Warning Letter Wednesday Posts

A weekly exploration of FDA warning letters and enforcement trends

February 9, 2022

Learning targets: Children, risky words, intranasal, ingredient benefits

Takeaway -

Use caution copy & pasting “ingredient benefits” onto commercial website

Warning Letter Wednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making ...

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 ...

January 5, 2022

Most GMP violations involve setting & documenting specifications

Takeaway -

Correct FDA 483s to avoid a warning letter

Warning Letter Wednesday reviews a cGMP manufacturing warning letter. This is a good teaching case about the basics of Good Manufacturing Practices (GMPs) for dietary supplements as this company made ...

December 22, 2021

Marketing CBD in OTC drugs is risky

Takeaway -

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals.

Warning Letter Wednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also ...

December 15, 2021

Learning Targets: definition of supplements, safety claims, disease statements

Takeaway -

Before marketing products check with a supplement expert

Today’s Warning Letter Wednesday is cringeworthy but also contains learning lessons for product marketers and developers. The product is a vape that contains caffeine, is labeled as a supplement, makes ...

December 8, 2021

Using words such as “inflammation” increase warning letter chances

Takeaway -

Replace “high risk” words with lower risk alternatives

High risk words should be avoided in all forms of marketing. The words “inflammation” or “anti-inflammatory” is being referenced in many warning letters. Read the full warning letter here. If truthful ...

December 1, 2021

Step #1 in reducing risk is removing high-risk “buzzwords”

Takeaway -

High risk “buzzwords” attract FDA/FTC “keyword web crawlers”

Step #1 in reducing online marketing risk is removing high-risk “buzzwords”. These include Alzheimer’s, cancer, diabetes, PTSD, opioid support, depression, and of course COVID. Other “buzzwords” include pain, anxiety, inflammation, ...

November 24, 2021

“Clinically proven” statements are high risk

Takeaway -

Use caution with “clinically proven” or “clinically studied” statements

Implying “Clinically Proven” or even “Clinically Studied” is high risk. This is a trend to watch out for. We are seeing references to “clinically proven” types of claims showing up ...

November 17, 2021

Affiliate Marketing Content Must Be Compliant

Takeaway -

Free speech protections go away when there is marketing material connection

Affiliate marketers continue to be scrutinized for making claims. A few years ago, affiliate warning letters were nearly nonexistent. Now regulators are savvy and are no longer tolerating claims where ...