Ultimately, NAC is largely used to build antioxidants – and it’s an immediate precursor to one of the most potent antioxidants in the human body, glutathione.
Glutathione helps with tissue building and repair, and plays an important role in effective immune function.
Now, you may have heard that NAC is banned, or is set to be banned, by the FDA.
The reason being, basically, the FDA believes NAC should be categorised as a regulated pharmaceutical product, rather than a food supplement.
They think this because in 1963, and then again in 1985, NAC was approved as an inhaled agent to treat respiratory conditions, and respectively then an oral medication, to help treat acetaminophen (or, as most of us outside of the US know it as, paracetamol) toxicity.
In effect, they are trying to recategorise this food supplement, that has been available in food supplement form for over 30 years (and thus deemed to be safe under the ‘Grandfathering’ rule of the Dietary Supplement Health and Education Act of 1994).
This creates problems for the FDA – since it’s a fairly unprecedented set of circumstances.
According to the rules laid-out by the Dietary Supplement Health and Education Act, NAC is absolutely permitted to be sold given the length of time it has been available on the marketplace for, in food supplement form.
It’s also important to note that the Council for Responsible Nutrition states that when congress passed this 1994 act, they specified that although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.
Now, the FDA’s argument against continuing to permit NAC in the market is not based on it being unsafe or concerns around its safety. It is purely based on a ‘technicality’ of product categorisation. It’s also pertinent that the patents on which they are arguing ‘pharmaceutical classification’ are long expired.
It’s also important to note that the FDA has not explicitly announced that it intends to ban the sale of NAC-containing supplements – the warning letters from the FDA to NAC brands and manufacturers, which prompted this scare, were based specifically on a spurious claim that NAC can help cure hangovers – a claim that carries no scientific evidence or approval for use on packaging.
So, quite rightly – the FDA was doing the job it should do in these cases – stopping false or unsubstantiated claims being made.
What amplified this situation into something far more concerning was when Amazon interpreted the FDA’s warning letters as impending action against NAC in general – and effectively banned the sale of all NAC-containing products from its marketplace in May 2021.
This prompted concern from supplement brands and manufacturers, and from consumers alike – since this had a marked effect both on the sales and the availability of NAC supplements.
In summary though – although the FDA can wield their axe on supplements of concern – they really are facing a deep web of legislation to prevent NAC from continuing to be sold, and there are terms – such as not imposing unreasonable regulatory barriers – that they would, at this stage and with the angle they are taking, and evidence they are basing this angle on, have to clearly break in order to impose the ban.
So, all evidence and arguments considered, it looks fairly unlikely that NAC will be banned by the FDA anytime soon. It seems a series of knee-jerk reactions by major retailers, and misinterpretation of the FDA’s initial warning letters, has led to a heightened fear that NAC will be banned.
So, there you have it. I hope this post provides you with some reassurance and the facts surrounding the supposed ban on NAC supplements.