On July 29, 2011, FDA issued a final rule to establish procedures for requesting exemptions from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act. Unfortunately, despite the vague statutory language regarding such exemptions, and numerous industry requests for more clarity regarding such exemptions, the final rule provided almost no guidance.
The Tobacco Control Act allows manufacturers to obtain an exemption from the substantial equivalence requirements applicable to new tobacco products. FDA can grant an exemption for tobacco products that are modified by adding or deleting a tobacco additive, or by increasing or increasing the quantity of an existing additive if FDA determines: (1) the modification is a minor modification, (2) a substantial equivalence report is not necessary for the protection of the public health, and (3) an exemption is otherwise appropriate.
On January 6, 2011, FDA issued a notice of proposed rulemaking, consistent with its obligation under the Tobacco Control Act to issue regulations implementing the provision on exemptions from substantial equivalence requirements. The proposed rule largely mimicked the statutory language, and comments on the proposed rule urgently requested more clarity. Among other things, comments noted that there are routine changes to tobacco products that are not intended to alter the chemical or perception properties of the product, and FDA should clarify that these charges are not modifications for which a substantial equivalence report or exemption request are required. Other comments suggested that FDA define “minor modification” or identify specific modifications that meet the criteria for exemptions, such as changes to ensure consistency, changes in “commodity” ingredients or changes in packaging text or graphics.
FDA rejected all of these comments, and the final rule provided no guidance regarding the standards by which FDA will evaluate exemption requests. (FDA did suggest that it may provide guidance in the future as it attains more experience regulating tobacco products.) The final rule did explain that an exemption request may be made only by a manufacturer of a legally-marketed tobacco product. The final rule also identified the type of information necessary to support an exemption request, such as a statement of the purpose for the modification and a description of the modification.