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Manufacturing information beyond GMPsManufacturing information beyond GMPs

During GMP inspections, FDA has been asking non-GMP questions about botanical forms and safety.

Timothy Stewart

April 11, 2019

2 Min Read
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It has become more common for FDA inspectors to ask questions about ingredient forms, justifications regarding the combinations of ingredients and the suggested serving size during their cGMP (current good manufacturing practice) inspections. These questions can be considered “data collection inquiries,” which are FDA’s way of gathering information on topics of interest:

  • Why does the firm use this botanical extract instead of the whole powder form of the plant (or vice versa)?

  • Why does the firm use this combination of ingredients with the botanical in the formula?

  • How does the firm know the suggested serving of the product formula is safe?

These “data collection inquiries” are not typical questions for a 21 CFR 111, “cGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements” FDA inspection because there isn’t a specific requirement in the regulation being cited. These questions are relevant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) itself.

In section 8, DSHEA states a dietary supplement must only contain dietary ingredients “which have been present in the food supply (prior to Oct. 15, 1994) as an article used for food in a form in which the food has not been chemically altered” and “there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe.” If these criteria are not met, the ingredient is defined as a new dietary ingredient (NDI) and a NDI notification must be submitted to FDA for review at least 75 days before the product is marketed in accordance to 21 CFR 190, Subpart B. In 21 CFR 190(b)(3).

Read the rest of this article and learn more about legal compliance issues surrounding herbs and other innovative ingredients in INSIDER’s botanicals digital magazine.

EAS independent advisor for dietary supplements, Timothy Stewart, holds a doctorate in chemistry and advises clients on FTC, attorney general and FDA regulatory compliance issues such as customs and border patrol, import alerts, state and federal observations/violations, consent decrees, California Proposition 65 requirements, and vendor qualifications. Prior to consulting, he worked in the dietary supplement industry as a quality control manager and researcher at Harvard Medical School and the University of Southern California.

About the Author(s)

Timothy Stewart

Independent Consultant

EAS (easconsultinggroup.com) independent consultant Timothy Stewart has a master’s degree in philosophy and chemistry from the University of Southern California and a bachelor’s degree in chemistry with a minor in biochemistry. He has been a consultant with EAS for four years, working with clients on GMP (good manufacturing practice) issues, quality control (QC) and compliance. Most common applications are raw material or finished product specifications, scientifically valid test methods, serious adverse event reporting (sAER), product whitepapers, retail labeling, Proposition 65, GMP and employee training. He is a former QC manager for Paragon Laboratories in Torrance, California, where his responsibilities included assuring GMP compliance. An accomplished athlete, he is a former professional cross-country mountain bike racer who qualified for the 1996 Olympics.


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