…In order to turn it into a restricted and expensive drug. Why?
The FDA has declared that N-acetylcysteine (NAC), a vital antioxidant with essential health benefits, is not a legal dietary supplement. The rationale is that it was long ago approved as a drug before it was sold as a supplement, but in practice banning the supplement form will put this critical nutrient out of reach for regular consumer use to support health.
This threatens consumer access to yet another life-saving dietary supplement, while granting drug companies monopoly profits. It is the exact opposite of what the FDA should be doing. Only Congress can stop it.
NAC is not so well known as common vitamins. But your body really needs it. NAC provides essential components of glutathione and glutathione is your body’s secret weapon to fight disease and stay healthy. If you don’t make enough of it, this can lead to all sorts of physical problems including Alzheimer’s, Parkinson’s, liver disease, heart attack, cancer, stroke, diabetes, and shortened lifespan, to name just a few. Glutathione also helps control the body’s response to viral and other infections. Your body needs to make glutathione and NAC helps your body succeed in doing so.
Glutathione levels decrease with age, but also because of poor diet, pollution, medications, stress, and infections. It can be difficult to boost glutathione levels because the body does not absorb much of it from food. Nor is it easy to boost it from a glutathione supplement. If the FDA bans NAC supplements, it will be much harder to restore our glutathione levels.
This isn’t the first time the FDA has removed or threatened to remove a supplement from the market for the benefit of drug companies. In 2009, in response to a drug company petition, the FDA determined that pyridoxamine, a natural form of vitamin B6, couldn’t be a supplement because it was being studied as a drug. The drug never happened but the supplement was gone.
Another drug company similarly petitioned the FDA to ban a different form of B6, pyridoxal-5-phosphate (P5P), in supplements. This form is the only form the body can actually use. All other forms must first be converted to P5P in order for the body to use it. And if we don’t have enough P5P, we die. Should this really be banned as a potential part of our diet and turned into a restricted and expensive drug? Only a drug company completely unconcerned with public health could wish this.
Not only is the FDA threatening to deny consumer access to supplements like NAC and vitamin B6. Companies selling them are blocked by federal law from explaining their incredible benefits, since only FDA-approved drugs can make health claims relating to treating or preventing disease.
These laws mean that producers can’t even inform the public about the benefits of basic nutrients like magnesium, zinc, or vitamin D for human health. Yet the Centers for Disease Control and Prevention tell us that low magnesium, for example, may be associated with high blood pressure, heart disease, bone loss, and headaches.
The Department of Health and Human Services and the US Department of Agriculture have found that large swaths of the American public are not getting the nutrients they need. Research shows that micronutrient inadequacies may impact long-term health, increasing risk for diseases like cancer, cardiovascular disease, type 2 diabetes, and yes, viruses. But again, supplement producers are barred from communicating these scientifically-supported benefits to the public.
Drug companies are expected to make billions of dollars from COVID vaccines: Pfizer alone expects its mRNA COVID vaccine, developed using taxpayer-funded research and paid for with public dollars, to generate $26 billion in revenue. Does the FDA want drug companies to control all our food and supplements too? Is that what Congress wants?
Instead, Congress should do something about the cozy relationship between drug companies and the FDA. It should also support access to information that can benefit our health by allowing food and supplements to share legitimate scientific research.
To learn more about these dietary supplement issues, please contact Jo Twombly at [email protected].