Biomarker Claims Enforcement
When will FDA go after “Nature’s Ozempic” claims
Making biomarker claims about dietary supplements has some risks, and here I explore enforcement trends to be aware of.
In recent years, the FDA has increased scrutiny of biomarker-related claims, especially those linked to serious health conditions like heart disease and diabetes. A significant shift occurred in 2022 when the FDA began issuing warning letters for claims that were previously considered risky but not ultra-high risk. These include statements such as “lowers LDLs,” “lowers cholesterol,” and even “lowers bad fats” without the use of higher-risk terminology like “hypertension.”
Other biomarker claims that have been cited include “lowering A1C levels and blood sugar,” which implies an effect on diabetes management, and “reducing arterial plaque,” which suggests an influence on preventing cardiovascular disease.
Interestingly, while FDA has cited heart health-related biomarker claims, there have not been notable warning letters related to C-reactive protein (CRP) or other inflammatory biomarkers. FDA seems to generally take a “hands-off” approach regarding discussions of inflammatory biomarkers, as long as no explicit disease claims are made. This suggests that while some biomarker claims may fall into the grey area, companies should use caution and keep up to date on enforcement trends to avoid crossing into disease claim territory. One hot area to watch is GLP-1 claims, which, when combined with claims such as “Nature’s Ozempic,” may be enough for a warning letter.
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