FDA changes in usage of NAC & it’s impact on Baseline+

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In July of 2020, the FDA sent warning letters to specific companies stating that N-acetyle-L-cysteine (NAC) cannot be lawfully marketed as a dietary supplement. In fact it was tested as a drug in the 1960s for treatment in acetaminophen poisoning and prevention of severe liver damage. With recent revelations of the efficacy of NAC in possibly treating and being highly effective as a component in drastically improving immune health, the FDA has decided to ban its sale as a supplement. This started with specific supplements used as hangover cures commonly sold on Amazon. With that, Amazon decided to continue the process of removing all supplements containing NAC from its website. Though there was a high amount of uncertainty for the rest of the year, in early 2021, the legality of NAC used and sold in supplement form was finalized. It’s expected that many retailers will be quickly pulling NAC off their shelves despite fundamentally disagreeing with FDA decisions. 

Under the Food, Drug, and Cosmetic Act, “products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.” Drugs must be evaluated by the FDA to determine safety and possible interactions with other FDA-approved drugs. 

NAC is an essential amino acid, we must consume it via supplementation because our body cannot create it naturally. NAC is a precursor to L-cysteine which is vital in replenishing levels of glutathione, an incredibly important antioxidant. L-cysteine is available through foods like animal proteins and legumes, but there are differences between the two amino acids. NAC independently is also an antioxidant. We’ve made it a key ingredient in Baseline+ to assist in detoxification of the liver. Healthy detoxification is necessary in the process of balancing hormone levels and reducing inflammation. 

When L-cysteine is in short supply within the body, our system will convert glutathione back into L-cysteine. So proper diet and supplementation is necessary for balance, especially when the immune system is under stress. 

NAC may also improve insulin resistance as well as increase ovulation and pregnancy occurrence in women with PCOS. Research has shown that NAC may be beneficial as part of treatment of psychological disorders like OCD and addiction.

Through research and confident decision making, we’ve resolved to replace NAC in Baseline+ with L-cysteine HCL. This form of L-cysteine is bound to hydrochloride to assist in absorption and still serves to promote higher levels of glutathione in the body. Serving the same purposes of NAC. L-cysteine HCL has still been shown to decrease inflammation, improve digestion, boost immune and lung health, and promote calm and feelings of well-being. L-cysteine HCL has also been shown to improve natural collagen production within the body. Though L-cysteine may be sourced from animal proteins, we’ve continued our commitment to being a vegan line and so our sources are plant based.

https://www.chiroeco.com/n-acetyl-cysteine-supplement/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649937/

https://mimicnews.com/fda-wants-to-ban-nac-now-that-it-combats-covid-19

https://health.economictimes.indiatimes.com/news/industry/n-acetylcysteine-a-promising-therapeutic-agent-or-just-another-fad-against-covid-19/82318877

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