Drugs undergo statutory approvals and not food supplements. The norm that was and is in play is that pharmaceutical products are to follow the mandated product approval norms by the FDA before hitting the market. And it's quite sensible to ascertain the reason why it is so.
One that stands as the benchmark that exposes the true intentions of the Pharma Giant of eliminating dietary supplements is the past fight of wiping-off Vitamin-B6 from the market on grounds of adulteration. The attempted, ‘will to close’, the supplements of NAC (N-acetylcysteine) in 2020 throws a much brighter light highlighting the old & ongoing efforts to eliminate the dietary supplements from the market in America. But that’s not it yet, another strategy that some big pharmaceutical giants adopted was the buy-outs of major supplement brands, and as a result, they now own plus 100 most reputed supplement brands cutting off the competition.
It’s a power play of thundering its monopoly. The mass buy-outs of the supplement brands layer extra leverage to the pharma giants pushing the nutritional brands to go through the approval stage, which we know, is going to be too difficult for them to get their products to pass through the statutory approval phase, that too hassle-free. The consistency of the Pharma Giants in trying to monopolize their market play seems to work out now.
The political director for the Organic Consumers Association (OCA), Alexis Baden-Mayer interviewed Gretchen DuBeau (Executive & Legal Director for the Alliance for Natural Health), and the conclusion so highlighted was that efforts are and were immense of the Pharmaceuticals Giants to eliminate major nutritional supplements competitor in collaboration with FDA. The Chairman of the Senate Health Committee - Patty Murray, and the Republican Leader Richard Mauze Burr couldn’t stop the draft legislation from institutionalizing that would, henceforth, mandate premarket approval of the dietary supplements. Many fail to comprehend the equation behind burdening the consumer with the extra cost and find no sense behind dietary supplement undergoing premarket approval despite being aware that it doesn’t hail from the drug fraternity.
The Durbin-Braun Premarket Approval Proposal was slipped into the draft legislation, which was released on May 17’ 2022, by the United States Senate Health, Education, Labor, and Pensions Committee (HELP), along with the re-regularizing aspects, like fees for medical device package, drugs, and biologics.
The Natural Product Association speculates about the cascading damage to other industries this legislation would cause once it’s in full play. The legislation pro groups state the availability of protection in the event of technical disagreement with the FDA, but the black clouds are much denser to cover up the clearer healthy clouds permanently off the market.
The only way to save the dietary supplements, that is, to detach the Dietary Supplement Listing Act 2022 from FDA Safety Landmark Advancements Act, is to actively stand in opposition against premarket approval and urge respective Senators of your place to support your voice. The U.S. Food and Drug Administration, one of the apex health bodies in the United States that holds power to pass-hold the pharmaceuticals product’s market launch, tried to ban certain health supplements earlier like - vitamin-B6 and NAC (N-acetylcysteine), re-categorizing them under the new drugs segment.
Featured Writer - Amit Rao
Google News Publication
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