The Food and Drug Administration regulates products that account for roughly 20 cents of every dollar Americans spend, but the term "FDA-approved" has a specific meaning that's often used loosely, according to a new explainer published June 10, 2026, by the R Street Institute. The report walks through how the FDA's regulatory authority evolved over more than a century, creating multiple approval pathways and terminology that vary dramatically by product type—from rigorous pre-market approval for new drugs to simple authorization for tobacco products.
The FDA's regulatory reach extends across tobacco products, cosmetics, veterinary products, medical devices, electronic products that give off radiation, dietary supplements, and biologics used in medicine. The agency was established in 1906 to address misbranded and adulterated food and drugs, but various public health crises prompted Congress to expand its authority over time. The Federal Food, Drug, and Cosmetic Act passed in 1938 following a mass-poisoning event, requiring all drugs to receive approval before being sold and bringing cosmetics and medical devices under FDA authority. A 1962 amendment required manufacturers to prove a drug's efficacy in addition to its safety and quality, while a 1976 amendment built a tiered classification system for medical device regulation based on risk of harm. Separate legislation in 1994 reaffirmed that dietary supplements should be regulated as food products, and a 2009 law formally brought tobacco products under FDA regulatory authority.
The report breaks down how different product classes face different standards. New drugs and biologics cannot be sold before seeking FDA approval, a rigorous process that involves reviewing a product's safety, quality, and effectiveness—if the FDA determines that benefits outweigh known risks, the product is approved for sale. Medical devices are either "FDA-approved" or "FDA-cleared" based on risk: Class III devices like mechanical heart valves must be FDA approved, Class II devices like dialysis equipment can pursue "510(k) clearance" by demonstrating they're substantially equivalent to a device already on market, and Class I devices like exam gloves don't typically require approval or clearance. The report emphasizes that there is no such thing as an "FDA-approved" tobacco product—instead, the FDA issues marketing orders that authorize a product to be legally marketed and sold. New reduced-risk products like e-cigarettes and nicotine pouches must submit extensive data to prove they are "appropriate for the protection of public health," while products substantially equivalent to pre-2007 products face a less demanding pathway.
The report notes this authorization structure has "the unfortunate effect of subjecting combustible cigarettes (the deadliest way to consume nicotine) to less rigorous review than reduced-risk products that could help people quit or minimize the harms of smoking." The authors argue these regulatory distinctions matter for public health, particularly in tobacco harm reduction, because marketing orders can put more legal, regulated harm reduction tools on shelves, cut down on the unregulated illicit market for nicotine products, and give healthcare providers more confidence in recommending harm reduction tools to patients struggling to quit via traditional methods. The FDA is starting to authorize more reduced-risk products for sale in the United States, which the report frames as a meaningful step toward expanding access to safer alternatives for nicotine users who can't or won't quit entirely.