The FDA (Food and Drug Administration) may potentially force supplement companies to stop the availability of NAC (N-acetylcysteine) as a dietary supplement and may make it available by prescription only.

NAC was for sale as a dietary supplement pre-DSHEA and should be considered a grandfathered ingredient. We want to see it continue that way.

Some studies have shown NAC could help lessen the severity of COVID-19, which should make it more widely available to the public, not harder to obtain. This is just another way for Big Pharma to make more money off the ailments of the public.

NAC has been available as a dietary supplement for almost 60 years. It is an antioxidant made up of a chain of three amino acids and is a precursor to glutathione, the master antioxidant. It supports the liver, the lungs and is instrumental in helping detoxification and the alleviation of many symptoms. It helps lessen oxidative stress. 

There is an ongoing case between the FDA and the Council for Responsible Nutrition.

As WholeFoods Magazine stated:

“In July, CRN states, FDA sent out warning letters informing companies that the FDCA prohibits companies from marketing products containing NAC as dietary supplements because the ingredient was first approved as a drug.

CRN challenged this position in a letter sent to FDA in December, noting concerns about the reliability of decades-old NAC drug approval records; suggesting that FDA’s past conduct towards NAC bars this “sudden and drastic change in practice,” a reference to the fact that FDA has considered dozens of structure-function claims for NAC without objection; and questioning the legality of FDA’s interpretation of the drug preclusion provision of the FDCA as being retroactive—in other words: Given that NAC has been marketed as a dietary supplement for years without FDA action, and noting FDA’s previous approval of structure/function claims for supplements containing NAC, can FDA now reverse those decisions due to the drug preclusion provision?”

The FDA failed to explain the policy change before sending warning letters to several NAC manufacturers in July 2020. The CRN wrote:

“In response to the extensive history of NAC being treated by FDA as a dietary supplement, manufacturers have invested substantial resources to develop hundreds of such products, and thousands of consumers have come to rely on such products to meet their daily nutritional needs.

Now, FDA has decided to not only change its decades-long policy, but to do so through the issuance of warning letters that fail to provide any reasonable explanation for this consequential policy shift.”

I, like many thousands of people with temporary or chronic illness, use NAC regularly to help thin mucus, support our organs, detoxify more efficiently, and alleviate symptoms. 

Join me in signing this petition to stop the FDA from allowing their greed and control to harm the health of the public. Help us keep NAC readily available.

Here are some potential benefits of NAC, as stated by medical articles and studies:

N-Acetyl L-Cysteine has a wide range of health benefits. It assists in the production of antioxidants. NAC may support the kidneys, liver, and lungs and promote healthy immune function. It may also contribute to healthy skin and support sexual health and brain function.

NAC supplements can effectively increase levels of glutathione in the body.

Glutathione deficiency is a big contributor to oxidative stress. Oxidative stress contributes to the pathogenesis of several diseases. Some of these diseases include liver disease, Alzheimer's disease, Parkinson's disease, cancer, heart attack and diabetes. 

Because of its ability to thin mucus, it’s been found helpful for those with COPD, bronchial distress and other viruses and diseases that cause chest congestion.

NAC contributes cysteine, which one study found is inversely associated with the risk of stroke in women. Two papers concluded that NAC shows promise in the treatment of psychiatric conditions, including addiction, compulsive disorders, schizophrenia and bipolar disorder. The treatment may benefit those whose condition has not responded to drugs and medication.

One team of scientists presented a review on different applications NAC may have in a variety of health conditions. This includes reducing insulin resistance and providing a therapeutic approach in the treatment of polycystic ovary syndrome.

Based on evidence, they hypothesized that NAC may reduce the number of premature births and recurrent pregnancy losses by exerting an anti-inflammatory effect in women who have bacterial vaginosis, a risk factor of preterm delivery and low birth weight.

They found there were positive influences that NAC exerted in patients who have ulcerative colitis, including decreasing oxidative stress, lowering cell apoptosis and improving recovery in the colon.

Lab studies and animal models have demonstrated NAC can protect normal cells from radiation therapy and chemotherapy but does not protect cancer cells.

NAC has preventive effects against airway hyperresponsiveness in animal studies using acute exacerbation of asthma. In a review, they found NAC was “safe and well tolerated” without considerable side effects.