Industry View: FDA Regulatory Update

Published in CSP Daily News

By  Thomas A. Briant, Executive Director

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Since mid-2013, the FDA’s Center for Tobacco Products (CTP) has considered additional tobacco regulations while implementing other tobacco-related actions. The FDA has focused on the use of menthol in cigarettes; potential regulations on cigars, pipe tobacco, electronic cigarettes and/or hookah tobacco; a new “Safety Reporting Portal” website page; and a study on raising the legal age to purchase tobacco products.

Menthol in Cigarettes

In August 2013, the FDA issued an Advance Notice of Rulemaking on menthol cigarettes, which essentially was a request for public comments on the use of menthol in cigarettes. The public responded by submitting about 225,000 comments on the issue. NATO submitted its own comments to the FDA and assisted more than 100 association retail members in sending theirs.

The FDA is in the process of reviewing these comments. While the FDA has not decided if new regulations will be drafted on the use of menthol in cigarettes, the FDA could decide to take no action on menthol or go so far as to propose a ban on menthol in cigarettes.

It is important to note that in the rulemaking notice, the FDA specifically asked the public for feedback on whether the agency should regulate menthol in other tobacco products. While the Family Smoking Prevention and Tobacco Control Act authorized the FDA to investigate only the health impact of menthol in cigarettes, the agency is seeking input on other kinds of menthol-flavored products even though Congress did not direct the FDA to do so.

Regulations on OTP

The FDA has drafted new proposed regulations on cigars, pipe tobacco, electronic cigarettes and/or hookah tobacco, and the proposed regulations are under review by the White House Office of Management and Budget (OMB). The OMB review process involves determining the impact of the new rules on companies that need to comply with the regulations. If the OMB approves the proposed regulations, the FDA will publish the regulations in the Federal Register. The public will have a 60-day period to submit comments on the regulations.

Once the comment period expires, the FDA will review the comments and consider changing the proposed regulations based on the comments. Then the OMB reviews the revised regulations a final time before approving the new rules. After the OMB gives final approval, the new regulations are published by the FDA and take effect on a date determined by the agency.

Safety Reporting Portal

On Jan. 10, 2014, the FDA announced the availability of a “Safety Reporting Portal” for consumers and health-care professionals to inform the FDA when they believe there is an unexpected health or safety issue with tobacco products. The FDA will accept reports about cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, electronic cigarettes and any other products made or derived from tobacco.

Specifically, the agency is seeking reports about damaged, defective or contaminated tobacco products. Also, the FDA wants to receive reports of fire caused by a tobacco product, burns or other injuries, accidental or unintended exposure of children, allergic reactions, poisonings and other toxicities, or an unusual reaction in a longtime user. Other possible issues to report include problems with labeling, packaging or instructions for use; tobacco product mix-ups; quality problems, such as unexpected appearance, smell or taste; or foreign objects in the product.

NATO has formally asked the FDA why it is allowing consumers and health-care professionals to submit reports about cigars, e-cigarettes and other products made or derived from tobacco when the agency has not yet exercised regulatory authority over these kinds of products.

Raising the Legal Age

The Institute of Medicine has established an ad hoc committee of public health, medical and other experts to conduct a study and prepare a report for the CTP on the public health impact of increasing the legal age to purchase tobacco products to 21 and to 25. The Family Smoking Prevention and Tobacco Control Act requires that an expert panel be convened to conduct the study.

It is important to note that the act is silent on what higher minimum age should be studied, while the Institute of Medicine intends to research raising the legal age to either 21 or as high as 25.

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