On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). NAC is a supplement form of cysteine, a semi-essential amino acid, which was approved by the FDA as a drug in 1963 to treat liver side effects from an overdose of Tylenol (acetaminophen) and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.
The new guidance explains the FDA’s intent to exercise enforcement discretion concerning the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
To learn about the FDA’s enforcement discretion for NAC supplements click here:
Know the requirements for marketing NAC Supplements:
The FDA requires that the manufacturer or distributor of an NAC supplement follows certain guidelines for labeling and safety. Make sure to read all labels carefully, as the label should detail everything you need to know about the product, including any warnings about potential side effects and contaminants. Additionally, ask your provider questions about NAC supplements before including them in your health regimen. This can help ensure you’re making informed decisions about what products are safe and beneficial for you.
Be aware of NAC Supplement labeling requirements:
When purchasing an NAC supplement, it’s important to be aware of certain labeling requirements as put forth by the FDA. These include both general and product-specific labeling, such as itemized ingredients, a description of what the product does, information about nutraceuticals, usage instructions and dosage information, safety warnings about potential side effects or adverse reactions due to drug interactions, and expiration date. Additionally, all NAC supplements must clearly state if they are dietary supplements.
Understand safety guidelines for NAC supplement products:
As with any supplement, it’s important to make sure that the NAC product you purchase meets safety guidelines. Look for reliable suppliers of high-quality NAC supplements and pay attention to any warning labels about potential drug interactions or side effects when taking them. Be sure to read the information carefully before taking a NAC supplement so that you can accurately understand the benefits, risks, and dosing instructions. Additionally, look for products that have been third-party tested for quality and purity.
Pay attention to current NAC Supplement updates:
Be sure to pay attention to current updates about NAC supplement regulations to ensure that you are fully aware of all FDA requirements. The FDA regularly evaluates supplements and issues updated guidelines or product recalls as necessary. Understanding and following the latest instructions related to dosing, labeling, ingredients, and manufacturing standards can help you stay informed.
Utilize FDA resources for guidance and advice:
Make sure you understand all relevant safety, labeling, and manufacturing standards for NAC supplements by taking advantage of FDA resources. The FDA provides helpful tips and guidance on its website as well as regulatory update alerts about any changes that have been made to the regulatory requirements. Additionally, you can contact the FDA directly with questions or comments regarding your products.