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Posted on 07/02/2021 6:00:47 PM PDT by nickcarraway
By Meryl Nass, MD | May 16, 2021 Last July, FDA sent out warning letters to supplement companies, informing them that N-acetyl cysteine (NAC) could no longer be marketed as an ingredient in food supplements, using the justification that it was also a licensed drug.
FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.
But other drugs, such as Coenzyme Q10 and Vitamin D, are licensed as drugs but also permitted to be sold as supplements. And the federal government’s PubChem website lists many virtues of NAC.
In the case of NAC, it has been available as a licensed drug for 57 years in the US. It is widely used and very safe. Unlike many supplements, it has been extensively studied. Clinicaltrials.gov lists 541 studies for the search term ‘N-acetyl cysteine.’ Why did FDA suddenly decide its OTC use should be restricted?
This is especially troubling as a number of doctors have said it is useful in the treatment of Covid-19, especially during the late, cytokine storm stage, since it works as an antioxidant and a substrate for the production of glutathione. In fact, there is a growing body of literature on its benefits for Covid. Here is just one review.
Last week, Amazon stopped selling all products containing NAC. While no absolutely final decision has been made by FDA regarding NAC, it might be the third effective Covid treatment that the FDA has attempted to suppress, after the chloroquine drugs and ivermectin. Stay tuned.
A New Treatment for Pot Addiction [U.S. Government Moves to Ban it]
The government doesn't want anything out there that will shut down the marijuana gravy train.
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Thank you. :)
Yep... Can’t have anything that will compete against big Pharma profits.
Stupid Amazon!
Frankincense (Boswellia Seratta) used successfully for ulcerative digestive disorders for thousands of years is similar to how big pharma weakened the use of red rice yeast for cholesterol.
Pi$$es me off when you can’t use a natural supplement that big pharma decides to synthesize and then capture as their own.
Yeah, this ticked me off. I had been getting N-A-C Sustain, a unique product, on automatic delivery.
Theres nothing dangerous about nac
It must be some degree of effective for them to take it down.
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Did you actually order it? I have an order somewhere, but it’s backordered.
Weakened?
Red rice yeast does lower cholesterol. Used it myself some years ago and can vouch for that.
But, while it is natural, it is still a statin. And that is why I stopped taking it. Statin’s risk is not justified to me, not for the return.
I’ve been taking NAC for over a year. It helps my arthritis, along with its effects on COVID. I had COVID early this spring, and it was a very mild case. I credit NAC and my other supplements for helping me fight it. It’s very frustrating to have difficulty sourcing it now.
From Wikipedia
U.S. regulatory restrictions[edit]
The US Food and Drug Administration (FDA) position is that red yeast rice products that contain monacolin K are identical to a prescription drug and, thus, subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. District Court in Utah ruled in favor of allowing the product to be sold without restriction. This decision was reversed on appeal to the U.S. Court of Appeals in 2001.[6] In 2007, the FDA sent Warning Letters to two dietary supplement companies. One was making a monacolin content claim about its RYR product and the other was not, but the FDA noted that both products contained monacolins. Both products were withdrawn.[16] In a press release the FDA “...is warning consumers to not buy or eat red yeast rice products... may contain an unauthorized drug that could be harmful to health.” The rationale for “harmful to health” was that consumers might not understand that the dangers of monacolin-containing red yeast rice are the same as those of prescription statin drugs.[16]
A products analysis report from 2010 tested 12 products commercially available in the U.S. and reported that per 600 mg capsule, total monacolins content ranged from 0.31 to 11.15 mg.[17] A 2017 study tested 28 brands of red yeast rice supplements purchased from U.S. retailers, stating “the quantity of monacolin K varied from none to prescription strength”.[18] Many of these avoid FDA regulation by not having any appreciable monacolin content. Their labels and websites say no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications”. The labeling on these products often says nothing about cholesterol lowering. If products do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol, they are not subject to FDA action. Two reviews confirm that the monacolin content of red yeast rice dietary supplements can vary over a wide range, with some containing negligible monacolins.[19][20]
Ping to Article-ICYMI
FDA Attempts to Stop OTC Sales of N-Acetyle Cysteine, an Adjunctive Treatment for Covid-19
Aletho News ^
Posted on 7/2/2021, 8:00:47 PM by nickcarraway
By Meryl Nass, MD | May 16, 2021 Last July, FDA sent out warning letters to supplement companies, informing them that N-acetyl cysteine (NAC) could no longer be marketed as an ingredient in food supplements, using the justification that it was also a licensed drug.
https://freerepublic.com/focus/f-chat/3972975/posts?page=1#1
Bkmk government
thanks ... i bought the ultra ajipure version for a few bucks more ...
looks like jarrow has chickened out and no longer makes their time-released NAC Sustain ... i always take that gram for gram with acetaminophen as a safety measure ... the phase I metabolite of acetaminophen is extremely toxic to the liver and will accumulate if too much is taken because Phase I metabolism occurs much quicker than Phase II, which is limited by the availability of glutathione ... glutathione supply can be increased by taking NAC along with acetaminophen because NAC is converted by the body in glutathione ... in fact, IV NAC is used in ERs to try to counter acetaminophen overdose ...
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