FDA Warning Letters

Covers major FDA compliance actions, analysis of warning letters, common pitfalls.

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 ...