Semi-OT - FDA goes after n-acetyl cysteine DS for BS reasons.
I am so screwed it's not funny - NAC literally helps keep me alive - I've been taking it daily since 2006. The ONLY reason the FDA suddenly moved on NAC because in the article below it mentions many alternative medical treatments for COVID have NAC near the top of the list (it's been mentioned on this board before) - this is all political BS. I just spent a small fortune buying a couple year's worth of NAC on eBay, the same brands I've taken before - after they run out, I'm in big trouble unless the FDA reverses course.
We're well aware of the FDA's sometimes ambiguous decisions of what is a drug and what is a supplement - icosapent ethyl (IPE) is modified EPA distilled from fish oil, which automatically makes it a drug (doesn't exist in that form in nature, see more about this below) - AMRN sued the ITC to ban the import of DS containing pure IP and they punted to the FDA, which said "we're not going to make a decision in this case", despite the fact that their own regs spell out in black and white that IPE is absolutely a drug. The DS warning letters usually only go to websites making medical claims, and all the need to do is remove the claims from the ads and they're still allowed to sell the DS - but this time, with the FDA going after Amazon and apparently Vitacost, they've really choked off the supply.
I know of at least one DS that was turned into an FDA drug, the reverse case (also impossible according to FDA regs) - methylated B-12 (comes in 3 forms) - some company did drug trials and found that a high dose could be effective at treating childhood autism, got approval to make it a drug (Deplin), but somehow made a deal with the DS industry that DS could still sell it but only at extremely low doses - like 1-3 micrograms - I take two of those per day too. Bottom line is FDA can do whatever the hell they want because nothing is a law, they're all non-binding "guidelines" - only when it's a scheduled drug and the DEA gets involved do real laws come into play.
A spate of warning letters issued by the Food and Drug Administration over the last year offers a clear indication that the agency wants to limit the availability of N-acetyl cysteine (NAC) in dietary supplement products.
NAC, a precursor to the key antioxidant glutathione, is widely recommended by functional medicine and naturopathic practitioners. It is a common component in many liver support, detoxification, and longevity promotion protocols.
Of the three amino acids necessary to form glutathione (cysteine, glycine, and glutamic acid), cysteine is the rate-limiting factor (Minich D. Brown B. Nutrients. 2019). Oral NAC supplementation is an effective way to boost cysteine levels.
There are more than 1,500 supplement products containing NAC listed in the National Institutes of Health’s Dietary Supplement Label Database. And, according to the Council for Responsible Nutrition, there are roughly 150 structure/function claims for NAC-based products filed with the FDA.
NAC supplements have been on the market for decades, and none of these claims have drawn prior objections from the agency.
Why Now?
The FDA is well within its regulatory jurisdiction to argue that NAC is an approved drug and therefore should not be sold as a supplement.
But the move has many people within the supplement industry asking, Why? And why now?”
It does seem strange that an agency which still does not have a confirmed commissioner would choose to take action–in the middle of a global pandemic–to limit consumer access to a harmless amino acid compound and antioxidant precursor.
“FDA has had ample opportunity to raise this issue in the past and yet has never done so,” writes attorney Stan Soper, one of a number of nutrition-focused lawyers alarmed by the agency’s insistence on drug-only status for NAC .
Some in the supplement field see this as part of a broader federal crackdown on non-pharma approaches to managing COVID.
“FDA has had ample opportunity to raise this issue in the past and yet has never done so.” –Stan Soper, Attorney
Many functional medicine physicians recommend NAC as part of their comprehensive nutrition-based protocols for mitigating the effects of SARS-CoV-2.
The Institute for Functional Medicine’s COVID-19 Task Force included NAC in its COVID treatment guidelines, noting that while there are no definitive clinical studies to show that NAC will reduce COVID symptoms or improve outcomes, there are human studies showing it can reduce episodes of influenza, and flu-related symptom burden among elderly people.
From the outset of the pandemic, the FDA and Federal Trade Commission (FTC) have been consistent in their stance that there are no approved drugs to treat COVID, and certainly no supplements for which antiviral claims can be made. The agencies have jointly issued hundreds if not thousands of warning letters to supplement companies, as well as to practitioners making COVID-related claims.
There are now 17 clinical studies of NAC in the context of COVID care listed in the government’s Clinical Trials registry. This includes a high-profile study now underway at Memorial Sloan Kettering Cancer Center involving 84 high-risk patients with COVID, treated with inhaled or intravenous pharmaceutical forms of NAC.
Others, like a 64-patient COVID study at Baylor College of Medicine, are using NAC supplements.
