Neuropathy-Adjacent Claims Lead To Warning Letter

I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a warning letter unless it is over the top. Instead, FDA tends to take a 10,000-foot view, piecing together multiple claims to form an overall picture of noncompliance. FDA also likes to make examples of companies that are not following the rules, particularly in areas where the agency is focusing its enforcement efforts. This is one reason it is so important to follow enforcement trends and Warning Letter Wednesday. Today’s WLW shows how a combination of “medium-risk” claims and higher-risk claims can collectively create an overall high-risk neuropathy marketing strategy.

The types of claims cited in this warning letter are somewhat common, but FDA likely issued this warning letter because of the risk that consumers will not seek medical help for diabetes and neuropathy, which can lead to serious issues.

From warning letter. “… is a patented formula that is clinically proven to reduce the overall symptoms of occasional burning, tingling, and numbness by ~76%.”

Asa comments: Words like “symptoms” increase the likelihood that it will be categorized as a disease, while words like “occasional” often help distance the statement from disease, as in the example “occasional sleeplessness.” However, it does not allow companies to say whatever they want. I also think FTC and plaintiff attorneys would have a field day with these types of medical + “proven” + quantifiable claims.

From warning letter. “… was founded by … , a Type 1 diabetic driven by his personal quest for relief from nerve discomfort. After years of dedicated research, William developed the unique formula for our flagship product, … You can find … products in the diabetes section of major pharmacies across the country . . ..”

Asa comments: “About Us” stories cross the line into marketing when they imply products can help with diseases. Although these statements are carefully crafted, when combined with the other claims cited in the warning letter, they paint an overall picture of noncompliance.

From warning letter. “targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…” “… burning, tingling, & numbness support.” “Supports damaged and needy nerves.”

Asa comments: These are some of the highest-risk claims in the warning letter. Also, I found the “supports damaged and needy nerves” statement interesting, as it shows that words like “supports” do not let companies say whatever they want.

This is a really interesting letter.