Warning Letter Wednesday® Posts

A weekly exploration of FDA warning letters and enforcement trends

March 9, 2022

Product catalogs are considered extensions of the label

Takeaway -

Remove high-risk claims in all marketing materials

Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to ...
March 2, 2022

Discussing ingredient benefits is a marketing claim

Takeaway -

Replace high-risk words on a commercial website

Discussing ingredient benefits on a commercial website can easily cross into product disease claims. This is a common marketing mistake, and I suggest fighting the urge to explain ingredient benefits ...
February 23, 2022

“Blood sugar” enforcement risks and review

Takeaway -

Use caution when promoting blood sugar products. Remove claims on social media.

Blood sugar claims enforcement remains top of mind for the FDA. Since January 2021, there have been 36 blood sugar related warning letters. Blood sugar support is not a high-risk ...
February 2, 2022

Learning targets: Blogs, risky words, testimonials, ingredient benefits

Takeaway -

Informational blogs on a commercial website are considered “labeling”

Today’s Warning Letter Wednesday is an important reminder that blogs, testimonials, and discussing ingredient benefits can easily cross the line into claims, especially when filled with high-risk buzzwords! The FDA ...
January 26, 2022

Anxiety claims enforcement up 95% in 2021

Takeaway -

Remove “anxiety” on all marketing platforms

Warning Letter Wednesday reviews the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear ...
January 19, 2022

Clean up old social media posts

Takeaway -

The FDA/FTC look at old posts the same as current ones

Warning Letter Wednesday highlights very old social media posts called out in this warning letter. It is common for the FDA to look back a couple of years on social ...
January 12, 2022

Insomnia claims continue to attract FDA attention

Takeaway -

Replace “insomnia” with lower-risk alternatives

Warning Letter Wednesday highlights insomnia claims that continue to attract FDA’s attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 ...