Permanent Injunction against Sci Fit

Bryan Haycock

Bryan Haycock

Administrator
Staff member
In what's being considered the first permanent injunction of its kind, a dietary supplement manufacturer, failing to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations, will no longer be able to make
and distribute more than 400 products in violation of the Federal Food, Drug, and Cosmetic Act.

To read the full press release and obtain links to two past warning letters, in addition to a notice of seizure,
click here.

I'm sure you'll agree that this sends a strong message to the industry.

Thanks to UNPA for this heads up.
 
Those warning letters are particularly interesting.

From what I have heard/read there seems to be alot of supplements with ingredients that have not been fully tested. What effect will this have on those sort of supplements? or were the substances listed in the warning letters particularly harmful?
 
ingredients used in dietary supplements have to be registered with an NDI (New Dietary Ingredient) submission to the FDA before they can be marketed to the public. The only exception being if the ingredient has existed in the food supply and has a reasonably long history of being safe. According to the Dietary Supplement Health and Education Act (DSHEA), a dietary supplement containing an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994 may be considered unsafe when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury.

This particular company was not following Good Manufacturing Process (GMP) so were shut down by the FDA.

Here is a flow of how new ingredients are handled by the FDA:
NDI.jpg
 
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