Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

Fri, Dec 21 2007 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: PulmonaryAllergy Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 20, 2008, from 8 a.m to 5 p.m.

Location: National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Avenue, Silver Spring, MD, 3014316400.

Contact Person: Teresa A. Watkins, Center for Drug Evaluation and Research, HFD21, Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 3018277001, fax: 3018276776, email: teresa.watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512545. Please ca

Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease,

Fri, Dec 21 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substancedisease relationships. The new scientific evidence may have the effect of weakening the substancedisease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substancedisease relationship for these qualified health claims.

The Federal Register

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease,