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Biomarker Claims Lead to Warning Letter

Expect arterial health claims to be cited in the future

Biomarker Claims Lead to Warning Letter

Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, listing these types of statements is now enough to attract a letter. I write more about this here.

There are other biomarker claims cited in this letter, such as “increased levels of TT3 and TT4," "reduced mean fasting serum glucose," and "promotes arterial elasticity." Keep an eye on your marketing statements relating to arterial plaque and elasticity, as I predict we will see these cited in 2023.

This is a warning to companies making similar biomarker claims, and now is the time to review marketing and find and replace these statements. In the past, biomarker claims were not typically enough for a warning letter, but the “Big 7” cardiovascular letters from November signal a change in FDA’s thinking.

There are other commonly cited higher-risk claims, such as “diabetes” and “depression,” in this letter. The more of these words used in marketing, the higher the likelihood of receiving a warning letter. You may be saying, “these companies should know better,” and in many ways, I agree. However, they may not have understood that mentioning ingredients in blogs or citing ingredient research is considered marketing. These mistakes are all too common and are a sign of companies who don’t understand the nuanced rules of dietary supplement marketing. Educating on these topics is one of the reasons I write Warning Letter Wednesday.

Blogs are mentioned in this warning letter. We are seeing blog titles like this mentioned in recent letters. They help bring traffic to the website but are also clear indications of intended marketing use. In this example, turmeric is in a product sold on the website, which is an implied claim.
From warning letter. “Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?”

To round this letter out, there are statements such as “Reduce Chance of Catching A Cold.” Talking about reducing the duration of a cold, flu, or respiratory infection is off-limits and should be avoided.

Read the full warning letter

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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