FDA Announces First Decisions on New Tobacco Products Through the Substantial Equivalence Pathway
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the U.S. Food and Drug Administration the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway.
Under the law, one way manufacturers can legally sell a new tobacco product is to establish that their product is substantially equivalent to a valid predicate product already on the market. The FDA works to ensure that any new tobacco product authorized through the substantial equivalence pathway will not present more harm to public health than the product with which it was compared.
“Today's historic announcement marks an important step toward the FDA's goal of reducing preventable disease and death caused by tobacco,” said FDA Commissioner Margaret A. Hamburg, M.D. “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.”
Once a company receives an SE Marketing Order for a product, it means only that the FDA has found that the new tobacco product is substantially equivalent to a predicate product and in compliance with the requirements of the Federal Food, Drug & Cosmetic Act (FD&C Act). An SE Marketing Order is not a finding that the product it is safe or safer than its predicate product, or less harmful in general. In addition the law makes clear that companies cannot say their products are FDA approved.
“Today's decisions are just the first of many forthcoming product review actions to be issued,” said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. “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 agency issued SE Marketing Orders for two Lorillard Tobacco Company cigarette products, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. The FDA concluded that, while the new products have different characteristics than the predicate products, the new products do not raise different questions of public health.
Any product that raises different questions of public health will be found not substantially equivalent (NSE) and will not be allowed to be marketed. A variety of factors contributed to the four NSE decisions announced today, including a lack of evidence to support that the addition of specific ingredients did not raise different questions of public health, a lack of information about the design of the product, and incomplete test data.
Additionally, the FDA has formally withdrawn 136 SE Reports at the request of the applicants. At any point during the FDA review process, a manufacturer may choose to withdraw their submission if they are not able to meet the FDA's standards, or for other business reasons.
The FDA also refused to accept 20 SE Exemption Requests because the manufacturers did not meet the requirements for such an exemption. The SE Exemption pathway may be available for certain minor modifications to tobacco products where the only change is to an additive. Each of the SE Exemption Requests that the FDA refused to accept did not conform to requirements in the FD&C Act or to the SE Exemption regulation. For example, the agency determined that some exemption requests were not limited to changes in additives.
SOURCE: FDA, June 25, 2013