The online retail giant announced in May 2021 that it was removing NAC-containing supplements from its virtual shelves in response to an FDA announcement that the ingredient was not deemed to be a legal dietary ingredient.
But Amazon’s stance now appears to have changed, seemingly in response the recent guidance from the Agency that it will exercise enforcement discretion for NAC, basically turning a blind eye to the sale of NAC-containing dietary supplement products so long as products are not making non-compliant disease claims.
NutraIngredients-USA contacted Amazon but did not receive a comment prior to publication. The company’s dietary supplement policies, which appear to be inline with the recent FDA guidance on NAC, can be found HERE. To read the full FDA guidance, please click HERE.
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), welcomed the move, telling us: “We’re excited about the development.”
Dan Richard, NOW Health Group, Vice President of Global Sales and Marketing, told us that NOW is aware of the change. “Amazon has communicated this to our company, though in a very low-key and quiet manner. We are in process of starting up sales of NAC on Amazon again,” he said.
Megan Olsen, Senior Vice President and General Counsel for the Council for Responsible Nutrition (CRN), told NutraIngredients-USA: “CRN has been in contact with Amazon about NAC since we first heard they were taking products off their platform last year. We immediately notified Amazon of FDA’s enforcement discretion – both the draft and final guidance and had conversations with Amazon about updating their policy to allow NAC supplements that complied with the FDA’s policy.
"We are pleased to confirm with our members that companies able to put NAC supplement products back on Amazon’s platform and that Amazon is recognizing the FDA actions allowing for the continued sale of this beneficial supplement.”
N-acetyl cysteine (NAC) is a derivative of the amino acid L-cysteine and a precursor of the cellular antioxidant glutathione. It is naturally occurring in foods like onions and garlic.
Despite being used as in supplements since the early 1990s, and therefore an “old dietary ingredient” according to the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA declared in July 2020 that NAC was not a legal dietary ingredient because of its prior approval as a drug. NAC was first approved as an inhaled mucolytic drug in 1963.
The NAC issue has been a concern for the industry as it saw the drug preclusion principle (which states an ingredient cannot be used in supplements if it is first approved as a drug) applied to an old dietary ingredient with decades of safe use. Many in the industry had assumed that such issues were settled for old dietary ingredients once DSHEA came into effect on Oct. 15, 1994.
In response to the FDA statements and market concerns, Citizen’s Petitions were filed in the summer of 2021 by NPA and CRN. The CRN petition asked the Agency to reverse its position that NAC-containing products cannot be dietary supplements. The NPA petition asked FDA to either determine that NAC is not excluded from the definition of a dietary supplement or, in the alternative, initiate rulemaking to make NAC a lawful dietary supplement under the Food, Drug, and Cosmetic Act.
At the end of March of this year, the Agency denied the CRN petition in its entirety and denied the first part of the NPA petition. In response to NPA’s request for rulemaking, FDA said it was considering this.
FDA’s Welch: Three to five years…
Speaking at the Dietary Supplement Regulatory Summit in Washington, DC, this summer, Cara Welch, PhD, FDA's director of the Office of Dietary Supplement Programs, said she hesitated on providing a definite timeline for NAC rulemaking.
“If we were to proceed, we would start with the proposed rule, those comments of course are really important and then move ahead to final rulemaking as appropriate. So that’s a ways down the road, I believe FDA’s estimate for traditional notice comment and rulemaking is 3-5 years,” said Dr Welch.
“We want to continue to look at the information we have on NAC. Rulemaking does require a certain amount of effort to ensure we're meeting all of what we think we need to issue a post rule and this would be precedent-setting. This is the first time that we are looking at this rudimentarily and so I think in a sense it may require additional work to make sure we understand how we want to use this authority–even outside of just NAC.”