Best Practices When Making Biomarker and Implied Claims

I often talk about disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the FDA has published the "Small Entity Compliance Guide on Structure Function Claims," which provides a Q&A with 10 criteria to help determine if a statement is a disease claim or a structure-function claim. It's really helpful!

In today's Warning Letter Wednesday, I am exploring Criterion #2, "Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology." This criterion shows the FDA's thinking on why biomarker claims like "lowers cholesterol" are disease claims.

👉From FDA Guide. "Some claims imply disease treatment or prevention because they are so intimately tied to a disease. For example, "inhibits platelet aggregation" or "reduces cholesterol" are such characteristic signs or symptoms associated with stroke and cardiovascular disease and interventions to treat those diseases that any claim about them would be an implied disease claim."

🔹 Asa Comments: This is where FDA shares insight on why biomarker claims like "lower LDLs" are disease claims. They also use heart disease examples, which highlight why most of the biomarker warning letters involve cardiovascular-related claims. I write more about this here in a post from 2022, and the enforcement trends have continued.

👉From FDA Guide: "Other signs or symptoms are associated with a wide range of disease and non-disease states and do not necessarily imply an effect on a specific disease. For example, although "improves absentmindedness" might imply treatment of Alzheimer's disease and "relieves stress and frustration" might imply treatment of anxiety disorders, both of these signs also are characteristic of non-disease states. So, if there is no context linking them to a disease, they would be appropriate structure/function claims."

🔹 Asa Comments: This shows how context matters and how structure-function claims can cross the line into disease claims. For example, in the FDA's "improved absentmindedness" example, if there was an image of a confused elderly person, this would elevate the likelihood of it being an Alzheimer's claim.

🔹 🔹 We've all seen the "maintain cholesterol levels already within a normal range statement, and this is where it comes from. The key takeaway here is being "absolutely clear" when making disease-adjacent is a safer strategy. Of course, I am just talking about FDA guidance here and this doesn't stop retailers like Amazon from unnecessarily flagging keywords like "cholesterol levels" which can lead to delisting. Retailers are increasingly tuning into "another regulatory group" to be aware of.

👉From FDA Guide. "There are many conditions that are "normal," but under certain circumstances are also disease claims. The rule states that such claims (for example, maintaining normal cholesterol levels) may be appropriate structure/function claims and would not imply disease if the claim made absolutely clear that the claim is referring to structure/function claims that are already normal. This context would remove the inference to an effect on a structure/function that was abnormal (for example, "maintain cholesterol levels that are already in the normal range")."

👉From FDA Guide. "The standard focuses on whether the labeling suggests that the product will produce a change in a set of one or more signs or symptoms that are characteristic of the disease. You can meet this standard using technical or layman's language and it isn't necessary that every possible sign or symptom is used."

🔹 Asa Comments: This section focuses on implied claims such as an EKG symbol, "lowers bad fats," or statements like "I never had to see my cardiologist again." Before-and-after pictures of an older person who no longer has mobility issues also apply here. In practicality, implied claims are somewhat less likely to attract regulatory issues because they may not contain "trigger words," but avoiding them is a good idea.

Read FDA's Small Entity Compliance Guide on Structure Function Claims here. This is a great resource! 

DATE ORIGINALLY POSTED: 4/9/25

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.