FDA Approves First Products Through Substantial Equivalence Pathway

WASHINGTON, D.C. – The Food and Drug Administration (FDA) today announced the first round of tobacco new products authorized through the substantial equivalence (SE) pathway. The SE pathway allows tobacco manufacturers to legally sell a new product by establishing that it is substantially equivalent to a valid predicate product already on the market and does not present more harm to public health than the product to which it is compared.

Lorillard Tobacco Co. received the FDA marketing authorization for two new products: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. These are the first tobacco products to be authorized for marketing since the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the authority to regulate tobacco products, took effect.

"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."

The FDA also announced today that it denied the marketing of four other new tobacco products. None of the six products are yet on the market.

The four products denied marketing authorization and the companies that submitted them cannot be named by law, said Mitch Zeller, director of the FDA's Center for Tobacco Products.

Under the SE pathway, the FDA found that the approved Lorillard products have different characteristics than their predicate products, but do not raise new questions of public health. The four products it rejected were found to have different characteristics than their predicate products, according to Zeller. Reasons for the denials included 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.

Most of the SE reports the FDA receives are incomplete, Zeller noted.

“Today’s decisions are just the first of many forthcoming product review actions to be issued,” he said. “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 FDA also reported today that it refused to accept 20 SE exemption requests due to manufacturers not meeting requirements for such exemptions. The SE exemption pathway may be available for certain minor modifications to existing tobacco products, such as the change of an additive. The SE exemption requests that it rejected did not conform to requirements in the Federal Food, Drug, and Cosmetic Act or to the SE exemption regulation, according to the agency.

Additionally, the FDA has formally withdrawn 135 SE reports at the request of the applicants, who can choose to withdraw their submission at any point in the FDA review process if they are unable to meet FDA standards or for other business reasons.

Approximately 4,000 tobacco products are still in the SE pathway queue at this time, said Zeller, with more than 3,500 of those products already on the market.