The FDA could be preparing to unleash an anti-supplement policy as early as next year that could eliminate tens of thousands of products from the market—in the middle of a pandemic. Action Alert!
Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.
Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.anh Clock Ticking For Supplements