NAC (N-acetyl-L-cysteine) is a derivative of the amino acid L-cysteine and is a precursor of the cellular antioxidant glutathione. The ingredient was first approved as an inhaled mucolytic drug in 1963. At present it is used in emergency rooms as a treatment in cases of acetaminophen poisoning to prevent severe liver damage.
Despite its early use as a respiratory medication, the ingredient has been widely used for many years in finished dietary supplements, frequently as a standalone product. A search of the Dietary Supplement Label Database from the NIHs Office of Dietary Supplements yields 1,468 products containing NAC (database accessed May 7, 2021), including some of the biggest brands in the industry.
Just last year, food and nutrition giant Nestl launched its Celltrient range, with one of those products featuring NAC as a central ingredient.
According to data provided by SPINS to NutraIngredients-USA, sales of NAC-containing products grow year-on-year, with combined sales of supplements* in the Conventional Multi-Outlet Channel** and Natural Channel totaling $5.68 million in 2020, a 32% increase from $4.31 million in 2019.
FDA was surely aware of the ingredient being on the market in supplement form for decades, but took no action regarding its status until the summer of 2020 when the Agency sentseven warning letters to companies making hangover treatment claims, which FDA construed to be illegal disease treatment claims.
In the warning letter to Wilmington, NC-based Happy Hour Vitamins, the Agency stated: FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.
The letters marked a sudden and drastic departure from past Agency practice, said the Council for Responsible Nutrition (CRN) in a letter to Steven Tave, then Director of the Office of Dietary Supplement Programs (December 2020).
For decades, manufacturers have safely marketed products containing NAC as dietary supplements in the United States, stated the letter, which was signed by Steve Mister, CRNs President and CEO, and Megan Olsen, Vice President and Associate General Counsel, CRN.
until recently, FDA has consistently and affirmatively permitted manufacturers to market these products. In fact, FDA has considered over 100 structure-function claim notifications regarding NAC and at least one qualified health claim petition for a dietary supplement containing NAC, and has not objected to the presence of NAC in any of these products, added the letter.
Speaking with NutraIngredients-USA, Olsen said: There is strong legal evidence that NAC is a grandfathered ingredient co-existing as a dietary ingredient alongside the drug for decades.
NAC has been available as a dietary ingredient in dietary supplements since before the passage of DSHEA [in 1994] and FDA has never raised any safety issues about the ingredient.
The recent reported move by Amazon to remove NAC-containing dietary supplements from its website has caused concern in the dietary supplements industry, although no other retailers have confirmed they are exploring similar measures.
Cara Welch, PhD, the current Acting Director of ODSP, responded to CRNs letter last week, noting that the Agency is closely reviewing the information provided in your letter and will provide a more substantive response once our evaluation is complete.
Olsen told us that the association has only been in contact with ODSP, and it is not clear if other offices or Centers within FDA are involved in the decision-making process.
CRN is recommending to member to keep selling the NAC-containing dietary supplements, she said. FDA has not given the final word on NAC.
Olsen noted that there is precedent for FDA reversing a stance, citing the KIND LLC issue from 2015 when the Agency sent a warning letter to the nutritional bar maker over label claims on its products and website that were deemed to step beyond the definition of 'healthy' because of the products' fat content. KIND pushed back and in 2016 the FDA conceded the point (with a couple of caveats).
Weve made clear with the Agency the seriousness of this [NAC] issue, said Olsen. This has real world repercussions for companies the longer this continues.
CRN is pleased with the level of correspondence weve received from the Agency, added Olsen. We sent the letter in December 2020 and received a response in May, and that was a response from the Agency during an Administration change, Id add.
---------------
* This covers products in the following categories: Amino acid, digestive aids & enzymes, herbal formulas, miscellaneous supplements, performance nutrition, vitamins & minerals
** The Conventional Multi-Outlet Channel (powered by IRI) covers the Grocery Outlet (store with $2M+ annual ACV), the Drug Outlet (chains and independent stores, excluding Rx sales), and selected retailers across Mass Merchandisers, including Walmart, Club, Dollar, and Military representing over 105,000 retail locations.
