The United States Food and Drug Administration is trying to implement new guidelines that will effectively kill the nation’s supplement industry.
A draft of the guidelines was issued July 1 to comply with the New Dietary Ingredient (NDI) notification protocols called for in the 1994 Dietary Supplement Health and Education Act (DSHEA). In the 17-plus years since the act was passed, supplement manufacturers have had little information to help them determine what makes a NDI and when or how to file NDI notification.
Now, we know the FDA wants to destroy the supplement industry.
The guidelines were reviewed by the Alliance for Natural Health, and the alliance determined them to be onerous and punitive. For example, any supplement developed since 1994 is now subject to FDA approval under the NDI.
Many important supplements have been developed since 1994. Under the new guidelines, those will have to come off the market for at least 75 days while the FDA decides whether it wants to approve them. On top of that, any supplements that were “grandfathered” in by the DSHEA that have been altered in any way — prepared by a different process, dosage increased, harvested from the plant at a different point in the life cycle, recommended for use by another demographic group, etc. — must also be pulled from the market and sent to the FDA for approval. And the kicker is that the FDA is under no obligation to approve them.
If any changes are made or unapproved substances are added to a supplement, the FDA considers it adulterated. As a result, the supplement could be confiscated by the FDA, the supplement manufacturer would be subject to severe sanctions and the manufacturing company’s officers could be imprisoned.
Additionally, any new supplement being considered for manufacture must have an NDI completed for each ingredient, regardless of whether those ingredients had been previously approved by the FDA for use in other supplements, or the same substances had been previously approved for manufacture by a different company. This will drown supplement manufacturers in paperwork and result in increased costs and the closure of many supplement companies.
It’s obvious the FDA and Big Pharma want to destroy the supplement industry and are not interested in letting Americans make their own health choices.
Call or email your Senators and Representative and tell them the FDA should not be imposing such draconian guidelines on the supplement industry. You can find the contact information for your Senators at www.senate.gov and your Representative at www.house.gov. Or you can call 1-800-333-4636.