Hi Anon.
My take is that if you have a failure of your product on stability and it is still within the standard expiration/shelf-life of the product, then you have a problem that should be identified to the FDA and work with the FDA to deal with it. I would suspect that if the product does not meet its label claims, that you would have a misbranded product on the market and as such, you have a violative product on the market since distribution of misbranded product is a prohibited act under the legislation. So while the rules may not "specifically" require stability testing or field corrections, remember supplements are under the FDA food regulations in many ways and I would suggest that a product failing to meet the label statements in the Supplement Facts box would necessitate a serious discussion with FDA and likely recall.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 19-Sep-2019 10:31
From: Anonymous Member
Subject: Dietary Supplements
This message was posted by a user wishing to remain anonymous
Probably many of you have more work experience in Pharma or medical device industries, but if somebody knows about dietary supplement I really appreciate your guide in the below question:
Someone knows the path to follow in Dietary supplements if we find out that the stability fails after the product was distributed? should we inform to the FDA and proceed with a recall? According to 21 CFR Part 111 there are not requirements for field alerts and there no requirements for stability testing for Dietary supplements. However, FDA requires that dietary supplement manufacturers ensure that each of the labeled dietary ingredient are present at 100% of the declared amounts throughout the expiration period of the product (Federal Register 62, 1997).
Thanks in advance for your help,