Why the FDA is Attacking NAC Supplements

by Alliance for Natural Health

Excerpts:

N-acetyl-L-cysteine (NAC) has been on the market as a supplement for decades—why is the FDA attacking it now?

A few weeks ago, we told you about the FDA’s recent actions threatening NAC supplements—products which the FDA has allowed on the market for decades.

The question is, why now, after all these years, is the FDA doing this?

Digging a bit deeper, it seems obvious that the FDA is clearing the market of affordable NAC supplements in an effort to eliminate competition for NAC drugs that could be coming to market in the next few years.

If our suspicions are correct, this would be another outrageous example of the FDA doing Big Pharma’s dirty work.

To briefly recap how we got here: In a slew of warning letters sent last year, the FDA targeted a number of supplement companies marketing “unapproved” cures for hangovers—which the agency absurdly considers to be a “disease.”

Some of these products contain NAC. In the letters to those companies, the FDA states that NAC does not meet the legal definition of a supplement because it was approved as a drug in 1963; according to federal law, any substance approved as a drug before it was sold as a supplement cannot be sold as a supplement. All of this means that the status of NAC as a supplement is currently in dispute.

So, why is the FDA threatening NAC now, during a pandemic when a new FDA commissioner hasn’t even been appointed? For starters, a drug company is investigating NAC as a treatment for a rare genetic disorder that damages the myelin sheath, which insulates nerve cells in the brain. The Phase 1 trial was completed in March 2020.

But that’s just the beginning. A search through the government’s clinical trials database shows considerable interest from the pharmaceutical industry in NAC. There are 17 trials looking at NAC, in both drug and supplement form, in the treatment of COVID.

Additionally, there are over 50 trials looking at NAC for a variety of other conditions, including: autism spectrum disorder, obsessive compulsive disorder, alcohol abuse disorder, rhinosinusitis, bronchiolitis, cardiac arrhythmia, and more.

Note that NAC drugs are currently available in generic form since it is off-patent, but a company could bring a new branded NAC drug to market if it was proven effective for an additional indication.

Given these facts, it seems reasonable to assume that the FDA is setting the stage for a new NAC drug to come to market by removing the competition from much cheaper NAC supplements.

We called it when the FDA pulled a similar move a few years back when they went after brain health supplements, trying to clear the market for a new Alzheimer’s drug—culminating in the recent approval of an Alzheimer’s treatment that many experts think is not effective.

CBD supplements may face a similar fate if Congress does not force the FDA’s hand by legalizing CBD in dietary supplements.

It is critically important to maintain access to affordable NAC supplements.

In a recent interview with the Life Extension Foundation, Dr. Daniel Amen noted that NAC “has shown promising results in people with bipolar disorder, schizophrenia, OCD, and addictions.

It can also decrease inflammation and may help delay brain atrophy in Alzheimer’s disease.” NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging. In Europe, NAC is a prescription medicine used to reduce congestion.

NAC is also a precursor to glutathione, one of the body’s most important antioxidants. Glutathione plays crucial roles in nutrient metabolism and the regulation of many cellular events (such as gene expression, protein synthesis, cell proliferation, and more); glutathione deficiency contributes to oxidative stress, which is implicated in the development of many diseases: Alzheimer’s, Parkinson’s, liver disease, HIV, heart attack, cancer, stroke, and diabetes.

Note that acetaminophen depletes glutathione, so those who regularly take it should consider, in consultation with an integrative doctor, supplementing with NAC to replenish glutathione levels. In fact, NAC is routinely used in hospitals to counteract acetaminophen toxicity.

NAC is far too important to be threatened by the FDA, especially under such dubious circumstances.

Read the full article at Alliance for Natural Health.

Clock Ticking For Supplements

by Alliance for Natural Health

Excerpts:

The FDA could be preparing to unleash an anti-supplement policy as early as next year that could eliminate tens of thousands of products from the market—in the middle of a pandemic. Action Alert!

Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. 

We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.

Here is some brief background. Under the Dietary Health and Supplement Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In implementing this policy, however, the FDA has turned a simple notification procedure into a de facto pre-approval process akin to that which is required of pharmaceutical drugs.

The FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry. How do we know this? An economic analysis estimated that the guidance would result in:

• tens of thousands of products disappearing from store shelves;
• an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
• the loss of between 55,270 and 104,475 jobs in the supplement industry.

How does the FDA’s guidance do this? First, the guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA’s guidance describes how to determine what kind of safety studies to submit with an NDI notification. The agency states that additional safety studies may be needed if the target population of supplements changes.

For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. Not even drugs are held to this standard: the FDA states that “most drugs prescribed for children have not been tested in children.”

Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable.

Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs.

This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.

The FDA is also broadening the group of substances that must submit new supplement notifications by adopting a loose definition of what it means for a supplement to be “chemically altered.”

If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting an NDI notification.

The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient.

This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed.

There are even more problems with the guidance that interested readers can reference in our previous coverage of this topic.

If the FDA sticks to its timeline of June 2022, the release of the final guidance could seriously hinder our ability to stay healthy, naturally, during this pandemic.

And using supplements to shore up our immune system against COVID is even more important as scientists learn more about the ability of multiple COVID variants to adapt and “escape” the immunity conferred by current vaccines and even natural infection. As noted in Science, “Such ‘immune escapes’ could mean more people who have had COVID-19 remain susceptible to reinfection, and that proven vaccines may, at some point, need an update.”

In light of these concerns, our friends at ANH International have wisely advised that we don’t rely exclusively on vaccines; we need a diverse array of tools to protect ourselves, including access to quality supplements. We can’t use these strategies if the FDA makes sure they’re out of reach.

We must push back against this bureaucratic indifference to our health and well-being.

Read the full article at Alliance for Natural Health.

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