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FDA and Public Health

by Cheryl Ho

FDA

What if Salmonella and E. coli outbreaks went uncontrolled and bacteria raged rampant in all of our foods? If you’ve ever experienced food poisoning, you know how utterly debilitating it can be. From the food label and nutrition facts on your morning breakfast cereal to programmable pacemakers and diagnostic x-ray machines, the Food and Drug Administration (FDA) regulates a wide variety of foods, medicines, and other products we use daily. Without their tight regulations on these products, the entire US population – over 300 million people, plus their pets – could be at increased risk for serious health threats. Whether it be routine consumer product testing or emergency response during an outbreak, the FDA uses scientific research to promote and protect Americans’ health.

Protecting public health is central to the FDA’s mission, which is accomplished by establishing and enforcing high standards for consumer products as required by public health laws such as the Federal Food, Drug, and Cosmetic Act. The FDA’s proposed budget for 2009 includes increased funding to strengthen the FDA’s food protection and drug safety initiatives, such as speeding the approval of generic drugs and improving the review processes for drugs and medical devices. So how large does an agency have to be to tackle these hefty tasks? As it turns out, the answer is: pretty big.

The FDA is one of the nation’s largest government agencies, employing nearly 10,000 individuals and comprising nine centers or offices. Some of these include the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA). In fact, about one-third of the FDA’s personnel serve in the ORA encompassing 13 laboratories throughout the US. These laboratories routinely analyze and test over 41,000 product samples every year to determine and enforce adherence to government standards for goods on the US market.

Another FDA watchdog, the Total Diet and Pesticide Research Center, works to analyze the levels of pesticide residues, industrial chemicals, and other toxic compounds in consumer food products. Researchers purchase foods from grocery stores four times a year, once from each US geographic region. These products are analyzed and the levels of contamination are combined with US Department of Agriculture (USDA) food consumption data to estimate average intake of chemical and pesticide residues.

One other organization that works closely with the FDA is the National Center for Food Safety and Technology (NCFST), a joint venture of government, industry, and academia that conducts research on food safety issues. The NCFST provides food safety training programs for industry and also provides industry and the FDA with scientifically sound information and technical services. Research from the NCFST has helped influence FDA policy regarding food safety and handling, including policies for processing of fresh juices and FDA approval of heat-sterilizing soups and other liquid/solid food combinations before packaging.

The FDA not only assesses food and drug safety and efficacy for health risk prevention but also takes measures to advance public health. The FDA funds programs that help speed developments to make food and drugs safer, more effective, and more affordable. For example, there are programs designed to promote the use of electronic medical records in clinical trials and others that involve collaborating with pharmaceutical companies to make medicines more personalized. Some also advance health education by giving the public accurate information about food, medications, and medical devices in the form of new regulations, drug package inserts, and consumer education materials (brochures, articles, Q&A pages online). All these developments and scientific information come from research scientists in FDA laboratories, of course!

The FDA’s role in protecting public health is often most visible when something goes wrong and becomes a threat to Americans’ safety. Earlier this year, Salmonella outbreaks in peanut products and pistachios sickened hundreds of people. But before we knew that the Salmonella came from these products, the FDA sent teams of microbiologists to hundreds of restaurants, grocery stores, and food processing centers to identify and follow the pathogen’s spread. The key to identifying the contamination source was manifold: laboratory and field scientists, epidemiologists, and a host of others collected samples, conducted interviews and inspections, traced product shipping routes, and analyzed and compiled data. With their merged efforts, the FDA was able to identify the source of contamination and alert the public to health risks associated with those foods.

Another time, the FDA came to the rescue by determining the cause of melamine toxicity from melamine-contaminated infant formula and animal feed. Melamine was supposedly a non-toxic compound, but the adulterated foods were in fact toxic, causing kidney disease in some pets and children. In addition, melamine could induce kidney stones when ingested in combination with cyanuric acid, another contaminant. To solve this problem, the FDA developed chemical testing methods to detect melamine in powdered milk-based infant formula. This procedure, based on liquid chromatography and mass spectrometry, was not only faster than previous methods, but could also detect both melamine and cyanuric acid residues in the food samples.

Imagine, for a moment, what life would be like, knowing your food could potentially be contaminated or that your pain relief medication was not appropriately tested for safety. Today, we have fewer of these fears, thanks to the FDA’s use of molecular biology, chemistry, epidemiology, and toxicology. The FDA has been entrusted with the important tasks of monitoring food and drug safety and advancing public health, playing an essential role in our daily lives. In collaboration with other organizations such as the USDA and NCFST, the FDA places scientific research in a position to benefit people every day.

    Sources:
  • http://www.fda.gov/oc/oms/ofm/budget/documentation.htm
  • http://www.fda.gov/opacom/7alerts.html
  • http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html
  • http://www.fda.gov/ora/science_ref/tdprc/tdprc.htm
  • http://www.ncfst.iit.edu/about/membership.html