Q4 2024 warning letter roundup with Asa WaldsteinQ4 2024 warning letter roundup with Asa Waldstein

Each quarter, I provide updates on notable FDA warning letters and enforcement trends. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional or 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.

2024 has been noticeably light in dietary supplement warning letters, and I don’t have a good guess as to why. Dozens of companies continue to make extreme disease claims — such as the treatment, prevention or mitigation of cancer — about their products or ingredients. I expect more regulatory action in the months to come.

My 2025 enforcement predictions:

- A reckoning is coming for companies making over-the-top GLP-1 types of claims. I expect more warning letters such as this and serious Federal Trade Commission action against companies comparing their products to drugs, making disease claims, and implying drastic weight loss potential.

- cGMP (current good manufacturing practices) violations will continue, with a focus on product and ingredient specifications.

Related:Q4 2023 warning letter roundup with Asa Waldstein

- Enforcement of TikTok disease claims and an FTC crackdown on influencers not disclosing a material connection (carryover from last year).

- I expect more cosmetic warning letters for disease claims. Since the Modernization of Cosmetics Regulation Act (MoCRA) regulations are tightening, I anticipate more warning letters like this, where companies’ packaging and secondary marketing claims turn the product from a cosmetic into a drug.

This has become an annual tradition. Here are my enforcement predictions from last year's Q4 2023 warning letter roundup. Let’s review how right or wrong my predictions were.

1. More rigid interpretation of cGMPs related to finished product identity and composition testing.

- This trend continued, as exemplified by the numerous warning letters this year. Many of these letters cite incomplete product and ingredient specifications, which are an essential cornerstone of cGMPs. As a counterpoint, validating finished product composition and identity is not always straightforward, since unique and expensive test methods are often needed.

2. Drug-spiked product warning letters.

- There were dozens of dangerous product violations in 2024 for spiked ingredients, as referenced in FDA’s Health Fraud Product Database. These were primarily related to sildenafil and sibutramine but also included adulterants like diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and yellow oleander.

3. Enforcement of TikTok disease claims and an FTC crackdown on influencers not disclosing a material connection.

- I've never been so surprised at being so wrong. There still have been no FDA warning letters against companies making product claims on TikTok, and FTC has generally been generally quiet about TikTok claims and influencers since they sent a group of warning letters to sweetener companies and influencers in late 2023. The National Advertising Division (NAD), however, continues to mention TikTok in some of its cases, such as this one about disclosing material connections when free products are given.

4. Homeopathic products will continue to be scrutinized.

- This enforcement trend continued, as FDA issued five homeopathic-related warning letters in 2024. These letters primarily covered manufacturing violations, higher-risk disease claims and ophthalmic (eye) products. There will likely continue to be a demand for homeopathic products that are manufactured in GMP-compliant facilities, use tested ingredients free from DEG contamination, are not intended for ophthalmic use, and are not promoted as treatments for serious diseases.

CBD update:

There were only nine CBD and delta-8-related warning letters in 2024, down 47% from 2023. Many of these letters involved joint FDA/FTC action against companies selling high-dose delta-8 in packaging that is favorable to children.

So, what will 2025 bring for CBD?

I expect delta-8 and CBD enforcement to continue, especially for companies making high-risk disease claims and selling psychoactive products in child-appealing packaging.

Follow Warning Letter Wednesday for weekly updates on interesting warning letters.