{"id":2333,"date":"2021-12-17T04:00:13","date_gmt":"2021-12-17T04:00:13","guid":{"rendered":"https:\/\/jewelryon.com\/?p=2333"},"modified":"2021-12-17T04:00:13","modified_gmt":"2021-12-17T04:00:13","slug":"fda-wants-more-info-on-nac-dr-mercola","status":"publish","type":"post","link":"https:\/\/jewelryon.com\/?p=2333","title":{"rendered":"FDA Wants More Info on NAC – Dr. Mercola"},"content":{"rendered":"
Read Full PDF fda-wants-more-information-on-nac-pdf<\/a><\/h5>\n

STORY AT-A-GLANCE<\/h3>\n
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  • The Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have filed separate citizen petitions with the FDA requesting that the agency reverse their position on NAC; the agency is now asking for more information on the 58-year-old supplement<\/span><\/li>\n
  • According to some legal experts, the actions taken by the FDA are not legal under U.S. code Title 21. The FDA has used the exclusion provision three other times, all of which financially benefited the pharmaceutical industry<\/span><\/li>\n
  • While past actions may have opened the door to the most recent attack against NAC, it is not difficult to understand why the FDA chooses now to target NAC, when it has demonstrated effective action against COVID-19<\/span><\/li>\n
  • Evidence suggests those with a glutathione deficiency have worse outcomes with COVID-19. NAC is a precursor to glutathione and may help lower the risk of severe disease<\/span><\/li>\n
  • NAC can be part of your early at-home treatment that is crucial to lowering the severity of the illness and reducing the risk of long-haul symptoms<\/span><\/li>\n<\/ul>\n<\/div>\n
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    N-acetylcysteine (NAC) is a powerful antioxidant that was approved as a drug in September 1963.1<\/span><\/sup>\u00a0Since that time it\u2019s been used as a nutritional supplement that is not found in natural sources.2<\/span><\/sup>\u00a0NAC contains the amino acid cysteine, which is a precursor to glutathione, also called \u201cthe master antioxidant.\u201d3<\/span><\/sup><\/p>\n

    Glutathione is made of three amino acids \u2014 glutamic acid, glycine and cysteine.4<\/span><\/sup>\u00a0However, NAC is only available in supplement form. The precursors to NAC can be found in foods that are high in cysteine, which include pork, beef, chicken, eggs, dates and sunflower seeds.5<\/span><\/sup><\/p>\n

    NAC is used in prescription form as an antidote for acetaminophen-induced hepatotoxicity.6<\/span><\/sup>\u00a0It is also a powerful mucolytic agent for use in upper respiratory conditions. Memorial Sloan-Kettering7<\/span><\/sup>\u00a0also lists uses in the treatment of depression, precancers, HIV and AIDS, and to alleviate cancer treatment side effects.<\/p>\n

    In 2020, NAC made the news when the FDA decided over-the-counter sales of this compound, which at that time had been available for 57 years, should require a physician’s prescription going forward. The FDA issued warning letters8<\/span><\/sup>\u00a0to seven companies the agency said were illegally selling hangover products. By May 2021, Amazon, which also owns Whole Foods, decided to remove any supplements containing NAC.9<\/span><\/sup><\/p>\n

    FDA Requests More Information on NAC<\/h2>\n

    As Natural Products Insider reports, the letters warned that NAC could not be \u201clawfully marketed in dietary supplements because it was first studied as a drug in 1963.\u201d10<\/span><\/sup>\u00a0The Council for Responsible Nutrition (CRN) sent a letter in December 2020 to the FDA\u2019s Office of Dietary Supplement Programs describing the position as \u201clegally invalid.\u201d11<\/span><\/sup><\/p>\n

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    The CRN and the Natural Products Association (NPA) filed separate citizen petitions with the FDA. The CRN letter in December 2020 challenged the FDA\u2019s determination that NAC should be precluded from supplementary use.12<\/span><\/sup>\u00a0They then filed a citizen position petition June 1, 2021, requesting the FDA reverse their position and outlining why this sudden policy change is \u201clegally invalid on multiple grounds.\u201d13<\/span><\/sup><\/p>\n

    The NPA filed a separate citizen petition with the FDA14<\/span><\/sup>\u00a0requesting that the agency not exclude NAC as a dietary supplement or, alternatively, that the Department of Health and Human Services (HHS) issue a regulation finding NAC is lawful in supplements. While the HHS has the authority, it has not been used in the 27 years since the law giving the HHS such power was enacted in 1994.<\/p>\n

    November 24, 2021, the FDA announced they were requesting more information about how NAC has been marketed as a dietary supplement.15<\/span><\/sup>\u00a0Natural Products Insider reports that this was encouraging to some in the industry as it signaled the FDA was open to the idea of issuing the regulation that NAC is a lawful ingredient in supplements.16<\/span><\/sup>\u00a0The FDA called this:17<\/span><\/sup><\/p>\n

