying to determine which products are legitimate.
The dietary supplement industry has worked hard to ensure consumers are getting the safest and most reliable products in the world. We have worked with state and federal regulators to bring the CBD market up to speed and establish an appropriate regulatory pathway for CBD as a dietary ingredient.
Inaction by the nation’s leading public health agency has left industry hamstrung. However, a glimmer of solace can be seen at the state level. At least 21 states currently allow the sale of hemp and CBD as a food or dietary supplement, including in New Hampshire, where we provided the committee with written testimony. While many states such as Florida, Ohio, Texas, and California have introduced or passed legislation, other states like Maryland have aligned with FDA’s position that CBD is not legal in food or dietary supplements.
In the wake of states establishing their regulations and standards guiding the industry, Congress should mandate that the FDA establish the Hemp Food & Supplement State Safety Cooperative Program (HFSSSCP). Modeled after the FDA’s State Milk Safety Cooperative Program, the HFSSSCP would establish a dosage recommendation based upon readily available data and develop an official analysis method for hemp-derived CBD products. This program would strengthen current state laws by protecting consumers from potentially unsafe or poor-quality CBD foods and supplements. Additionally, implementing these regulations would serve as the uniform standard for testing foods and dietary supplements that purport to contain CBD.
A program such as this would delineate both the FDA’s and the state’s responsibilities, all while standardizing controls over CBD in foods and supplements. As states continue to develop their standards, the FDA must assist state regulatory agencies in preventing adulterated products from coming to market. Programs such as this would provide the industry with the guidance we so desperately desire.
Modernizing How We View Our Health
February 2, 2021
Daniel S. Fabricant, Ph.D.
Over the last year, we have become increasingly aware of the importance nutrients play on our immune systems. A recent study in the American Journal of Clinical Pathology revealed people who have low levels of vitamin D are at higher risk of contracting COVID-19 and suffering more severe illness. The researchers also found vitamin deficiency upon admission to the hospital resulted in 3.7-fold higher mortality rate of individuals with the disease, regardless of other risk factors.
The findings from this study aren’t a new revelation, in fact, several studies have been published citing a connection between vitamin deficiency and COVID-19 mortality. At a time when consumers are acutely aware of the importance of nutrition, consumers should be able to utilize savings accounts, like Flexible Spending Accounts, Health Savings Accounts, and Health Reimbursement Accounts, to pay for expenses related to their health and wellness.
These savings accounts are set up by an employer for an employee and allow enrollees to contribute a portion of their regular earnings to pay for qualified expenses related to medical costs. These pre-tax dollars can be used for things such as bandages, feminine hygiene products and crutches. However, vitamin supplements such as vitamin-D, vitamin-C or zinc are not eligible for purchase without a prescription.
North Dakota Senator Kevin Cramer’s bill S.4463 from last Congress would modernize the treatment of vitamins like vitamin-D so consumers would be able to use their HSA/FSA/HRA. If legislators are serious about promoting healthy choices and lifestyles, then supporting this legislation for re-introduction in the 117th Congress is a must.
Legislation like this, provides consumers with greater choice, promotes healthy lifestyles, and encourages consumers to take preventative measures when it comes to their health. It comes at no cost for government all while modernizing how we view our health, especially the concept of self-care.
Per the WHO – “Self-Care is what people do for themselves to establish and maintain health, and to prevent and deal with illness. It is a broad concept encompassing hygiene (general and personal), nutrition (type and quality of food eaten), lifestyle (sporting activities, leisure, etc.), environmental factors (living conditions, social habits, etc.) socio-economic factors (income level, cultural beliefs, etc.) and self-medication”
Committing to self-care (Nutrition) will preserve your ability to rise to the challenge of this time. As we return to a new normal, we cannot overlook the damage done to America’s physical and mental health during this pandemic, therefore we are all are forced to care more for ourselves, and that will only come to fruition by having greater freedom in the marketplace by removing the barriers to make choices for self-care.
Senator Cramer’s legislation is a great first step. However, there must be more leaders in Washington who will take the initiative to not just support this legislation but bring it up for a vote. Be sure to write your senators and representatives in the US house demanding they take the necessary steps here.
New Year, Same You
January 6, 2021
Daniel S. Fabricant, Ph.D.
A Happy New Year to all of the fine folks out there that occasionally hang in this corner of the internet. You might have noticed that it has been a little quiet over here. We’ve been fighting for the industry to ensure that businesses like yours can stay open and serve millions of Americans that are turning to products you sell to support their health during the pandemic. The federal government acknowledged that we are essential, and we have fought in every single state in the country to keep your doors open.
We’re starting the year off right and planning to get this blog up and running again. Because New Year, new me, new content, right? But unfortunately, we’re seeing more of the same old bad ideas out of the state legislature in New York.
Just this week, a bill was introduced in the NY state legislature that would ban the sale of nutritional supplements like protein powder to minors, placing unnecessary burdens on small businesses, and driving people to online retailers while brick-and-mortar stores like yours are fighting to stay open.
We’ve fought similar proposals like this before, we’re already fighting this one, which is why you belong to NPA (and if you read the blog – become a member, no one likes freeloaders) but why does this seem to become an annual (or depending on the state legislative session, biannual) rite of passage for the industry?
Why do legislators think it’s a good idea to attack our industry, especially now with all the goodwill surrounding our efforts and the science on ingredients like vitamin D, Zinc, and so many other Americans are using to stay healthy? We’re unsure why, but what we do know is that we need you as an industry, and as a member of NPA to take action and let lawmakers know that proposals like these are unacceptable.
When we see proposals that burden small businesses, or create programs serving only narrow interests, including the narrow interests of politicians, we have an obligation to speak up. If you have never contacted any of your elected officials (Federal, State or Local) about your role in the industry and the good you or your company does, we’ll make it easy for you. Click here to take action today.
Unless of course you’ve already given up hope on your resolutions for 2021.