Clinical Study Names Can Be Marketing Claims
Use caution when using scientific literature to sell products
This is a bizarre one. It involves a functional mushroom and herbal company that received a warning letter for claims made in clinical study and other citations in the “Newspaper” tab of its website. Typically, citations are not mentioned in warning letters unless they are explicitly used to sell products, such as in the body of a product-oriented blog.
Let’s review a little deeper. I looked at the Wayback Machine and many of cited claims in this warning letter hyperlinked to external documents or PubMed studies. In many cases the simply linked study names without qualification and did not overtly tour their ingredients for disease prevention. However, on this “Newspaper” page some product images and ads were in close proximity to the cited claims. Here’s the Wayback link for all my regulatory geek detectives out there.
From warning letter. “Under the “Research on Red Reishi (Ganoderma lucidum) mushrooms” header… “Ganoderma lucidum exerts anti-tumor effects on ovarian cancer cells – International Journal of Oncology – May 2011”
Here’s FDA’s stance on this from the letter. I don’t necessarily disagree with this, but in this letter, it seems like a rigid inprepretation.
From warning letter. “Your website includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.”
To be fair, FDA inspected the company and issued a Form 483. According to the warning letter the company did not properly respond to the 483, which is probably the primary reason for this letter.
From warning letter. “We have reviewed your response to the FDA Form 483, dated June 13, 2025, and find it does not adequately address the violation. In your response, you stated that you (b)(4). However, you did not provide documentation to support that those changes to the label have been made.”
Apex Compliance has received Meta permission to review nearly any business Facebook account without authentication, a huge unlock, and we are finding “forgotten” disease claims on many reputable brands Facebooks accounts. I looked at this company’s Facebook (and website) and found a lot of very high risk marketing claims that seem more relevant than the study citations. I’m surprised FDA didn’t cite these.
Read this warning letter.
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