In a constituent update released yesterday, the U.S. Food and Drug Administration rejected two citizens` petitions, one from the Council for Responsible Nutrition and the other from the Natural Products Association, demanding that NAC be recognized as a legal dietary ingredient. “We are terribly appalled by the FDA`s response here. We think they really evaded the legal issues,” Herr told NutraIngredients-USA. Agencies consider infertility to be a medical condition, which means that supplement companies cannot make legal claims about it. “Reading the disclaimer to include the approved elements for each route of administration is entirely consistent with the requirement that a dietary supplement be intended for ingestion,” Stearn wrote, who also raised several other legal arguments in citizens` petitions. “Although the FDA has previously recognized NAC as a legal and safe supplement, the agency is attempting to create the power to remove legitimate supplements from the market that the law clearly does not give it,” he said in a statement. “While the ingredient we`re talking about now is NAC, there`s a broader issue at play: the FDA`s ability to ban proven dietary ingredients for supplements and give drug companies a monopoly on those ingredients, with few options for industry to challenge these measures.” In July 2020, the FDA sent warning letters to some companies stating that N-acetyl-L-cysteine (NAC) cannot be legally marketed as a dietary supplement. In fact, it was tested in the 1960s as a drug to treat acetaminophen poisoning and prevent severe liver damage. With recent revelations about the effectiveness of NAC in the potential treatment and its high efficacy as a component to significantly improve immune health, the FDA has decided to ban its sale as a dietary supplement.
It started with specific supplements used as hangover remedies commonly sold on Amazon. With this, Amazon has decided to continue the process of removing all dietary supplements containing NAC from its website. Although there was a high level of uncertainty for the rest of the year, the legality of NAC in the form of dietary supplements was finalized in early 2021. Many retailers are expected to quickly remove NAC from their shelves, even if they fundamentally disagree with the FDA`s decisions. Herr added: “The FDA claims to have that authority, whether the food ingredient under study is marketed for the same intended uses, in the same dosage forms, or in the same dosage as the drug. Today`s decision sets a dangerous and extrajudicial precedent for other supplements. The statement also says the agency is considering a rule-making process for NAC, which the NPA petition had called as an alternative to a full declaration of NAC`s full status as a legal food ingredient. This renewed confusion about the legality of the NAC highlights major gaps in the additional legislation. For NAC and other legally confusing ingredients like CBD, nothing is black and white.
Unlike drugs, there is NO approval process for dietary supplements. If a dietary supplement contains dietary ingredients that were used in dietary supplements prior to DSHEA (1994) or that have since been considered reasonably safe, it may be legally sold to consumers. This is very different from drugs, which must go through a thorough approval process BEFORE entering the market. Those in the dietary supplement industry say there is no reason for the FDA to take retroactive action to remove products that have been available for years without clear safety concerns. They also worry that it could open the door for the FDA to make the same decision regarding other products like fish oil and vitamin K. In a notice to its members today, the American Herbal Products Association noted that it had submitted comments to the FDA supporting the idea that NAC should be considered a legal food ingredient because it was on the market before the grandfather date. The sale of pharmaceutical ingredients as dietary supplements is generally illegal. But the FDA has yet to take the crucial step of officially banning NAC in dietary supplements.
Currently, it is still legal for companies to sell products containing NAC, for practitioners to recommend them, and for consumers to buy them. But if Amazon goes all the way with its purge, it could become harder to get it. “We are currently consulting with our members on next steps, but all options – including immediate legal action – remain on the table,” said Mr. The FDA has tacitly approved the sale of NAC products as dietary supplements for several decades. As recently as July 2020, as part of a series of warning letters to companies that market hangover remedies, the agency said NAC was not a legal food ingredient due to its previous use as a drug. The main caveat to the use of NAC (n-acetyl-L-cysteine) in dietary supplements is that these products are “legal”, i.e. they do not make non-compliant disease claims. In other words, the FDA isn`t suing you just because you have NAC in the bottle, but today`s draft directive doesn`t give carte blanche to market NAC for non-supplemental indications. The draft NAC guideline released today by the FDA was seen as an industry victory. But observers leave it with key legal questions about the interaction between supplements and airborne drug use.
NAC was first approved by the FDA as a respiratory drug in 1963. It is also used to prevent severe liver damage due to acetaminophen poisoning. But it`s been available in supplements for decades — the ingredient itself is probably safe for most people. The FDA has pushed back the use of NAC in supplements since 2010, but this year it has increased significantly. Some speculate that this is due to new clinical research on the use of NAC in COVID-19. The FDA states that there is no evidence that NAC was used as a supplement prior to its use as a drug – so including NAC in a supplement makes the product an unapproved drug and therefore illegal. The FDA concluded that NAC cannot be legally marketed in dietary supplements due to its approval as a drug in 1963. In legal arguments presented in separate citizen petitions, the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have called on the FDA to change its position. N-acetylcysteine (NAC) comes from the amino acid L-cysteine. It has been available as supplements for decades. But now, the FDA is warning companies that it cannot be legally included in supplements. The tug-of-war between industry and the FDA is confusing and highlights the big differences in supplement and drug regulations.
“Although the FDA has previously recognized NAC as a legal and safe supplement, the agency is attempting to create the power to remove legitimate supplements from the market that the law clearly does not give it,” the FDA concluded. The FDA explained that today`s draft guideline is a response to two petitions from citizens, one submitted by the Council for Responsible Nutrition and the other by the Natural Products Association. Both petitions demanded that the FDA decide that NAC is a legal food ingredient because it was clearly on the market as a supplement prior to October 15, 1994. The AFN petition also included an option for a formal rule that would grant an exemption for NAC. The FDA rejected the grandfather date approach, but said it intended to move in with the rule-making proposed in the NPA petition. M. said CRN is considering its future options, including a potential legal challenge and/or a request for relief from the new legislation. Three of these hangover products contained NAC. In these letters, the Agency stated that as a result of the previous investigation into NAC as a drug, which took place under today`s draft guidance document in 1963, the compound was not a legal food ingredient within the meaning of the so-called “exclusion clause”. In a constituent update dated March 31, 2022, the FDA announced that it had confirmed that NAC is excluded from the definition of a dietary supplement.
The FDA`s response to CRN and NPA`s petitions describes the legal context for its interpretation that the Health and Dietary Supplement Education Act of 1994 (DSHEA) provides only two exceptions to the exclusion of an element such as NAC that has been approved as a new drug from the definition of dietary supplement. namely: (1) The item was marketed as a dietary supplement or food prior to this approval (or approval for Investigation as a new drug if extensive clinical trials have been published) or (2) the FDA issues a prescription to allow the item to be used in a dietary supplement. The FDA noted that acetylcysteine (another name for NAC) was released on September 14. September 1963 was approved as a new drug for inhalation administration, it is the same “item” for the purposes of the exclusion clause as NAC for ingestion, which is the first FDA evidence for marketing as a dietary supplement or as a food an August/September 1991 advertisement for a supplement containing NAC.