Avoid Comparing Products to Drugs (most of the time)

Comparing supplements to drugs is a great way to irritate FDA and attract a warning letter.

In today’s Warning Letter Wednesday, I am exploring Criterion #6, “Claims to be a substitute for a product that is a therapy for a disease.” This criterion shows the FDA’s thinking on why products marketed as alternatives to prescription drugs may be disease claims.

I often discuss 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!

From FDA Guide. “A claim that a product is a substitute for a drug or other therapy for disease, or has fewer side effects than a therapy for disease, is an implied disease claim. Such claims carry with them the clear implication that the dietary supplement is intended for the same disease treatment or prevention purpose as the therapeutic product.”

Asa Comments. FDA pays extra attention to drug comparison claims when the ramifications of not taking that drug can have serious consequences, such as heart disease and depression medications. Here is an example from a warning letter. ” Numerous double-blind studies have shown that 5-HTP has equal effectiveness compared to drugs like Prozac, Paxil, and Zoloft (SSRI’s).”

From FDA Guide. “However, if a dietary supplement claims to be a substitute for a drug that is not intended to treat or prevent disease (i.e., a drug intended to affect the structure or function of the body), the claim comparing the drug and the dietary supplement would not be a disease claim.”

Asa Comments. I have to be honest. I don’t think I’ve ever read this portion of this criterion, which clarifies that not all drug action comparisons may be a deal breaker. The key point here is not to use disease terminology. Here are some possible examples.

Possible allowable structure-function claim. “Ginger-Plus calms the stomach as effectively as Dramamine so you can enjoy the ride. without drowsiness.” If substantiated, this may be allowed since motion sickness is not a disease, according to the FDA preamble.

Example of how it would cross the line into a disease claim. “Stops nausea like prescription anti-vomiting drugs.”