FDA warns on unapproved CBD products marketed for pain relief

FDA warns on unapproved CBD products marketed for pain relief


The Food and Drug Administration issued a warning to two companies selling over-the-counter products labeled as containing cannabidiol (CBD) without receiving the agency’s approval to do so. The agency has accused the companies, identified as Honest Globe Inc. and Biolyte Laboratories LLC, of violating the Food, Drug and Cosmetic Act (FD&C Act).

Currently, the FDA has only approved one prescription drug containing CBD that is designated for the treatment of seizures associated with several syndromes.

Honest Globe Inc. and Biolyte Laboratories LLC received warning letters from the FDA. 
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In the letter sent to Honest Globe Inc., the FDA said the company is selling “ELIXICURE ORIGINAL PAIN RELIEF with CBD)” (roll-on and pump versions) and “ELIXCURE LAVENDER PAIN RELIEF with CBD” (roll-on and pump versions) which are “misbranded drugs” that cannot be legally marketed without an approved new drug application, regardless of whether the CBD is presented on the labeling as an active ingredient or an inactive ingredient.

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Biolyte Laboratories LLC was warned on it’ “(b)(4) Silver Gel,” “(b)(4) Silver Gel with Aloe,” “(b)(4) Silver Liquid Supplement,” “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream,” and “(b)(4) Magnesium Oil Spray.”

“Your “(b)(4) Silver Gel,” “(b)(4) Silver Gel,” “(b)(4) Silver Gel with Aloe,” “(b)(4) Silver Liquid Supplement,” “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream,” and “(b)(4) Magnesium Oil Spray” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body,” the FDA warned.

The companies will now have 15 days to state how they will address the violations they stand accused of, or provide reasoning and supporting information as to why they believe the products are not in violation of the law.

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“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” Amy Abernethy, M.D., Ph.D., FDA principal deputy commissioner, said in the March 22 notice. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”



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