Hemp Industries Association Responds to FDA Warning Letters Regarding Mislabeling of Cannabidiol (CBD) Products
19 Feb 2016
Washington, DC – Hemp Industries Association (HIA), the non-profit North American hemp trade association, has published its statement in response to recent warning letters sent by the Food and Drug Administration (FDA) to manufacturers of CBD products, regarding mis-labeling of drug claims on said products. Available on the FDA website, the letters explain that per the Federal Food, Drug and Cosmetics Act, CBD products may not be marketed as drugs, meaning manufacturers cannot make claims regarding CBD products’ efficacy in the cure, mitigation, treatment or prevention of disease. Furthermore, the FDA asserts that cannabidiol products may not be marketed as supplements, because ‘new drug’ consideration is currently pending for CBD. To view these letters in their entirety, dated February 4, 2016, please visit:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/.
It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’ As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending ‘new drug’ approval by the FDA. Though none of the companies in receipt of these warning letters are current or former HIA members, the HIA urges these CBD product manufacturers to revise their product labeling and marketing such that no medical claims are made.
“There is great potential for the CBD market to expand in the U.S., but we need to move forward as an industry on a path that defines cannabidiol products as dietary supplements, much like multi-vitamins and herbal products,” said Eric Steenstra, Executive Director of the Hemp Industries Association.
Unlike FDA approved pharmaceutical drugs, which are new compounds developed and patented by drug companies and go through rigorous clinical trials before reaching the market, and can only be administered with a prescription; cannabidiol is a botanically derived, floral extract that exists organically in nature. The Dietary Supplement Health and Education Act of 1994 explicitly defines ‘supplements’ as an extract of a botanical. As such, the HIA maintains that CBD products are indeed supplements, and that attempts by the FDA, or other agencies, to discourage lawful manufacturing and marketing of these products demonstrates unjust bias toward the hemp industry.
To read the HIA’s joint statement regarding best practices for labeling and manufacturing of medicinal cannabis and hemp products, please visit:
http://thehia.org/HIAhemppressreleases/3236544.
Original press release: http://www.thehia.org/HIAhemppressreleases/3832489
