Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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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

PTSD Claims Enforcement Increasing

Find and remove high-risk “buzzwords”

Twitter Claims Enforcement Increasing

Claims made on social are top of FDA’s mind

FDA Crackdown on CBD in Animal Products

Product review engagement leads to a warning letter

Disease Claims Turn Supplements Into Unapproved New Drugs

Disease Claims Turn Supplements Into Unapproved New Drugs

Screen all blogs and social media for disease claims

GMP Violations & Unanswered 483s Lead to a Warning Letter

GMP Violations & Unanswered 483s Lead to a Warning Letter

Ensure 483 responses are complete

10 Companies Cited for NDIs and Impermissible Ingredients

10 Companies Cited for NDIs and Impermissible Ingredients

Supplement should contain safe ingredients

CBD Company Cited For Claims Made in Blogs and Socials

CBD Company Cited For Claims Made in Blogs and Socials

Blogs on a commercial website are marketing claims

Product Tags & Metatags Attract FDA Attention

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”

All social media is “fair game” for enforcement

LinkedIn Posts Mentioned in Warning Letter

All social media is “fair game” for enforcement

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

GMP Pitfalls: Marketing, Manufacturing, & Labeling

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”

Anxiety claims enforcement up 95% in 2021

Remove “anxiety” on all marketing platforms

Clean up old social media posts

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

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”