High-Risk Disease Claims Trigger Warning Letter

Any product marketed online is “fair game” for FDA enforcement. In this warning letter, a dietary supplement company was cited for making disease claims. Let’s see what we can learn.

From warning letter. “Bromelain: Has anti-inflammatory properties”

Asa comments: I categorize “anti-inflammatory” as a medium risk claim. In my “Asa risk ladder,” this means it may be mentioned in a warning letter, but it is unlikely to be the sole reason for one, as there are typically higher-risk disease claims present.

From warning letter. “Helps restore vein function and optimal circulation”

Asa comments: Yes, supplements generally should not claim to “restore” vein function or improve circulation in a way that implies treatment of impaired vascular function. That said, this was an interesting claim to include because, on its own, I’d consider it low-to-medium risk compared with more overt disease claims. It was likely included because claims about circulation and vein function can quickly become heart- or vascular-disease-adjacent. Marketers, this is where your regulatory team keeps pushing you back to words like “support” and “maintain.” Little words matter.

From warning letter. “Reduces certain risk factors for cardiovascular disease and lowers the risk of recurrent heart attacks”

Asa comments. This is one of the main reasons for the warning letter, as it is ultra-high risk.  Cancer, depression, and cardiovascular disease are common claims-related warning letters. If the company had used Apex Compliance, it could have identified and addressed these issues before they became problems.

Read the full warning letter.