Summary

                            To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, to provide for the establishment of product standards for vapor product batteries, to provide for regulation of vapor products, and for other purposes.

Introduced in House
FDA Deeming Authority Clarification Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to: (1) revise
premarket review and reporting requirements for products newly deemed by the
Food and Drug Administration (FDA) to be tobacco products; and (2) grant the FDA
the authority to regulate vapor products, which include products that produce
vapor with nicotine (e.g., e-cigarettes) and nicotine intended to be used with
such a product (e.g., nicotine cartridges).

A product is not subject to premarket review by the FDA if it is marketed before
it is deemed a tobacco product.

The bill delays deadlines for reports to the FDA on products similar to a
marketed product that are introduced to market less than 21 months after that
type of product is deemed a tobacco product.

The bill grants the FDA regulatory authority over vapor products that is in
addition to the FDA's existing authority to regulate vapor products as tobacco
products.

Provisions of the FFDCA applicable to tobacco product components also apply to
vapor product batteries. The FDA must establish standards for vapor product
batteries. Vapor products first marketed not later than 24 months after
enactment of this bill are not subject to premarket review or reporting
requirements based on changes to the product's battery to conform to standards.

Vapor products may not be advertised in publications, except publications with
adult readership.

Vapor products may be sold only face-to-face, through vending machines in
facilities where only adults are permitted, or by mail order.

Vapor products must be labeled with their nicotine content and specified
phrases.

Retailers of vapor products must register with the FDA.



                        

Actions

  • Referred to the Subcommittee on Health.

    Feb 17th, 2017
  • Referred to the House Committee on Energy and Commerce.

    Feb 16th, 2017
  • Introduced in House

    Feb 16th, 2017
  • Introduced in House

    Feb 16th, 2017