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FDA Releases Warning Letters to CBD and Hemp Oil Companies

Last week the Food & Drug Administration (FDA) made public three new warning letters to Cannabidiol (CBD) and hemp oil product companies sent by FDA and the Federal Trade Commission (FTC). FDA has previously targeted cannabis product companies.

The new warning letters are consistent with FDA Commissioner Scott Gottlieb’s recent statements that the FDA will go after manufacturers of CBD products that make health and wellness claims that FDA views as egregious. For example, the CBD companies in question allegedly marketed their products for Alzheimer’s disease, fibromyalgia, inflammation, skin conditions, autoimmune disorders, anxiety, cancer pain, PTSD and depression, to name a few symptoms. These companies are making food, dietary supplements, and cosmetic products, as well as products for pets (CBD for dogs). Some highlights:

  1. One letter specifically calls out a CBD isolate product (blue CBD crystals isolate 1500 mg). Some have advanced arguments that a CBD isolate product is distinguishable from the FDA-approved CBD drug, Epidiolex. But these recent actions indicate that FDA does not agree that a CBD isolate product is permissible to introduce into interstate commerce.
  2. FDA asserts that the products are misbranded, unapproved new human or animal drugs.
  3. FDA says the products are marketed as dietary supplements, but do not meet the definition of a dietary supplement.
  4. FDA cites to posts it views as misleading, as they imply that CBD fights cancer and has an anti-tumor effect.
  5. FDA states that the use of a nutrition facts panel on a CBD oil is inappropriate because the oil is a food to which a drug (CBD) has been added; the Federal Food, Drug, and Cosmetic Act prohibits the introduction into interstate commerce of any food to which a drug has been added.
  6. FTC asserts that it is unlawful under the FTC Act to advertise products that can prevent, treat or cure human diseases unless a company possesses competent and reliable scientific evidence—including human clinical studies—that substantiate the claims at the time they are made.
  7. FTC says that making or exaggerating claims, directly or indirectly, through the use of a product name, website name, metatags or other means without rigorous scientific evidence sufficient to substantiate the claims violates the FTC Act.
  8. FTC cites specific actions that it may take with respect to the products subject of the letter:
    1. A federal district court injunction; and/or
    2. An administrative cease and desist order, which may require the company to pay back money to customers.

Here are the links to the letters:

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About this Author

Marc E. Sorini Alcohol Distribution Attorney McDermott Will law firm
Partner

Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C. office.  He heads the Firm’s Alcohol Regulatory & Distribution Group, where he focuses on regulatory and litigation issues facing the alcohol beverage industry and non-beverage alcohol users.

Marc's alcohol beverage practice covers licensing, labeling, advertising, trade practices, distribution, import-export, formulation and excise taxation.  He has represented alcohol beverage suppliers before federal and state courts, the Alcohol &...

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