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

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

Basics of GMP’s Cited

Functional mushroom products under increased scrutiny

12/11/24

Influencers Must Disclose Material Connection

Free products should also be disclosed

11/20/24

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

Refusing FDA Inspection Access

Be nice to FDA investigators & follow inspection SOPs

12/26/24

Fruit Snack Wars

NAD challenge cases explored

12/4/24

Warning Letter Issued for Eye Color Changing Drops

Product reviews are marketing claims

11/13/24

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

GLP-1 Product Receives Warning Letter

Marketing strategies should consider “reasonable consumer expectations” to avoid issues

12/18/24

Lack of Allergen Labeling Leads to Potential Death

Nutrition fact panels must be in a compliant format

11/27/24

GMP Issues

Following SOPs is essential to compliance

11/7/24

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