FDA Warns on CBD Dietary Supplements

July 17, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals

In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added. FDA has further stated that CBD products are outside the statutory definition of a dietary supplement. Finally, an unapproved new drug cannot be distributed or sold in interstate commerce.”

Although the FDA’s comment is not a formal observation, the agency appears to be setting the stage for a potential enforcement initiative against CBD products. Agency actions such as this may be a good signal for any company rushing headlong into the market to pump the brakes and exercise a reasonable amount of caution.

 

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