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Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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Another Delta 8 Warning Letter

Formats that are favorable to children should be avoided

12/6/23

Improper 483 responses

Re-review online marketing after FDA inspection

11/15/23

Improper Written Specifications Lead To Warning Letter

Batch records should be complete

10/25/23

Blog Claims Result in Warning Letter

Blogs are marketing statements

10/4/23

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

Eye Care (Ophthalmic) Products Under Increased Scrutiny

Companies are responsible for co-manufactured products

11/29/23

GMP Labeling Lessons

Minor violations can signal the authorities

11/8/23

Herbal Ingredients Should Be Listed Correctly

Use AHPA's Herbs of Commerce

10/18/23

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

FTC Letters To Sugar-Promoting Influencers

Influencers must disclose material connection

11/22/23

Printed Brochures Are Labeling

Ensure ingredients are GRAS for the marketed population

11/1/23

Website Marketing Claims Lead To Warning Letter

Learn from other’s marketing mistakes

10/11/23

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

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