After three years as the director of FDA’s division of dietary supplements, Dr. Daniel Fabricant, has rejoined the Natural Products Association (NPA) as its CEO. In his first presentation to industry as the CEO of NPA, Dr. Fabricant spoke mainly about new dietary ingredients (NDIs) and ensuring that all ingredients in dietary supplements are grandfathered ingredients (marketed before October 1994) or that new dietary ingredient petitions have been filed to the FDA for those ingredients classified as NDIs. It was clarified that NDI notifications should comply with 21 CFR 190.6 (requirement for premarket notification of NDI) and determination of an NDI depends on documentation showing previous use and marketing, identifying any chemical alterations, and use of the article in the diet. It was highly recommended that companies follow the current draft guidance document before preparing their notifications to the FDA. Products containing NDIs without having NDI notifications filed can be recalled depending on the available safety data. To help encourage industry to submit all new NDI notifications, the NDI review and response time has been decreased from the 75 day turnaround period.
Dr. Fabricant reviewed trends in warning letters and indicated that the FDA is seeing a major trend with dietary supplement manufacturers selling ingredients that are NDIs with no notification filed to the FDA. The FDA is also seeing a trend that many NDI notification filed are being withdrawn after FDA issues an inadequate response letter. The inadequate response letter does not necessarily mean that the evidence is inadequate rather it is just the explanation of safety evidence in which the FDA does not agree with.
GMP inspections will also be taking on a new focus where emphasis will not be placed on verification and validation of methods in the manufacturing process and laboratory testing. Dr. Fabricant is encouraging all companies to start looking into the process for validation of all their methods to ensure that evidence is available for coming inspections.
The final topic touched on by Dr. Fabricant was structure/function claims versus diseases claims. Dr. Fabricant explained that not using wording such as “treat”, “cure”, and “prevent” does not mean that a disease claim is not being made. However, it is possible for structure/function claim to use wording such as “treat”, “cure”, and “prevent” and not be a disease claim. There is sometimes a fine line between a disease claim and a structure/claim and it is up to industry to examine each claim to determine if there is anyway a structure/function claim could possibly imply a disease claim.
It was a great first presentation from Dr. Daniel Fabricant in his new position as CEO of NPA. We look forward to seeing more great things from Dr. Fabricant in his new role.
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