Sunday, February 7, 2016

Concerned about food and drug safety now? Look back aways . . .

While critics often rail about government regulation, laws providing for the safety of our food, drugs, cosmetics and medical devices followed public uproar in response to exposes and tragedies. Americans demanded more regulation, not less.

Concerned about food and drug safety now? Look back aways . . .

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The recent government shutdown brought a halt to most of the work of two agencies overseeing food safety. (Meat and poultry inspection continued under the auspices of the U.S. Department of Agriculture). The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, medical devices, most of our nation’s food supply, all cosmetics, dietary supplements, and products that give off radiation and for regulating tobacco products. Outbreaks of food-borne illness are monitored by the Centers for Disease Control and Prevention (CDC). This is a critical public health task. As the CDC notes, in 2012, it monitored between 16 and 57 potential food poisoning clusters each week (emphasis mine).

While critics often rail about big government regulation, the fact is that laws providing for the safety of our food, drugs, cosmetics and medical devices resulted from public uproar following exposes and tragedies. Over the past century, Americans have demanded more regulation, not less. And the result has been to make us safer and healthier.

Government oversight of our food, drugs, cosmetics and medical devices came as the result of public insistence on cleanliness, safety, and honest labeling. Muckraking journalists, public health advocates and progressive women’s organizations together helped to secure passage of 1906 Pure Food and Drug Act that was signed into law by President Theodore Roosevelt. Many credit Upton Sinclair’s horrifyingly graphic novel about the stockyards, The Jungle, published in 1906, for prompting public outrage that persuaded lawmakers to take action. As a result of this law, meat inspection began, the manufacture, transport and sale of adulterated food products and poisonous patent medicines was forbidden, and habit-forming drugs (among them cocaine and heroin) were required to have accurate labeling.

The 1906 Act did not ensure the safety of drugs, medical devices, and cosmetics. Two incidents prompted new stronger regulation. A display at the Chicago World’s Fair in 1933 presented images of women blinded by an unregulated cosmetic dye: Lash Lure. Women were literally dying to be beautiful. And drugs prescribed to save lives sometimes turned out to be deadly. In 1937 the medicine Elixer Sulfanilamide was prepared using a poisonous solvent leading to at least 100 deaths. Calls for safety followed. In 1938 President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act.

Amendments to the 1938 Act followed, leading to proper food labeling (Food Additives Amendment of 1957) and the prohibition in food of substances found to induce cancer in humans or laboratory animals. (the Delaney Clause). In response to what became known as the “thalidomide tragedy,” in which thousands of children (mostly in Europe and Asia) were born with severe birth defects after their mothers took the drug thalidomide while pregnant, the 1962 Kefauver-Harris Amendments to the 1938 Act required that manufacturers prove the safety and effectiveness of their drugs before they gain approval and that advertising for those drugs disclose their side effects. (If your children are asking you “what’s a four-hour erection?,” blame Sen. Estes Kefauver!)

Other amendments followed, further regulating medical devices, biologic products (such as blood and tissues for transplantation) prescription drug approvals, and tobacco products. A huge part of our public health infrastructure is necessarily devoted to ensuring the safety of things we put in our bodies. The FDA is regulating over 1 trillion dollars worth of products every year.

Before you swallow your next pill, take a bite of your lunch, put new batteries in your hearing aid, or paint your face for a night on the town, stop and think about what those activities would mean without the public health work of the FDA and other federal agencies. But don’t relax too much. The federal budget sequestration is still in effect and this means the FDA has to cut back on its work and Congress has yet to agree on a longterm budget. It’s enough to make you reach for some (federally regulated) anti-nausea medication.

Janet Golden, a Rutgers University history professor, specializes in the histories of medicine, childhood and women.
Read more at http://www.philly.com/philly/blogs/public_health/The-government-shutdown-a-threat-to-health.html#J4VcXB9Asj5JlEz5.99

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About this blog

What is public health — and why does it matter?

Through prevention, education, and intervention, public health practitioners - epidemiologists, health policy experts, municipal workers, environmental health scientists - work to keep us healthy.

It’s not always easy. Michael Yudell, Jonathan Purtle, and other contributors tell you why.

Michael Yudell, PhD, MPH Associate Professor, Dornsife School of Public Health, Drexel University
Jonathan Purtle, DrPH, MSc Assistant Professor, Drexel University School of Public Health
Janet Golden, PhD Professor of history, Rutgers University-Camden
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