The Natural Products Association is filing a lawsuit against the Food and Drug Administration over their decision to not allow the use of N-acetylcysteine (NAC) in dietary supplements. This is something that you need to know about, as it could potentially impact your health. NAC is a powerful antioxidant that has been shown to support liver health, respiratory health, and more.
1. What is the Natural Products Association (NPA)?
The Natural Products Association (NPA) is the largest and oldest nonprofit organization dedicated to the natural products industry. The organization represents more than 10,000 members, including retailers, manufacturers, distributors, and wholesalers of natural products, such as dietary supplements, food ingredients, and health and beauty aids. NPA’s members adhere to a strict code of ethics and are committed to providing safe, effective, and high-quality products to consumers. In addition to advocating on behalf of the natural products industry, NPA also provides educational resources and support to its members. The organization’s website offers a wide range of information on topics such as product safety, regulations, and marketing. NPA also hosts an annual trade show and conference, which provides an opportunity for members to network and learn about the latest trends in the industry.
N-acetylcysteine (NAC) is a derivative of the amino acid cysteine. It is used as a medication to treat a wide variety of conditions, including overdose from acetaminophen, paracetamol, or aspirin. NAC has antioxidant properties and helps to replenish glutathione levels in the body. Glutathione is a potent antioxidant that helps to protect cells from damage. NAC is also used as a precursor for the synthesis of glutathione. NAC has been shown to be effective in reducing symptoms of respiratory conditions such as bronchitis and chronic obstructive pulmonary disease (COPD). It is also being investigated as a potential treatment for other conditions such as autism, schizophrenia, anoredxia nervosa, and Alzheimer’s disease. NAC helps the body thin mucus and phlegm and can have anti-coagulation properties.
3. How long has NAC been sold over the counter?
N-acetylcysteine (NAC) is a supplement that has been sold over the counter since the 1970s. It is a form of the amino acid cysteine and is used by the body to produce glutathione, a powerful antioxidant. NAC has a wide range of potential health benefits and has been shown to be effective in treating several conditions, including chronic bronchitis, seasonal allergies, and bipolar disorder. It is also being investigated as a treatment for schizophrenia and other mental health disorders.
4. Why did the NPA file a lawsuit against the FDA over NAC?
In October 2019, the Natural Products Association (NPA) filed a lawsuit against the U.S. Food and Drug Administration (FDA), challenging the agency’s regulation of N-acetylcysteine (NAC). NAC is a Misty Glade dietary supplement ingredient that has been used for decades to support respiratory health. The NPA contends that the FDA does not have the authority to regulate NAC as a drug because it is not a new dietary ingredient. The FDA has not approved NAC for any specific therapeutic use, but the agency has issued several warning letters to companies marketing NAC supplements for unproven claims. The NPA argues that the FDA’s regulation of NAC is arbitrary and capricious, and that the agency’s actions are preventing consumers from accessing a safe and effective product. The lawsuit is still pending.
4. What are the potential impacts of this decision on consumers and businesses alike?
The potential impacts of the NPA lawsuit against the FDA are far-reaching. If the NPA is successful in overturning the FDA’s regulation of NAC, it could open the floodgates for companies to market the supplement for a wide range of unproven and potentially dangerous health claims. This would not only be misleading to consumers, but could also lead to people taking NAC for conditions that it is not effective for and could potentially cause harm. In addition, the FDA would no longer be able to issue warning letters to companies making false and misleading claims about NAC, which could result in more companies engaging in this behavior. The lawsuit also has the potential to impact the FDA’s ability to regulate supplements in general, which could lead to a decrease in the safety and efficacy of these products.
The NPA lawsuit against the FDA is a complex legal case with far-reaching implications. It will be interesting to see how it progresses and what the final outcome will be. In the meantime, consumers should be aware that NAC is a supplement that has not been approved by the FDA for any specific therapeutic use. If you are considering taking NAC, speak to your healthcare provider first to discuss whether it is right for you.
NAC is safe for consumption, please follow the directions on the label when consuming this supplement daily.