NMN Sales Ban: Why Is the FDA Delaying Action on NMN?
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In this session , we will introduce the FDA's indefinite extension of its measures against NMN following the NMN sales ban .
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In March 2023, the Natural Products Association (NPA) and the Natural Health Alliance (ANH) requested that the FDA not exclude NMN from its definition of a dietary supplement and not enforce its existing ban on the sale of NMN as a supplement.
According to a press release, Cara Welch, Director of the FDA Office of Dietary Supplement Program (ODSP), responded to the Natural Products Association (NPA) and the Natural Health Alliance (ANH) stating, “While we were unable to make a decision on your petition within the first 180 days due to competitive agency priorities under 21 CFR 10.30(e)(2), we would like to assure you that our staff is evaluating your petition.”
*21 CFR 10.30: The Citizen Petitions section of the Code of Federal Regulations (CFR) allows individuals and community groups to request changes to the FDA's healthcare policies. 21 CFR 10.30(e)(2) stipulates that petitions are prioritized based on both the subject matter and the agency's overall operations.
No substantive response from the FDA regarding NMN.
Here's the timeline for the FDA's marketing ban on NMN:
(1) In November 2022, the FDA approved NMN as a new dietary ingredient (NDI) for use in dietary supplement products.
(2) The FDA has decided to ban the sale of NMN, citing the fact that it has been approved as a new drug and has been the subject of clinical trials, thus not considering it a dietary supplement. In other words, the ban was not due to adverse effects of the raw material, but rather to ongoing drug review. Rather, this issue has become an issue because it disproves NMN's outstanding anti-aging efficacy and effectiveness.
(3) The citizen petition was filed after the FDA concluded in November 2022 that NMN could not be legally sold as a dietary supplement. If NMN were to be classified as a drug rather than a nutritional supplement, its price would inevitably rise as a prescription drug, and this cost would ultimately be passed on to consumers. Therefore, the petition has been pursued in the face of negative public opinion and opposition from several nutritional supplement companies.
(4) In this announcement, the U.S. Food and Drug Administration (FDA) has not yet decided how to respond to a citizen petition filed by the Natural Products Association (NPA) and the Natural Health Alliance (ANH) requesting the agency determine the regulatory status of NMN. Dr. Cara Welch, director of the FDA's Office of Dietary Supplement Programs, stated that the FDA has not made a decision due to "competing priorities."
Dr. Fabricant criticized the FDA's May 2022 reversal of its NDI approval to SyncoZymes (Shanghai) Co. Ltd., the Chinese manufacturer of NMN , calling the FDA's reversal "basically throwing away the NDI process."
The broad industry implications of the FDA's reversal of the decision to ban NMN sales.
The FDA's decision not to define NMN as a supplement has had a significant negative impact on the NMN market, which was estimated at approximately $280.2 million in the United States in 2022. Following the FDA's decision, Amazon, the world's largest retail platform, has banned retailers from selling NMN starting in March 2023.
Dr. Fabricant predicted that the FDA would "continue to stall" on the citizen petition. As a result, other sales platforms will eventually suspend NMN, potentially leading to years of delays without the FDA actually responding to the petition. He stated, "The FDA 's negligence has caused significant economic harm to the dietary supplement industry. This decision to indefinitely suspend NMN after six months of deliberation not only threatens the NMN market but also undermines the New Dietary Ingredient (NDI) process for manufacturers seeking to provide new and innovative ingredients for other dietary supplements to American consumers."
“We are disappointed, but not surprised, by the FDA’s continued inaction regarding NMN,” said Dr. Rob Verkerk, executive and scientific director of the Alliance for Natural Health (ANH). In a press release, Verkerk said, “ The FDA recognizes that its Investigational New Drug (IND) process favors pharmaceutical companies while limiting easy and affordable access to effective dietary supplements like NMN. “It appears that litigation will be necessary to lift the FDA’s ban on NMN through an IND submission without congressional intervention,” he said.
Currently, NMN is available as a health supplement through various global sellers, excluding Amazon. In Korea, NMN can be purchased through overseas direct purchase (up to six bottles at a time) using a personal customs clearance code issued by the Korea Customs Service .
As a representative seller of NMN, our company also used to have a raw material called NAC.
There is a precedent for sales being halted and then resumed by the FDA.
Unless Korean customs directly blocks NMN
We plan to continue selling to Korean customers.
With other NMN companies in the US
We will do our best to promote NMN as a health food, not a pharmaceutical product.
[References]
[1] NMN Update: FDA Responds to Petition with No Decision Due to 'Competing Priorities'
[2] NDI Déjà vu: Another Ingredient Falls Victim to FDA's Interpretation of Drug Preclusion Clause
[3] The FDA Prolongs Its Inaction Regarding NMN
[4] CFR - Code of Federal Regulations Title 21
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