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Recent Developments from the FDA

It is only March and already the Food and Drug Administration has had a busy start to 2018.  The FDA’s recent initiatives include developments on three significant health issues: the flu, concussions, and nicotine addiction.

This current flu season has been one of the worst epidemics in a decade.  New FDA regulations are raising the standard on the reliability of rapid flu tests. The FDA’s goal is to make flu tests quicker and more reliable. Flu tests have proven to result in too many incorrect results, prolonging the illness and leading to other illnesses, such as bronchitis or pneumonia.  The FDA’s new standard is that rapid flu tests cannot result in false negatives more than 20% of the time. Flu tests are required to meet the FDA’s new standards by January 12, 2019.

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Banyon Biomarkers Inc. has developed a blood test to measure proteins released by the brain in the hours following a concussion. Photo courtesy of the New York Times.

Another topic that has garnered a lot of attention is the risks associated with concussions.  The FDA has approved a new way to diagnose concussions, a concussion blood test. The blood test developed by Banyon Biomarkers Inc. measures the proteins that the brain releases during the 12-hour period following a concussion.  According to the FDA, the test results can be made available in three to four hours following the test.

Perhaps the most significant health crisis in history is addiction to tobacco.  According to an FDA press release on March 15th, tobacco use, primarily from cigarette smoking, remains the leading cause of preventable disease and death in the U.S., killing more than 480,000 Americans every year.  In the press release, the FDA issued an advance notice of its proposal to explore a nicotine-product standard that would lower nicotine to minimally or non-addictive levels.  The FDA is conducting a review of the scientific understanding regarding the role that nicotine plays in making cigarettes addictive.  The FDA is seeking “public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health? Should a product standard be implemented all at once or gradually?” Part of the FDA’s plan includes making it possible for adult smokers to receive nicotine from alternative and less harmful sources, including e-cigarettes.  Simultaneously, the FDA clearly stated that it plans to take enforcement steps to ensure that tobacco companies are not advertising their products, which include e-cigarettes, to children. The FDA further stated, “No youth should use a tobacco product.”

The FDA cited a recent New England Journal of Medicine report stating that a new nicotine-product standard would cause 5 million adult smokers to quit smoking within one year of implementation, with an even greater impact of 33 million people avoiding smoking altogether by the year 2100.

By: Julia Whitney’21, Staff Writer

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