FDA warns against 'unapproved CBD products' touting arthritis pain relief
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The FDA has issued warning letters to Honest Globe Inc. and Biolyte Laboratories LLC for allegedly illegally marketing unapproved, over-the-counter drugs labeled as containing cannabidiol, or CBD, for arthritis and other pain indications.
“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,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a press release. “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.”
The FDA warning letter to Honest Globe, based in Santa Ana, California, specifically targets the company’s “Elixicure Original Pain Relief” and “Elixicure Lavender Pain Relief” products, both of which are labeled to contain CBD and claim to relieve pain related to arthritis, muscle strains, cramps, back aches and tendonitis.
In the letter, dated March 15, 2021, the FDA alleged that these products are unapproved new drugs that are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Meanwhile, in its letter to Biolyte Laboratories, in Grand Rapids, Michigan, the FDA branded the products “Silver Gel,” “Silver Gel,” “Silver Gel with Aloe,” “Silver Liquid Supplement,” “Therapeutic Pain Gel,” “Pain Relief Cream” and “Magnesium Oil Spray” as unapproved new drugs. The letter, dated March 18, 2021, also alleged that the products were misbranded under the FD&C Act.
Among the named products from Biolyte Laboratories, “Therapeutic Pain Gel” and “Pain Relief Cream” are labeled to contain CBD, according to the FDA. Both products, as well as the company’s “Magnesium Oil Spray,” claim to relieve pain related to arthritis and other causes.
“Although CBD is labeled as an inactive ingredient in the labels of your ‘Pain Relief Cream’ and ‘Therapeutic Pain Gel’ products, the labeling for these products clearly represent CBD as an active ingredient,” according to the letter to Biolyte Laboratories. “For instance, your product label for ‘Pain Relief Cream’ features the statement, ‘Pain Relief Cream with rejuvenating CBD,’ and the product label for ‘Therapeutic Pain Gel’ features the statement, ‘CBD 560mg.’”
The letter continues: “Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed because the product would not be eligible for marketing under section 505G of the FD&C Act.”
The FDA noted that none of the above products have been subject to its approval process, nor has there been any evaluation of whether they are effective for their claimed uses, what an appropriate dose might be, how they could interact with other drugs or products, or whether they have dangerous side effects or other safety concerns.
The FDA has requested that both companies respond within 15 working days. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction. The FDA has issued several similar warning letters to companies selling unapproved CBD products since 2015.
“OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient,” according to the FDA release.
The single CBD product approved by the FDA is Epidiolex (cannabidiol, Greenwich Biosciences), for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome.
“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,” Abernethy said in the release. “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.”
Perspective
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There is a reason why the Federal Food, Drug and Cosmetic Act exists — and thank goodness it does! Products that claim to treat a medical condition when there is no basis in fact are not only misleading and dangerous but can also be deadly. Unsafe manufacturing processes, low quality ingredients and contaminants hide behind the term ‘dietary supplement’ that claim to be harmless, but how do we really know?
The terms ‘CBD’ and ‘THC’ are often used interchangeably in the mainstream media, but are very different. Patients who are frustrated with their medications’ lack of efficacy may turn to these supplements to get the pain relief they want without telling their health care provider. Drug interactions and harm could result since we have no evidence-based data to support the concomitant use of these products with many of the pharmaceuticals currently used in our practice.
Luckily, the FDA is acting against these illegal products and are holding the manufacturers responsible for the potential risk they pose to the public health. Our focus needs to be on patient education of the potential risks associated with these products. Clearly, CBD and THC products will continue to be of interest to the public and we need to be proactive in securing answers to the most basic questions.
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