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FDA Issues Warning Letters to Two Companies Selling CBD Products for Pain Relief

By Alexander Beadle

Published: Mar 25, 2021   
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California’s Honest Globe, Inc. and Michigan’s BioLyte Laboratories, LLC, have become the latest in a long line of companies to receive official warning letters from the US Food and Drug Administration (FDA) for the illegal marketing of unapproved CBD-containing drugs.

Honest Globe was warned over four pain relief products it had available for sale via the company’s website, which were advertised as including CBD. The warning letter issued to BioLyte Laboratories referenced the sale of one pain relief cream that had been marketed as including “rejuvenating CBD.”

The letters sent to both companies also highlighted other non-CBD related complaints, regarding poor quality control and poor testing practices respectively, that were discovered during FDA inspections.

The two firms now have until April 7 to provide a written response to the FDA outlining how they will address these violations.

CBD products for pain relief legally classed as drugs

The CBD products at the center of this most recent round of warning letters were advertised as providing pain relief, as well as a number of other beneficial therapeutic effects, such as reducing inflammation and feelings of anxiety.

From a legal perspective, the products were clearly marketed as intended for use in the treatment and/or prevention of some kind of ailment. As per the Federal Food, Drug, and Cosmetic Act, these products would thus meet the general definition of a drug.

Any over-the-counter drugs must be approved by the FDA or meet special requirements for marketing without an approved drug application, regardless of whether the product contains CBD. As CBD-containing products are not classed as “generally recognized as safe” and have recognized pharmacological activity, CBD-containing drugs blanketly do not meet the requirements for such an exemption, and so have to be specially approved by the FDA.

To date, the only CBD-containing drug approved by the FDA is a prescription drug meant for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome.

“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, in a statement. “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.”

As the CBD-containing pain relief products sold by Honest Globe and BioLyte Laboratories were classified as CBD-containing drugs, the FDA saw fit to issue warning letters against both companies. The letters give the firms 15 working days to respond to the FDA with how they intend to fix the marketing and other violations listed in each warning letter, with failure to do so possibly resulting in legal action.

FDA continues to focus enforcement efforts on unsubstantiated health claims

The 2018 Farm Bill effectively legalized the production and sale of hemp-derived CBD products. However, the legislation also delegates the regulation of these and other hemp-derived cannabinoid products to the FDA.

The current FDA stance is that it is “unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” Essentially, while hemp-derived CBD products are legal, CBD-infused foods and products marketed as drugs or dietary supplements are not.

However, the federal agency does appear to be willing to consider sensible reform to its CBD policy. The FDA is in the process of exploring pathways that would allow for CBD to be legally marketed as a dietary supplement and is actively planning several CBD-focused research projects.

In the meantime, the federal agency has focused its enforcement actions towards companies that make unsupported health claims relating to CBD in their products.

“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. “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.”

In order to avoid receiving an FDA warning, companies are advised to refrain from making and medical claims, expressed or implied, about their CBD-containing products.


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