Are Supplements FDA Approved? (The Answer Might Surprise You)

Published February 28, 2026 · SupplementScanner.app Editorial · 10 min read

No. Dietary supplements are not FDA approved. Not a single one.

That one-sentence answer shocks most people. A 2019 CRN consumer survey found that 85% of U.S. adults express confidence in the safety and quality of dietary supplements. Many assume that if something is sold on store shelves in America, the government must have approved it. For drugs, that's true. For supplements, it's not even close.

The gap between what consumers believe and what actually happens is the result of a single law passed over three decades ago.

DSHEA: The 1994 Law That Changed Everything

The Dietary Supplement Health and Education Act, known as DSHEA, was signed into law by President Clinton on October 25, 1994. It fundamentally redefined how the U.S. government regulates dietary supplements.

Before DSHEA, the FDA had the authority to regulate supplements more aggressively. There was ongoing debate about whether supplements should require pre-market approval similar to drugs. The supplement industry, fearing restrictive regulation, launched one of the largest grassroots lobbying campaigns of the 1990s. Millions of consumers wrote to Congress. Celebrity endorsements flooded the airwaves. The message was clear: don't take away our vitamins.

DSHEA was the result. And it did something remarkable: it shifted the burden of proof from the manufacturer to the government.

Under the drug approval framework, a pharmaceutical company must prove its product is safe and effective before selling it. Clinical trials, FDA review, and formal approval are all required. Under DSHEA, a supplement manufacturer doesn't need to prove anything before going to market. The FDA can only step in after a product is already being sold — and only if it can demonstrate that the product is unsafe.

That's a monumental difference. The system operates on the assumption that supplements are safe until proven otherwise.

What the FDA Actually Does (And Doesn't Do)

Here's a practical breakdown of the FDA's role in supplement oversight:

The FDA Does Not:

• Approve supplements before they go on sale
• Test supplements for safety, purity, or potency before they reach consumers
• Verify that supplement labels are accurate
• Evaluate whether a supplement actually works as claimed
• Require clinical trials or efficacy data for supplements

The FDA Does:

• Require manufacturers to follow Good Manufacturing Practices (GMP) — though enforcement is limited
• Require that serious adverse events be reported by manufacturers
• Review new dietary ingredient (NDI) notifications for ingredients not sold before October 1994
• Take enforcement action against products found to be adulterated, misbranded, or containing undeclared drug ingredients
• Issue warning letters to companies making illegal drug claims (like "cures cancer" or "treats diabetes")
• Maintain a database of recalled supplement products

The FDA itself is transparent about these limitations. Their own website explicitly states that the agency does not approve dietary supplements and that manufacturers and distributors are responsible for ensuring their products are safe.

The One Exception: New Dietary Ingredients

DSHEA created a narrow notification requirement for new dietary ingredients (NDIs) — any ingredient that was not sold as a dietary supplement before October 15, 1994. For these ingredients, manufacturers must submit an NDI notification to the FDA at least 75 days before marketing the product. The notification must include information demonstrating a reasonable expectation of safety.

This is not approval. The FDA reviews the notification and can raise safety concerns, but the company can proceed to sell the product after the 75-day period regardless. And honestly, compliance with this requirement has been spotty. A 2011 report from the Department of Health and Human Services Inspector General found that many supplement companies were not filing required NDI notifications for new ingredients.

Between 1994 and 2024, the FDA received roughly 1,400 NDI notifications. Given that there are an estimated 95,000+ supplement products on the market (with thousands of new ones launching annually), the notification system captures only a fraction of new ingredient introductions.

Real-World Consequences

The lack of pre-market oversight has led to documented problems. These aren't hypothetical risks.

Tainted Supplements

The FDA's Tainted Supplements database lists products found to contain hidden active pharmaceutical ingredients — actual drugs that aren't declared on the label. Between 2007 and 2024, the FDA identified over 1,100 tainted supplement products. The most common categories were sexual enhancement products (containing sildenafil or tadalafil, the active ingredients in Viagra and Cialis), weight loss products (containing sibutramine, a banned drug), and bodybuilding products (containing anabolic steroids or designer steroids).

These aren't labeling errors. These are products deliberately spiked with prescription drugs to make them "work" — sold to consumers who think they're buying an herbal supplement.

Heavy Metal Contamination

Multiple studies and investigations have found supplements contaminated with lead, arsenic, mercury, and cadmium at levels exceeding safe limits. A 2018 study published in the Journal of Clinical and Translational Science tested Ayurvedic herbal supplements and found that 40% contained detectable levels of lead, and nearly 20% exceeded FDA-recommended limits.

