The letter was signed by the leaders of the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the United Natural Products Alliance.
Products flooding market
The letter notes the 2018 Farm Bill, which has opened the flood gates for hemp growing and processing and for the development of CBD finished goods, specifically preserved the US Food and Drug Administration’s authority to regulate these products. But it also noted that FDA has made it clear that under its rulemaking procedure (which is the same for all federal regulatory agencies), a new regulatory framework for CBD products is at least three to five years away. And this is the expedited version.
Compounding the issue is the oft-noted lack of resources for FDA. The agency, with fewer than 30 full time employees in its main office devoted to the regulation of dietary supplements, was struggling to keep up with the development of the marketplace as it was. Now thousands of CBD products, whose legality is an open question, are inundating the market.
“Given the rapidly growing marketplace of products, it is crucial that Congress take quick action to clarify the legal status of hemp-derived CBD dietary supplements. At the same time, it is equally essential for FDA to have the resources it needs to protect the public from unsafe CBD products,” the letter noted.
Exemption for hemp-derived CBD
The trade associations are advocating that Congress craft an exemption for hemp-derived CBD under the provisions of the Food Drug and Cosmetic Act that govern the use of ingredients in both drugs and foods. The existence of a prior IND on CBD by GW Pharma for its drug Epidiolex is at the moment a logjam for further regulatory action by FDA. The agency has stated that its reading of law means CBD is not a legal dietary ingredient for this reason.
The associations’ advocacy for CBD is specific to “CBD derived from hemp.” The letter states that any new hemp-derived CBD products that are covered by the exemption must meet all of the requirements that other dietary ingredients do.
“To be subject to this limited waiver, CBD would have to be derived from hemp as defined by the 2018 Farm Bill, and any dietary supplement containing hemp-derived CBD must fully comply with applicable requirements for new dietary ingredients under the FDCA. Importantly, these products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims,” the letter states.
The associations’ letter also notes that while a recent appropriations bill specifically sets aside an additional $2 million for FDA to address CDB issues, more needs to be done.
“We urge Congress to go even further to include substantial new resources to enable effective FDA oversight of this fast-growing category, including funding for efficient and timely review of new dietary ingredient notifications and enforcement of existing laws governing the safety, manufacturing, and labeling of dietary supplements containing CBD. We urge that you work with FDA to determine a level of funding adequate to assure effective regulation of the CBD marketplace that does not detract from other agency enforcement priorities,” the letter states.
Ashish Talati, partner at Amin Talati Wasserman, told NutraIngredients-USA: "I applaud the dietary supplement trade associations for sending the letter to Congress. It is crucial for Congress to act quickly. A targeted legislation that allows CBD in foods and dietary supplements is the need of the hour. FDA can then devote resources to compliance and enforcement."
Steve Mueller, founder of CBD testing and extraction company Mile Hi Labs, said the letter was a very welcome development in the industry. Mile Hi Labs held a grand opening ceremony for its 400,000 square foot manufacturing facility in Broomfield, CO yesterday.
“This is what we’ve been building this whole company for,” Mueller told NutraIngredients-USA.
“Right now, FDA is not holding people accountable. If you go into a pharmacy, you know the products on the shelf are safe to take because they are regulated by FDA. That’s not happening in CBD right now. We make sure we are complying with dietary ingredient regulations. Other companies are not,” he said.
“If they [Congress] can make this change it will be positive for the industry and positive for the consumer,” Mueller added.