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FDA sends 7 Cardiovascular Disease Related Warning Letters

FDA sends 7 Cardiovascular Disease Related Warning Letters

Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was cited for this and also for commenting on a post. I suggest companies fight the urge to engage with disease-related comments.

From warning letter.  “Yes, it really works! my bad cholesterol drooped by 60 pts . . .” You endorsed this testimonial by responding, “That is amazing Jon! Thank you for sharing.”

A key takeaway from this group of seven letters is talking about lowering blood pressure, lowering cholesterol, or even mentioning lowering LDL or “bad fats” can lead to a warning letter. Heart disease-related claims have always been top of mind for FDA, but I found some of the “mid-risk” diagnostic claims, such as “LDL reduction,” surprising. I encourage everyone to review their heart products to ensure there is no mention of these types of statements. This signals FDA’s concern that these claims may encourage consumers not to use cholesterol-lowering and other heart disease medication.

FDA news release. “Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition.

Claims made in a company’s Amazon storefront were cited in two of these letters, and statements made on platforms like Amazon and Walmart continue to be cited in warning letters. Now is an excellent time to review all marketing material, including the “forgotten” content on Amazon, to ensure there are no implied cardiovascular disease claims.

Nine warning letters mention claims made on YouTube this year, demonstrating that videos are marketing claims and are, therefore, fair game for enforcement. In warning letters that mention videos or social media, there is always a statement like “this links to a website where customers can order products.” This is the link to commerce and establishes the “commercial bridge.” Read more about YouTube claims enforcement

From warning letter. (2:57-3:08) “Now next is Hawthorn Berry [an ingredient in your BPS-5 product]. Used in traditional Chinese medicine for thousands of years, Hawthorn Berry is a popular ingredient used to fight back against blood pressure, blood disorders, and heart disease.”

Product names are considered claims, as seen in this recent warning letter. I agree “Cholesterol” is regarded as a claim, but it is not as blatant as other product names, such as “Anxiety support.”

From warning letter. “The product’s name (iwi Cholesterol) is an implied claim that it reduces cholesterol.” Discussing ingredient benefits is considered marketing in the eyes of FDA. Here is a video about this. 

From warning letter. “Garlic powder [an ingredient in CholestAid] has been found to help your body reduce high cholesterol.”

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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