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Testimonials & Video Claims Lead To Warning Letter

“Arthritis” claims elevate risk

Testimonials & Video Claims Lead To Warning Letter

The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. If the company had cleaned up its website before the last FDA website review, it probably could have avoided this warning letter. Do your teammates ever ask you what happens if you receive a warning letter? I made a one-minute video about this.

Testimonials are cited in the letter. Third-party non-curated, non-compensated, honest reviews are unlikely to be scrutinized, but they become marketing when used to sell products. This includes:

“Liking” or “saying thanks” on a social post
Interacting with a product review
●Showcasing a product review

This company has a page specifically for testimonials which makes them curated, which is marketing. →From warning letter. On your Testimonials page: “I prefer …  over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.”

As we have discussed before, claiming a supplement is better than drugs is a quick way to irritate FDA and attract a warning letter.

No GMP manufacturing claims are cited in this letter, which means they are probably doing a good job making the product, but they have crossed the compliance line with their marketing claims. If interested in talking about the nuances of marketing compliance, I would be happy to meet for 30 minutes at no charge. I am here to (try to) help!

YouTube claims are cited again in this warning letter. This is the third FDA warning letter that mentions YouTube videos this year. Are you interested in seeing the others? You can search old Warning Letter Wednesday posts by keyword here. This is intended to be an ongoing resource for your regulatory and marketing teams.

Claims about “pain” are cited in this warning letter. While it is unlikely a company would receive a warning letter without higher-risk words like “arthritis,” occurrences of “pain” do elevate the overall likelihood of agency action. Did you know that “arthritis” is the most common “itis” in warning letters? If accurate, replacing “arthritis” with “joint discomfort” can help to lower risk.
→From warning letter. “… is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.”

I’m writing this #WarningLetterWednesday post as I fly to Vitafoods in Geneva, where I am speaking about US supplement regulations and marketing best practices. Let’s meet if you are in Geneva!

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.

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