Certain tobacco products that came onto the market or were altered after February 15, 2007 will have to be reviewed by the FDA (Food and Drug Administration), the Agency announced as it published a new guidance today. Any company which markets a tobacco product needs to prove that it is “substantially equivalent” to those that were on the market on February 15, 2007.

What does “substantially equivalent” mean? The ingredients, composition, heating source, design and other characteristics must be the same as an existing, single predicate product. If it has different characteristics, there must be no public health concerns.

Lawrence R. Deyton, M.S.P.H., M.D., director of the FDA’s Center for Tobacco Products, said:

“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 FDA to carefully examine the impact those products may have on the public health. Products that are equivalent to those which were on the market on February 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health.”

Kathleen Sebelius, Health and Human Services Secretary, said:

“This piece of the Tobacco Control Act protects the health of all Americans. 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.”

Since the Family Smoking Prevention and Tobacco control act, which was passed in June 2009, the FDA has had regulatory authority over tobacco products. If marketing a new product poses a risk to public health, the new law generally allows the Agency to turn down submissions for approval.

In a communiqué, the FDA wrote:

“FDA may deny applications for substantial equivalence if the marketing of that modified product would raise different questions of public health. An example would be a product that poses an increased health risk to users of the product or to nonusers by causing more of them to start smoking.”

Manufacturers of roll-your-own tobacco, smokeless products and cigarettes will have to apply for equivalency by May 22, 2011 if their product was introduced into the market or altered after February 15, 2007, if they want to continue selling them legally. Manufacturers will have to submit a new-product application and get a marketing order from the FDA before being allowed to bring a product onto the market.

Deyton said:

“No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such. 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.”

Source: FDA

Written by Christian Nordqvist