FDA advises tobacco firms on new ingredient rules

By late March, tobacco companies must begin telling the Food and Drug Administration about new additives and other alterations to most of their products — enabling the agency to weed out ingredients that make cigarettes and other products more addictive or more harmful.

The FDA was directed to collect the information by the 2009 Tobacco Control Act, and on Wednesday the agency offered guidance to the industry about the kind of details it’s looking for.

Tobacco products “are the only mass-consumed products in which users don’t know what they’re consuming,” Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a telephone briefing. “No longer will changes be made without anyone knowing.”

Tobacco companies have a history of adjusting levels of nicotine and other additives to make products more appealing.


Companies have until March 22 to file their reports.

“This may be one of the most important actions the FDA takes on tobacco regulation,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “They’re going to get the chemistry. They’ve never had that before.”

Under the new reporting requirements, companies must notify the agency about any tobacco product introduced into the market or changed in the last four years. And the new or altered products must have “substantial equivalence” to products on the market on Feb. 15, 2007 — the date the tobacco legislation was introduced in Congress — or risk removal from the market.

If manufacturers don’t submit a substantial-equivalence report, they must pull their products from the market by March 23, according to FDA guidelines.


Companies are being asked to disclose the composition of a product before and after an alteration is made so evaluators can isolate the changes and determine the potential for harm.

Companies unveiling products after the March deadline must submit an application and get an FDA market order before selling to the public.

Firms that don’t comply with reporting requirements could face product seizures, injunctions and other penalties.

“No known existing tobacco product is safe,” Deyton said. “These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products.”


A recent federal filing indicates about 230 new tobacco products are marketed annually.

The reporting obligation applies to makers of cigarettes, roll-your-own tobacco and smokeless tobacco products. It does not apply to other forms of tobacco or to electronic cigarettes, which are battery-operated devices that deliver nicotine or other substances via inhaled vapor.

David Howard, a spokesman for R.J. Reynolds Tobacco Co. of Winston-Salem, N.C., said the company was still studying the FDA guidance but had already submitted several reports on products it believes meet the substantial-equivalence test.

“We look forward to working together with FDA on developing an effective, science-based regulatory framework,” said Howard, whose employer makes Camel, Pall Mall and other cigarette brands.


Reynolds, along with Lorillard and Altria Group’s Philip Morris USA, dominate the U.S. tobacco market.