Product Names Are Marketing Claims

This warning letter involves claims made in catalogs and product labels collected during a GMP inspection.

Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. 👉Sign up here.

Everything the FDA investigator sees is “fair game.” Sometimes they gather non-compliant literature, and the company never hears from FDA, but in cases of extreme claims and GMP violations, this often turns into a 483 or a warning letter. In this brief video, learn about the difference between a 483 and a warning letter.

There are a lot of non-compliant product names cited in this warning letter. Yes, product names are marketing and, therefore, must be compliant. Here are some particularly over-the-top examples.
👉From warning letter. “Children’s Antibiotic Formula … product name implies the product is intended to cure, mitigate, or treat bacterial infections.”
👉From warning letter. “Hepatitis C Formula Glycerite” and “Children’s Antiviral Formula.”

A key learning point is anything can be collected and reviewed. This includes box stuffer promotional materials and printed catalogs. I remember during an inspection; we had haphazardly left old non-compliant product brochures lying around our shipping room. We were not using them anymore, but if the investigator had seen them, it could have led to a warning letter. I carry this lesson with me forever.

Even claims which are not considered high-risk are cited in this letter. Here is an example from the company’s product catalog.
👉From warning letter “Product catalog: “A blend of herbs with antimicrobial, anti-inflammatory…actions….”

There are also some glaring 483 citations that the company appeared not to address. This includes the "greatest hits" such as not setting specifications. I review GMP violations in previous Warning Letter Wednesday's.

Read the warning letter here. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.