Regarding NAC, that is N-acetyl-L-cysteine. For a long time, this ingredient was treated as a medicine. The nutritional product manufacturing industry and its related industries have certain restrictions on the sales of products.
But in August of this year, the U.S. Food and Drug Administration (FDA) issued its final guidance on the Enforcement Discretion for Certain Nutrition Labeling Requirements under the Federal Food, Drug, and Cosmetic Act (the Enforcement Discretion Guidance). This guidance is intended to provide the industry with flexibility in complying with certain provisions of the Nutrition Facts label (NAC) regulation while the FDA continues its work on a compliance policy for the revised NAC requirements.
The Enforcement Discretion Guidance applies to four specific areas of the NAC regulation:
1) The requirement to list “total sugars” on the label
2) The requirement to list “added sugars” on the label
3) The requirement to use the new Nutrition and Supplement Facts label format
4) The requirement to include “Declaration of Percent Daily Value for Added Sugars” on the label
Maybe there is a part of people who still don’t know this event clearly. So, here is a summary of the details of what happened as follows to help people get a clear realization about this guidance:
In July 2020, the FDA announced it was sending warning letters to companies claiming to have products linked to hangovers. The dietary supplement industry caused an uproar when the FDA announced in a warning letter that NAC had been excluded from the definition of dietary supplement due to its approval as a drug in 1963. And on September 14, NAC was approved as a new drug. That is a reason why several letters mentioned that NAC was excluded from the definition of dietary supplement. According to documents by FDA, industry trade groups say NAC has been safely sold in nutritional products since at least the early 1990s.
In May 2021, Amazon confirmed (to Natural Products Insider) that it was removing supplements containing NAC from its e-commerce platform. In June, the Council for Responsible Nutrition, always called CRN, filed a citizen petition asking the FDA to reverse its stance on federal law barring manufacturers from selling products containing NAC as dietary supplements. CRN offered several legal arguments for why the FDA’s position was invalid. In August, the Natural Products Association (NPA) filed a citizen petition asking the FDA. It demands that NAC is not excluded from the definition of dietary supplements or to recommend that the U.S. Secretary of Health and Human Services issue regulations through a notice and comment that find NAC in supplements are legal. In December, the NPA sued the FDA, seeking a preliminary and permanent injunction barring the FDA from taking any regulatory action against a distributor, manufacturer, or seller of NAC based on so-called drug exclusions in the Dietary Supplement Health and Education Act (DSHEA) retroactively applicable to NAC.
On March 31, 2022, the FDA confirmed in its response to two citizen petitions filed by NPA. They say that NAC is excluded from the definition of dietary supplements. However, The FDA said it was considering starting rules to authorize the use of NAC in dietary supplements in response to a request made by the NPA in its citizens’ petition. The FDA also revealed that it is considering exercising enforcement discretion over certain NAC-containing products labeled as dietary supplements and plans to issue guidance on its policy.
And on April 21, 2022, the U.S. FDA announced the availability of a draft FDA policy guidance on labeling products containing N-acetyl-L-cysteine (NAC) of dietary supplement products. When finalized, the draft guidance will explain to exercise enforcement discretion with respect to the sale and distribution of certain products containing N-Acetyl Cysteine (NAC), which are labeled as dietary supplements. If NAC is not excluded from the definition of “dietary supplement” and does not violate the Federal Food, Drug, and Cosmetic Act, simply called FD&C Act, this enforcement discretion policy will apply to legally market dietary supplement products.
While our full safety review of NAC is still ongoing, our initial review has not identified safety concerns regarding the ingredient’s use in or as a dietary supplement. In addition, NAC-containing products, represented by dietary supplements, have been marketed in the U.S. for over 30 years. Most consumers like to buy and continue to seek access to such products. Therefore, FDA continues to evaluate requests to initiate rulemaking. And at the same time, FDA has issued this draft guidance. It aims to explain our policy regarding products labeled as dietary supplements containing NAC.
