Hemp Industries Association responds to FDA warning letters

Hemp Industries Association responds to FDA warning letters

Not-for-profit US organisation, the Hemp Industries Association (HIA) has issued a statement in response to warning letters sent by the US Food and Drug Administration (FDA) to manufacturers of cannabidiol products. The FDA asserted that cannabidiol products may not be marketed as supplements because ‘new drug’ consideration is currently pending.

“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,” said the HIA in a press release. “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.” 

Eric Steenstra, Executive Director of the Hemp Industries Association added, “There is great potential for the CBD market to expand in the US, 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.” 

 

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