On March 22, the FDA released a warning that said that several OTC products were being illegally marketed as pain medication containing cannabidiol (CBD), as they are unapproved by the administration. “The FDA has not approved any OTC drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application,” the statement says. “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.” And for more warnings on OTC meds, If You’re Taking This OTC Medicine More Than Twice a Week, See a Doctor.ae0fcc31ae342fd3a1346ebb1f342fcb The FDA sent warning letters to two U.S.-based manufacturing companies it says violated the Federal Food, Drug, and Cosmetic Act by selling CBD-containing OTC pain products: Honest Globe and Biolyte Laboratories. According to the letters sent by the FDA, Honest Globe sold several products labeled as “Elixicure Pain Relief with CBD,” and Biolyte sold CBD-containing products labeled “Therapeutic Pain Gel” and “Pain Relief Cream.” “Currently, a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient,” the FDA letter to Honest Globe states. The FDA says it has requested “written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law.” And for more up-to-date information, sign up for our daily newsletter. The FDA says 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.” And since these products have not been evaluated by the FDA, the administration cannot say whether these products are effective for the uses the manufacturers claim. The administration has previously sent warning letters to other companies that were illegally selling unapproved CBD products, which included claims that CBD could “prevent, diagnose, mitigate, treat, or cure various diseases.” The administration says that they cannot determine “what an appropriate dose might be” for the OTC products sold by Honest Globe and BioLyte Laboratories. Nor could they determine how these products “could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns,” since they have not yet been evaluated. And for more medication risks, If You’re Taking Tylenol With This, Your Liver Is in Danger, Experts Say. FDA Principal Deputy Commissioner Amy Abernethy, MD, says the FDA has only “approved one drug containing CBD as an ingredient,” which is a prescription drug for the treatment of seizures. Any OTC product claiming to include this ingredient is not FDA-approved and “may have dangerous health impacts and side effects,” according to the agency. “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 her statement. “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.” And for more from this administration, If You Have This Sauce at Home, Throw It Away Now, FDA Says.
