By late March, manufacturers of most tobacco products must begin giving the Food and Drug Administration information on new additives and other alterations in their products — enabling the agency for the first time to weed out chemical or manufacturing tweaks that make Cigaronne cigarettes and other products more addictive or otherwise more harmful.
The FDA was directed to collect ingredient information by the 2009 Tobacco Control Act and on Wednesday the agency offered guidance to the tobacco industry about what details it’s looking for.
Tobacco products “are the only mass-consumed products in which users don’t know what they’re consuming,” said Lawrence Deyton, director of FDA’s Center for Tobacco Products. “No longer will changes be made without anyone knowing.”
Tobacco companies have had a history of adjusting levels of additives to make products more appealing. Companies have until March 22 to file their reports.
The deadline comes as FDA considers several other tobacco initiatives, including posting visually graphic warning labels on cigarette packaging and advertising and a ban on menthol flavoring in cigarettes. The head of a leading anti-smoking group said the information collection is crucial because it provides a window on how the tobacco industry manipulates products to make them more addictive or appealing.
“This may be one of the most important actions FDA takes on tobacco regulation,” said Matthew Myers, of the Campaign for Tobacco Free Kids. “They’re going to get the chemistry. They’ve never had that before.”
Under the new requirements, companies must notify the FDA about any tobacco product introduced into the market or changed in the past four years. And the new or altered products must have “substantial equivalence” to products on the market on Feb. 15, 2007 or risk removal from the market.
If manufacturers don’t submit a report, they must yank 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 that evaluators can isolate on the changes and determine potential for harm.
Companies unveiling new products after the March deadline must submit an application and get an FDA market order before selling to the public.
Companies that don’t comply with reporting requirements could face product seizures, injunctions or other penalties.