FDA Law Blog: Proposed Legislation Would Link the “Grandfather” Date in the Tobacco Control Act to FDA’s Deeming Regulations

FDA Law Blog: Proposed Legislation Would Link the “Grandfather” Date in the Tobacco Control Act to FDA’s Deeming Regulations

Proposed Legislation Would Link the “Grandfather” Date in the Tobacco Control Act to FDA’s Deeming Regulations

Posted: 29 Apr 2015 10:58 PM PDT

By David B. Clissold –

A bill, H.R. 2058, introduced into the House of Representatives is short in length, but potentially long on effect for many tobacco product manufacturers.  The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) established February 15, 2007 as the date on which tobacco products are deemed to be “new tobacco products.”  New tobacco products are subject to the premarket review requirements in the Tobacco Control Act — notably either a report under § 905(j) of the Federal Food, Drug, and Cosmetic Act (FDC Act) demonstrating substantial equivalence to a product that was commercially marketed in the U.S. as of February 15, 2007, or a premarket tobacco product application (PMTA) under § 910(b) of the FDC Act.  Thus, tobacco products that were commercially marketed in the U.S. as of February 15, 2007, are not “new tobacco products,” and FDA refers to these products as “grandfathered.”

Anticipating inevitable regulation, manufacturers of e-cigarettes and other novel tobacco products almost immediately recognized that it could be difficult to find a product on the market before February 15, 2007 to which they could show substantial equivalence, thus leaving the more burdensome PMTA as the only route to market.  In April 2014, when FDA issued the proposed deeming regulations that would make e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and certain dissolvable tobacco products subject to regulation under the Tobacco Control Act (see our story here), the Agency recognized this dilemma:

Based on initial information FDA has gathered and received from industry, many tobacco products we are proposing to deem that are currently being sold may not be “grandfathered” tobacco products because many were not commercially marketed or modified until after February 15, 2007.  We understand that this may be particularly true in the case of e-cigarettes and similar novel products.  Moreover, new products that come on the market in the future would never be grandfathered tobacco products because they would be coming on the market after February 15, 2007. We do not believe that we have the authority to alter or amend this grandfathering date, which is set by statute.

Among its requests for comment on many elements of the proposed deeming regulation, FDA asked for public comment on whether the Agency should consider “other legal interpretations of the substantial equivalence grandfather provision.”

H.R. 2058 would eliminate this predicament.  The bill simply removes all references to February 15, 2007 and replaces it with “the effective date of the regulation under which a tobacco product is deemed subject to the requirements of” the Tobacco Control Act.  Thus, the new grandfather date would be tied to the date on which FDA makes the deeming regulations effective.  As a result, many more current tobacco products would be “grandfathered” and thus exempt from the premarket review requirements, and future tobacco products would have a larger number of products to reference for substantial equivalence.  Despite the simplicity of the bill, these larger consequences may be expected to generate much public debate.