FDA Deeming Authority Clarification Act of 2015

Bill: 114-hr-2058
Sponsor: full_name: Rep. Cole, Tom [R-OK-4]
Introduced: 2015-04-28
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Drug, alcohol, tobacco use

Food and Drug Administration (FDA)
Latest action: action_date: 2015-05-01
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-04-28
action_desc: Introduced in House
text: <p><b>FDA Deeming Authority Clarification Act of 2015</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to revise premarket review and reporting requirements for products deemed by the Food and Drug Administration (FDA) to be tobacco products.</p> <p>A product is not subject to premarket review by the FDA if it is introduced to market before that type of product is deemed a tobacco product.</p> A person introducing a tobacco product that is substantially similar to a marketed product less than 21 months after that type of product is deemed a tobacco product must submit a report to the FDA on the similar product not later than 21 months after that type of product is deemed a tobacco product. (A report is required at least 90 days prior to introduction of a tobacco product that is substantially similar to a marketed product if that type of product has been deemed a tobacco product for 21 months or more.)

tv_txt: I 114th CONGRESS 1st Session H. R. 2058 IN THE HOUSE OF REPRESENTATIVES April 28, 2015 Mr. Cole introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, and for other purposes.

1. Short title This Act may be cited as the FDA Deeming Authority Clarification Act of 2015 . 2. Date for application of Federal Food, Drug, and Cosmetic Act to deemed tobacco products Section 901(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387a(b) ) is amended— (1) by striking This chapter shall apply and inserting the following: (1) In general This chapter shall apply ; and (2) by adding at the end the following new paragraph: (2) Deemed tobacco products For each tobacco product deemed subject to the requirements of the Act pursuant to paragraph (1), each reference in sections 905(j) and 910(a)— (A) to February 15, 2007 , shall be considered to be a reference to the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1) ; and (B) to 21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act , shall be considered to be a reference to 21 months after such effective date . .