Good Health Medicine

Main Menu

  • Home
  • Health medicine
  • Dietary supplements
  • Dietary nutrition
  • Alternative medication
  • Medicine price

Good Health Medicine

Header Banner

Good Health Medicine

  • Home
  • Health medicine
  • Dietary supplements
  • Dietary nutrition
  • Alternative medication
  • Medicine price
Dietary supplements
Home›Dietary supplements›FDA Releases Draft NAC Supplement Guidelines

FDA Releases Draft NAC Supplement Guidelines

By Rebecca C. Myers
April 21, 2022
0
0

The FDA on Thursday announced the availability of draft guidelines that, if finalized, would indicate “the agency’s intention to exercise its enforcement discretion” regarding the distribution and sale of products. labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine).

The draft guidelines, to be published April 22 in the Federal Register, were released three weeks after the FDA reaffirmed its position in response to two citizen petitions that NAC is excluded from the definition of a supplement. food because the ingredient was first approved as a drug in 1963.

Related: FDA rejects NAC petitions but signals it won’t enforce them

The FDA, however, is still considering initiating regulations to allow the use of NAC in supplements. To date, the agency has not identified any safety issues related to the ingredient.

“The discretionary enforcement policy would apply to products that would be legally marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the FD&C [Federal Food, Drug & Cosmetic] Act,” the FDA said in the draft guidance, which was announced via a constituents update.

Unless the FDA identifies “safety concerns” during its ongoing review, the agency said it intends to “exercise enforcement discretion” until that it has completed the development of notice and comment rules to permit the use of NAC in supplements or that it denies the regulatory application.

“Although our full safety review of NAC is ongoing, our initial review did not reveal any safety concerns regarding the use of this ingredient in or as a dietary supplement,” the FDA said in the statement. draft guidelines. “Additionally, NAC-containing products marketed as dietary supplements have been sold in the United States for over 30 years, and consumers continue to seek access to these products.”

The FDA said it would notify stakeholders by withdrawing or revising the guidance if it determines the enforcement discretion policy is no longer appropriate.

To ensure that FDA considers comments on the draft guidance before beginning work on a final document, the agency requested electronic or written comments within 30 days of posting the draft guidance in the Federal Register.

Although the draft guidelines, when finalized, will represent the FDA’s current thinking on NAC products labeled as dietary supplements, the guidelines do not create any rights for anyone and are not binding on the FDA or the public, the statement said. ‘agency.

Related posts:

  1. New Trends in Ganoderma Lucidum (Lingzhi or Reishi) Supplements Market Size 2021
  2. Best Supplements for Fatigue – Best Ways to Stop Fatigue
  3. Chronic Pain Management: Relieve Pain With Oily Fish, Flax Seeds, and Supplements
  4. Saudi Arabia Dietary Supplement Markets, Competition, Forecast and Opportunity, 2026: Focus on Combination Dietary Supplements, Vitamins, and Herbal Supplements – ResearchAndMarkets.com | Company
  • Alternative medication
  • Dietary nutrition
  • Dietary supplements
  • Health medicine
  • Medicine price
  • Survey compares how consumers and nutrition experts rate healthy foods – AgriNews
  • Bone & Joint Health Supplements Market to Witness a CAGR of 8% (2022-2028) Driven by Growing Prevalence of Orthopedic Disorders and Micronutrient Deficiencies | UnivDatos Market Overview
  • Police arrest scammer entangling hundreds of IPB students in online loans
  • Know which one is better for nutrition, skin and health
  • Your answers on cancer: What to know about stomach cancer? | Health, Medicine and Fitness
  • November 2022
  • October 2022
  • September 2022
  • August 2022
  • July 2022
  • June 2022
  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • August 2020
  • May 2020
  • March 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • March 2018
  • February 2018
  • January 2018
  • November 2017
  • October 2017
  • September 2017
  • August 2017
  • August 2016
  • June 2016
  • May 2016
  • February 2016
  • October 2015
  • August 2015
  • April 2015
  • March 2014
  • December 2013
  • September 2012
  • October 2011
  • September 2011
  • July 2011
  • June 2011
  • April 2011
  • March 2011
  • March 2010
  • September 2007
  • Privacy Policy
  • Terms and Conditions