Ingredient Benefits, Clinical Studies, & Blogs Lead to Warning Letter

Comparing a supplement product to a drug is a quick way to attract FDA attention. In this warning letter, the company compared turmeric, an ingredient in their product, to the effectiveness of NSAIDs (such as aspirin). Although, in many cases, it may be true that supplements can work better than drugs without side effects, these statements do not belong in compliant marketing. Below is the statement cited in the warning letter. The use of disease words like “inflammation” and “pain” and the reference to clinical studies added to the risk of scrutiny. Instead, sticking with statements about an ingredient’s soothing properties and quality of life statements such as “feel ready to go hiking” can be a lower-risk marketing strategy.
👉From warning letter. “….are a great option for those looking for a natural alternative to over-the-counter pain relievers. In fact, studies show that turmeric is just as – if not more – effective in reducing inflammation and joint pain than NSAIDs.”

🔷This company already received a warning letter last December, which I write about here. It seems FDA deleted the December warning letter and reissued it recently, as the person named in the original warning letter was not part of the company at that time.

🔷There are several references to clinical studies in this warning letter. Implying that an ingredient or product has supporting clinical data, such as “studies show” statements, can lead to increased scrutiny, especially from FTC and plaintiff attorneys. Here’s a post about “clinically proven” claims.
👉From warning letter. “2016 study showed that taking a high dose of 1000 mg of curcumin each day for an average of 8-12 weeks helped reduce inflammation and joint pain.”

🔷Blogs are commonly referenced in warning letters, and this company crossed the line from education to marketing by talking about ingredients they sell. Even if there is no cross-linking, simply mentioning an ingredient in a disease context, such as a “Thyme is a strong antimicrobial that can help promote relief,” can elevate warning letter and litigation risk. I see companies making this mistake all the time.

There is a lot more to this warning letter, including numerous GMP violations. See my previous post about this, or read the full warning letter here. 

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.