Honest Globe Inc. and Biolyte Laboratories LLC have marketed pain relief products that the FDA is calling unapproved new drugs.
Honest Globe was warned in a letter that its facilities do not conform to current good manufacturing processes (cGMPs), making its drug products adulterated under the FD&C Act. The company also sells “Elixicure Pain Relief with CBD” products, available to consumers for purchase without a prescription; FDA’s letter to the company states that the products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of the FD&C Act, and that the products are misbranded drugs introduced or delivered for introduction into interstate commerce. The company made claims regarding the use of CBD for pain relief on its website, in product brochures, on its CBD FAQ page, and on social media. Honest Globe cited information National Institute of Health, which FDA called out as a claim.
While Honest Globe listed CBD as an inactive ingredient on product labels, the letter from FDA states that “the product labeling clearly represents CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effect in the diagnosis, cure mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.” However, even if CBD were an inactive ingredient, the products would still need an approved drug application to be legally marketed, as they don’t conform with the general requirement in FD&C Act that inactive ingredients must be “safe and suitable,” while CBD has “known pharmacological activity with demonstrated risks” and “no known functional role as an inactive ingredient in a finished drug product.”
Additionally, Honest Globe issued a press release available on the company’s Instagram that states that Elixicure’s OTC drug registration has been certified by FDA “following a successful year-long process.” FDA points out that drugs are subject to listing with FDA, not registration, and that 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… The assertion of ‘certified registration with FDA’ and ‘FDA registered’ status in conjunction with your products misleadingly suggests that your ‘Elixicure Pain Relief with CBD’ products are approved or endorsed by FDA in some way when this is not true,” which constitutes misbranding.
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BioLyte Laboratories, which makes silver products and pain relief products, was warned for “significant” violations of cGMP regulations, as well as for misbranding a variety of products. On the company’s website and product packaging, BioLyte claims that its Silver Gel product is “Used as an antimicrobial to help treat minor skin wounds, burns, infections…” and that the product is “Useful for wounds, burns, bandages, and more… topically used against infections… topically used against several skin conditions (Hives, Rashes, eczema, diaper rash).” The Silver Gel with Aloe product includes claims such as “Silver Gel is used to resolve a wide variety of skin problems” and lists “recommended uses” such as “wound care,” “diaper rash,” and “fungal infections.”BioLyte also offers a pain relief cream. FDA listed phrases regarding the ingredients such as “Arnica… It is known to reduce swelling and decrease pain” and “Hypericum… treat wounds on the skin and improve tissue generation” as claims. The letter also appears to cite reviews for the company’s Magnesium Oil Spray as claims, listing phrases such as “after using the magnesium spray, for the first time in years, I finally have relief from the persistent pain I’d wake up to in the mornings.”
BioLyte faces many of the same charges as Honest Globe, as well, with regards to two products that are labeled to contain CBD as an inactive ingredient.
Both letters can be found in full here.
“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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in a press release from FDA. “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.”
