The distinction between dietary supplements and FDA approved drugs became murkier earlier this year when Amazon announced their decision to ban supplements containing the popular antioxidant cysteine N-acetyl-L-cysteine (NAC.)
While NAC is used medically to treat acetaminophen overdose, it’s more commonly available in commercial dietary supplements as an antioxidant in treating chronic bronchitis and the promotion of a healthy liver function. But the difference between an approved drug and a supplement isn’t a clear one. In 2020, the FDA issued warning letters to seven companies marketing alleged hangover cures containing NAC that their products could no longer be marketed as dietary supplements since the ingredient was first studied and approved as a drug in 1963.
Under section 201(ff)(3)(B)(i) of the Federal Food, Drug & Cosmetic Act (FFDCA), products containing NAC can not be marketed as a dietary supplement since FDA evaluation indicated it was considered a drug intended for use in the cure, treatment, or prevention of disease. Yet at the same time, NAC has been widely marketed as a dietary supplement and not a drug for the past 57 years. What brings about the FDA’s sudden change?
Supplements and Drugs: Definitions and Regulations
Dietary supplements are defined as “any product, intended to supplement the diet that contains a vitamin, mineral, herb or botanical, dietary substance, or a concentrate, metabolite or extract” so long as it isn’t deemed harmful under 1994’s Dietary Supplement Health and Education Act (DHSEA.) They cannot, however, be designated as a drug used in “the cure, mitigation, treatment, or prevention of disease” under FFDCA guidelines.
The distinction isn’t isolated to clinical treatment by medical professionals, however. Federal law does not require a supplement to meet FDA safety standards prior to being marketed. So long as they do not present an unreasonable risk to public health or make unsubstantiated claims, the chief regulatory policy for dietary supplements requires that they simply be labeled as such.
A drug, on the other hand, must meet strict regulatory guidelines regarding its efficacy, and must be used in the diagnosis, cure, prevention or treatment of a disease and recognized by an official pharmacopoeia or formulary. There’s a reason why they’re subject to stringent review, and those reviews have led to FDA recalls of 195 specific prescription drugs between 2017 and 2019.
NAC: A Question of Marketing?
Under section 5 of the FFDCA, manufacturers cannot market products as dietary supplements if they contain an article that FDA has approved as a “new” drug unless that article was marketed in dietary supplements prior to its approval as a regulated drug. According to a letter filed by the Council for Responsible Nutrition (CRN) against the FDA’s sudden decision to classify NAC-based supplements as drugs, regulatory approval of NAC being classified as a new drug is entirely unclear being based on two conflicting dates of 1963 and 1985—the latter of which was well after its widespread commercial usage as a dietary supplement.
The CRN also argues that the sudden policy change is an arbitrary act rendered invalid under the Administrative Procedure Act of 1946, which governs the process by which federal agencies issue regulations and allows for public input before a final decision is made. But it’s precisely this lack of clarity that has forced Amazon to remove any and all products containing NAC rather than argue over the finer points of semantics and legal technicalities.
Amazon Policy, Supplements and Sudden Removal
Amazon’s decision isn’t the first time they’ve proactively taken steps to comply with regulatory concerns towards dietary supplements in recent months. Most notable, their decision in December 2020 to require documentation from an ISO/IEC 17025 accredited laboratory to ensure both purity and accurate dosage of ingredients in supplements has raised an eyebrow among many of the top selling brands on the platform. But while Amazon does permit the sale of FDA approved over the counter drugs, the FDA’s decision to reverse policies on NAC raises an entirely new question of accuracy in marketing.
“Third-party sellers are independent businesses and are required to follow all applicable laws, regulations and Amazon policies when listing items for sale in our store,” an Amazon spokesperson told Natural Products Insider in an emailed statement on the topic. “We have proactive measures in place to prevent prohibited products from being listed and we continuously monitor our store. Those who violate our policies are subject to action, including potential removal of their account.”
While groups such as CRN vow to fight the FDA’s policy reversal, current sellers of any supplement containing NAC should be forewarned that product lines may be subject to removal until a final decision on policy has been issued by the FDA.
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