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April 12, 2023 By: Asa Waldstein

Company Cited For Not Testing Known Contaminants

Takeaway -

All dietary ingredients must be tested for identity

Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its manufacturing.

The known contaminant in glycerin is diethylene glycol (DEG). During one GMP inspection I helped oversee, FDA was happy to see we had tested for DEG in glycerin. This showed we were aware of the potential safety issue with glycerin and were taking steps to ensure the finished product was safe.
Learn more with the FDA’s guidance document, Testing of Glycerin for Diethylene Glycol.

Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for?

The company that received this letter is an OTC and homeopathic drug manufacturer, but supplement folks can learn from this. Also, FDA cited the company for not proving their method was sufficient to test for DEG. As I discussed last week, proving test method suitability is top of mind for FDA investigators.

Read the full 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.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices
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