FDA Fields Requests for Deeming Regulation Extension


ROCKVILLE, Md. -- The clock is ticking on the public comment period for the proposed deeming regulation released by the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) in late April. The 75-day public comment period is set to expire July 9, but that date may be pushed back.

During a webinar on the proposal held Thursday, Gerie Voss, senior regulatory counsel with the Office of Regulations, CTP, said the FDA is "actively considering" numerous requests to extend the public comment period. Any extension would be announced in the Federal Register.

Voss noted that it helps the FDA if any comments are supported by research and data. Any unpublished research or data should include the methodology.

On April 24, the FDA released its long-awaited proposed deeming regulation extending its authority under the Family Smoking and Tobacco Control Act of 2009 to additional tobacco products, including electronic cigarettes, cigars, pipe tobacco, nicotine gels and hookah tobacco. It also includes certain dissolvables not already under FDA authority.

The agency currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

According to Voss, the proposed deeming regulation has two options: one that applies to all products that meet the statutory definition of a tobacco product, and a second option that excludes products that meet the FDA's proposed definition of a premium cigar.

The proposal calls for minimum age and identification restrictions to prevent sales of the products to underage youth; requirements to include health warnings; and prohibition of vending machine sales unless in a facility that never allows minors, such as bars and nightclubs.

The health warnings, Voss explained, would be required on the packaging and advertisements of all the tobacco products covered under the FDA's authority. The warning itself would state the addictiveness of nicotine.

Under the proposed rule, cigars would be required to rotate through four other health warnings, which are included in the Federal Trade Commission consent agreement of 2000. However, when cigars are not sold in packaging -- such as those in humidors -- a retailer would have to display the health warning in a sign at the point-of-sale, she explained.

In addition, manufacturers of newly deemed tobacco products would have to submit applications for FDA review for any products not marketed in the United States before Feb. 15, 2007 -- the grandfathered date included in the Tobacco Control Act. The three pathways to market newly deemed products are: premarket tobacco application, substantial equivalence, and substantial equivalence exemption.

Once the deeming regulation is final, manufacturers will have a 24-month compliance period to submit a product for review. A product can still be marketed during that compliance period, and also during the time it takes the FDA to complete the review. However, the product must be pulled if the FDA denies the application after review.

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