In 2009, the Family Smoking Prevention and Tobacco Control Act allowed the FDA to regulate tobacco products. For the first time since that regulation, the FDA has authorized the marketing of two new tobacco products and denied 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 the public health than the product with which it was compared.
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. 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.
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, 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.
The FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. Instead, the FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco use causes.For more information visit the FDA website.