Learning targets: Old social media posts, hashtags, sketchy ingredients, and high-risk claims
Hashtags can make compliant posts very non-compliant
#WarningLetterWednesday contains old social media posts, claims made in hashtags, sketchy ingredients, and high-risk claims.
🔷Old social media posts containing claims is a strong enforcement trend, but the ages of the posted cited in recent letters are more aged than the standard 2-3 years. I recently wrote about a 2014 re-tweet being mentioned in a letter here.
👉This letter includes Facebook posts from 2016. Wow, the FDA is digging deep into the company's social media, and this is an enforcement trend. Guess what, I made a "helpful hints" video about this.
➡️ From warning letter.
June 2, 2016 (Facebook) post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.”
Hashtags are claims and this is a great example of how a company has taken a relatively lower risk post and made it high risk with a high risk hashtag. Here is a video on this topic.
➡️ From warning letter. On your February 27, 2017 (Instagram) post: #anxietyrelief” and “MOOD ELEVATION -ENHANCED SLEEP- HEIGHTENED FOCUS”
🔷I am unsurprised this letter contains the high-risk words anxiety and depression. Anxiety products claims enforcement was up 95% in 2021, and 75% of those warning letters had both anxiety and depression, a one-two compliance punch. It is important to remember this includes all online marketing, and these are pieced together for one picture of noncompliance. Here is a video and post about anxiety claims enforcement.
👉Insomnia claims are also mentioned in the letter which I have also written about here. These darn companies need to read Warning Letter Wednesday.😁
🔷There are some surprisingly low-risk structure-function claims cited in this warning letter. In my opinion, these are "secondary addition" claims that are not likely to attract a warning letter on their own. It is, however, interesting to see what the FDA considers a claim worthy of a warning letter "call out."
➡️ From warning letter.
..Product packaging: • “Stress Reducing • Mood Boosting”
Also worth mentioning is the use of phenibut, which the FDA does not consider a dietary ingredient.
🔷Read the warning letter here.
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