5 Years of Warning Letter Wednesdays

5 years of WLW posts! I appreciate you!

For five years, every week, I’ve written this newsletter. We plan our Tuesday dinners around this post, as we always know that Tuesday night, I’ll need a few quiet hours to research and write WLW, so the dinners (I am the cook) should be easy. This post gives me the opportunity to dig deep into enforcement trends, and this learning has helped inform the fine-tuning of Apex Compliance and some of the Supplement Advisory Group consulting questions I receive. WLW has also led to numerous speaking opportunities, interesting conversations, colleagues, friends, and pretty sweet swag (get a free sticker here).

Five years ago, I wrote my first WLW, and I did not expect to still be writing it every Wednesday five years later. After 260 consecutive weeks, one of the most interesting things has been watching enforcement trends change in real time.

Years ago, I spent a lot of time writing about obvious disease claims such as anxiety, insomnia, inflammation and COVID claims. It’s been fun to watch the metrics, such as in 2021, anxiety-related FDA warning letters increased about 95% over the previous year.

Then came CBD. In 2022, there were 20 CBD-related FDA warning letters by June alone. I remember predicting that the excitement around CBD and COVID research could lead to enforcement. Not long after, I wrote 7 CBD Companies Cited for Implied COVID Claimswhich highlighted how citing studies for marketing and using disease hashtags can lead to trouble. https://warningletterwednesday.com/7-cbd-companies-cited-for-implied-covid-claims/

Back then, CBD-related enforcement was common, but today, CBD warning letters are rare.

But the compliance net has also become much wider. A post that stands out to me was 6-Year-Old Social Media Posts & Hashtags in Warning Letter, which was a good reminder that old social media posts are considered active marketing.

Over the years, I have written about FDA, FTC, and NAD citing:

Etsy and LinkedIn posts

Hashtags

Product tags and metatags

YouTube videos

Affiliate and MLM distributor claims

Amazon and Walmart marketplace activity

Before-and-after imagery (understanding net impression is an essential part of marketing compliance)

Testimonials

TikTok Shop (woo hoo)

AI-generated quality documents (this was a fun one)

So many GMP issues

Five years ago, I thought mostly about website claims and GMP issues, but today, the website is only one small part of the marketing ecosystem.

One of my biggest takeaways from writing WLW is that regulators have become increasingly sophisticated at understanding the total marketing context.

A company does not necessarily need to say, “This product treats a disease.” The product name, image, testimonial, mechanism of action, study title, hashtag, affiliate post, and before-and-after photo can create the net impression.

Another change has been that enforcement follows cultural trends.

Five years ago, it was CBD and COVID, but more recently, I wrote GLP-1 Product Receives Warning Letter, involving claims around Ozempic, GLP-1 agonist action, and clinical proof, and although there are not many GLP-1-related warning letters, there are many class action lawsuits about this.

I have since written about semaglutide sold as “research use only,” TikTok Shop, and illegal online sales of ketamine. I even wrote a Warning Letter Wednesday with the takeaway that blaming the AI agent is not a defensible compliance strategy, which I did not see that one coming in 2021 (smiles).

The products have changed, but some of the regulatory “greatest hits” do not go out of style, such as poor specifications, incomplete 483 responses, disease claims, GMP issues.

One of the reasons I enjoy writing Warning Letter Wednesday is that I learn something nearly every week. Sometimes the most interesting warning letters are not the outrageous ones, but the quiet ones where the FDA appears to leave a clue about a shift in enforcement priorities.

My goal with WLW has never been to call out companies or write exposés. That just isn’t my style. The goal has always been to educate and, hopefully, raise the tide of compliance, and to help companies see an issue in a Warning Letter Wednesday post before it becomes their warning letter, lawsuit, or retailer problem.

Five years and 260 Wednesdays later, I am grateful to everyone who reads, comments, disagrees, sends me warning letters, pictures of OTT marketing, and tells me, “You should write about this one.”

I ask you:

What Warning Letter Wednesday post or enforcement trend do you remember most?

And what do you think I will be writing about five years from now?

What would you like me to write about?

Thank you for being part of this Wednesday tradition!