Warning Letter Wednesday Posts

A weekly exploration of FDA warning letters and enforcement trends

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 ...

November 10, 2021

FDA cracks down on unsubmitted NDI ingredient hordenine

Takeaway -

Ensure ingredients are not on FDA’s “naughty list”

The FDA is starting to crack down on unsubmitted NDI’s. Today’s Warning Letter Wednesday reviews a recent hordenine warning letter. Hordenine and higenamine warning letters also include high risk disease ...

November 3, 2021

Ingredient benefit discussions can be marketing claims

Takeaway -

Use caution when discussing ingredient benefits on a commercial webpage

Ingredient descriptions are considered marketing claims when used to sell a product. Today’s Warning Letter Wednesday highlights this common marketing mistake. This is an example of a well-intentioned writer and ...