When the Dietary Supplement Health and Education Act (DSHEA) was passed back in 1994, it came with a new dietary ingredient (NDI) provision requiring the FDA to be notified at least 75 days in advance of a new NDI-containing product coming to market.
For years, the FDA did not enforce this NDI provision, and in fact has never in the 26 years since DSHEA became law finalized any standards for how the process should work. The FDA is finally now coming out with a plan, but the Alliance for Natural Health USA (ANH-USA) says the way it is worded threatens the viability of the entire supplement industry.
While the intended purpose of the NDI provision is to ensure that no unsafe ingredients of an unknown nature end up in dietary supplements, the FDA is apparently twisting it to create a drug-like pre-approval system for supplements that experts say will result in the elimination of tens of thousands of supplement products from the market.
What was designed to be a simple notification system has the potential to become an egregious regulatory roadblock for dietary supplement companies – the very thing DSHEA was created to help prevent.
“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,” ANH-USA warns.
“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.”
According to ANH-USA, none of this is an accident. The FDA, because it exists as a revolving door with the pharmaceutical industry, has long tried to destroy dietary supplements because they threaten the viability of Big Pharma – and this latest attempted move is no exception.
With the FDA seemingly trying to slip in another Trojan Horse under the guise of protecting Americans against adulterated supplements, it is up to us to make our voices heard.
“It’s the same old story,” ANH-USA warns. “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.”
ANH-USA has put together an Action Alert that we are encouraging our readers to sign. It links to a comment page set up by the FDA itself to hear what you have to say about this proposed new guidance.
Our suggestion is to tell the FDA that while it is important to ensure that new dietary ingredients are safe, this should not be used as an excuse to make it prohibitively difficult, if not impossible, for new supplements to come to market.
It should also not be used as an excuse to pull from the market many of the dietary supplements that Americans have come to rely on for their personal health. Some of these may have been the ones Donald and Melania Trump used to treat their Wuhan coronavirus (COVID-19) diagnoses.
For more related news about dietary supplements, be sure to check out Natural.news.
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