Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices

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By Bronwyn Mixter

A new final rule from the FDA clarifies for manufacturers when the agency will regulate tobacco products as drugs or devices.

The rule, released by the Food and Drug Administration Jan. 6, describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination drug/device product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The FDA said the final rule (RIN:0910-AH19) will help companies that intend to market tobacco products, and investigators planning to study tobacco products for medical uses, to determine the requirements that apply to their proposed studies. The agency also said the rule will help consumers distinguish between tobacco products that are intended for medical use from products marketed for other uses.

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 Bloomberg BNA in a Jan. 6 e-mail. 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.

Jim Stansel, general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), told Bloomberg BNA in an e-mail PhRMA is disappointed the rule “disregards the rulings of multiple courts protecting the right of free speech.”

The rule will be published Jan. 9 in the Federal Register is effective Feb. 8.

Healthy Revision

“For years we struggled to understand intended use, and the potential impact of mere knowledge of an off-label use. And indeed, those concerns grew out of the tobacco litigation many years ago where that theory was advanced,” Thompson said. “So it’s only fitting that in the tobacco realm FDA is now putting to rest that concern.”

Thompson said “this is a matter of fundamental fairness, because off-label promotion is potentially a criminal violation. And it always seemed to me to be a stretch to argue that someone could be effectively off-label promoting if they did absolutely nothing to promote the off-label use, but merely knew that’s how other people were using their product. So this is an extremely healthy revision.”

Industry Concerns

“The FDA acknowledges that doctors are allowed to prescribe pharmaceutical products for uses not included in the drug label the agency approved. In fact, these unapproved uses are often the accepted treatment for particular illnesses, including many forms of cancer,” PhRMA's Stansel said. “But the FDA’s rule could lead to restrictions on the dissemination of truthful and non-misleading information that would otherwise be used to help physicians and payers in their decision-making.”

Stansel said “this is bad medicine for patients and is inconsistent with decisions of the Supreme Court and lower courts granting first amendment protections to truthful and nonmisleading communications of clinical information.”

A spokesman for the Advanced Medical Technology Association (AdvaMed), a device makers' group, told Bloomberg BNA the group has “no comment” on the final rule.

Major Provisions

The Family Smoking Prevention and Tobacco Control Act, a 2009 law, amended the FD&C Act to provide the FDA with the authority to regulate tobacco products, the FDA said. Excluded from the definition of a tobacco product is any article that is a drug, device or combination product.

Under the final rule, a tobacco product intended for human consumption is regulated as a drug, device or combination product if:

  •  the product is intended to be used in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease; or
  •  the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products before March 21, 2000.

The rule also clarifies the remaining circumstances where a product is subject to regulation as a tobacco product, the FDA said.

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The rule is at

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