近期，FDA 发布关于某些 NAC 产品执法自由裁量权的最终指南。现将全文(网页链接：https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-final-guidance-enforcement-discretion-certain-nac-products）予以转载并附翻译文本予以参考，请有需要的单位及企业予以关注。
FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products
FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products | FDA
Constituent Update
What's New
November 29, 2023
Today, the FDA has added its systematic review of literature regarding N-acetyl-L-cysteine (NAC) to the Peer Review Agenda. The agency has completed its review of safety information related to NAC, which will now go through the peer review process as a next step. The FDA undertook this review as part of its evaluation of a citizen petition’s request for the agency to undertake rulemaking to provide that NAC is not excluded from the definition of “dietary supplement.”
August 1, 2022
The FDA is announcing the availability of a final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). This guidance explains our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This finalizes the draft guidance on this policy from April 2022. Please see the Federal Register Notice for additional information.
Original Constituent Update
April 21, 2022
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The draft guidance, when finalized, will explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This 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 are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
As we discussed in a recent response to two citizen petitions, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. However, we have not yet reached a final decision on one petitioner’s request to issue a regulation to permit the use of NAC in dietary supplements, and we are considering initiating rulemaking to provide by regulation that NAC is not excluded from the definition of dietary supplement. If, among other considerations, the FDA does not identify safety-related concerns as we continue our review of the available data and information, we are likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement.
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. In addition, NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. Accordingly, while the FDA continues its evaluation of the request to initiate rulemaking, the FDA issued this draft guidance to explain our policy regarding products labeled as dietary supplements that contain NAC.
Unless we identify safety-related concerns during our ongoing review, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (if we move forward with such proceedings) or we deny the citizen petition’s request for rulemaking. If the FDA determines that this enforcement discretion policy is no longer appropriate, we will notify stakeholders by withdrawing or revising the guidance.
To Submit Comments
To ensure comments about this draft guidance are considered before the FDA begins work on the final guidance, please submit written or electronic comments within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. You may submit electronic comments to Regulations.gov using Docket No. FDA-2022-D-0490.
If you are unable to submit comments online, please mail written comments to:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's Docket No. FDA-2022-D-0490.
For More Information
· Guidance for Industry: Policy Regarding N-acetyl-L-cysteine
· FDA Issues Response to Two Citizen Petitions on NAC in Dietary Supplements
FDA 发布关于某些 NAC 产品执法自由裁量权的最终指南
FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products | FDA
法规更新
最新进展
2023 年 11 月 29 日
今天，FDA 已将有关 N-乙酰基-L-半胱氨酸 (NAC) 的系统性文献评议纳入同行评议流程。FDA已完成对 NAC 相关安全信息的审评，下一步将进行同行评议流程。FDA进行此次评议是为了评估公民请愿书的一部分，该请愿书要求FDA制定法规，规定 NAC 不被排除在“膳食补充剂”的定义之外。
2022 年 8 月 1 日
FDA 宣布发布FDA关于标签含有 N-乙酰-L-半胱氨酸 (NAC)的膳食补充剂产品的政策的最终指南。 该指南解释了FDA将对某些贴有膳食补充剂标签，但含有 NAC产品的销售和分销行使执法自由裁量权。如果NAC没有被排除在“膳食补充剂”的定义之外，并且没有违反《联邦食品、药品和化妆品法》（FD&C 法），则本执法裁量权政策适用于合法销售的膳食补充剂产品。本指南是2022 年 4 月指南草案的最终版。请参阅《联邦公报通知》了解更多信息。
原始法规更新
2022 年 4 月 21 日
今天，美国食品药品管理局 (FDA) 宣布发布FDA 关于含有 N-乙酰基-L-半胱氨酸 (NAC) 的膳食补充剂产品的政策指南草案。 该指南草案最终确定后，将解释我们对某些贴有膳食补充剂标签的含有 NAC产品的销售和分销行使执法自由裁量权的做法。如果NAC没有被排除在“膳食补充剂”的定义之外，并且没有违反《联邦食品、药品和化妆品法》（FD&C 法），则这项执法裁量权政策将适用于合法销售的膳食补充剂产品。
正如我们在最近对 两份公民请愿书的回应中所讨论的，因为NAC在作为膳食补充剂或食品上市之前已被批准为新药，FDA 确定NAC被排除在 FD&C 法下的膳食补充剂定义之外。 然而，我们尚未就一名请愿者提出的发布法规以允许在膳食补充剂中使用 NAC的请求做出最终决定，并且我们正在考虑启动法规制定，以通过法规规定 NAC 不被排除在膳食补充剂的定义之外。 除其他考虑因素外，如果FDA在审评现有数据和信息时没有发现安全相关问题，我们可能会提出一项法规，规定 NAC 不被排除在膳食补充剂的定义之外。
虽然我们对 NAC 的全面安全性审评仍在进行中，但我们的初步审评尚未发现其做为膳食补充剂成分或其作为膳食补充剂的安全问题。 此外，以膳食补充剂为代表的含有NAC的产品已在美国销售 30 多年，消费者不断寻求获得此类产品。 因此，在FDA继续评估启动法规制定的请求的同时，FDA 发布了这份指南草案，以解释我们有关含有 NAC的标签为膳食补充剂的产品的政策。
除非我们在持续审评期间发现与安全相关的问题，否则FDA将打算行使执法自由裁量权（如指南草案中所述），直到发生以下任一情况：我们完成法规制定征求意见，允许其作为膳食补充剂成分或作为膳食补充剂（如果我们推进此类程序）；或者我们拒绝公民请愿书的法规制定请求。 如果 FDA 确定此执法裁量权政策不再合适，我们将通过撤回或修改指南来通知利益相关方。
提交意见
为了确保在 FDA 开始制定最终指南之前考虑有关本指南草案的意见，请在联邦公报发布指南草案的通知后 30 天内提交书面或电子意见。您可以使用案卷号 FDA-2022-D-0490 向Regulations.gov 提交电子版意见。
如果您无法在线提交意见，请将书面意见邮寄至：
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
所有书面意见均应标明本文件的案卷号 FDA-2022-D-0490。
了解更多信息请参阅
· 行业指南：有关 N-乙酰基-L-半胱氨酸的政策Guidance for Industry: Policy Regarding N-acetyl-L-cysteine
· 联邦公报通知Federal Register Notice
· FDA 对两份关于膳食补充剂中 NAC 的公民请愿书做出回应FDA Issues Response to Two Citizen Petitions on NAC in Dietary Supplements
· 膳食补充剂Dietary Supplements
来源：美国FDA驻华办公室
