20/02/2026
🎉🎉🎉重大勝利！美國 FDA 正式確認 NMN 膳食補充劑的合法地位🎊🎊🎊
Major Victory!
U.S. FDA Formally Reinstates NMN as a Lawful Dietary Supplement
2025/12/11
iHealth 親愛的會員：
我們懷著振奮的心情，向您宣布一項關於 NMN（菸鹼醯胺單核苷酸）在美國監管
地位的重大消息。美國食品藥品監督管理局（FDA）已正式扭轉其先前的裁定，確認
NMN 可作為膳食補充劑在美國市場上合法銷售 。
This is a joyful and significant announcement for all our loyal members. The U.S.
Food and Drug Administration (FDA) has officially reversed its previous determination,
confirming that NMN (Nicotinamide Mononucleotide) can be lawfully marketed as a dietary
supplement in the United States.
一、NMN 監管的來龍去脈：一場法律的撥亂反正
👉I. The Regulatory Journey of NMN: A Legal Reversal of Course
NMN 的監管之路充滿挑戰。為了讓您更清楚地了解這次勝利的意義，我們將為您
回顧過去幾年 NMN 監管地位的關鍵變化：
The path to securing NMN's status has been arduous. To fully appreciate the
significance of this victory, here is a concise timeline of the key regulatory changes over the past few years:
時程
(Timeline) 事件 (Event) 說明 (Description)
👉May, 2022首次承認（Initial Acknowledgment)
FDA 向主要 NMN 製造商（如 SyncoZymes
(Shanghai) Co. Ltd.）發出「新膳食成分通知
（NDIN）」的「不反對」信函，業界稱之為「好日子信函」（Good Day Letter），承認其合法性 。
The FDA issued a "no-objection" letter for the New
Dietary Ingredient Notification (NDIN) to major
NMN manufacturers (such as SyncoZymes（Shanghai) Co. Ltd.), which the industry termed a
"Good Day Letter," thereby acknowledging its legality.
👉Nov, 2022 地位撤銷
(Status Revoked)
FDA 突然推翻先前的裁定，援引《藥物排除條
款》（Drug Preclusion Clause），指出 NMN 已被授權作為新藥進行調查（MIB-626），因此宣布NMN 不得作為膳食補充劑銷售 。
The FDA abruptly reversed its previous ruling,citing the Drug Preclusion Clause, pointing out that NMN had been authorized for investigation as
a new drug (such as MIB-626), and thus declared that NMN could not be sold as a dietary supplement.
👉2023–2025 業界反擊
(Industry Fightback)
天然產品協會（NPA）等組織對 FDA 提起訴訟，
並提交修正公民請願書，挑戰 FDA 對法律的錯誤解讀和「追溯性執法」 。
Organizations like the Natural Products
Association (NPA) filed lawsuits against the FDA
and submitted an amended citizen petition,
challenging the FDA's misinterpretation of the law and "retroactive enforcement"
👉Sep, 2025 正式扭轉
(Formal Reversal)
FDA 在 2025 年 9 月 29 日正式回應公民請願書，修訂其對「搶市條款」（Race-to-Market Clause的解釋，承認 NMN 在被授權作為藥物調查之前，即已作為膳食補充劑在美國銷售，確認 NMN不應被排除在外 。
On September 29, 2025, the FDA formally
responded to the citizen petition, revising itsinterpretation of the "Race-to-Market Clause." It acknowledged that NMN had already been marketed as a dietary supplement in the U.S.before it was authorized for drug investigation,
confirming that NMN should not be excluded.
👉Dec, 2025 最終確認（Final Confirmation)
FDA 於 2025 年 12 月 2 日發函，正式恢復了 NMN產品的「好日子信函」狀態 。 NMN 作為膳食補充劑的合法地位得到最終立 。
On December 2, 2025, the FDA issued a letterformally reinstating the "Good Day Letter" statusfor NMN products. The legal status of NMN as a dietary supplement was thus finally established.
