FDA Clarifies Rule on Tobacco Products in Medical Realm


The Food and Drug Administration sometimes regulates tobacco products as drugs, devices or combination drug/device products. A new final rule (RIN:0910-AH19) from the agency is intended to clarify this determination.

The FDA said the final rule will help companies that intend to market tobacco products and investigators planning to study tobacco products for medical uses. It also will help consumers distinguish between tobacco products that are intended for medical use from products marketed for other uses. The rule is effective Feb. 8.

As part of the rule, the agency said unless there are “extraordinary circumstances,” it doesn’t consider a company “as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”

This clarifies that manufacturers aren’t promoting off-label uses of their products if they just know how doctors are using their products, Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told me. While doctors can prescribe medical products for unapproved uses, manufacturers are prohibited from promoting such uses.

The rule’s statement on off-label promotion is a “big clarification,” he said. Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory and clinical trial issues.

My full article on the rule is here.

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