• FDA Protects COVID-19 Vaccine Makers, Seeks Withdrawal of Competing Dietary Supplement

    Posted May 22, 2021: by Bill Sardi

    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 synthetically made in 1961and 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)  cysteine  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.

    The regulatory statute that authorizes emergency use of vaccines carries with it the caveat that as long as “there are no adequate approved and available alternatives.”  NAC may just be such an alternative that would block emergency use of COVID-19 vaccines.

    These first of a kind coronavirus vaccines are reported to be 95+% effective at preventing symptomatic infection, but that is only among those who are exposed and infected.  Since less than 1% of any population is infected at any given time, that is 95% of one-percent effectiveness.  Ninety-nine people have to be immunized to prevent 1 infection.  Actually it is more like 1 in 1000 for COVID-19

    The presumption is that all vulnerable unvaccinated individuals will eventually be exposed and infected by COVID-19 and will develop antibodies upon future infection.  But that is called natural immunity, something the medical community ignores.

    Rather than enhance the immune system with essential vitamins A, C, D, and trace minerals zinc and selenium, pharmaceutical companies want to artificially intervene and introduce their patented antibody-provoking vaccines.  There are three problems with that approach.

    1. A problem with this approach is that COVID-19 is rapidly mutating, just like influenza viruses, which renders these RNA-targeted vaccines useless.  There is not adequate data to show the COVID-19 vaccines now in use address variant strains of the virus.
    2. The B-I-G problem is that vaccine-induced antibody levels that neutralize COVID-19 viral infection are reduced in adults age 45 to 60 when compared with younger subjects.  Neutralizing antibody drugs are under development and may help those who don’t respond to COVID-19 vaccines, but until they gain regulatory approval, NAC is proposed to fill the therapeutic gap.
    3. Because it has been found that T-cells, not antibodies, control COVID-19 infection long-term, NAC becomes more attractive because of its ability to raise T-cell counts via its ability to increase glutathione levels.  Furthermore, NAC activates a type of white blood cell (natural killer cells) that kills virally infected cells.

    Hence, the idea to use NAC.  A report published in the British Medical Journal advocates NAC’s use at least as an adjuvant (secondary, auxiliary) treatment.

    NAC: Severe Cases COVID-19

    Moreover, clinicians writing in the British Medical Journal alert the medical community that “a distinctive feature of COVID-19 is the presence of mucus plugs in the respiratory tract that explain the severity of this disease… we recommend treatment with NAC to relieve bronchial obstruction.”

    OK, but that would typically be among severely infected patients in the ICU under a doctor’s care who would prescribe NAC.  But this does show NAC addresses both the severely infected as well as the vulnerable uninfected individuals.

    COVID-19 vaccines aren’t initially intended to save lives or prevent disease

    At this point it must be emphasized that current studies to gain licensure for COVID-19 vaccines are not designed to prove these inoculums prevent or cure.  The bar has been set very low to gain FDA licensure.

    The so-called measurable end points to gain licensure are 50% reduction in severity or prevention.  In other words, these vaccines don’t have to prove they save lives or even prevent infection to gain licensure, as long as they reduce severity of symptoms. (Page 14, Development & Licensure of Vaccines To Prevent COVID-19, Guidance For Industry, HHS, June 2020; COVID-19: Vaccines To Prevent SARS-CoV-2 Infection, Up-To-Date.com)

    COVID-19 mortality studies would take a few years to complete.  So, any data that would claim COVID-19 vaccines save lives is a long way off.

    NAC: Implied effectiveness

    Based upon a study published in 1997 showing 600 milligrams of oral NAC reduced flu symptoms from 79% to 25% in virus-infected subjects, NAC was recently suggested for use with COVID-19 infected patients.

    A report published in the journal Therapeutics & Clinical Risk Management proposes 600 milligrams/day of NAC would prevent COVID-19, particularly for health care workers who are repeatedly exposed to infected patients, says a report in Future Microbiology.

    Published studies also point to NAC as an effective antidote to vaccine side effects as well as being an immune booster.

    Several scientific reports are coming to the conclusion “the oral administration of NAC is likely to attenuate (reduce) the risk of developing COVID-19.”  Numerous clinical trials are underway to sort out NAC’s ability to quell COVID-19 coronavirus infection.

    NAC addresses spike protein

    NAC actually addresses the spike protein that is causing all the lung damage in COVID-19 this is explained and demonstrated eloquently in a report published in Circulation Research of April 2021 regardless of viral strain.

    Method of action

    Recently researchers investigated the biological activity stimulated by NAC.  Unexpectedly, researchers found NAC is a poor antioxidant but as a sulfur molecule converts to hydrogen sulfide, primarily in the cell energy compartments of cells called mitochondria, that actually raises glutathione levels and produces the health benefits.

    A hypothesis is that glutathione deficiency “is the most plausible explanation for serious manifestation and death in COVID-19 patients has been proposed.  NAC is proposed as the most obvious and already proven way of raising glutathione levels in respiratory disease.

    Safety profile

    NAC works with minimal side effects (sometimes nausea, vomiting) when properly dosed.  There is no disagreement that NAC is remarkably safe.

    To withdraw NAC from the open marketplace while thousands of people are hospitalized and many are dying, seems unconscionable.

    Of course, the confinement of NAC to prescription-only status would not likely extend to Mucomyst, which is an over-the-counter remedy for bronchitis.

    Withdrawal of NAC from store shelves would necessitate a visit to the doctor’s office to obtain a prescription, which adds cost to the consumer.

    NAC is often used by mothers for behavioral conditions (not diseases) that affect their children, such as skin picking, hair pulling, or nail biting (which affects a surprising 20-30% of the population), or for simple chronic bronchitis which affects 9.5 million Americans or 4% of the population, would appear to be harmful.

    In a sane world, there ought to be an emergency use provision for NAC to quell the current COVID-19 pandemic.  Consumers might want to purchase a bottle of NAC for health security reasons while they are still on store shelves.  In the meantime, let’s see where this standoff between the supplement industry and the FDA ends up.

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