The Food and Drug Administration has issued “draft guidance” requiring anyone selling anything as a dietary ingredient (this would include all supplements such as vitamins) that was “created” (meaning formulated) in the past 17 years must file a New Dietary Ingredients with the FDA. This “notification” can be denied by the FDA, effectively blocking the sale of the supplement or anything with the specific ingredient denied.
Yes, if you make a complex supplement with multiple ingredients, you must file an NDI for each ingredient, not just one for the supplement. Then if the FDA decides to “deny” your notification for any reason, you could be subject to jail time for not complying.
Of course, the FDA claims that this is just to ensure that no “bad” ingredients are being included in supplements. We all know the FDA’s history with vitamins and supplements and “medical” claims, though.
The administrative fees for the NDI are (for now) relatively low, but they are under no binding to keep them that way and an easy back door to destroying the non-mainstream pharmaceutical competition of supplements is to hike up those prices to make it either too expensive to manufacture or too expensive to purchase those supplements. The obvious plan would be to force most supplements to play on the same level as pharmaceuticals, which enjoy a healthy profit margin in comparison to most supplements.
The NDI was created by the Dietary Supplement Health and Education Act of 1994 which specifically said that the system was to be used only for manufacturers to notify the FDA of the new ingredients (invented after 1994) of their products. It was not for any other purpose. Yet the FDA is attempting to create an approval process rather than a notification process.
Their plan? Create extremely rigid and tough-to-comply-with notification requirements and then reject any NDI that doesn’t exactly match those specs. Worse, the FDA is imposing other requirements not intended by the original law, such as requiring human trials.
Other bureaucratic twists are being added to the NDI requirement in order to further bastardize the process and create arbitrary approval. This includes an un-mandated 75 day wait and the interpretation of what “chemical alteration” means when requiring new NDI filings.
It’s a scam by the FDA to gain powers of oversight over the supplement industry they’ve long sought to destroy in favor of their revolving door politics with Big Pharma. You can stop it by signing this petition from the Alliance for Natural Health.