U.S. Senate Confirms Dr. Robert Califf to Lead FDA

Feb 25

From: Scientific American

The agency will be tackling thorny topics including food safety, biologic drugs and how to regulate e-cigarettes

By Reuters Staff

WASHINGTON (Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to confirm Dr. Robert Califf as head of the Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.

Califf, 64, a well-regarded cardiologist and researcher, takes the helm at the FDA when lawmakers are pressuring the agency to speed the approval process for drugs and medical devices and finalize a proposed rule giving it authority to regulate e-cigarettes.

Read the full post
Comments (0)

Public health hang-up on e-cigs makes little sense

Feb 09

From: Charleston Gazette-Mail

By James Felsen

***

Regulations advocated by various groups, including the CDC and FDA, would make it so onerous to approve e-cigs as a “harm reduction” strategy that — even if approved — they would likely cost $10 or more per use, encouraging tobacco smokers to stick to cigarettes. Banning the use of these devices in public where they emit essentially the same substances as normal respirations — and far less than certain cooking, grilling and commercial processes — makes little sense scientifically. Theoretical risk of explosion or release of certain toxins at exceptionally high temperature are rarely reported and could be easily controlled by engineering changes and safety regulations.

Read the full post
Comments (0)

CPSC May Get New Authority Over Liquid Nicotine Containers for E-Cigarettes

Feb 02

From: The National Law Review

Sheila A. Millar, Azim Chowdhury, Nathan A. Cardon

For all of you who know the U.S. Consumer Product Safety Commission (CPSC), you know that the agency distinctly does not have authority over tobacco or tobacco products. This arguably wasn’t always the case. Early on, the American Public Health Association petitioned the CPSC to regulate cigarettes containing more than 21 mg of tar. When the Commission voted not to take action, a district court ordered it to under the Federal Hazardous Substances Act (FHSA), but Congress amended the law before the CPSC could take action. See Consumer Product Safety Commission Improvements Act,Pub. L. 94–284, 90 Stat. 503 (May 11, 1976); see also Food & Drug Administration v. Brown & Williamson Corp., 529 U.S. 120, 150–151 (2000) (discussing the petition, litigation, and statutory amendment). Tobacco and tobacco products have been explicitly excluded from CPSC jurisdiction since that 1976 law.

Read the full post
Comments (0)