FDA Hits CBD Cos. With Warning Letters for Pain Relief Claims

Bucking the trend towards legalization of CBD products, the FDA issued Warning Letters to Honest Globe, Inc. and BioLyte Laboratories, LLC this month, for claims that their CBD products can be used for pain relief. 

CBD products exist in a gray area of U.S. law and regulation.  On one hand, the sale and distribution of CBD derived from the hemp plant is legal under the USDA’s 2018 Farm Bill, so long as it contains less than 0.3% delta-9 tetrahydrocannabinol (“THC”) on a dry weight basis.  On the other hand, however, the status of CBD products under FDA regulations is unclear. Pursuant to the Food, Drug and Cosmetic Act, the FDA can examine, seize, and prevent the sale and distribution of CBD oil and related products that do not comport with FDA regulations.  While there is a movement within the FDA to classify certain CBD products and uses of such products as safe, the FDA has issued several warning letters to companies that manufacture and sell CBD products based on misbranding and adulteration.  The FDA is cracking down on what it believes to be deceptive marketing claims, namely, any claims that the product can treat, prevent or cure a disease. 

The March 2021 Warning Letters to Honest Globe and BioLyte Laboratories take this approach one step further by classifying generic claims of “pain relief” as inappropriate health claims, rendering the products “unapproved new drugs” rather than dietary supplements.  The Warning Letters are summarized below, and available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honest-globe-inc-597177-03152021 (Honest Globe, Inc.); https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biolyte-laboratories-llc-603584-03182021 (BioLyte Laboratories, LLC).

Honest Globe

The FDA leveled Unapproved New Drug charges, among others violations, at Honest Globe, related to the labeling of its CBD products.  Specifically, the FDA found that Honest Globe marketed the CBD products as if they were drugs, rather than dietary supplements. 

Examples of the offending claims included the following:

• Elixicure is the world’s first CBD-infused over the counter (OTC) topical pain relief cream product
• What are the health benefits of CBD? . . . Benefits of activating the CB1 receptors may include: relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more.
• Your Endocannabinoid System (ECS) plays an important role in keeping your internal processes stable. According to the National Institute of Health, introducing external cannabinoids like CBD into the ECS could be useful in treating a variety of medical ailments, including pain and inflammation.

Notably, the FDA also examined Honest Globe’s social media, and found problematic claims on its Instagram account, including “Did you know that Elixicure was the first over-the-counter CBD-infused topical pain cream product to receive FDA certified registration. Our all natural plant-based ingredients, like organic menthol, are strong enough for even your toughest pain….”  The FDA concluded that these claims “clearly represent[] CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effect on the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.”

BioLyte

The FDA also leveled misbranding charges at BioLyte, finding that it made inappropriate health claims about its Therapeutic Pain Gel and Pain Relief Cream CBD products, rendering those products unapproved new drugs.  The offending claims included the following:

• For temporary relief of occasional: . . . minor aches and pains of muscles and joints associated with simple backache - arthritis – bruises - strains
• A gentle, clear, odourless, 97% natural pain relief gel for skin irritations, bruising, soreness, muscle strains, back pain, knee pain, and arthritis-related pain
• Pain Relief Cream with (b)(4) rejuvenating CBD . . .Uses . . .For temporary relief of occasional: . . .minor aches and pains . . .Stiffness of muscles, joints and tissues

FDA found that BioLyte’s products could not be labeled as homeopathic drugs and did not meet the requirements for marketing without an approved application because they contain CBD.

Honest Globe and BioLyte must respond to the Warning Letters stating how they intend to address the violations or explain why their products do not violate the law.  Failure to adequately address the violations or support their legality could result in an injunction against the companies or seizure of their CBD products by the FDA. 

Key Takeaways for Industry

Through these two Warning Letters, the FDA made clear that CBD companies cannot get around drug approval requirements by labeling CBD as an “inactive” ingredient because “an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage.  CBD, however, has known pharmacological activity with demonstrated risks.”

The key takeaway for industry here is that labeling or marketing CBD products for pain relief may convert those products from lawfully marketed dietary supplements to unapproved and, hence, illegal drugs in the eyes of the FDA.  These two Warning Letters pose potentially far-reaching consequences for those in the CBD retail business.  It is worth noting, however, that both companies had multiple red flags, including failure to comply with the FDA’s current Good Manufacturing Practices (“cGMP”) and mislabeling certain products as “FDA registered,” thus increasing the chances of landing on the FDA’s radar. We will be monitoring the FDA’s next steps closely.  Stay tuned for future updates.