From Tobacco Info No. 6 - July 2011
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FDA introduces quasi-moratorium on new tobacco products

New or certain existing products will require equivalency reviews

If the tobacco industry wishes to introduce a new product to the market, they will have to prove that it is ‘substantially equivalent’ to products on the market four years ago.

The US Food and Drug Administration (FDA) announced on January 5, 2011, that certain tobacco products introduced or changed after February 15, 2007, must be reviewed by the agency, outlining a course of action for marketing such products that its parent company must have evaluated.

In a press release, the FDA characterized ‘substantially equivalent’ as the products must be the same in terms of ingredients, design, composition health source and other characteristics as an existing, single predicate product or have different characteristics, but not raise different questions of public health.

“This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. The law requires the FDA to carefully examine the impact those products may have on public health,” said Lawrence R. Deyton, Director of the agency’s Center for Tobacco Products. “Products that are equivalent to those which were on the market on Feb. 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market or withdrawn if they are already available, if the changes raise different questions of public health.”

What this means is that in order to continue to market such tobacco products, manufacturers of these products that were introduced or changed after February 15, 2007, including cigarettes, roll-your-own tobacco and all smokeless products, must have applied for equivalency by March 22 of this year. Any manufacturer introducing a product to market after that date must apply to the FDA for equivalency for the new product and must acquire a marketing order before the product can hit the shelves.

The FDA will require manufacturers submit a vast amount of information, including side-by-side comparisons of each new product with its predecessor with respect to ingredients and their levels; design features and other materials; description of the heating source and composition (these apply primarily to cigarettes); and harmful and potentially harmful constituents, among numerous other criteria.

“This piece of the Tobacco Control Act protects the health of all Americans,” said US Department of Health and Human Services Secretary Kathleen Sebelius.“It does this by setting a clear deadline for tobacco companies to provide important product information to the FDA so the agency can then begin evaluating tobacco products for any potential new risks to public health.”

The Family Smoking Prevention and Tobacco Control Act, which became law on June 22, 2009, granted the FDA regulatory authority over tobacco products. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. In this case, the law generally affords the FDA the power to deny applications for new products if marketing the products poses an increased health risk. Also, the FDA may deny applications for substantial equivalence if different health questions were raised with the marketing of modified products.

“No known existing tobacco product is safe and a market order issued by the FDA for these products should never be interpreted as such,” said Deyton. “One of the FDA’s missions required by this new law is to ensure new products do not pose an increased threat to the American public. 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.”

Over the years, the World Medical Association’s moratorium policy has gained significant traction in Canada with groups like Physicians for a Smoke-Free Canada, Ontario Medical Association, Quebec Coalition for Tobacco Control, Quebec division of the Canadian Cancer Society and Quebec Council on Tobacco and Health, urging governments in Canada to implement a ban on all new tobacco products.

By Joe Strizzi