The FDA said in a statement that the products that are the subject of the warning letters have not gone through the FDA drug approval process and are considered unapproved new drugs.
The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The companies are Honest Globe and BioLyte Laboratories.
The letter sent to Honest Globe referenced the products “ELIXICURE ORIGINAL PAIN RELIEF with CBD” (roll-on and pump versions) and “ELIXICURE LAVENDER PAIN RELIEF with CBD” (roll-on and pump versions) (hereinafter referred to as “ELIXICURE PAIN RELIEF with CBD” products). The “ELIXICURE PAIN RELIEF with CBD” products were labeled as containing cannabidiol (CBD) and require no prescription.
The letter reads, “Your “ELIXICURE PAIN RELIEF with CBD” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your “ELIXICURE PAIN RELIEF” products are misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 502(a), 502(ee), and 301(a) of the FD&C Act, 21 U.S.C. 352(a), 352(ee), and 331(a).” The FDA also said that although CBD was listed as an inactive ingredient in the labels of the “ELIXICURE PAIN RELIEF with CBD” products, the product labeling clearly represented CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Ultimately an inactive ingredient should not exert pharmacological effects.
In addition to the marketing, Honest Globe was cited for production issues. The letter stated, “Your Quality Unit (QU) lacked control over your topical over-the-counter drug manufacturing operations and failed to ensure that you had adequate procedures. In your response, you committed to working with your contract laboratory to investigate the cited OOS results and future OOS results. Your response is inadequate because you did not address your responsibilities to investigate potential manufacturing deficiencies that may have led to the OOS results. Your response also failed to evaluate batches with OOS test results that had been distributed and were still within expiry.”
Honest Globe also got itself in trouble with claiming its products to be registered with the FDA. “To state that any drug product is “FDA registered” is inaccurate; drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed.”
Biolyte Laboratories LLC was the other company that received a letter. The company made medical claims about its products. Examples given were “Silver Gel,” – used as an antimicrobial to help treat minor skin wounds, burns, infections . . .” “Silver Gel” – “USEFUL FOR WOUNDS, BURNS, BANDAGES, AND MORE . . . TOPICALLY USED AGAINST INFECTIONS . . . TOPICALLY USED AGAINST SEVERAL SKIN CONDITIONS (Hives, Rashes, eczema, diaper rash).”
“Based on the above labeling claims, your products “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream,” and “(b)(4) Magnesium Oil Spray” are drugs intended for use as external analgesics. We are not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream”, or “(b)(4) Magnesium Oil Spray” are generally recognized as safe and effective (GRASE) for use under the conditions suggested, recommended, or prescribed in their labeling.”
The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.
The FDA said in a statement that the products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There have been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers to claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.