SPINS Natural Enhanced Channel is composed of full-format stores with $2 million+ in annual sales and 40% or more ofUPC coded sales from natural/organic/specialty products. It Includes co-ops, associations, independents, and large regional chains(excludes Whole Foods & Trader Joes).
More here:
CRN: 'This is not the final word on NAC' - NutraIngredients-usa.com
- Creatine and Caffeine: Benefits, Risks, Dosage - Health.com - April 16th, 2024 [April 16th, 2024]
- Fiber Supplements Are Once Again Popular But Pick The Right One | mindbodygreen - mindbodygreen - April 16th, 2024 [April 16th, 2024]
- The Ministry of Health Warns the Public Against Use of Food Supplements Manufactured by Kobayashi Pharmaceutical ... - Gov.il - April 16th, 2024 [April 16th, 2024]
- Study: Vitamin D and Calcium Supplements May Reduce Cancer Risk - Prevention Magazine - March 20th, 2024 [March 20th, 2024]
- Magnesium for Sleep: The Best Type, When to Take It and More - Good Housekeeping - March 20th, 2024 [March 20th, 2024]
- Food ingredients drive growth in beauty supplements - IngredientsNetwork.com - March 20th, 2024 [March 20th, 2024]
- Best Ozempic Weight Loss Alternative Supplements Money Can Buy (Top OTC Semaglutide Alternatives) - Vashon-Maury Island Beachcomber - March 20th, 2024 [March 20th, 2024]
- Can Fiber Help with Ozempic, Wegovy Side Effects? - Health.com - March 20th, 2024 [March 20th, 2024]
- Vitamin B12 and Magnesium: Benefits, Risks, Dosage - Health.com - March 20th, 2024 [March 20th, 2024]
- Taking a Daily Fiber Supplement Might Help Boost Brain Function in Older Adults - Health.com - March 20th, 2024 [March 20th, 2024]
- Moringa: Benefits, Side Effects And Risks Forbes Health - Forbes - October 22nd, 2023 [October 22nd, 2023]
- What to Know About California's New Law Banning Food Additives ... - Smithsonian Magazine - October 18th, 2023 [October 18th, 2023]
- How to Treat Iron Deficiency - The New York Times - October 18th, 2023 [October 18th, 2023]
- The Importance of Micronutrients for Optimal Health - Everyday Health - September 11th, 2023 [September 11th, 2023]
- How can companies stand out in the immune health category in 2023? - Nutritional Outlook - June 20th, 2023 [June 20th, 2023]
- Kemin's BetaVia Pure immune and gut health ingredient gains ... - Nutritional Outlook - June 20th, 2023 [June 20th, 2023]
- Steadfast Nutrition expands its portfolio with four supplements - Asia Food Journal - June 20th, 2023 [June 20th, 2023]
- Martyn Ford Reveals Food & Supplements of 10000 Calorie Diet for ... - Fitness Volt - June 20th, 2023 [June 20th, 2023]
- Nutrition & Longevity Experts Love This Metabolism Supplement ... - mindbodygreen - June 20th, 2023 [June 20th, 2023]
- Ric Flair Reveals Diet, Training & Supplements to Stay Jacked at 74 ... - Fitness Volt - June 20th, 2023 [June 20th, 2023]
- ADM licenses gut-health ingredient from Gnubiotics for pet food ... - Nutritional Outlook - May 18th, 2023 [May 18th, 2023]
- Global Sorbitol Market Report 2023: Increasing Demand for Non-medical Dietary Supplements Drives Growth - Yahoo Finance - May 18th, 2023 [May 18th, 2023]
- Fat-Soluble Vitamins: What They Are and How To Get the Most Out of Them - Health Essentials - May 18th, 2023 [May 18th, 2023]
- Six of the Best... food, treats & supplements - Dogs Today Magazine - May 18th, 2023 [May 18th, 2023]
- 9 Anti-Inflammatory Supplements Backed By Science Forbes Health - Forbes - May 18th, 2023 [May 18th, 2023]
