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How the FDA Regulates in Comparison to the World

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The United States Food and Drug Administration (FDA) has a massive amount of responsibility. The organization is in charge of regulating everything from medications to fresh food, tobacco products, and cosmetics, and as of March 2020, the FDA has its hands full thanks to COVID-19 (commonly known as coronavirus).

The virus has quickly enveloped the world, and ordinary citizens are scrambling to access both emergency provisions and information. The FDA has taken on much of the responsibility of helping to control the spread of COVID-19 in the U.S. On February 29, for example, the FDA issued a new policy for diagnostics testing related to public health emergencies. The organization continues to monitor the spread of coronavirus in addition to its everyday responsibilities.

For now, the hysteria surrounding COVID-19 has eclipsed the majority of questions related to how the FDA operates. However, consumer concerns remain relevant, especially regarding the safety of the national food supply and medication efficacy. Some critics have even referred to the FDA’s food safety efforts as “ineffective” and “inadequate,” noting that FDA standards differ considerably from regulatory bodies in Europe and elsewhere. In the wake of the worldwide COVID-19 epidemic, how does the FDA stand up?

Health and Medication Concerns

Every medication or medical device intended to treat or cure an illness, disease, or chronic health condition must be reviewed by the FDA prior to sale. The FDA will then affix an appropriate label on the medication or medical device, such as “FDA cleared” or “FDA approved.” The process is known as pre-market approval, or PMA, and it is a rigorous endeavor.

During the PMA process, FDA officials attempt to confirm that the benefits of a medication or treatment method are greater than the potential risks. These risks include possible side effects. The FDA gathers information from relevant scientific studies and trials in order to determine a product’s safety and effectiveness. According to Medical News Today, a negligible 1% of products pass the PMA process.

It’s important to note that vitamins and supplements are not reviewed by the FDA; thus, those manufacturers cannot claim that their products effectively treat a particular health condition or symptoms. The bulk of prescription medications, however, are subject to the PMA process.

Even if FDA approved, manufacturers must disclose potential side effects. For example, the FDA has approved Truvada as a treatment for HIV infection, but notes that serious side effects of the drug may include bone loss, lactic acidosis, and kidney problems. In the case of Truvada, the FDA has clearly determined that its benefits trump the potential risks.

The FDA’s Role in Food Safety

Along with medication efficacy and safety, ensuring the safety of what we eat represents another crucial job for the FDA, but FDA standards may not be up to par when compared to the rest of the developed world. Notably, the oxidizing agent potassium bromate is considered a cancer risk by Canadian, Brazilian, and EU governments who have all banned its use in food products.

The FDA, however, has made no such move, and potassium bromate remains a common ingredient in a wide variety of foods despite its carcinogenic properties. That’s just a single example of how the FDA tends to turn a blind eye when it comes to food-related hazards.

Few can deny that Americans are a rather unhealthy bunch with approximately 160 million men and women considered obese or overweight. Then there’s the prevalence of foodborne illness to consider. On an annual basis, 48 million Americans contract a food-related illness. Some solutions to this problem are available at the service level such as ensuring that food prep surfaces and equipment are sufficiently sanitized and that food is kept at the proper temperature.

FDA plays a major part in food safety as well, ensuring that food labels are accurate while also overseeing the quality of substances sold as food in the U.S. Today, however, these concerns often take a back burner to more pressing matters in the realm of medications and viruses.

Can the FDA Help Prevent Future Epidemics?

COVID-19 has effectively spread like wildfire, quickly snowballing into a pandemic. Because of this, people across the globe have eagerly pointed judgmental fingers at governmental leaders and organizations. In the U.S., the FDA is an easy scapegoat despite its best efforts to help contain the virus and increase access to respiratory devices and medications.

Controversy and criticism are nothing new to the FDA, which boasts a regulatory history spanning more than a century. The FDA was founded in 1906 and has faced a number of crises over the years as well as made dubious decisions. Unlike many other nations, the FDA has yet to ban asbestos, a natural mineral that boasts a wide variety of applications in the cosmetics, construction, and automotive industry. Like potassium bromate, asbestos is a known carcinogen that can lead to serious health conditions including mesothelioma, an aggressive form of lung cancer. It’s unclear why the FDA still allows the widespread use of asbestos.

Despite the organization’s shortcomings, at the end of the day, FDA regulations are in place to protect the health of the general public. No matter your opinion on the ability of the FDA to do an effective job, it’s important to remember that the organization is often at the forefront of life-or-death situations. Whether the inspection or approval process involves a potentially life-saving drug, questionable food additives, or a new medical device, the FDA has a massive job in working to keep Americans safe and healthy.

Posted by jhamilton at March 30, 2020 12:54 PM
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