Recently, NAC has been in the news because it’s been banned from the market. Retail giant Amazon removed dietary supplement products that contain NAC after the FDA sent letters to seven companies warning them to pull their NAC-containing products. The companies claimed their product–a dietary supplement–cured hangovers, a claim that can only be made by a drug.
Supplements are not regulated the same way that drugs are, meaning there are no parameters as to how effective they actually are or how much each dosage should be. By selling products with these claims, consumers are exposed to potential side effects that have not been studied.
This ban is forcing companies to take a side in the battle between the FDA and consumers: by banning not just the product that’s claiming to cure hangovers, the FDA has instead opted to ban the ingredient itself.
Under the Federal Food, Drug, and Cosmetic Act, drugs are classified as products that intend to treat, cure, or prevent diseases. Because of this, they are rigorously tested and regulated for their effectiveness whether they are labeled as drugs or supplements. NAC was approved as a drug in 1963 but has been sold as a supplement, so it’s interesting it’s taken half a century for these letters to be issued.
The FDA has now decided to ban NAC because it was first studied as a drug. This is a bold claim because outside of the mentioned benefits, NAC has been shown to lower blood pressure, blood sugar, and even reduce the size of breast tumors. NAC as a drug and NAC as an ingredient serve different purposes. The Council for Responsible Nutrition argued for the FDA to change its position. The drug that was first studied in 1963 is inhaled and is not an oral supplement. All oral NAC drugs had already been withdrawn that were marketed before 2016, so over-the-counter NAC has been the only option now for decades.
NAC is not the only nutrient that is used as both a drug and supplement. Niacin, for example, is found in most grocery stores in vitamin form and available as Niaspan, the extended-release prescription-strength version. To ban NAC as a supplement limits how it can be studied for health benefits that are currently unknown.
Although Amazon removed several NAC-containing products, some are still being sold through their platform. There are other products that also act as a drug and supplement, including fish oil and potassium. Like NAC, fish oil, and potassium aren’t always sold as drugs or supplements but they also don’t make claims that would require them to be sold as drugs. This key difference is what brought NAC off the market.
Limiting the availability of NAC inhibits future research and puts it at a standstill. Due to the ban, there is currently no way of exploring other avenues of the benefits of NAC.
You can still buy NAC and it’s still available. It’s only banned as a supplement, not a drug, so it’s available with a prescription. Supplements flew off the shelves during the pandemic as it’s useful for opening up the lungs and thinning mucus. NAC is also useful for those who want their bodies to make more glutathione.
The reason for the banning of NAC isn’t because it’s both a drug and a supplement, it’s banned because of the claims made by several companies selling it as a supplement. A drug is used for treating ailments and diseases, while a supplement is treated like food and isn’t regulated by the FDA. Food isn’t regulated the same way as drugs, therefore the research and testing are completely different. However, since NAC has already been widely studied as a drug and supplement, it’s likely that it’ll make a comeback to the market eventually.
At this time it’s too early to tell when or if NAC will be sold on the market again as a supplement. It’s fairly likely that after it has been tested and regulated up to the FDA’s standards that we will see the powerful supplement return, and with a clearer idea of its benefits. In the meantime, it can still be prescribed for certain conditions.
NAC supports cognitive function, brain health, women’s reproductive health, and more. It’s a versatile and diverse nutrient that supports several areas of the body, which is why it’s crucial it still be studied both as a supplement and a drug.
Don’t miss part one of this article HERE.
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