Substantially equivalent review - tobacco products

In the first FDA press/news release of 2011, the FDA notes that it will require substantial equivalence reviews for new tobacco products. This release is available on

The information released means that “certain” tobacco products introduced or changed after February 15, 2007? must be reviewed by the agency. What was outlined was a pathway for marketing a product where the company marketing that product MUST prove that it is “substantially equivalent” to products commercially available on Feb 15, 2007.

While this sounds confusing when first read, the FDA notes that “no known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such.” It appears that the intent of this new requirement is to protect the public from new products that post an increased threat to the American public. New products will NOT be safer, but will not be more dangerous.

As has been noted in the Essential Guide to Prescription Drugs in many editions, “there are no data to show that smoking is good for you.” Products included in this new mandatory review are cigarettes, smokeless tobacco and roll-your-own tobacco that were introduced or changed after feb 15, 2007.

The FDA will introduce a webinar series to give guidance. Public comment is welcomed. You can comment by visiting and inserting the docket number (FDA-2010-N-0646) in the search box. Follow the prompts once you've done this.

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