Question of the Week

February 9, 2009


Over the past several months, food contamination and the United States Food and Drug Administration (FDA) have both been in the news.

"On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Asian communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. No Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States."

While the FDA has warned consumers about potential contamination, it has also worked to pacify consumers' fears.

"Many American consumers, apparently disregarding the fine print of the salmonella outbreak and food recall caused by a peanut plant, are swearing off all brands of peanut butter, driving down sales by nearly 25 percent. So far, the salmonella outbreak has been linked to 575 illnesses and eight deaths, and more than 1,500 products have been recalled, including cookies, ice cream and pet food. Only one brand of peanut butter sold to consumers, Parnell's Pride, a specialty product, has been recalled, but that has not assuaged consumers' fears. ... The contaminated peanut butter traced to the Georgia plant represents a small percentage of the total $800 million in annual sales by the peanut butter companies in the United States. But the public relations problem for the rest of the industry is unlikely to ease anytime soon."

For the most current and potentially hazardous product recalls, people can visit the FDA's "Recalls, Market Withdrawals and Safety Alerts" page.
"This page includes the most significant product actions of the last 60 days, based on the extent of distribution and the degree of health risk."

While most people have heard of the FDA, not everyone understands its purpose.

"FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public."

As the production and distribution of food has changed over the years, so has the need for such an agency.

"A century ago, at the dawn of food safety laws, inspection amounted to little more than opening a bin of flour and looking for something wiggly. It's a different story now. ... So labyrinthian has the nation's food production and distribution network become that a salmonella outbreak that has sickened 575 people in 43 states and resulted in the recall of more than 1,500 foods is traced to one plant making a mere 1 percent of the county's peanut products."

As issues have arisen, the role of the FDA has changed to meet the demands of the public and the ever-evolving technology.

  • "The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
  • The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.
  • The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices. Today, the FDA regulates $1 trillion worth of products a year."

While the FDA is responsible for much of the regulation for food and prescription products (as its name implies), understanding where the regulation under the FDA ends and the regulation under other government agencies begins can be confusing for many.

"FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. ...

  • The Federal Trade Commission is the federal agency which regulates all advertising, excluding prescription drugs and medical devices. ...
  • The labeling and quality of alcoholic beverages are regulated by the Treasury Department's Bureau of Alcohol, Tobacco, and Firearms. ...
  • While FDA regulates a large portion of the products that consumers purchase, the agency has no jurisdiction over many household goods. The Consumer Product Safety Commission (CPSC) is responsible for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packages, and baby toys. ...
  • Illegal drugs with no approved medical use--such as heroin and marijuana--are under the jurisdiction of the Drug Enforcement Administration. FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse. ...
  • FDA does not regulate health insurance, the cost of health care products or procedures, or reimbursement for health and medical expenses. ...
  • The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for the safety and labeling of traditional meats and poultry. (FDA regulates game meats, such as venison, ostrich and snake.) ...
  • FDA, USDA, and the Environmental Protection Agency share the responsibility for regulating pesticides. ...
  • Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments. ...
  • The regulation of water is divided between the Environmental Protection Agency and FDA. EPA has the responsibility for developing national standards for drinking water from municipal water supplies. FDA regulates the labeling and safety of bottled water."

Additionally, there are products where the manufacturers are legally responsible for the appropriate labeling, but the products do not need FDA approval before they can be marketed to consumers.

"In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed."

Questions of the Week:
Why is it important for you (and other consumers) to understand what the FDA does and does not regulate? Why do you think it is difficult for consumers to understand which products are safe when there is a broad recall or potential product contamination? Where should consumers take their concerns when there are recalls or concerns about food safety? If you have a product that is causing concern, how would you determine which agency you should contact? What issues might make it challenging when trying to determine which agency you should contact? What kinds of information should you have available when contacting the regulatory agency?

Please email me with any ideas or suggestions.
Note: Due to increasing amounts of SPAM sent to this account, please include "QOW" in the subject line when sending me email.

I look forward to reading what you have to say.

Health Community Coordinator
Access Excellence @ the National Health Museum

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