How are dietary supplements like Neurocept regulated in the U.S., and what does 'not evaluated by FDA' actually mean?
This fact-check may be outdated. Consider refreshing it to get the most current information.
Executive summary
Dietary supplements such as Neurocept are regulated in the U.S. as a category of food under the Dietary Supplement Health and Education Act (DSHEA), which places primary responsibility for product safety, labeling, and truthful claims on manufacturers rather than on premarket FDA approval [1] [2] [3]. The ubiquitous label line “This statement has not been evaluated by the FDA” means the agency did not review or approve the product’s efficacy or structure/function claims before marketing — supplements are subject to post‑market oversight, adverse‑event reporting, and enforcement actions if products are adulterated or misbranded [4] [5] [6].
1. Regulatory framework: supplements are treated as foods, not drugs
Since DSHEA amended the Food, Drug, and Cosmetic Act in 1994, dietary supplements have been legally categorized as a subset of foods, which means the FDA does not review or authorize their safety or effectiveness prior to sale in the way it does for prescription drugs — the law explicitly does not provide for premarket approval of most supplements [1] [2] [3].
2. Manufacturer responsibility and required notifications
Under DSHEA manufacturers and distributors are required to ensure their products are not adulterated or misbranded and to register facilities and comply with good manufacturing practices; for any “new dietary ingredient” (one not marketed before October 15, 1994) the company must notify FDA and provide evidence of reasonable safety, although enforcement gaps and incomplete guidance have limited how robust that review is in practice [1] [6] [2] [7].
3. What “not evaluated by FDA” actually means in plain terms
The standard disclaimer accompanying structure/function or general wellness claims — “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” — signals that FDA has not assessed the scientific evidence for the claim and that the product was not reviewed as a drug would be; companies may make structure/function claims if they have substantiation, but those claims do not receive agency preapproval [4] [6] [8].
4. Post‑market tools, limitations, and enforcement realities
FDA and FTC both have enforcement authority after a product hits the market: FDA can inspect facilities, require adverse event reports, and act against adulterated or misbranded products, while FTC policing focuses on advertising claims; however, scholars and public‑health commentators note statutory limits — such as the need for FDA to demonstrate that a marketed supplement is unsafe before removal, sparse premarket evidence requirements, and inconsistent guidance on acceptable safety data — all of which mean surveillance and enforcement are often reactive rather than preventive [6] [9] [10] [11].
5. Quality variation, consumer risk, and conflicting incentives
Research and FDA guidance acknowledge that quality, purity, and labeling accuracy can vary widely across supplements — botanical and herbal products are especially prone to variability — and industry incentives to grow market share can encourage aggressive claims that skirt the drug/supplement boundary; consumer disclaimers may be overlooked, and critics argue that current rules allow potentially unsafe or ineffective products to remain available until the agency proves harm [7] [10] [2].
6. Where responsibility lies and what reform advocates recommend
Under the current system the burden for premarket substantiation lies mainly with manufacturers, with FDA relying on post‑market data and targeted inspections; reform advocates and some policy analyses call for clearer premarket safety standards for new ingredients, improved adverse‑event surveillance, and stronger enforcement resources — recommendations drawn from medical journals and regulatory analyses that see DSHEA’s statutory design as the root of enforcement friction [10] [11] [9].
7. Bottom line for a product labeled “not evaluated by FDA”
That label is not a quibble — it is a legal acknowledgment that the product was not vetted by FDA for efficacy or disease claims and that consumers are relying on manufacturer‑provided substantiation and post‑market oversight; the FDA can and does act if evidence of adulteration, contamination, or false claims emerges, but the timing and scope of action are constrained by DSHEA and resource limits [4] [5] [3].