The FDA could be completing policies that will wreak havoc on the supplement industry. They must be opposed. Action Alert! The FDA is asking for comments on its procedures for submitting new dietary ingredient (NDI) notifications. This NDI notification system (think of it as “new supplement” notification) threatens the entire future of the supplement industry
The FDA could be completing policies that will wreak havoc on the supplement industry. They must be opposed. Action Alert!
The FDA is asking for comments on its procedures for submitting new dietary ingredient (NDI) notifications. This NDI notification system (think of it as “new supplement” notification) threatens the entire future of the supplement industry and must be opposed.
We’ve covered the major problems with this system in the past. According to the 1994 Dietary Supplement Health and Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of plans to market the product. The problem is that the FDA is using this part of the law to create a drug-like pre-approval system for supplements that experts have estimated will result in the elimination of tens of thousands of supplements from the market.
Part of the issue is that the FDA is adopting a broad definition of an NDI and thus expanding the number of supplements that will be subject to NDI notification procedures. For example, supplements that have not been “chemically altered” are not required to comply with these procedures; but the FDA is adopting an expansive definition of what it means to be “chemically altered” such that almost all modern supplements would probably qualify and thus be subject to NDI requirements. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement industry.
It’s the same old story. The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.
The FDA has not yet completed its NDI guidance, which to this day remains in draft form 26 years after DSHEA was passed. But that may change soon. Steve Tave, the director of the FDA’s Office of Dietary Supplement Programs, said recently: “We’re trying to get that guidance, or at least parts of that guidance, as close to final as we can.”
As we’ve written previously, the president himself was treated for COVID with supplements, but the public is not allowed to learn about the benefits of supplements for COVID and other diseases because of the gagging of doctors and others to support the drug industry. This is unacceptable.
Action Alert! Send a message to Congress and the FDA opposing the draft NDI guidance. Please send your message immediately. By sending this message, you will also be supporting our petition to ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.