The Food and Drug Administration
Dateline: 02/13/98
Background
America has been enacting legislation intended to protect consumers from
unsafe food and medicine since 1785 when Massachusetts passed a "general
food adulteration" law. In what year would you guess the first law requiring
warning labels on poisons was passed? 1800? 1850? Try 1927 - The Caustic
Poison Act.
Also in 1927, Congress created the Food, Drug, and Insecticide Administration, which in 1930 became the modern Food and Drug Administration. FDA - An Overview.
Regulatory Authority
As perhaps the highest profile of all our consumer protection agencies, the
FDA backs its bark with quite a regulatory bite. Take 1959, for example,
when three weeks before Thanksgiving the FDA recalled the entire US cranberry
crop to test it for traces of a weed killer that had caused cancer in laboratory
animals.
Just this January, the agency again drew attention by declaring that they would be the agency to regulate human cloning in America. (Forms not yet available.)
FDA draws its considerable authority from enforcement of the Federal Food, Drug, and Cosmetic Act and several other related laws.
Enforcement Powers - Product Recall
FDA's most visible regulatory gun is the product recall. Basically, FDA can
order the recall of any food, drug, medical device, biological product (like
blood), or cosmetic sold for use by humans, or animals. ("Medical devices"
can include anything from an x-ray machine to computer software.) In addition,
products are often recalled by manufacturers themselves when they become
aware that their production procedures were not in compliance with FDA
regulations. Such "voluntary" recalls must be reported to the FDA and can
trigger site inspections or even stronger enforcement measures. All recalls
are reported on the FDA Web site. The recall list for 01/28/98 can be viewed
in this
FDA
Enforcement Report.
Every year, about 3,000 products are recalled and another 30,000 products being imported into America are held or seized due to non-compliance with FDA requirements.
Enforcement Powers - Legal Sanctions
Under extreme conditions of non-compliance, FDA can go to court and obtain
severe legal sanctions against manufacturers. A company can be forced to
stop making a product and have existing stock seized and destroyed. In the
worst cases, a business can be completely shut down and criminal penalties
-- including prison -- can be sought.
Areas of Control - Food
The FDA's
Center for
Food Safety and Applied Nutrition (CFSAN) is just one of several
regulatory offices charged with testing and controlling the safety and quality
of America's food supply. Among others are the
USDA,
Centers for Disease
Control, and the
EPA. Here's
a
complete list of "The Food Team" from the FDA.
What can you get from bad food? Pretty sick. If you're trying to control the old appetite, take a look at CFSAN's Bad Bug Book: Introduction to Foodborne Pathogenic Microorganisms and Natural Toxins and Foodborne Illness.
FDA/CFSAN's work to keep us from getting those Bad Bugs is part of the National Food Safety Initiative.
Areas of Control - Drugs, Medical Devices, and Biologic Products
Determining the safety and effectiveness of drugs in the job of the
FDA Center for Drug Evaluation
and Research. FDA employs 2,100 scientists -- chemists and
microbiologists -- in 40 laboratories around America. The FDA scientists
carry on a constant cycle of analyzing existing products and evaluating test
results from companies seeking FDA approval of new drugs, medicines, food
products, and medical devices.
A good current example of FDA's work in the area of drug safety can be seen on the Fen/Phen Information Page. For current news, visit the Drugs - Latest News page.
FDA defines a biological products as, "medical preparations made from living organisms and their products." Examples include insulin, vaccines, blood and plasma. (and human clones?) These products fall under the jurisdiction of the FDA's Center for Biologics Evaluation and Research (CBER).One of the primary concerns of the CBER is ensuring the safety of America's blood supply. FDA regularly inspects blood bank operations and every unit of blood used in America's hospitals must have passed a stringent series of FDA required tests.
FDA depends heavily on consumers to report cases of problems with medical products. The MedWatch reporting system. Here's reporting form you can download now: MedWatch Form to report Adverse Reactions & Medical Product Problems
Areas of Control - Cosmetics
FDA applies the same level of scrutiny toward the safety and effectiveness
of
cosmetics
as they do for food and medical products. If you think cosmetics would be
simple compared to drugs, take a look at
Cosmetic
Safety: More Complex than at First Blush.
One of the most controversial practices in the cosmetics industry is the use of animals in product safety testing. You might find FDA's Policy on Animal Testing very interesting.
Other Consumer Features
Lately, FDA has focused its public health function on
Children
and Tobacco and provides a nice page of Q&A called,
Frequently
Asked Questions About Children and Tobacco.
Also see: More Information from FDA for Consumers
And: FDA Center for Veterinary Medicine - Animal Drugs
Conclusion
Of all our federal agencies concerned with ensuring America's public health,
FDA is clearly one of the most important and without a doubt, the most powerful.
FDA has been named 1997 WINNER - Innovations in American Government.
FDA operates within the Public Health Service as part of the Health and Human Services Department and is currently headed by Commissioner David A. Kessler, M.D.
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