Five Ways FDA's New Final Rule On Intended Use Could Affect Consumer Products

• Published date: 02 November 2021
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Sidley Austin LLP
• Author: Coleen Klasmeier, Diane C. McEnroe and Jeffrey M. Senger

Cosmetic, food, dietary supplement, and other consumer products, even without therapeutic claims, may now be subject to regulation as drugs or medical devices under the U.S. Food and Drug Administration's (FDA) recent final rule (86 Fed. Reg. 41,383) amending its regulations defining intended use. The final rule, which was published on August 2, 2021, and went into effect September 1, provides that FDA can find that an "article" is subject to FDA regulation under the drug or medical device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) based on any ingredients or other design or compositional features, even where the manufacturer is not making drug or medical device claims for the "article." The preamble accompanying the final rule also expands the definition of intended use to include any "relevant" evidence and addresses the circumstances in which a cosmetic, food, or dietary supplement clinical trial could require an investigational new drug exemption (IND).

Under the final rule, FDA may assert that an article is subject to regulation as a drug or medical device even if no medical or therapeutic claims are made for it. The final rule abandons the general principle that intended use means "objective intent" as "determined by" the manufacturer's "expressions." Under the revised provision, objective intent "may be shown" by such expressions. As a result, the promotional claims of the manufacturer are no longer the linchpin of intended use determinations. As FDA itself explains in the final rule, promotional claims are not required, and the agency "may look to any relevant source of evidence, including a variety of direct and circumstantial evidence," to determine a product's intended use.¹ According to FDA, these sources may include the following:

1. "expressions," such as "labeling claims advertising matter, or oral or written statements"
2. product "design or composition"
3. "the circumstances surrounding ... distribution"
4. the circumstance that a manufacturer knew that its product was being "offered or used for a purpose for which it is neither labeled nor advertised"
5. "evidence of a manufacturer's marketing plans"
6. "evidence of a manufacturer's ... directions to its sales force"
7. "evidence of the well-known uses and abuses" of the manufacturer's product
8. "circumstantial evidence relating to the sale and distribution of the product"
9. evidence that a product "contain[s] a pharmacological ingredient"
10. "internal firm documents and circumstances surrounding the sale of products"
11. "consumer intent"
12. ...