Observations

When Chief Chemist Harvey W. Wiley, M.D., asked Congress for money in 1899 to determine whether food preservatives "should ever be used ... and if so, what preservatives and in what quantities," it's unlikely he could have imagined where his scientific experiments would lead.

One hundred years later, computer models and sophisticated laboratory tests have replaced Wiley's group of volunteers who sprinkled substances believed to be toxic onto their food. Magnetic resonance imaging, microscopes capable of picking out strands of DNA--the building block of life--and the mapping of the human genome promise to change the practice of medicine.

In the not-too-distant future, physicians will treat people as individuals, not as members of a "population." And the biology of the disease, not just the symptoms, will be the basis of the treatment. The FDA will play an important role in the development and regulation of personalized medicine, just as it did 100 years ago with the advent of food and drug regulation. For an overview of the FDA's first century of protecting the health of Americans, and a glimpse of what the future may hold read our cover story titled "The FDA At Work: Cutting-Edge Science Protecting Public Health."

Building on Wiley's work, the FDA's Center for Food Safety and Applied Nutrition ensures the safety of about 80 percent of all food consumed In the United States. The FDA's food-related portfolio is diverse--cosmetics, dietary supplements, genetically engineered foods, the labeling of foods, and, in recent years, food-related provisions of the Bioterrorism Act. For more on this world leader on food and cosmetic safety, see our feature story titled "A Century of Ensuring Safe Foods and Cosmetics."

It may be difficult to believe that a century ago, useless products claiming to cure a variety of ailments filled the marketplace. At best, using a product like William Radam's Microbe Killer may have done no harm. But with no federal regulations in place to protect people from the potentially dangerous substances in so-called patent medicines, there were no guarantees. Check out our feature titled "Promoting Safe and Effective Drugs for 100 Years," to find out more about the development of today's drug review process, considered to be the world's standard.

On any given day, the FDA's law enforcement arm--the Office of Regulatory Affairs--conducts inspections, collects and analyzes samples, and implements the Agency's regulatory policies. For more on the FDA's primary regulatory team, read our feature titled "FDA Law Enforcement: Critical to Product Safety."

Biologics include medical products made from living sources such as humans, animals, plants, and micro-organisms. Today, the FDA's Center for Biologics Evaluation and Research regulates products such as vaccines, blood and blood components, gene therapy products, and cells and tissues for transplants. For more on this FDA product center, see our feature titled "The Road to Biotech Revolution: Highlights of 100 Years of Biologics Regulation."

Hearing aids, X-ray machines, wheelchairs, band-aids, toothbrushes, and contact lenses are among the medical products regulated by the FDA's Center for Devices and Radiological Health. For more on the youngest of the Agency's product centers, read our feature titled "Medical Device and Radiological Health Regulations Come of Age."

We hope you enjoy this special issue dedicated to the FDA and its employees as much as we enjoyed putting it together.

Raymond Formanek Jr.
Editor

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