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Animal Product Testimonials Lead to Warning Letter

Biomarkers claims elevate enforcement risk

Animal Product Testimonials Lead to Warning Letter

Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements.

Animal product claims seem to have a lower “acceptance level” than human supplements. For example, mentions of “pain” or “anxious feelings” are probably not enough to attract a warning letter for a human product, but these seem to tip the scale into warning letter category for animal products. This, of course, is not the case with this letter, where several very high-risk statements like “kill most urinary infections” are present.

🔷Here are my thoughts on testimonials.
The authorities have been “hands off” in going after companies for third-party user-generated non-compensated reviews, such as those that appear to come through widgets like Trust Pilot. These “protections” go away when the review is engaged with, or showcased such as in a website banner, social post, or on their own review page. This warning letter congregated product reviews on their own page, which means they are curated and are, therefore, marketing.

🔷Here are my thoughts on biomarkers.
In the past, claims about biomarkers such as “lowers LDLs” were not cited in warning letters unless higher-risk words were present. This changed last year when FDA sent warning letters to companies solely based on heart disease-related biomarkers, even when no disease words like “heart disease” were present. I write about this here.
Heart disease-related biomarkers are high-risk, but others, such as creatine or bilirubin, do not seem to attract the same scrutiny. This is what makes this warning letter interesting, and I wonder if there were no high-risk disease words used if FDA would have cited the company simply for statements like “liver levels.”

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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