Warning Letter Wednesday^® Posts

Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the “small things” like line thickness are compliant is important. When FDA looks at a label ...

Small words can drastically increase claim risk A children’s brain health applesauce product received a National Advertising Division inquiry for cognitive and immune-related claims. This is an important reminder that ...

Ensure 483 responses are complete This letter is a great reminder of the basics of Good Manufacturing Practices, starting with developing specifications to ensure the ingredients and products are correct ...

Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by ...

Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be ...

Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons ...

Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves ...

This is one of the cringiest Warning Letter Wednesday posts I’ve ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has ...

Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and ...

The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch’s Fruit Snacks (PIM’s). In the commercials, chef Gordon Ramsay throws ...

Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts ...

Disclosing material connections is an important part of influencer and ambassador marketing, including when customers receive free products and post about them. Drunk Elephant, a well-known skincare brand, was recently ...