September 9, 2026

“#1” Pet Product Claims Attract NAD Scrutiny

Takeaway -

Support the exact claim consumers are likely to take away

A few weeks ago, I wrote about a “#1 Best Selling Beets Brand” NAD case. This week, let’s look at “#1” claims in the animal-product world. This National Advertising Division ...
September 2, 2026

“Made in USA” Claims Draw FTC Warning Letters

Takeaway -

Review country-of-origin claims across all marketing

In the past couple of months, FTC recently sent warning letters to eight companies that appear to have misrepresented certain products as “Made in the USA (MUSA)” and “Made in ...
August 26, 2026

GMP Inspection Surfaces Alleged Record Falsification

Takeaway -

Following good documentation practices is a cornerstone of compliance

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues. From warning letter. “Pages were removed from your logbook and ...
August 19, 2026

Exploring “#1 Best Selling” Statements

Takeaway -

Review all marketing in context

“#1 Best Selling Brand” is a bold statement to make. In this case, the National Advertising Division (NAD) helps clarify what this means and how to substantiate it. One of ...
August 12, 2026

When Puffery Claims Become Performance Claims

Takeaway -

Review all marketing in context

I love puffery. In advertising, puffery is described as an exaggerated, boastful, or subjective promotional claim about a product or service that a reasonable consumer would not take as a ...
August 5, 2026

Review Social Media Claims After GMP Inspection

Takeaway -

Importance of facility cleanliness for safe products

FDA inspected this supplement manufacturer and marketer in November 2025 and issued some 483s related to sanitation and GMP documentation issues. The company then sent four 483 responses to FDA ...
July 29, 2026

Neuropathy-Adjacent Claims Lead To Warning Letter

Takeaway -

Words like “occasional” do not fully mitigate risk

I often use this example to explain how FDA enforcement works. A single disease-type claim is unlikely to trigger a warning letter unless it is over the top. Instead, FDA ...
July 22, 2026

GMP Violations + Online Disease Claims = Warning Letter

Takeaway -

Old social posts are active marketing

This dietary supplement company was inspected by FDA in November and issued 483s and several months later, the FDA reviewed its website and social media.  Online disease claims, along with ...
July 15, 2026

5 Years of Warning Letter Wednesdays

Takeaway -

Understanding enforcement trends is the basis of compliant marketing

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 ...
July 8, 2026

10 Ketamine Warning Letters Issued

Takeaway -

Compliance is essential to product safety

FDA just issued a batch of 10 warning letters to companies selling the drug ketamine online. I am still surprised when I see drugs openly sold via standard e-commerce, and ...
July 1, 2026

Dietary Supplement GMP Lessons

Takeaway -

Manufacturing equipment flaws, theoretical yields, incomplete 483 responses, oh my

The warning letter covers manufacturing equipment flaws, theoretical yields, incomplete 483 responses, missing product specifications, and other issues. Fun reminders of the importance of GMP compliance. First, the manufacturing equipment ...