二、對長期服用 NMN 會員的意義
II. Significance for Long-Term NMN Members
這項裁定對於像您一樣長期信賴 NMN 功效的愛健康會員來說，是一個極大的好息：
This ruling is excellent news for iHealth members who have long trusted NMN's
benefits:
👉1. 市場穩定性獲得保障： 過去的監管不確定性已告終，現在 NMN 的合法地位在聯邦層面得到明確，確保了產品的持續供應與市場穩定性 。
Market Stability Guaranteed: The past regulatory uncertainty is over. NMN's legal
status is now clear at the federal level, ensuring stable and continuous product
supply.
👉2. 品質與信心的保證： 這項勝利是對整個 NMN 產業合法性與品質的認可，您所選擇的健康生活方式獲得了最高的法律保障.
Assurance of Quality and Confidence: This victory confirms the legitimacy and
quality of the NMN industry, ensuring your chosen healthy lifestyle is protected by
the highest legal standards.
三、愛健康的承諾與準備
III. iHealth's Commitment and Preparation
愛健康始終將您的健康權益放在首位。面對這次監管變化，我們已採取必要措施，
確保您能持續安心地使用我們的產品：
iHealth always puts your health interests first. In anticipation of this regulatory
resolution, we have taken proactive steps to ensure you can continue using our products with confidence:
• 確保產品合規性 (Ensuring Product Compliance): 我們持續與供應鏈夥伴合作，確保所有 NMN 原料皆符合最新的法規要求，包括 美國食品藥品監督管理局 FDA 最終確認的 NDI 狀態 。
We continue to collaborate with our supply chain partners to ensure all NMN raw materials comply with the latest regulatory requirements, including the FDA’s final confirmed NDI status.
• 自由銷售證明書 (the Free Sale Certificate): 我們早在這些爭議過程中積極準備並早已取得由 美國食品藥品監督管理局 FDA 簽發的自由銷售證明書 (Free Sale
Certificate)，這是產品在國際市場流通的重要法律依據，證明其符合所有美國法規，我們的產品可以在美國市場合法銷售。
We proactively prepared for and have already obtained the Free Sale Certificate
issued by the FDA during these contentious periods. This is a crucial legal basis for the product's circulation in the international market, proving its compliance with all U.S. regulations and confirming our product's lawful sale in the U.S. market.
面對瞬息萬變的各項規定，我們將繼續緊密關注 NMN 及其它膳食補充劑的監管發
展，為您提供最優質、最安全、最可靠的健康產品。
We will continue to closely monitor the regulatory development of NMN and other
dietary supplements to provide you with the highest quality, safest, and most reliable
health products.
iHealth 團隊敬上
Sincerely yours,
The iHealth Team
參考文獻 (Reference)
以下是本次聲明所依據的官方新聞稿與法律文件連結：
日期 (Date) 類別 (Category) 事件描述 (Event Description)
2025/12/10 最終勝利新聞（Final Victory News)
FDA 在 NPA 訴訟後恢復 NMN 作為膳食補充劑的地位 (NPA 官方新聞稿)
FDA Reinstates NMN as Dietary Supplement After NPA Lawsuit (NPA Official Press Release)
https://www.npanational.org/news/fda-reinstates-nmn-as-dietary-supplement-after-npa-lawsuit.
2025/9/29
推翻藥物排除
(Reversal of Drug Exclusion)
Amid Pressure From NPA, FDA Declares NMN
Lawful In Dietary Supplements (NPA 相關新聞稿)
Amid Pressure From NPA, FDA Declares NMN
Lawful In Dietary Supplements (NPA Related Press Release)
https://www.npanational.org/news/amid-pressure-from-npa-fda-declares-nmn-lawful-in-dietary-supplements/
2022/11/4
原始撤銷文件
(Original Revocation
Document)
FDA 對 SyncoZymes 新膳食成分通知 (NDI 1240)
的補充回應信函 (證明 2022 年撤銷)
FDA Supplemental Response Letter to
SyncoZymes Regarding New Dietary Ingredient Notification (NDI 1240) (Documenting the 2022 Revocation)
https://downloads.regulations.gov/FDA-2022-S-0023-0027/attachment_2.pdf
2022/2023
公民請願備案
(Citizen Petition Filing)
NPA 公民請願書 (修正版) 於 FDA 法規資料庫中的備案號碼
NPA Citizen Petition (Amended) Filing Number in the FDA Regulations Database
