Hemp Industries Association Responds to FDA Warning Letters

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Washington, D.C. – In response to the U.S. Food and Drug Administration’s (FDA) warning letters regarding mislabeling, the Hemp Industries Association (HIA), the non-profit North American hemp trade association, put out a statement underscoring their position that cannabidiols (CBDs) can be marketed as dietary supplements, not only as pharmaceutical drugs.

According to the FDA website, eight letters were issued on February 4, 2016 to manufacturers of CBD products, regarding mislabeling of drug claims. In each letter, the FDA states the Federal Food, Drug, and Cosmetic Act was violated due to products being established as a drug with the intent “for use in the cure, mitigation, treatment or prevention of diseases.”

The letters also stated CBD products are excluded from the dietary supplement definition under the provision, “if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”

While none of the companies that were issued a warning letter are current or former HIA members, HIA released a response establishing that “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.”

HIA also pointed out in its response that since CBDs are “botanically derived, floral extracts that exists organically in nature,” under the Dietary Supplement Health and Education Act of 1994 (DSHEA), CBD products are indeed supplements. The group did state, however, that unsubsantianted health claims should be removed from supplement product labels.

“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 multivitamins and herbal products,” said Eric Steenstra, executive director of the Hemp Industries Association.

Published on WholeFoods Magazine Online 2/19/2016