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N-acetyl L-cysteine (NAC) now a Restricted Product on Amazon

by Seller_mZlwS8hcPpVJQ

N-acetyl L-cysteine (NAC), a dietary supplement, has been flagged as a “drug-only active ingredient” on Amazon.

Several of our listings have been flagged for product compliance policy issues and product detail pages taken down.

It seems some FDA warning letters sent during summer 2020 to several “hangover cure” products which contained NAC have made it to the ranks of Amazon policy bots. Despite NAC being listed on CRN’s ODI list, it seems it is now a restricted product.

A friendly “heads up” to other supplement sellers active on this forum.

Tags: Compliance, Detail page, Listings, Pricing, Restricted Products
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Seller_fGluy2Rns9Cfx
In reply to: Seller_mZlwS8hcPpVJQ's post

That’s got to be an 8 figure product on Amazon…

no joke

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Seller_LMf9CF5P8NlmA
In reply to: Seller_mZlwS8hcPpVJQ's post

I see them available on Amazon, what does your compliance note from Amazon say?

here is Amazon’s choice:

I ask because I get stuff from Amazon saying that products are against some policy or another and I end up sending Amazon back links to products that they are telling me are against policy.

I havn’t seen a complete removal of a supplement in a long time on here.

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Seller_sUfyk7ajzPzny
In reply to: Seller_mZlwS8hcPpVJQ's post

@ASV_Vites, may I ask if you can weigh in here with your usual pertinent advice?

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Seller_TomCeqnvu6WUU
In reply to: Seller_mZlwS8hcPpVJQ's post

We also had a product go down yesterday for having NAC as an ingredient.

I just don’t understand why Amazon would only target specific products with this ingredient, and leave others untouched. Especially when Amazon is still able to sell their version of the product.

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Seller_8heIxAf1mLwgp
In reply to: Seller_mZlwS8hcPpVJQ's post

Reading that ad made me get up off the chair and brew some green tea.

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Seller_bWJDvYx2wtfAj
In reply to: Seller_mZlwS8hcPpVJQ's post

Supplement listings are getting hit extremely hard right now.

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Seller_fGluy2Rns9Cfx
In reply to: Seller_mZlwS8hcPpVJQ's post

I’ve been told by an insider, that this is the FDA’s doing

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Seller_PgTujaWEOtEnD
In reply to: Seller_mZlwS8hcPpVJQ's post

Here is what our amazon rep says about why straight NAC products are still on amazon, while multi-ingredient supplements containing NAC are being removed:

Essentially, to sell NAC on Amazon, NAC must be the only active ingredient. It cannot be included in a multi-vitamin or any supplement with other active ingredients. This violates Amazon’s Drugs & Drug Paraphernalia policy. Please see the below blurb which contains the exact FDA guidelines around NAC. The Restricted Products team is identifying and removing all ASINs which contain NAC plus additional active ingredients. Unfortunately, there are no appeal paths for this decision. Please take a look at the linked policy and the below statement and let me know if you have any questions.

Based on the product label, it appears that you intend to market your product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. Your product cannot be a dietary supplement, because it does not meet the definition of dietary supplement under section 201(ff) of the Act [21 U.S.C. § 321(ff)]. 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.

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Seller_AE7DG5jgcMHeh
In reply to: Seller_mZlwS8hcPpVJQ's post

Amazon removed our listing saying the same thing.

The problem is that our product is Glutathione and there is no NAC. We appeal and they answered again that NAC is not allowed.

There is more than 1,000 Glutathione selling on Amazon right now and they removed our listing saying that our product contain NAC.

I can’t understand.

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Seller_mZlwS8hcPpVJQ
In reply to: Seller_mZlwS8hcPpVJQ's post

Same. We now have 14 listing suppressed - none of which have NAC in them.

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