The U.S. Food and Drug Administration (FDA) has just allowed the marketing of two new tobacco products from Lorillard Inc and denied the marketing of four others.

This is the first time that the agency has used it’s authority to regulate tobacco products since the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the right to regulate tobacco products with the substantial equivalence (PE) pathway.

The U.S. Food and Drug Administration said that tobacco products introduced or changed after Feb. 15, 2007 have to be reviewed by the agency. The new law only allows companies to sell tobacco products if their product is equivalent to a valid existing product on the market.

The SE pathway allows the FDA to evaluate any new tobacco product that wants to enter the market and assess whether it will present more harm to the public health than a predicate tobacco product.

Lawrence R. Deyton, M.S.P.H., M.D., director of the agency’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.”

According to the FDA, a predicate tobacco product is either “one that was commercially marketed (other than in a test market) as of February 15, 2007, or previously found to be substantially equivalent by the FDA and in compliance with the requirements of the FD&C Act.”

FDA Commissioner, Margaret A. Hamburg, M.D., said that the “historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco.”

She added that the FDA has “unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”

When the agency decides that a new tobacco product is substantially equivalent to a predicate product and in compliance with the Federal Food, Drug & Cosmetic Act (FD&C Act) requirements, the company that makes it or plans to market it receives an SE Marketing Order.

However, the companies are not allowed to say that their products have been approved by the FDA because of an SE Marketing Order.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said:

“Today’s decisions are just the first of many forthcoming product review actions to be issued. The FDA is committed to making science-based decisions on all product applications and providing the agency’s scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law.”

The two SE Marketing Orders were issued for the following Lorillard Tobacco Company cigarette products:

    1 – Newport Non-Menthol Gold Box 100s
    2 – Newport Non-Menthol Gold Box

Although the new products have some different characteristics to the predicate products, the FDA said that they do not pose any different questions of public health.

Products that raise questions of public health that are not substantially equivalent (NSE) will be denied approval to enter the market.

The four products that the agency didn’t approve lacked evidence to suggest that they did not raise different questions of public health.

So far, at the request of the applicants, the FDA has formally withdrawn 136 different SE Reports. A manufacturer can decide to withdraw their submission at any time during the review process if they believe their product does not meet the agency’s standards.

Written by Joseph Nordqvist