Washington, D.C., September 20, 2019— The Council for Responsible Nutrition commends Senate Majority Leader Mitch McConnell’s additions to the Senate Agriculture Appropriations bill that provide $2M to FDA to further implement the provisions of the 2018 Farm Bill legalizing hemp-derived cannabidiol (CBD) and that urge the agency to move quickly to develop a legal pathway to market for these ingestible products.
CRN strongly encourages FDA to exercise the statutory discretion provided to it in the Food, Drug & Cosmetic Act to recognize a new legal category of CBD dietary supplements. Despite the general presumption, often cited by FDA, that a dietary supplement may not use an ingredient that was previously on the market or clinically investigated as a drug if the drug was marketed first, FDA has compelling reasons to make an exception in the case of CBD. (In this case, GW Pharmaceuticals has an epilepsy drug, Epidiolex, containing CBD currently approved and on the market.) The strong consumer interest in CBD, the burgeoning market for these products, and the vast differences in dosages between prescription drugs and supplements containing CBD all argue for the quick exercise of that discretion by FDA.
Once that regulatory pathway is created, CRN believes FDA should fully enforce all the legal and regulatory requirements on the books that currently exist for other dietary supplements. These would include the requirements for all new dietary ingredients that their marketers demonstrate the products are reasonably expected to be safe prior to their entering the market. Senator McConnell’s provision for a period of enforcement discretion by FDA will allow firms already marketing CBD products to bring their dietary supplements into compliance and incentivize manufacturers to conduct new research and share their safety data with the agency.
The creation of a clear legal pathway along with strong enforcement by FDA of all requirements for these CBD products is the best way to foster new research around the safety and benefits of CBD and assure consumers of a safe and innovative marketplace.
CRN President and CEO Steve Mister made the following statement further articulating CRN’s position:
“When a marketer puts a Supplement Facts Label on a product, it is a very real promise to obey the rigorous rules policing supplement manufacturers. That means, among other things, that it is adhering to good manufacturing practices, registering its facilities with FDA, giving consumers a manner to report any adverse events, accurately listing all ingredients on the label, and refraining from making illegal drug-like claims.
The instant FDA creates a legal CBD supplement market, there is a well-developed body of law and regulations governing dietary supplements that can and should be enforced. While CRN is always seeking additional resources for the FDA, it won’t take much for the FDA to have a big impact. Several high profile enforcement actions would change the calculation of risk by companies who may be skirting the requirements of the law and can immediately change behavior.
The FDA could literally take this action tomorrow and begin fully regulating the CBD supplement industry, and we implore them to do so. That’s the surest path to safety and innovation.”
Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements, Facebook, and LinkedIn.