Combating Foodborne Illness: The Food Safety Modernization Act

Approximately one in four Americans get sick by foodborne illness each year [1]. Of those 76 million people, an estimated 325,000 are hopitalized and 5,000 die. Indeed, foodborne disease outbreaks reported to the CDC alone through the Foodborne Disease Outbreak Survelliance System recorded 1,247 outbreaks in 2006 [2].

farmers-market

The vast majority of known foodborne illnesses are associated with products regulated by the U.S. Food and Drug Administration (FDA). According to Jeff Levi, Ph.D., Executive Director of Trust for America’s Health, a non-profit, non-partisan organization working to make disease prevention a national priority [3]:

Our food safety system is plagued with problems, and it’s leading to millions of Americans becoming needlessly sick each year. The system is outdated and unable to effectively deal with today’s threats. Its current structure actually prevents the kind of coordinated, focused effort that Americans need more than ever and have a right to expect.

Health Highlights – October 7th, 2008

Health Highlights is a biweekly summary of particularly interesting articles from credible sources of health and medical information that we follow & read. For a complete list of recommeded sources, see our links page.

Health Highlights

FDA Attempting to Regulate Dietary Supplements

A new U.S. Food and Drug Administration (FDA) docket was published on the FDA website last month. The draft guidance, when finalized, will represent the FDA’s current thinking on complementary and alternative medicine (CAM). Docket No. 2006D-0480: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration [1] discusses when a CAM product is subject to the Federal Food, Drug, and Cosmetic Act (the Act) or the Public Health Service (PHS) Act.

Clinical Trials

A clinical trial, also called a clinical study, is a research study designed to answer specific questions about new medical approaches (e.g. drugs, therapies) or new ways of using existing approaches. These studies can test screening methods as well as prevention, diagnosis or treatment of a condition or disease. A clinical trial is one of the final steps in the research process. Health professionals run clinical studies according to strict guidelines set by the Food and Drug Administration (FDA) to ensure that people who agree to be in the studies are treated as safely as possible. Clinical trials are usually conducted in four phases with patients to evaluate the effectiveness of new medical approaches. The FDA requires strict testing of all drugs and vaccines prior to their approval for use as therapeutic agents in the general population.