NPA Submits Comments for the Record
WASHINGTON – As the Food and Drug Administration (FDA) continues to defy mounting requests from the US Congress and the natural products industry to provide science-based and public health regulations for CBD, more states are rushing in to fill the vacuum. The State of Hawaii recently joined Virginia and Texas in proposing new state regulations for consumable hemp and CBD products.
NPA has been the leader in asking the FDA to regulate CBD since 2017, has testified on a number of occasions, and has held several meetings with top FDA officials on the issue. NPA also helped craft legislation passed by the U.S. House of Representatives that provides resources so the FDA can perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the U.S. are considered illegal by the federal government.
“While it is good that more states realize the public health risk of completely unregulated products in the marketplace, this is creating the regulatory nightmare and patchwork approach that is the worst of all worlds. This is a federal regulatory issue, FDA needs to do its job, and they need to do it now. Further delay by FDA is not good for public health or for the CBD industry, because the best approach is one uniform national standard based on sound science that is enforceable,” said NPA Director for Government Affairs Kyle Turk.
Official NPA comments on the Hawaii proposal can be found here.
The bill, HB 2102, introduced in the Hawaii State Legislature, would:
- Establish a hemp processor registry for hemp-derived products that consists of labeling and independent laboratory testing to ensure products do not contain contaminants unfit for human consumption;
- Prohibit hemp processors, distributors, and retailers from making unwarranted health claims of their hemp derived products;
- Prohibit the sale or furnish of any hemp product to a person under twenty one years of age;
- Prohibit the sale, hold, offer, or distribution for sale of any hemp-derived products designed to be appealing to children;
- Require these products to be properly labeled to be legally allowed for sale in the State;
- Require certain warning statements to be placed on the packaging of hemp-derived products; and
- Appropriate funds into the Hawaii hemp processing revolving fund.
New developments related to CBD are also providing policymakers with more urgency to act:
- The UK’s Food Standards Agency recently set deadline for the CBD industry to provide more information about CBD products and their contents. It also advised vulnerable groups not to take CBD, and healthy adults to take no more than 70mg a day.
- The Food Safety Authority of Ireland (FSAI) recently recalled various CBD foods and food supplements due to unsafe levels of delta‐9‐tetrahydrocannabinol (THC).
- A new study from Cornell University revealed that high THC levels in hemp may be more likely due to genetics than growing conditions. During the research, the team also learned that as many as two-thirds of the seeds they obtained of one hemp variety – which were all supposed to be low-THC hemp – produced THC above the legal limit of 0.3 percent, underscoring how risky is it for farmers to grow the plant.
- A recent Freedom of Information Act (FOIA) request filed by NPA for CBD inspection data revealed that the FDA had only inspected four firms that manufactured CBD and only tested three CBD products for THC. There are over 1,500 products that contain CBD on the market.
- The Department of Transportation recently warned workers about using CBD, saying Federal employees could still lose their jobs if they test positive for THC.
Recent NPA Actions on CBD:
- NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform an HHE and is leading a grassroots effort urging the Senate to act.
- In 2019, NPA published a poll that shows 70 percent of registered voters believe FDA should have already established safety standards for CBD products.
- On May 31, 2019, NPA testified at the FDA’s first public hearing on CBD.
- On March 14, 2019, NPA submitted official comments to the FDA concerning approaches to CBD regulation that will also help facilitate the discussion.
- On October 24, 2018, NPA sent a letter to FDA asking for regulatory leadership on CBD products.
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Natural Products Association
The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 650 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.npanational.org.