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Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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Ingredient Benefits, Clinical Studies, & Blogs Lead to Warning Letter

Comparison to drugs is high risk

5/31/23

Testimonials & Video Claims Lead To Warning Letter

“Arthritis” claims elevate risk

5/10/23

Key Takeaways From FTC “Warning” to ~670 Companies

All claims should be substantiated

4/19/23

More Marketing Lessons From COVID Letter

Claims in hashtags, videos, and testimonials should be avoided

3/29/23

MLM Distributors Cited in FTC Lawsuits

Webinars are “fair game” for enforcement

3/8/23

GMP Violations Continue to be Cited in Warning Letters

Hire experts to help with 483 responses

2/15/23

Labeling Errors Lead to Warning Letter

Nutrient content claims must be compliant

1/25/23

Biomarker Claims Lead to Warning Letter

Expect arterial health claims to be cited in the future

1/4/23

Small Herbal Company Cited For Marketing Claims

Product names are marketing

5/24/23

Hordenine HCL Ingredient Leads To Warning Letter

Ensure ingredients are lawful for supplements

5/3/23

Company Cited For Not Testing Known Contaminants

All dietary ingredients must be tested for identity

4/12/23

Product Names Are Marketing Claims

Printed catalogs must be compliant

3/22/23

IBS & Cholesterol Claims Cited in Warning Letter

Scan marketing for “mid-risk” heart health claims

3/1/23

Incomplete 483 Responses Lead to Warning Letter

Key GMP learning opportunities explored

2/8/23

Male Enhancement Products Found with Drug-Spiked Ingredients

FDA will test suspicious products for drugs

1/18/23

GMP Inspection Leads to Online Scrutiny

Study citations are marketing

12/28/22

Weight Loss Claims Trigger FDA Product Testing

Ensure weight loss products are tested for drugs

5/17/23

Online Marketing & GMP Lessons

Re-review marketing if FDA has inspected you

4/26/23

Noncompliant Testing Methods Lead to Warning Letter

Use qualified reference samples

4/5/23

Digestive & Cholesterol Claims Cited in Warning Letter

Remove testimonials with claims

3/15/23

Animal Product Claims Under Increased Scrutiny

Old social posts are “active” marketing

2/22/23

FDA Crackdown on Monkeypox Claims

Learning from other’s mistakes is a good strategy

2/1/23

The First 2023 Warning Letter Belongs to a CBD Company

Remove COVID claims including on YouTube

1/11/23

Website “About Us” Claims Cited in Warning Letter

Discussing ingredient benefits is marketing

12/21/22

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