Casting a Shadow
In an interview with Natural Products Insider, Council for Responsible Nutrition president Steve Mister contended that the FDA is attempting to “cast a shadow on NAC as a dietary supplement, which would encourage the drug companies to go forward under the thought that they could get a monopoly on the ingredient if it pans out.” Steve Mister, Esq, President, Council for Responsible Nutrition
This is not the first time FDA has invoked the Drug Exclusion Provision to retroactively eliminate specific ingredients from the supplement sector. Over the years, it has taken similar action—to varying degrees of success–against vinpocetine, red yeast rice, vitamin B6 (pyridoxamine), and CBD. [red yeast rice actually contained the same compound that was in one of the first statins, could cause liver damage because levels in DS were not standardized, so they were justified for taking that off the market]
Mister argues that the agency is misusing the Provision which, he says, “was intended to create a race to market so that you didn’t take away the incentives for drug companies to study products for potential disease uses. But it was never meant to be a shield to just go out and start removing (supplement) products from the market.
He sees it as evidence of a deep-seated bias within FDA that favors pharma, “which makes sense because FDA has a lot more control over bringing a drug to market than they do foods or cosmetics or supplements.”
Predictably, FDA officials have dismissed this and other similar allegations.
NAC Still Legal
For the moment, 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 follows through with its purge, they could become more difficult to obtain. [none of the usual DS sites I use were selling NAC]
Industry trade groups are rallying to urge FDA to reconsider its position on NAC.
On his blog, attorney Stan Soper states: “I’m sure you will shortly hear objections from the major trade associations, who are likely to work with industry to try to find evidence that NAC was part of the supplement or food supply prior to 1963 or find some other basis to challenge FDA’s position. It remains to be seen whether FDA will exercise enforcement discretion and allow NAC to remain on the market as a supplement or will otherwise back down from this new aggressive posture.”
Regardless of how the NAC issue ultimately resolves, it is clear that even without a commissioner, the agency is increasing its scrutiny of the supplement sector."”
US Senator and The Natural Products Association (NPA), who also filed a CP, requests hearing with FDA about NAC, FDA blows them off - Vascepa and Lovaza are referred to as part of the DS vs. drug mess, as are other drugs turned into DS. The DSHEA fits in here somehow, that has come up in the ITC case over DS IPE, but we also know that if an IND has ever been filed for a compound it's supposed to be forever a drug and cannot be a DS - FDA has created a huge mess by ignoring Congressional intent for grandfathered GRAS. How anyone can take an essential amino acid and make it a drug is beyond me, again points to this being politically driven, no valid scientific or regulatory reasons for this sudden action against NAC as far as I'm concerned.
In addition to requesting a public hearing, Lee asked FDA to answer several questions related to NAC, including the specific date FDA identified the ingredient being used as both a drug and supplement in the U.S.
While Lee requested FDA answer him by Aug. 10, the agency had not responded as of Aug. 17, Brecken Denler, a staff member for the senator, said in an email.
An FDA spokesperson said the agency received the senator's letter and will respond directly to him.
“FDA’s sudden change of policy” regarding NAC is harming stakeholders in the supplement sector, according to the citizen petition filed by Dan Fabricant, president and CEO of NPA.
“The current situation with NAC is yet another example of the inconsistent and mercurial way in which FDA chooses to both interpret DSHEA and then determines how to best use resources under DSHEA to protect the public health,” wrote Fabricant, who previously oversaw FDA’s then-Division of Dietary Supplement Programs. “Despite repeated requests from multiple stakeholders, FDA has been unable to articulate any risk to the public health posed by NAC when marketed as a dietary ingredient or dietary supplement.”
NOW Health Group Inc. CEO Jim Emme said his company has been selling NAC since October 1993—a year before Congress passed DSHEA. NOW Foods, a manufacturer and distributor of dietary supplements, is a division of NOW Health Group.
NOW has sold millions—perhaps billions—of pills of NAC supplements with no adverse event reports (AERs) received, Emme shared. He added he’s not aware of other brands having received AERs related to NAC either.
Emme said he can’t understand why FDA said NAC can’t be sold as a supplement anymore after it’s been on the market in dietary supplements for about three decades.
"Why are they picking on people [who] are rule followers?" he asked. "We follow the rules. We want to work with the agency."
According to FDA in 2020 warning letters, its conclusion is based on a provision of DSHEA that says an ingredient cannot be sold in supplements if it was first approved as a drug.
But industry sources counter plenty of examples exist in which an ingredient is sold in both supplements and drugs, like fish oil. They also have questioned whether Congress intended for the drug preclusion language in DSHEA to apply to ingredients lawfully on the market in supplements prior to passage of the law.
NPA’s citizen petition quoted an Oct. 8, 1994 Senate report published by the Committee on Labor and Human Resources, chaired by then-Sen. Orrin Hatch (R-Utah)—one of the chief architects of DSHEA. The report cited examples of ingredients in both supplements and FDA-approved drugs, including caffeine and L-carnitine.
The Thought Police: To censor and protect. Craig Bruce
