The U.S. Food and Drug Administration (FDA) is coming down on companies that it says are selling products containing cannabidiol (CBD) that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Among FDA’s December hot list are two company’s that sell CBD products for pets: G&L Wellness LLC in Wisconsin Rapids, Wis., and NextL3vel Services Group LLC dba This Stuff Is Good for You in Las Vegas.
“The FDA’s first priority is to protect the health and safety of Americans,” Amy Abernethy, M.D., Ph.D., FDA principal deputy commissioner, said in a Dec. 22 statement referring to the agency’s most recent warning letters, two of which were for companies selling CBD products for pets. “Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD. 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 the greatest risk of harm to the public.”
This isn’t the first time the FDA has sent warning letters to companies that it says illegally sell unapproved CBD products that claim to prevent, diagnose, mitigate, treat or cure various diseases in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food, and some of the products were impermissibly marketed as “dietary supplements,” officials noted.
In the case of G&L Wellness LLC, the company’s C Better Daily Pet Formula is called into question. In the warning letter, FDA officials said that the company’s product, an eye drop containing CBD, is an unapproved new animal drug that is unsafe under the FD&C Act.
FDA officials also brought attention to some of G&L Wellness products for human use.
“These products [both human and pet] are especially concerning from a public health perspective because ophthalmic drug products can pose serious risk of harm to humans and/or animals if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result,” officials said in the letter.
The FDA’s letter to Las Vegas-based NextL3vel Services Group LLC dba This Stuff Is Good for You pinpointed the following pet products: reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties) and reLeaves CBD Full Spectrum Tincture (all varieties).
FDA officials also highlighted some of the company’s products for human use.
“The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs,” officials said in a statement. “It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of these unapproved CBD-containing drug products has not been subject to FDA review as part of the human or animal drug approval processes, so it is not known what the manufacturing conditions of, or contaminant levels in these products may be.”
The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction, according to officials.
To read the FDA notice, click here.
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