To prohibit the sale of any alcohol without liquid machine without premarket approval, and for other purposes.

September 29, 2004

Mr. BEAUPREZ introduced the following bill; which was referred to the Committee on Energy and Commerce

To prohibit the sale of any alcohol without liquid machine without premarket approval, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Alcohol Without Liquid Machine Safety Act of 2004'.

SEC. 2. ALCOHOL WITHOUT LIQUID MACHINES.

(a) Prohibition- It shall be unlawful for any person to introduce or deliver for introduction into interstate commerce any alcohol without liquid machine, unless an approval of an application submitted pursuant to subsection (b) is in effect with respect to such machine.

(b) Application- Any person may file with the Commissioner an application for premarket approval of an alcohol without liquid machine. Such an application shall be submitted in such manner, and containing such information, as the Commissioner may require.

(c) Approval- Upon receipt of an application submitted pursuant to subsection (b), the Commissioner shall--

(1) issue an order approving the application if the person submitting the application demonstrates to the Commissioner's satisfaction that the alcohol without liquid machine is safe; or

(2) deny approval of the application if the person submitting the application fails to demonstrate to the Commissioner's satisfaction that the alcohol without liquid machine is safe.

(d) Withdrawal of Approval- The Secretary may issue an order withdrawing approval of an application submitted pursuant to subsection (b) if the Secretary finds that the alcohol without liquid machine is unsafe.

(e) Penalty- The provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) shall apply to a violation of subsection (a) in the same manner and to the same extent as such provisions apply to a violation of section 515 of such Act (21 U.S.C. 360e; regarding premarket approval of class III devices).

(f) Definitions- For purposes of this Act:

(1) The term `alcohol without liquid machine' means a device designed or marketed for the purpose of mixing alcohol with oxygen or another gas to produce a mist for inhalation for recreational purposes.

(2) The term `Commissioner' means the Commissioner of Food and Drugs.

END