- Dietary Supplements Market Size to Reach Globally with Growing ... - Digital Journal - May 18th, 2023 [May 18th, 2023]
- These 11 Vegan Vitamins Are Made With Fruits and Vegetables - VegNews - May 18th, 2023 [May 18th, 2023]
- Hemptown's Kirkman Subsidiary Named One of the 50 Most Admired Companies to Watch in 2023 - Yahoo Finance - May 18th, 2023 [May 18th, 2023]
- What is biotin? Foods to eat and if you should take it every day - USA TODAY - May 18th, 2023 [May 18th, 2023]
- Best vitamins to be taking as seasons change, according to health expert - Daily Record - May 18th, 2023 [May 18th, 2023]
- KITTEN YOGA RETURNS TO EAST BANK REGIONAL LIBRARY ... - Jefferson Parish - May 18th, 2023 [May 18th, 2023]
- 8 Best Fiber Supplements of 2023, Tested by Experts - Good Housekeeping - May 18th, 2023 [May 18th, 2023]
- FDA Passes the Buck (Back) to Congress for Legislative Solution on ... - JD Supra - May 18th, 2023 [May 18th, 2023]
- The Wellness Trap: Break Free from Diet Culture, Disinformation, and Dubious Diagnoses, and Find Your True Well-Being - Next Big Idea Club Magazine - May 18th, 2023 [May 18th, 2023]
- Fruit And Vegetable Supplements: A 2023 Guide Forbes Health - Forbes - May 18th, 2023 [May 18th, 2023]
- FDA: SARMs not worth the health risk 'for a few extra likes' - NutraIngredients-usa.com - April 29th, 2023 [April 29th, 2023]
- Are Melatonin Gummies Safe? Here's What (Kinda Scary) New Research Says - POPSUGAR - April 29th, 2023 [April 29th, 2023]
- New paper discusses the rationale for proprietary blends in ... - Nutritional Outlook - April 29th, 2023 [April 29th, 2023]
- The Best Brain Supplements For Cognitive Health Forbes Health - Forbes - April 29th, 2023 [April 29th, 2023]
- Protein powders: Are they bad for your health? - BBC - April 29th, 2023 [April 29th, 2023]
- New Regulation on Turkish Food Codex Nutrition Claims Has Just ... - Lexology - April 29th, 2023 [April 29th, 2023]
- Selenium: Benefits, Side Effects, and More - Verywell Health - April 29th, 2023 [April 29th, 2023]
- FDA Warns of Use of Selective Androgen Receptor Modulators ... - FDA.gov - April 29th, 2023 [April 29th, 2023]
- Probiotic supplements may do the opposite of boosting Gut Health ... - WholeFoods Magazine - April 22nd, 2023 [April 22nd, 2023]
- Do hangover supplements actually work? - Nutritional Outlook - April 22nd, 2023 [April 22nd, 2023]
- Common Sense Health: Fish oil is the superhero of supplements - The Independent - April 22nd, 2023 [April 22nd, 2023]
- Red yeast rice nutritional supplements health benefits, risks ... - Chicago Sun-Times - April 22nd, 2023 [April 22nd, 2023]
- From forest to fork - All About Feed - April 22nd, 2023 [April 22nd, 2023]
- Could Certain Foods Help With Hot Flashes? - The New York Times - April 22nd, 2023 [April 22nd, 2023]
- Consumer interest in cognitive, immune health rising - Food Business News - April 22nd, 2023 [April 22nd, 2023]
- 15 Best Vitamin Brands of 2022: A Dietitians Picks - February 24th, 2023 [February 24th, 2023]
- Dietary supplements for weight loss - Mayo Clinic - February 24th, 2023 [February 24th, 2023]
- Emergency Food Supplements | DSHS - Washington - December 28th, 2022 [December 28th, 2022]
- Guidance & Regulation (Food and Dietary Supplements) | FDA - December 25th, 2022 [December 25th, 2022]
- Food Labeling & Nutrition | FDA - December 25th, 2022 [December 25th, 2022]
