Warning Letter Wednesday

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Asa Waldstein

Community, Compliance, Natural Health

Marketing Strategy Compliance √

A weekly exploration of FDA warning letters and enforcement trends

Labeling Lessons

Minor label issues signal deeper compliance issues

6/11/25

Unallowable Ingredient Results in Warning Letter

Here are tips on using FDA’s ingredient directory

5/21/25

Best Practices When Making Competitor Comparison Claims

Ensure statements are not disparaging

4/30/25

Best Practices When Making Biomarker and Implied Claims

Use FDA’s helpful resource (Criterion 2)

4/9/25

Injectable CBD Warning Letter

Curated testimonials are marketing claims

3/19/25

Celebrity Endorsement Lessons

Disclosing material connection is essential for compliance

2/26/25

GMP Labeling Lessons

Small issues signify deeper noncompliance

2/5/25

“Non-Toxic” Claims Require Extensive Substantiation

Safety related product claims attract scrutiny

1/15/25

Delta-8 Inhalable Product

Dangerous products will be cited even if they do not contain disease claims

6/4/25

3 Animal Product Companies Receive Warning Letters

Extra attention is paid to animal CBD products

5/15/25

Navigating the Risks of Therapy-Adjacent Health Claims

Use FDA's helpful resource (Criterion 7)

4/23/25

In-Process Quality Testing

A look at the manufacturing and quality process

4/3/25

Amazon & Others Cited for Selling Injectables

Distributors are responsible for the products they distribute

3/12/25

Records Refusal Leads To Warning Letter

Take FDA inquiries seriously

2/19/25

"Promotes Brain Health” Claim Challenged

Small words can drastically increase claim risk

1/29/25

FDA Crackdown on Animal Product Seizure Claims

Amazon compliance still needs improving

1/9/25

Avoid Comparing Products to Drugs (most of the time)

Use FDA’s helpful resource (criterion 6)

5/28/25

Celebrating 200 Weekly WLW Posts!

Learning from others' mistakes helps you be compliant

5/7/25

OTC Topical “Inactive” Ingredient Marketing Claims

“Extra” claims are often non-compliant

4/16/25

Influencers Must Disclose Free Product

Brands should monitor influencer posts for compliance

3/26/25

Heavy Metal Contamination Leads to Recall

Following specifications prevents greater issues

3/5/25

Environmental Claims Increase Scrutiny

Ensure ESG claims are substantiated

2/12/25

Incomplete Batch Records & Ingredient Specifications

Ensure 483 responses are complete

1/22/25

Product Review Engagement

Trustpilot reviews can be “marketing”

1/1/25

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