Unless we find safety-related concerns during our ongoing review, FDA will intend to exercise enforcement discretion guidance until whatever one of the following occurs: if we advance such a process which we complete notification and comment rulemaking to Permitted in or as a dietary supplement, or if we deny a citizen petition’s rulemaking request. If FDA determines that this enforcement discretion policy is no longer applicable, we will notify stakeholders by withdrawing or amending this guidance.
In August 2022, the FDA announced final “enforcement discretion” guidance on NACs. In the final guidance, the FDA said it intends to exercise enforcement discretion until it completes notification and comment rulemaking or denies the NPA’s request for rulemaking unless the FDA finds any safety-related concerns in its review of supplements containing NAC.
Many people inside and outside the industry have had their say about the release of the final guide.
NPA President and CEO Dan Fabricant, who challenged the FDA’s stance on the NAC in a lawsuit filed in U.S. District Court in Maryland, described the final guidance as “a huge victory” but “certainly bittersweet.” “Citizen petitions and lawsuits are extreme measures and should be the rare exception, not the rule,” Fabricant said in a written statement. “The industry has suffered significant economic damage as a result of the agency’s years-long and inexplicable restrictions on the NAC. Losses. But luckily, our actions held the FDA accountable and forced them to issue final guidance.”
But in the meantime, the NPA’s lawsuit against the FDA is still pending. As we all know, obtaining final guidance on the NAC has always been one of the goals of the NPA’s lawsuits, rather than relying solely on petitions from its citizens. Related industries, especially large online retailers, should now get a level of clarity and comfort from agents to get back into the business of selling NAC.
Megan Olsen, CRN’s senior vice president and general counsel, said in a written statement that her organization appreciates the FDA providing this ultimate enforcement discretion, but CRN continues to disagree with the FDA’s response to the need for An explanation of the policy’s drug exclusions.
However, Olson also raised doubts. The FDA delayed the initiation of rulemaking, and she encouraged the agency to explore ways to expedite rulemaking, such as using an interim rulemaking agency.
She said the FDA suggested it could not initiate the rulemaking process without a drug exclusion clause because it is still reviewing the safety of NACs. Over six months, the ingredient has been marketed as a dietary supplement for decades without raising any safety concerns. The FDA has plenty of time to raise any safety concerns; continuing to delay rulemaking at this point will only hurt businesses and consumers.
In response to this question, an FDA spokesperson also responded, “The FDA is reviewing information related to the safety of NAC for use in or as a dietary supplement, and we do not currently have any projected timelines.”
Duffy MacKay, senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), welcomed the FDA’s final guidance but expressed concern about the impact of the amount of government and industry resources devoted to such issues.
“The FDA’s decision to allow continued use of NAC as a dietary supplement is a great news for consumers who benefit from this safe ingredient,” McKay said in an emailed statement. “However, the amount of industry and federal resources devoted to resolving confusion surrounding single ingredients such as CBD and NAC has shifted the focus of the FDA and industry away from key issues such as the need for a comprehensive modernization of dietary supplement regulations to provide market certainty “While CHPA appreciates the FDA’s progress on NAC, we remain focused on long-term improvements to improve product safety and integrity while increasing industry transparency.”
As of now, Amazon did not immediately respond to the matter.
All in all, the Enforcement Discretion Guidance is significant because it provides flexibility to the FDA in how it enforces regulations. This could have a major impact on the use of non-clinical studies in support of INDs and BLAs in the future. The reason is this could lead to more non-clinical studies being conducted in support of INDs and BLAs, which would ultimately benefit public health. And the guidance could make it easier for sponsors to conduct non-clinical studies and, as a result, could increase the use of such studies in drug development. Therefore, we have to admit that the influence of Final’ Enforcement Discretion’ Guidance on NAC by the FDA in the future is expected to be positive as it provides more flexibility to the FDA in the enforcement of regulations. It can enhance the nutritional product manufacturing industry and its related industries sale NAC-related products to meet consumers’ demand.