FDA Doesn't Approve Supplements Before Sale. Cara Welch Explains Who Does.

TL;DR: FDA does not approve dietary supplements or their labels before sale — manufacturers are responsible for product safety and truthful claims, and federal oversight mostly happens after products reach the market.

Washington does not clear a supplement or its label before shoppers can buy it, and the companies that make and market the products carry the legal duty to keep them safe and their claims honest. That is the core of FDA's "Q&A with FDA" episode on supplement oversight, where Dr. Cara Welch, director of the agency's Office of Dietary Supplement Programs, walked through the rules. The podcast sketches the scale: a market worth more than $60 billion, as many as 100,000 products, and about 75% of Americans using supplements.

The newest piece of the framework landed on October 19, 2026, when FDA released final guidance on the identity and safety information companies should include in new dietary ingredient notifications. A separate proposed rule, published August 11, 2026, would require companies to submit notices for substances they market as generally recognized as safe. Its comment window closes December 9, 2026.

What counts as a supplement

The category covers vitamins, minerals, botanicals, probiotics and comparable products people take alongside their diet, often to support or maintain a healthy lifestyle. Pills and tablets qualify, but so do liquids, gummies and powders. Two lines matter: the product must be swallowed, which excludes anything applied to the skin or inhaled, and it cannot stand in for meals. Welch said conventional foods should always be the main source of nutrients.

Companies hold the safety obligation

The legal foundation is DSHEA, the Dietary Supplement Health and Education Act of 1994, which placed supplements inside the food category rather than the drug category. Because of that, FDA does not review a product or its label before it goes on sale, and most supplements can reach the market lawfully without the agency ever hearing about them. Manufacturers and marketers must ensure their products are safe and that label claims are truthful and substantiated. Some products containing certain new ingredients need a safety submission on file with FDA at least 75 days before marketing.

Oversight that begins after launch

Welch's description of FDA's work is largely post-market: watching the marketplace, testing products, examining imports, inspecting plants for manufacturing and labeling compliance, reviewing new-ingredient notifications, and investigating adverse event reports and complaints. If FDA finds a product unsafe or unlawful, it can work with the company on fixes or remove the item, weighing public health priorities and available resources.

The blind spot FDA wants Congress to fix

FDA has no systematic way to learn that a new supplement has launched or what it contains, Welch said, leaving the agency at a disadvantage when it tries to identify dangerous or illegal products. What FDA has backed is a legislative remedy: a listing requirement covering the brand, the product's name, and how much of each ingredient it contains. Welch said such a registry would map the market and help the agency find products sharing an ingredient faster.

In Congress, H.R. 8370 — the Dietary Supplement Listing Act of 2026 — would create that requirement. Rep. Maxine Dexter introduced the bill on April 20, 2026, and it was referred to the House Energy and Commerce Committee. NutraIngredients reported that the measure appeared among a House Democratic working group's pre-election recommendations for the first 100 days of the 120th Congress, after Democratic victories in both chambers in the November 3 midterms. They were not adopted as a formal caucus agenda. Trade groups are divided: the Council for Responsible Nutrition backs a mandatory registry, while the Natural Products Association opposes listing.

What 2026 added to the rulebook

FDA's October 19 guidance finalizes three sections of a 2016 revised draft: characterizing a new ingredient, using history of use or other safety evidence, and summarizing the basis for a safety conclusion. FDA says it will keep finalizing the remaining sections in stages. The guidance is nonbinding but sharpens expectations. Companies relying solely on a history of safe use should generally point to about 25 years of widespread consumption; shorter histories are not automatically inadequate but need more supporting evidence. Where history falls short, FDA suggests toxicology, animal, human or alternative-method data, and it wants the evidence gathered into a single safety narrative.

AHPA president Graham Rigby said the guidance offers constructive refinements, including removal of a recommendation that each product formulation be notified separately, but leaves long-standing concerns unresolved, Nutritional Outlook reported. CRN welcomed added flexibility while criticizing the retained 25-year benchmark and warning that basic questions — what makes an ingredient "new," and when a notification is required — remain open.

Separately, the August 11 GRAS proposal would replace voluntary notification with a mandatory system for covered human and animal food substances. Welch has said the agency expects more ingredient safety submissions to flow into the NDI pathway if companies lose the ability to self-certify GRAS status, and that NDIN volume has risen from roughly 40 to 50 a year to about 70, Nutraceuticals World reported in February 2026. She has also acknowledged limits on reach: inspection coverage has extended to only a single-digit percentage of known U.S. supplement manufacturing facilities.

In October, Welch stressed modernization. "Three out of four Americans rely on dietary supplements as part of their self-care routines, and they deserve an oversight approach that keeps pace with a dynamic and evolving marketplace," she told NutraIngredients on October 12, 2026.

What labels can and cannot claim

Supplements may carry structure/function claims — statements about how a nutrient affects normal body function — but may not claim to diagnose, treat, cure or prevent a disease. Products making such claims must display the DSHEA disclaimer noting that FDA has not evaluated the statement.

Consumer advice from FDA's supplement chief

Welch's practical guidance centers on drug interactions. People should talk with a doctor or pharmacist before starting a supplement, she said, because ingredients can change how prescription drugs are absorbed or broken down. FDA does not approve supplements before sale, so a bottle on a shelf is not evidence of agency sign-off. When a product causes a serious problem, companies are required to report serious adverse events, and consumers can file their own report through FDA's Safety Reporting Portal.

Dates and next steps

Comments on the GRAS proposal close December 9, 2026. FDA says it is continuing to finalize additional sections of the NDI guidance. H.R. 8370 remains with the House Energy and Commerce Committee, and the 120th Congress convenes in January.