HR 2058
114th Congress
House
Health
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)
FDA Deeming Authority Clarification Act of 2015
Everywhere this bill has been
4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 1, 2015
Referred to the Subcommittee on Health.
Apr 28, 2015
Referred to the House Committee on Energy and Commerce.
Apr 28, 2015
Sponsor introductory remarks on measure. (CR E596)
Apr 28, 2015
Introduced in House
Plain-English summary
FDA Deeming Authority Clarification Act of 2015
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.
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.
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.)
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
2