FDA Protects Covid-19 Vaccine Makers Seeks Withdrawal Of Competing Dietary SupplementBy Bill Sardi with Matthew Sardi
May 22, 2021
Amazon Appeases FDA Removes Sulfur-Based Dietary Supplement From Online Offerings Because It Cures COVID-19 And Threatens Vaccine Emergency-Use Provisions.
Late last year (2020) the FDA issued a warning letter that a sulfur-based dietary supplement couldn’t be lawfully marketed because it was first studied as a drug in 1963 and marketed in that same year under the trade name Mucomyst to break up mucus accumulation in the upper respiratory tract (bronchus, lung).
The dietary supplement industry legally challenged the FDA over this categorical restriction for use solely as a drug to treat disease to the exclusion of its use to promote health, which is the what dietary supplements are permitted to claim.
In May of 2021 Amazon.com, obviously the major online marketer of dietary supplements, caved in to the FDA and removed the sulfur-based pills, called N acetyl cysteine, or NAC for short, from its online offerings. The dietary supplement industry is advising its members to continue selling NAC supplements. The FDA and supplement industry are in a standoff.
The FDA holds that any marketer of a dietary supplement like NAC cannot make any claim that their products prevent, treat or cure any disease. The first use of the molecule determines whether it is classified as a prescription-only drug or commercially available nutraceutical without need for a doctor’s prescription.
History of NAC
NAC lives two lives— one as a drug and one as a supplement. A guide to the use of Mucomyst can be found online at drugs.com. Mucomyst is categorically on both sides of the Rx vs non-Rx issue as it is an over-the-counter non-prescription drug, not a dietary supplement.
NAC has been marketed for many years as a non-prescription dietary supplement and is largely without side effects when used properly.
NAC was first [url=https://www.sciencedirect.com/topics/neuroscience/acetylcysteine#:~:text=2 N%2DAcetyl Cysteine (NAC,%2C %26 Rumack (1988).]synthetically made in 1961[/url]and patented by Mead Johnson in 1965 as an agent that broke up mucus in the respiratory tract in 1986 and as the antidote for acetaminophen (Tylenol) overdose poisoning of the liver in 1988.
NAC was first noted as a molecule that can restore glutathione levels in 1991 (pronounced gloo-tuh-thai-own), glutathione being the master antioxidant in the human body. The chemical pathway for glutathione is N-acetyl cysteine (NAC) à cysteine à glutathione.
L-cysteine, the sulfur-based precursor to glutathione, is found in garlic, eggs and fowl.
NAC’s presence in garlic has been confirmed. So, it could be said that NACs first use was as a component of dietary garlic that preceded its use as a synthetically produced drug molecule in 1963. But certainly, the first use of synthetically-made NAC was for a disease – bronchitis.
An FDA lawyer says: “We do not favor anybody. We read the law. We look at facts, not favoring one commodity over another, and we make our determinations.” But the FDA may have another motive for its timing to take NAC off store shelves.
NAC supplements don’t claim they treat diseases
NAC is marketed today without any disease claims so, what is the big stink over?
It’s about NAC curing COVID-19. In its overcommitment to vaccination to quell infectious diseases, the FDA appears to be hiding behind its own regulations on behalf of vaccine and drug makers who are allowed to market their experimental vaccines under emergency use provisions of the law given that COVID-19 allegedly threatens the life of every human being on the planet.
MORE HERE: https://www.lewrockwell.com/2021/05/no_author/fda-protects-covid-19-vaccine-makers-seeks-withdrawal-of-competing-dietary-supplement/
Thanks to: https://www.lewrockwell.com