FDA Warning Letters

This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims ...

I often talk about disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the ...

A look at the manufacturing and quality process GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials ...

Everyone loves free products, but influencers who receive free products and post about them must disclose this material connection. In a recent National Advertising Division monitoring case, a large publicly ...

Injectable CBD? The first CBD warning letter of the year is an odd one. The company was cited for selling injectable CBD products and making disease claims on its website ...

Another Amazon warning letter, this time for distributing products apparently intended for injection, such as the “L-Carnitine Body Serum Ampoule.” This is part of a group of at least six ...

Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings ...

Disclosing material connection is essential for compliance Lessons in endorsement guidelines. Celebrity Kevin Hart came under the scrutiny of the National Advertising Division’s (NAD) monitoring of endorsement disclosure compliance. These ...

Take FDA inquiries seriously Being unresponsive to official FDA requests can lead to serious issues. A drug manufacturing facility in India received a records request from FDA. After several attempts, ...

Ensure ESG claims are substantiated We love the environment, but companies making broad sustainability claims are asking for increased scrutiny. This is because statements like “environmentally friendly” and “sustainably sourced” ...

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 ...