Article · Healthcare

Claims That Turn a Product Into a Drug: FDA Regulation of Supplements, Cosmetics, and Wellness Marketing

21 U.S.C. §§ 301

Type
Article
Jurisdiction
National
Date
2024-12-05
Topic
Healthcare

A product's legal identity under federal law is decided not by what is in the bottle but by what the seller says it does. This article explains the intended use doctrine that turns a lotion into a drug and a supplement into an unapproved new drug, and works through the categories the Food, Drug, and Cosmetic Act creates. It covers the dietary supplement framework created by DSHEA including the structure-function claim safe harbor, the disclaimer, new dietary ingredient notification, and the drug exclusion provision that keeps CBD out of the supplement category. It then covers the health claim tiers and the First Amendment litigation in Pearson v. Shalala that produced qualified health claims, the cosmetic rules as changed by MoCRA in 2022, and the FTC's separate and stricter advertising substantiation regime after POM Wonderful. Later sections cover the device pathways and their very different preemption consequences, drug labeling preemption from Wyeth v. Levine through Bartlett, off-label promotion after Caronia and Amarin, and the enforcement ladder that ends with individual criminal liability under the responsible corporate officer doctrine.

Claims That Turn a Product Into a Drug: FDA Regulation of Supplements, Cosmetics, and Wellness Marketing

Healthcare > FDA and Life Sciences | Published 5 December 2024 - Updated 16 February 2026 | UpLaw - uplaw.us

In brief. Under the Food, Drug, and Cosmetic Act, a product's category is determined by its intended use, and intended use is established by what the seller says — on the label, on the website, in the ads, in the influencer's script, and in the customer service email. Change the sentence and you change the statute that applies.

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