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FDA on Thursday announced the availability of a draft guidance that, if finalized, would state the agency’s “intent to exercise enforcement discretion” regarding the distribution and sale of products labeled as dietary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The draft guidance, which is scheduled to be published April 22 in the Federal Register, was released three weeks after FDA reaffirmed its position in responses to two citizen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supplement’ and that are not otherwise in violation of the FD&C [Federal Food, Drug & Cosmetic] Act,” FDA stated in the draft guidance, which was announced via a constituent update.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revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement," FDA stated in the draft guidance.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To ensure FDA considers comments about the draft guidance before it begins its work on a final document, the agency has requested electronic or written comments within 30 days of the draft guidance’s publication in the Federal Register.
Although draft guidance, when finalized, will represent FDA’s current thinking on NAC products labeled as dietary supplements, the guidance neither creates any rights for anyone nor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.
A variety of NAC supplements are still available at Swanson: https://www.swansonvitamins.com/q?kw=n-acetyl%20cysteine
when this started I thought any geneticist should be able to handle it so I started making calls. I kept getting cancer geneticists. I finally got a hold of one and asked her. She told me. You had to have a referral. It took 4 months to get an appointment.
Major research hospital should have one that sees patients.
Any Doctor can order a genetics test. It doesn’t even need to be a Doctor. You just have to have a certain license number (can’t think of it at the moment)
But I have found that Doctors would rather a geneticist do it if possible.
There is an inexpensive way to get a whole exome test of your body with www.nebula.org. I am probably going to do that even though interpretation will be challenging.
Invitae Genetics has some panels paid for by drug companies if you meet certain criteria.
Thank you!
here is the link to the free ones
https://www.invitae.com/en/sponsored-testing/
but you still have to have someone order it. Even when I qualified for two family members to get free testing based on my results the family members had to go to someone in their state to get the order.
“Surprisingly walmart.com sells it. NOW brand”
personally, i feel the NOW brand is crappy ... swanson’s own brand is decent ... ones like jarrow are the best ...
Sounds about right.
i just checked Nebula. they actually have a sale at the moment. I missed the one around thanksgiving and have been watching for it to happen again. it’s $100 bucks off right now for the deep version of the test at $199. Usually it costs $299. dont know how long it will last. You do have to pay a subscription fee but if you have got a situation where you need this the subscription fee is peanuts
If you are just curious you can do 23andme version that gives you some analysis of your genes and upload the raw data to prometheus and get their analytics. I will warn you...deciphering the variations and what they mean is a challenge for a variety of reasons. You can do 23andme with a fake name
if you seriously need a look at your genes Nebula has got a sale today at 199 for the deep testing. That’s 100 bucks off what has been every time I have checked it this year.
it looks like nebula kind of mickey moused around with the pricing.
they took off the ability to apply the $50 coupon code and the subscription yearly is a little higher while base price is $199.
This is kind of typical for genetics. I had a test that was billed for $6000 from myriad genetics but if you have no insurance the price comes way down.
There is one called Avise for immune diseases. they bill the insurance $1700 but if you check a certain income level (and they supposedly dont check) it’s $45 if you dont have insurance. i think for one person the income level is something like $68k
Don’t you love how the FTC is always going after supplement manufacturers and sellers yet not one word on a product called ‘BEYOND MEAT’ that contains zero meat?
Shouldn’t they have to call it ‘Beyond Meet’ in the same way ‘Froot Loops’ isn’t named ‘Fruit Loops’ because there is no real fruit in it?
Bkmk health
What specifically is the FDA saying is bad now?
Thanks for the ping
A supplement called NAC.
Thank you!
Yes, you do try not to take more then the recommended dosage but acetaminophen can be easy to over do. It is in a lot of combination medicines. I try to only have single medicines, no combos, in the medicine cabinet but over the last two years sometimes the singles have not been available.
So NAC.
And it does help with my respiratory problems. So a twofer!
...the one I bought upset my stomach. I may try a different one.
____________________________
I had some issues the 1st time I tried it. Waited a few days and tried again, 1 600 mg capsule on an empty stomach, followed in 30 minutes with either kefir or some high probiotic yogurt. Works well.
“no combos”
totally!
Thanks.
This reminds me, it’s probably time for me to order more. I keep a running six month supply if not more, but I see my inventory is getting low. Thanks.
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