Madison Area Lyme Support Group

FDA’s Continued Assault on NAC and Promising Pushback

N-acetylcysteine (NAC) is a powerful antioxidant which contains the amino acid cysteine, a precursor to glutathione, that was approved as a drug in 1963 and has been widely used as a nutritional supplement since it is not found in food.  It is also used in prescription form as an antidote for acetaminiphen-induced toxicity as well as for depression, precancers, HIV & AIDS, to alleviate cancer treatment side-effects, and as a mucolytic agent for upper respiratory conditions such as COVID. 

The FDA abruptly decided in 2020 that NAC should suddenly require a doctor’s prescription and issued a warning to seven companies who were illegally selling hangover products with NAC in them.  Amazon then completely stopped selling it.

The timing of this abrupt decision is suspicious at best, since NAC very well may help lower the risk of COVID and the fact those with glutathione deficiencies have worse outcomes.  Many doctors have recommended NAC as part of an early at-home treatment that is safe, cheap, and effective.  Within this article is a video where a pulmonologist explains NAC is necessary to reduce the oxidative stress associated with severe COVID and thus may significantly impact the sales of antiviral drugs.  Drugs, in fact, which our conflict-riddled public health ‘authorities’ have a stake in.

Natural Products Insider reports, the warning letters stated that NAC could not be “lawfully marketed in dietary supplements because it was first studied as a drug in 1963.” The Council for Responsible Nutrition (CRN) sent a letter in December 2020 to the FDA’s Office of Dietary Supplement Programs describing the position as “legally invalid.”

To appear reasonable, the FDA announced they wanted more information on how NAC has been marketed as a dietary supplement.

Quick to respond, numerous associations have submitted proof to the FDA of numerous NAC-containing products sold pre-DSHEA and that the FDA is misapplying the prior drug-restriction to NAC, and that it can’t be applied retroactively from the date of DSHEA’s enactment.  They also submitted comments, countering FDA’s safety concerns, noting that NAC has been in use for decades and that FDA had access in that time to its own Adverse Event Reporting System, to manufacturing facility inspections, and other tools, as well as data from publicly available research studies conducted on NAC or NAC-containing formulations. CRN pointed to data provided by Pure Encapsulations, a brand marketed by Nestlé Health Science, which includes nine years of adverse event data for the company’s supplement containing NAC:

• From 2013 to the present day, the adverse event rate per unit sold of NAC-containing products was only 0.002%
• those adverse events were mild and resolved on their own
• Sevo Nutraceuticals reported fewer than 10 adverse events for approximately 500,000 unites sold

In a press release, Megan Olsen, CRN’s VP and Associate General Counsel, commented:

“The agency’s continued failure to address the singular legal issue on the table is inexplicable. Their refusal to act is causing harm to consumers and businesses.”

A press release summarized The United Natural Products Alliance’s (UNPA) position on the matter as of January 25, 2022:

• The FDA, in attempting to exclude NAC from the dietary supplement market, is acting outside of its statutory jurisdiction and authority.
• UNPA provided definitive evidence of pre-DSHEA use of NAC – it is an ODI (Old Dietary Ingredient), NAC is safe, and there is broad agreement on this.
• The UNPA NAC Working Group will pursue this important issue until a proper outcome is reached, which is recognition of NAC as a lawful ODI and FDA abandons its misguided retro lookback policy.

The FDA appears to be in hot-water these days and is embroiled in yet another fiasco. The FDA has long been accused of corruption, and ties to Big Pharma which has resulted in unsafe pharmaceuticals. Interestingly, while it approves and promotes toxic drugs like remdesivir and COVID injections which aren’t vaccines and have caused more adverse reactions and death than any other vaccine in the history of VAERS, it squashes safe supplements and proven drugs like NAC, vitamins D, C, zinc, and ivermectin which could improve cases and remove the need altogether for COVID injections. If you have less than 4 minutes, go here to listen to Dr. Kory passionately explain the situation. It literally brought tears to my eyes. Doctors who are truly attempting to help patients are bullied, censored, and shouted down. Kory’s frustration is tangible.

The current top-down, “one-sized fits all” approach to medicine puts everyone into a 4-cornered box regardless of medical history, health status, and individual needs. I highlight how this current dangerous, singular approach, which also includes mainstream media and Big Pharma colluding with public health officials, is removing our precious medical freedoms in this article, as well as is causing a shortage of medical professionals in the U.S. Front-line workers, who were heroes a year ago but are currently being bullied and summarily dismissed without a job or pay simply for not taking an experimental, fast-tracked gene therapy that doesn’t stop infection or transmission.

Unless we educate others and speak and act now it may be too late to roll this back, and it will restrict Lyme/MSIDS patients more than they already are. Mark my words.