For NIE Magazine’s feature article, “Washington and the Natural Industry,” we asked Steve Mister, President and CEO, Council for Responsible Nutrition (CRN), Washington, D.C., www.crnusa.org the following question:
The FDA’s very confusing statements about hemp and CBD have many wondering what is the long-term future for CBD, hemp and other hemp-derived compounds. How should retailers approach stocking CBD products in particular? Can they reasonably include CBD/hemp tinctures, salves and supplements in their product plans for 2019 and 2020? If so, why? If not, why?
Here is his response:
“FDA is clear that the agency considers CBD to be prohibited for use in dietary supplements or food. However, CRN is concerned that the marketplace has exploded around FDA from lack of enforcement, and the agency needs to move quickly to find a legal pathway to market for CBD.
CRN is advising both members and retailers that FDA has been unequivocal in its decision and they should not take any comfort in the fact that FDA has not prosecuted companies, except for the ones who are making claims. FDA has been clear that it does not have an official enforcement discretion policy, the agency is only prioritizing their enforcement actions and going after low hanging fruit, like disease or cancer claims.
However, there is nothing to suggest that FDA is not looking at other products. In fact, CRN is urging FDA to look at CBD containing products marketed as supplements and vigorously enforce other supplement requirements against those products separate from whether or not they contain CBD.
The agency must assure that CBD containing products comply with the law for whatever regulatory lane they are swimming in. If a CBD containing product is marketed as a dietary supplement, contains a dietary supplement statement of identity on the label, or carries a Supplement Facts box, the marketer of that product has implicitly signaled to FDA and to consumers that it should be held to the regulatory framework for dietary supplements.
Retailers should understand that if a product has a Supplement Facts label, it should be sure that it is compliant with all the other supplement regulations. For example, this means the product should be made in a facility registered with FDA, and subject to GMP inspection, the label should comply with all general regulations for supplements, the marketer should have an adverse event reporting system in place, any structure-function claims should be noticed to FDA and all CBD-containing supplements should be treated as new dietary ingredients, subject to notification. Hemp is not the only issue here. If a product is marketed as a dietary supplement, the product better act like a dietary supplement.”