    \u201c\u2026 tentative responses to both citizen petitions, requesting additional information from the petitioners … and noting that the agency needs additional time to carefully and thoroughly review the complex questions posed in these petitions.\u201d<\/em><\/p><\/blockquote>\n

    The FDA18<\/span><\/sup>\u00a0also requested information and data on the date that NAC was first marketed as a dietary supplement, reports of adverse events and details on how the products are marketed and sold. The data are requested by January 25, 2022. Steve Mister, president and CEO of CRN said in a statement:19<\/span><\/sup><\/p>\n

    \u201cThe provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) may not be interpreted retroactively to remove ingredients that were lawfully marketed in 1994 and have enjoyed a long history of safe use since then. The delay in clearing up the status of NAC by asking for more data and refusing to admit its error disregards the law and disserves consumers who use NAC.<\/em><\/p><\/blockquote>\n

    This is not a complicated determination for the FDA to make. DSHEA makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace. Thus, pharmaceutical manufacturers could not have had any expectation of exclusivity in the years prior to the creation of this provision of the law.<\/em><\/p><\/blockquote>\n

    Given the long history of safe use of NAC, FDA cannot now try to establish a safety concern in order to award this ingredient exclusively to drug makers.\u201d<\/em><\/p><\/blockquote>\n

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    FDA First Used Legally Questionable Drug Exclusion Provision<\/h2>\n

    U.S. code Title 21,20<\/span><\/sup>\u00a0specifically defines what a dietary supplement is and is not. According to experts, the actions of the FDA in banning the sale of NAC and finding it a \u201cmedication\u201d is illegal under the law. Attorney Stan Soper21<\/span><\/sup>\u00a0writes that under Title 21 \u00a7321 paragraph (ff)(3)(b)10 the actions of the FDA do not meet the Drug Exclusion Provision.<\/p>\n

    According to Soper,22<\/span><\/sup>\u00a0the exclusion provision has only been invoked a few times, specifically when used to keep red yeast rice, vitamin B6 and cannabidiol (CBD) from being sold as supplements. In each of these cases there was a potential pharmaceutical financial loss that triggered the assertion the supplement was illegal.<\/p>\n

    In the case of red yeast rice, it contains a naturally occurring substance that acts in a similar manner to Lovastatin, a statin medication.23<\/span><\/sup>\u00a0In 2005, drug manufacturer Biostratum filed an investigational new drug (IND) application with the FDA to use vitamin B6 in the treatment of diabetic kidney disease.<\/p>\n

    Their argument was there was \u201cno evidence that it was marketed as a dietary supplement or food prior to its IND and Phase II investigations.\u201d24<\/span><\/sup>\u00a0In 2009 the FDA declared vitamin B6 was not a dietary supplement despite documentation that it had been sold as such before the IND application.<\/p>\n

    The FDA has also invoked the Drug Exclusion Provision against CBD, warning that it is not a legal dietary supplement since there was no meaningful evidence it was marketed as such before drug investigations were approved for Sativex and Epidiolex, which are drugs that contain CBD.<\/p>\n

    After the 2018 Farm Bill was signed legalizing hemp, then-FDA secretary Dr. Scott Gottlieb made the statement that it was illegal to introduce CBD into the food supply or market it as a supplement.25<\/span><\/sup>\u00a0Soper postulates26<\/span><\/sup>\u00a0that the use of the Drug Exclusion Provision against CBD may have opened the door for the FDA to use it against NAC.<\/p>\n

    Why Take Aim at NAC?<\/h2>\n

    In the citizen petition27<\/span><\/sup>\u00a0sent to the FDA June 1, 2021, CRN argued that the FDA failed to sufficiently explain this sudden change in policy on NAC, thus \u201crendering it arbitrary and capricious.\u201d According to CRN, before the seven warning letters in July 2020, \u201cit was FDA\u2019s longstanding policy to permit the marketing of dietary supplements containing NAC.\u201d<\/p>\n

    Even though the agency had reviewed more than 100 notification structure\/function claims for NAC-containing supplements over the years, they never raised the drug exclusion clause. In one response to a petition for a qualified health claim, the FDA had even stated that NAC was considered a dietary supplement.<\/p>\n

    While the Drug Exclusion Provision on CBD may have opened the door, it still raises the question of why the FDA chose now to target NAC. Historically the provision was used inappropriately to protect the finances of pharmaceutical companies. That is also likely the root of the motivation to ban NAC as a supplement.<\/p>\n

    As pulmonologist Dr. Roger Seheult succinctly explains in the MedCram video below, NAC is a crucial chemical compound necessary to reduce the oxidative stress associated with severe COVID-19 infections and thus may significantly impact the sales of antiviral drugs. And, as I and other health experts have pointed out in the past, without severe disease, is there truly a need for a vaccine?<\/p>\n

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