Without mandatory pre-market testing, contaminated products can be sold for months or years before anyone catches the problem.

Ephedra: The Case Study

The most prominent example of DSHEA's limitations was ephedra. This herbal stimulant was widely sold in weight loss and energy products throughout the 1990s and early 2000s. It was linked to heart attacks, strokes, and deaths — including the high-profile death of Baltimore Orioles pitcher Steve Bechler in 2003.

The FDA first received adverse event reports about ephedra in the mid-1990s. But under DSHEA's framework, the agency couldn't simply pull it from shelves. It had to build a case proving the ingredient was dangerous. That process took nearly a decade. The FDA didn't ban ephedra until April 2004, and even then, the ban was challenged in court (it was ultimately upheld).

Ten years from first warning signs to regulatory action. That's the timeline when the FDA has to prove danger rather than the manufacturer proving safety.

Recent FDA Enforcement Actions

Despite its limited proactive authority, the FDA has become more aggressive with enforcement in recent years. Some notable actions:

• 2023-2024: NAC (N-Acetyl Cysteine) reversal. After initially questioning whether NAC could legally be sold as a supplement, the FDA reversed course and allowed it, responding to industry pressure and congressional inquiry. This showed both the FDA's power and its political constraints.
• 2023: Dozens of warning letters issued to companies marketing supplements with unapproved drug claims, particularly targeting products claiming to treat Alzheimer's disease, diabetes, and COVID-19.
• 2024: Tianeptine crackdown. The FDA issued alerts and pursued enforcement against supplements containing tianeptine, an opioid-like substance marketed as a dietary supplement and linked to serious adverse events including hospitalizations and deaths.
• Ongoing: Mandatory Product Listing proposal. The FDA has pushed for mandatory product listing for dietary supplements, which would require companies to register their products in a public database. As of early 2026, this requirement has not been enacted into law, though bipartisan legislation has been introduced multiple times.

How Other Countries Handle It

The U.S. approach isn't the only model. Other countries regulate supplements quite differently:

Canada's system is often cited as a middle ground. Natural health products must receive a Natural Product Number (NPN) before being sold, which requires evidence of safety, efficacy, and quality. It's not as rigorous as drug approval, but it provides a level of pre-market review that doesn't exist in the U.S.

What This Means For You

The regulatory reality doesn't mean all supplements are unsafe or worthless. Many supplement companies operate with integrity, invest in quality testing, and produce products that meet high standards. But the system doesn't require them to, and there's no easy way for consumers to distinguish the good actors from the bad ones just by looking at a bottle.

Here's how to protect yourself in an environment where pre-market approval doesn't exist:

1. Don't assume safety from store presence. A supplement being sold at a major retailer doesn't mean the FDA has reviewed or approved it. Retailers do vary in their vetting processes — Costco and Whole Foods, for example, tend to have stricter internal standards — but shelf presence alone guarantees nothing.
2. Look for third-party certifications. USP, NSF, and ConsumerLab provide the independent verification that the FDA doesn't. These certifications aren't required, and they're expensive, so their presence signals a company willing to invest in quality. (See our guide to third-party testing for details.)
3. Check the FDA's databases. The FDA maintains a searchable database of warning letters, recall notices, and tainted supplement alerts. A quick search of a brand name can reveal enforcement history.
4. Report adverse events. If a supplement causes a problem, report it to the FDA through the MedWatch system. These reports are one of the primary tools the FDA uses to identify dangerous products.
5. Use technology. Supplement scanner apps like Suppi can rapidly analyze a product's ingredients against clinical evidence databases, flagging safety concerns and evidence gaps that you'd never catch from the label alone.

Will Regulation Ever Change?

There's been growing bipartisan support for updating supplement regulation. The most prominent proposal is mandatory product listing, which would require supplement companies to register every product with the FDA, disclosing ingredients, label claims, and manufacturer information. Proponents argue this would give the FDA a basic inventory of what's being sold — something that, remarkably, doesn't currently exist.

Industry groups are split. Major companies with established brands generally support increased transparency because it raises the bar for lower-quality competitors. Smaller companies and some industry trade groups have pushed back on cost and administrative burden concerns.

Whether meaningful reform happens depends on congressional action. DSHEA has proven remarkably durable — it's survived essentially unchanged for over 30 years despite periodic calls for reform. The supplement industry remains one of the most effective lobbying forces in the consumer products space, and consumer advocacy groups, while vocal, have struggled to build the political momentum needed for legislative change.

In the meantime, informed consumers are their own best regulators.