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Asa Waldstein

Community, Compliance, Natural Health

Marketing Strategy Compliance √

Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

OTC Companies Cited For Refusing Records Request

Test ingredients for common adulterants

9/27/23

Labeling Violations & Web Claims

Small labeling issues increase warning letter risk

9/6/23

TCM Company Cited for Claims & GMP Violations

Re-review online marketing if inspected by FDA

8/16/23

Animal Product Testimonials Lead to Warning Letter

Biomarkers claims elevate enforcement risk

7/26/23

YouTube Claims Lead To Warning Letters

Review videos for compliance concerns

7/5/23

Discussing Ingredient Benefits Leads To Warning Letter

Hashtags elevate marketing risk

6/14/23

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

Batch Production Record & Labeling Lessons

Re-review websites if inspected by FDA

9/20/23

GMP Labeling Lessons

Learn from warning letter enforcement

8/30/23

11 Companies Cited For Not Testing For Contaminants

Test products like glycerin for adulterants

8/9/23

Kratom Company Issued Warning Letter for Opioid Support Claims

Kratom companies should be aware

7/19/23

Company Selling Adulterated Product Leads To Additional Product Testing

Test “sketchy” products for adulterants

6/28/23

Learning Lessons From NAD

Ensure substantiation is suitable for each claim

6/7/23

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

7 Homeopathic Eye Product Warning Letters

Ensure vendors are properly qualified

9/13/23

Amazon and Walmart Cited For Distributing Homeopathic “Drug” Products

Homeopathic products under increased scrutiny

8/23/23

Another Delta 8 Warning Letter

Repeat warning letters can have serious consequences

8/2/23

FDA/FTC Cites Six Companies For Selling Delta 8 Products

Product formats & packaging should not appeal to children

7/12/23

Education vs Marketing Discussion

Small business learning lessons

6/21/23

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

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