Warning Letter Archives - Green Market Report

Debra BorchardtMay 9, 2022
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7min10940

Last week, the Food & Drug Administration (FDA) sent out warning letters to five cannabidiol (CBD) companies for Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The companies receiving the letters were  Kingdom Harvest, Delta 8 Hemp, ATLRx Inc., BioMD Plus and M Six Labs Inc. The FDA reviewed all of the company’s websites and said the following:

The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).

The FDA also zeroed in on the Delta-8 aspects saying:

FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.

The FDA also took issue with bringing “products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).”

Mostly the FDA was concerned with companies making unsubstantiated claims about the products.

COVID Claims

The FDA noted that the Kingdom Harvest website said, “Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19.” The FDA says if a company makes a claim like this then the product is a drug and has to have the appropriate testing in order to make that claim. The FDA wrote, “These products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”

Farm Animals

The FDA was also concerned in its warning letters that CBD products were being offered to farm animals that could produce a food products for humans. The FDA wrote,

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5).

Cancer Claims

In addition to Covid claims, the FDA noted in its letter to Delta-8 Hemp that the company was making cancer claims. That letter highlighted a comment from the company’s website that said, “Delta-8 is known to be successful in many cancer treatments.” The FDA told the company, “Your Delta-8 THC products for humans are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). ”

Mental Health

While many CBD companies suggest that the product helps anxiety, some of the companies in the latest batch of warning letters went even further. There were suggestions that it could help people suffering from schizophrenia and Alzheimer’s based on very small studies. The FDA is concerned that some patients would stop other medications and use these instead.

No Information

Of course, since the FDA hasn’t set any guidelines for CBD products, the companies aren’t able to introduce any information regarding dosage. The FDA complains the companies aren’t labeling the products correctly, but also won’t allow the companies to express these descriptions.

The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.


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