Posted on 04/22/2022 10:38:49 AM PDT by nickcarraway
FDA on Thursday announced the availability of a draft guidance that, if finalized, would state the agency’s “intent to exercise enforcement discretion” regarding the distribution and sale of products labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine).
The draft guidance, which is scheduled to be published April 22 in the Federal Register, was released three weeks after FDA reaffirmed its position in responses to two citizen petitions that NAC is excluded from the definition of a dietary supplement because the ingredient was first approved as a drug in 1963.
FDA, however, is still considering commencing a rulemaking to permit the use of NAC in supplements. To date, the agency has not identified any safety concerns related to the ingredient.
“The enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of ‘dietary supplement’ and that are not otherwise in violation of the FD&C [Federal Food, Drug & Cosmetic] Act,” FDA stated in the draft guidance, which was announced via a constituent update.
Unless FDA identifies “safety-related concerns” during its continuing review, the agency said it intends to “exercise enforcement discretion” until it completes notice-and-comment rulemaking to permit the use of NAC in supplements or it denies the rulemaking request.
"While our full safety review of NAC remains ongoing, our initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement," FDA stated in the draft guidance. "In addition, NAC-containing products represented as dietary supplements have been sold in the United States for more than 30 years, and consumers continue to seek access to such products."
FDA said it would notify stakeholders by withdrawing or revising the guidance if it determined the enforcement discretion policy was no longer proper.
To ensure FDA considers comments about the draft guidance before it begins its work on a final document, the agency has requested electronic or written comments within 30 days of the draft guidance’s publication in the Federal Register.
Although draft guidance, when finalized, will represent FDA’s current thinking on NAC products labeled as dietary supplements, the guidance neither creates any rights for anyone nor is binding on FDA or the public, the agency said.
I bought some last week at Walgreens, but it was behind the pharmacy counter. The clerk didn’t know what I was talking about, but the pharmacist did. Told me in the future to ask for it a week before I wanted it. $8 for 60 pills?
Prepping supplies ought to include OTC meds and dietary supplements as well.
The best deals I have found are at Swanson Vitamins. They have good quality, often single ingredient supplements (if that’s important for you) and you can usually have them in a couple days.
Considering what the entrenched government is trying to do to us in regard to destroying our health, and what with supply chain issues, having at least a good multivitamin should be close to the top of everyones prep list. They seem hell bent on denying us anything that might even be remotely good for us.
Great advice. We stocked up, originally, when the ScamDemic started.
Have topped off, ever since.
Swanson’s has great sales, as well as these sites....I check all three, when getting ready to place an order....
https://www.allstarhealth.com/
Taking NAC can prevent that damage.
here we go.....
G Larry :” When your goal is Population Control, you can’t have too many effective healing agents available.... “
See especially Posts #22 and #23 for thoughts about your medical supplies and medicine cabinet; some sources mentioned
“Store what you use; and used what you store”
To be forewarned is to be forearmed for your and your families health !!
Evaluate what your needs may be now, and in the future
Remember that the supply chain is still crippled, China is effectively "Shut down",and what you are accustomed to may not be available
We definitely have regulatory capture of the FedGov public health establishment by Big Pharma.
Yes, it’s available at several places.
I bought it when I was suffering from chronic bronchitis, but the one I bought upset my stomach. I may try a different one.
“If you are on blood thinners the only thing you can use for pain is Tylenol. Which can damage your liver if you take fifty percent more then the recommended dose. Taking NAC can prevent that damage.”
totally! i ALWAYS take NAC with acetaminophen, and yes it’s the only thing i can take ... already on DAPT, so more aspirin is out, and other NSAIDs very bad for ppl with heart disease ...
Pretty much. They’re saying that even though it’s classed as a drug they don’t see any safety issues in treating it as a supplement.
They’re exercising their discretion and not regulating it.
Many here don’t understand what the FDA is doing.
Big pharma doesn’t like the idea of NAC being feely available (any more than they like the idea of ivermectin being readiy available) because it is a very useful treatment for certain conditions that competes with certain drugs sold by big pharma which are much more expensive. Big pharma wants medical tyranny over us to protect their profits.
I know of a few co-workers and friends who used NAC to get over extended coof problems(coughs, lung congestion, smell issues, etc). All anecdotal, of course.
“Unless FDA identifies “safety-related concerns””
Actually big pharma pounced on this opening when a study came out a few years ago suggesting NAC interfered with the body’s hypoxia sensing signaling, leading to fears it could result long term in pulmonary hypertension. This study was overblown using dosages that were much higher than most people take, and anyway there’s speculation that there are other mechanisms by which the body can override that errant sensing. Here’s the study:
https://www.sciencedaily.com/releases/2007/09/070904175353.htm
Rather ironic since NAC is now being studied as a preventative of pulmonary hypertension.
https://pubmed.ncbi.nlm.nih.gov/15862602/
And there is one other issue with NAC, it is one of the few antioxidants that can negate the anti-cancer effects of many herbs. Most supplements used for anti-cancer purposes rely upon their pro-oxidant effect to kill cancer cells, and NAC was shown in some studies to prevent that. Some supplements like grapeseed extract are advertised as being antioxidants actually become pro-oxidant after being metabolized in the body, but NAC isn’t one of them. So I take my dose of NAC in the morning, and my anti-cancer supplements in the evening so as not to cancel out their effects.
I’m not surprised, it’s a mucolytic and was once a prescription drug prescribed for that purpose. It also raises the body’s innate antioxidant glutathione, which itself has many benefits.
Surprisingly walmart.com sells it. NOW brand. Online only.
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