- Health & Food Supplements Information Service - HSIS - November 21st, 2022 [November 21st, 2022]
- Food Security Community Food Security Coalition - November 21st, 2022 [November 21st, 2022]
- Expert Voices: Diet and Nutrition for People With Parkinson's... - Parkinson's News Today - October 19th, 2022 [October 19th, 2022]
- The regulatory state of play of the sports and active nutrition sector - NutraIngredients.com - October 19th, 2022 [October 19th, 2022]
- The Digestive Health Supplements Market Is Set To Grow At A More Than 9% Rate Due To Rising Cases Of Digestive Diseases As Per The Business Research... - October 19th, 2022 [October 19th, 2022]
- FSAI highlights incidents, recalls and fraud in its annual report - Food Safety News - October 19th, 2022 [October 19th, 2022]
- Global Cannabidiol Legalization Trend to Shape the CBD Market's Future Growth - PR Newswire - October 19th, 2022 [October 19th, 2022]
- The FoodNavigator Podcast: Mood food for mental wellbeing how can the industry capitalise? - FoodNavigator.com - October 19th, 2022 [October 19th, 2022]
- 6 Ways to Find Relief from Your Menopause Symptoms - Health Essentials - October 19th, 2022 [October 19th, 2022]
- NutraCast: How amendments in the 2023 Farm Bill could shape the hemp industry - NutraIngredients-usa.com - October 19th, 2022 [October 19th, 2022]
- South Korea starts year-long inspection of probiotics imported from US, Europe - NutraIngredients-Asia - October 19th, 2022 [October 19th, 2022]
- Nveda employs a variety of dietary supplements made of natural ingredients for a fit and healthy life - The Hindu - October 13th, 2022 [October 13th, 2022]
- Vitamin C Market to See Healthy Growth of USD 1,899.69 Million with Excellent Compound Annual Growth Rate of 7.60% by 2029, Size, Opportunities,... - October 13th, 2022 [October 13th, 2022]
- Global Microalgae Market to Reach $1.3 Billion by 2027 - GlobeNewswire - October 13th, 2022 [October 13th, 2022]
- Dietary supplements that are safe to take, which to avoid: experts - Insider - September 27th, 2022 [September 27th, 2022]
- 6 Best Fiber Supplements That Will Keep Your Gut Happy - CNET - September 27th, 2022 [September 27th, 2022]
- Do You Actually Need To Take A Multivitamin? The Answer May Surprise You - The Zoe Report - September 27th, 2022 [September 27th, 2022]
- Global overview for probiotics: Trends, markets, and harmonization - Regulatory Focus - September 27th, 2022 [September 27th, 2022]
- Combining Your Medication With This May Have "Life-Threatening Effects" - Best Life - September 27th, 2022 [September 27th, 2022]
- Aroma-Zone opens a new store in Paris and prepares to grow abroad - Premium beauty - September 27th, 2022 [September 27th, 2022]
- Fertility Supplements And Vitamins For Women: What You Need To Know - Forbes - September 27th, 2022 [September 27th, 2022]
- ITA offers webinar focusing on supplements and informed decision-making (part 1) - IHF - September 27th, 2022 [September 27th, 2022]
- Awards recognize the latest innovative pet food products - Pet Food Processing - September 27th, 2022 [September 27th, 2022]
- On-mind and on-trend: formulating products for cognitive well-being - Nutraceutical Business Review - September 27th, 2022 [September 27th, 2022]
- The #1 Sign You're Taking "Too Many Vitamins" Eat This Not That - Eat This, Not That - September 7th, 2022 [September 7th, 2022]