Warning Letter Wednesday
A weekly exploration of FDA warning letters and enforcement trends
Supplement company’s brochures and online marketing lead to a warning letter
There are no FDA approved supplement facilities or products
300%+ Increase in CBD Warning Letters This Year!
Companies marketing CBD products should avoid making disease claims
Citing Clinical Studies & Labeling Errors Lead To Warning Letter
Citing studies leads to increased scrutiny
Supplement & CBD company cited for disease claims
Words like “may help with” is not a get-out-of-claims-jail-free card
MLM Company Cited For Claims Made By Their Affiliates
Companies that compensate influencers or affiliates may be responsible for claims they make
Company Cited For Selling Selective Androgen Receptor Modulators (SARMs)
The FDA regulates based on intended use
FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal
Find high-risk words lurking in old blogs, testimonials, and socials
GMP inspection leads to a warning letter for disease claims and GMP violations
Plan for FDA inspections by addressing common violations
Ingredient Company Cited For Refusing An FDA Inspection
Plan for inspections with an “FDA Inspection” SOP
Disease Claims Turn Supplements Into Unapproved New Drugs
Screen all blogs and social media for disease claims
10 Companies Cited for NDIs and Impermissible Ingredients
Supplement should contain safe ingredients
CBD Company Cited For Claims Made in Blogs and Socials
Blogs on a commercial website are marketing claims
Product Tags & Metatags Attract FDA Attention
Everything used to market products must be compliant
Best Practices For Reducing Risk in Blogs
Blogs can easily cross the line from “education” to “disease claims”
6-Year-Old Social Media Posts & Hashtags in Warning Letter
Uncompliant hashtags attract FDA attention
7 CBD Companies Cited for Implied COVID claims
Citing clinical studies on a commercial website is high risk
Online company fined $4.2M for blocking negative product reviews
Product reviews must be honest and truthful
Product catalogs are considered extensions of the label
Remove high-risk claims in all marketing materials
Discussing ingredient benefits is a marketing claim
Replace high-risk words on a commercial website
“Blood sugar” enforcement risks and review
Use caution when promoting blood sugar products. Remove claims on social media.
Learning targets: Old social media posts, hashtags, sketchy ingredients, and high-risk claims
Hashtags can make compliant posts very non-compliant
Learning targets: Children, risky words, intranasal, ingredient benefits
Use caution copy & pasting “ingredient benefits” onto commercial website
Learning targets: Blogs, risky words, testimonials, ingredient benefits
Informational blogs on a commercial website are considered “labeling”
Insomnia claims continue to attract FDA attention
Replace “insomnia” with lower-risk alternatives
Most GMP violations involve setting & documenting specifications
Correct FDA 483s to avoid a warning letter
Marketing CBD in OTC drugs is risky
Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals.
Learning Targets: definition of supplements, safety claims, disease statements
Before marketing products check with a supplement expert
Using words such as “inflammation” increase warning letter chances
Replace “high risk” words with lower risk alternatives
Step #1 in reducing risk is removing high-risk “buzzwords”
High risk “buzzwords” attract FDA/FTC “keyword web crawlers”
“Clinically proven” statements are high risk
Use caution with “clinically proven” or “clinically studied” statements
Affiliate Marketing Content Must Be Compliant
Free speech protections go away when there is marketing material connection
FDA cracks down on unsubmitted NDI ingredient hordenine
Ensure ingredients are not on FDA’s “naughty list”