NAC Supplement

NAC, n-acetyl-cysteine is the precursor to glutathione, protects your liver, lungs & so much more. Why then would the FDA want it banned? It became increasingly popular during the past year. As a therapeutic, it can relieve symptoms of respiratory conditions by acting as an antioxidant and expectorant, loosening mucus in your air passageways. It helps replenish glutathione levels in your lungs and reduces inflammation in your bronchial tubes and lung tissue. It may lower heart disease risk by reducing oxidative damage to tissues in your heart and boost immune function with an almost complete restoration of natural killer cells. Last but not least, in immune-compromised situations, such as the flu, NAC may hamper the virus’s ability to replicate. This is why it was so popular, as it could reduce the illness’s symptoms and lifespan.

Now the federal agency has banned it, and nutraceutical companies have their legal team dealing with this unfortunate course of events.

Here’s the backstory.

The FDA’s records fail to reliably show the relevant section of the FDCA applies to NAC. In searching for the NAC drug FDA reported was approved in 1963 as an inhaled medication, CRN obtained a letter through a Freedom of Information Act (FOIA) request.
The letter contains what appears to be a handwritten approval date of 1963. This handwritten notation raises several questions about the reliability of this record, not the least of whether the approval date was 1963 or sometime later, why was the approval data handwritten, when the notation was made, and who made it. This is not the type of document that should be regarded as authentic.

Records suggest FDA didn’t approve an NAC drug “for oral use only until 2016, well after dietary supplement companies had been marketing NAC as a supplement. According to the “Orange Book,” which identifies drugs approved by FDA, NAC drugs were approved for inhalation and oral use as early as 1982, the trade association acknowledged.

FDA has failed to sufficiently explain its policy change, rendering it arbitrary and capricious as it was FDA’s longstanding policy to permit the marketing of dietary supplements containing NAC.

The legal teams state that the FDA is barred from enforcing its NAC policy due to the “equitable defense of laches.” The defense requires proof of (1) lack of diligence by the party against whom the defense is asserted, and (2) prejudice to the party asserting the defense,” the U.S. Supreme Court held in a 1963 case, Costello v. United States.

Some speculate this swift action is due to new clinical investigations into the use of NAC for the virus of the pandemic. The FDA claims that including NAC in a supplement makes the product an unapproved drug and thus illegal.

Hopefully, another therapeutic will not bite the dust.
Watch the YT video about NAC.

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