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Q2 FDA warning letter roundup with Asa Waldstein

July Top 10
In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements.

Each quarter, I provide updates on notable FDA warning letters. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional and dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which I review here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends.

Company LinkedIn posts and hashtags: In the past, a few FDA warning letters mention claims made on a company’s LinkedIn page, but this is the first example I’ve seen where FDA cites specific posts. It shows FDA is monitoring posts on LinkedIn, which are “fair game” for enforcement. In this warning letter, the company shares an article or study and then adds a Covid hashtag, an easy way to attract attention. The company also elevates risk by including a hashtag with its product’s name. This demonstrates how simply adding a hashtag can increase the likelihood of a warning letter and is an important reminder to ensure all social media team members are trained in compliance. I expect to see more LinkedIn posts cited in warning letters as well as claims made on TikTok.

GMP inspections lead to website review: Any supplement manufacturer that has been subject to an inspection for compliance with cGMPs (current good manufacturing practices) knows the investigator reviews their website before the visit. FDA sometimes inspects a facility, then, up to 11 months later, conducts a website and social media review. Disease claims found in these reviews lead to warning letters that also mention previous inspection observations. The lesson is any company who’s been visited by FDA in the past year should again take a close look at its online material to ensure it is compliant. I write about some of these warning letters here and here.

Blocking unfavorable product reviews: This company was fined $4.2 million for allegedly blocking negative reviews under a proposed settlement with the Federal Trade Commission (FTC). This case involves a proposed fine (not a warning letter) in connection with an administrative complaint against an online fashion retailer rather than a supplement company. Still, it’s a good reminder that the supplement industry can learn from other government agency actions. Here are the learning targets.

In related warning letters to companies offering review management services, FTC expressed its concerns when firms take inappropriate steps to avoid collecting or publishing negative reviews. “Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally.”

The proposed settlement with the online fashion retailer included exceptions to the “post all product reviews” rule. This is excellent information, as I did not know reviews containing unrelated issues such as shipping may be blocked. Per FTC’s press release announcing the proposed settlement, the company “must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns.”

Below are some additional trends to keep a close eye on.

Blogs: This year, claims made on blogs have been referenced in five warning letters, including this letter that included claims made in a blog from 2018. In my Q1 warning letter roundup, I discussed the FDA enforcement trend of citing claims made in old social media posts. This trend seems to have carried over to blogs. The critical takeaway here is any marketing—even those multi-year-old blog posts—can attract the attention of regulators. I suggest re-reviewing or archiving old posts to ensure they don’t lead to a warning letter.

Sharing articles and research: As discussed in the “CBD update” section below, companies sharing articles and research easily blur the line between education and marketing intent. FDA and FTC are paying closer attention to this. I always suggest a “gut feeling check” to determine if a reasonable consumer would think sharing the information implies product benefits.

CBD update: After news of cannabinoids and Covid preliminary studies were publicized, many companies incorporated this research into their product marketing. Unsurprisingly, this resulted in agency action. In March, FDA and FTC sent seven joint warning letters to CBD companies, citing Covid research and corresponding articles on their commercial websites. These warning letters provide additional insight into FDA’s view on sharing articles and research on commercial websites and social media accounts.

Sharing information that discusses the disease benefits of an ingredient such as CBD, when a product containing that ingredient is being sold, can result in a warning letter, especially when high-risk words such as Covid are used. Marketers must ensure their content writers understand the everchanging enforcement environment and run all content by in-house or out-of-house regulatory teams before posting.

Follow #WarningLetterWednesday on LinkedIn and Twitter for weekly updates on interesting warning letters.

Asa Waldstein is a certified clinical herbalist and a 20-year dietary supplement executive who has helped oversee three FDA inspections with no 483s. He is principal of the consulting company Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. Waldstein is the founder and host of Asa’s Regulatory Education Series, a free educational platform focusing on GMP (good manufacturing practice) compliance, enforcement trends and marketing tips for the supplement and hemp industries. He also chairs the American Herbal Products Association’s (AHPA) cannabis committee. Learn more and contact him at asawaldstein.com.

 

 

 

 

 

 

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