Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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FDA sends 7 Cardiovascular Disease Related Warning Letters

FDA Issues Five CBD-Related Warning Letters

CBD enforcement is top of mind for FDA

Product “Tags” With Disease Claims Elevate Risk

Ingredient research can be considered a marketing claim

Supplement Labeling Errors lead to Warning Letter

Common labeling errors can be avoided

Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims

Distributors are responsible for the products they sell

Ayurvedic Product Company Receives Covid Warning Letter

Discussing ingredient benefits is a marketing claim

Kratom Claims Enforcement Increasing

Opioid support claims are high risk

Common Labeling Errors Lead to Warning Letter

Following label format is important

Small Herbal Company in Big Trouble for Disease Claims

“Brain Fog” claims related to Covid will attract scrutiny

Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter

Scan socials and websites for risky words like “hordenine”

Anxiety Claims Enforcement Review

Increase in claims cited in blogs and social media

Discussing Ingredient Benefits Leads to a Warning Letter

No such thing as “too small to be on FDA’s radar”

YouTube Claims Lead To Warning Letter

Claims in videos are “fair game” for enforcement

A Review of 56 Diabetes Related Warning Letters

Warning letters show claims made in socials, blogs, testimonials & hashtags

Uncompliant Product Name Leads To Warning Letter

Citing ingredient research is a marketing claim

Supplement company’s brochures and online marketing lead to a warning letter

There are no FDA approved supplement facilities or supplement 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”