New Final Rule Expands ‘Intended Use’ Definition: Attorneys

Three Sidley attorneys say a new FDA final rule amending the agency’s regulations defining intended use opens many consumer products without therapeutic claims to regulatory oversight as drugs or medical devices. In their analysis, the attorneys say the rule provides that the agency can find a product subject to regulation based on any ingredients or other design or compositional features, even when the manufacturer is not making any drug or medical device claims for the product.

“The preamble to 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 IND exemption,” the post says.

The attorneys say the rule has potentially far-reaching effects on many types of products. “Consumer products that are positioned as wholly beyond the scope of FDA’s regulatory authority under the Federal Food, Drug, and Cosmetic Act may nevertheless be subject to regulation if they are ‘intended’ for drug or device use as defined in the statutory drug or medical device provisions, and FDA has asserted broad authority to find the requisite intent even in the absence of medical or therapeutic claims,” the attorneys write…. “Because FDA can consider a wide range of evidence in making intended use determinations under the final rule, product developers and entities involved in the research or manufacture of products having attributes with potential medical application should reconsider their degree of exposure to FDA regulation.”