FDA Extends Comment Period on Various Potential Regulatory Targets

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FDA Extends Comment Period on Various Potential Regulatory Targets

06/11/2018
ANPRM for flavored tobacco products
The agency grants another 30 days to comment on regulatory issues concerning nicotine levels, flavored tobacco and premium cigars.

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is giving the public more time to provide comments on a slew of advance notices of proposed rulemaking (ANPRM) it issued in March.

With an additional 30 days to comment, the new deadlines are:

  • Tobacco Product Standard for Nicotine Level of Combusted Cigarettes – July 16
  • Regulation of Flavors in Tobacco Products – July 19
  • Regulation of Premium Cigars – July 25
  • Draft Concept Paper: Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard – July 16

The agency published the first ANPRM targeting nicotine levels in combustible cigarettes in the Federal Register on March 16. The move came eight months after the FDA unveiled a new approach to tobacco regulation — placing nicotine in the center of the plan, as Convenience Store News previously reported.

The Draft Concept Paper: Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard was issued the same day.

It followed with an ANPRM seeking comments, data, research results, or other information related to the role that flavors, including menthol, play in tobacco product use. The ANPRM also covers potential regulatory options the agency could take, such as tobacco product standards and measures related to the sale and distribution of flavored tobacco products.

Less than a week later, the FDA took aim at premium cigars, issuing an ANPRM looking for comments, data, research results, or other information that may inform its regulatory action for premium cigars. Topics included the definition of premium cigars, the use patterns of premium cigars, and the public health considerations associated with premium cigars.