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  • 2021-08-30 (xsd:date)
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  • No, the FDA hasn’t approved cigarettes, or any tobacco product (en)
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  • It didn’t take long after the Food and Drug Administration’s full approval of the PfizerCOVID-19 vaccine for skeptics to spread false claims about the agency’s track record. One post claimed that the FDA approved thalidomide, a dangerous, faulty drug once used to treat pregnancy morning sickness. That never happened , because an FDA medical officer raised concerns about the drug maker’s claims. Another post claimed that the Pfizer vaccine’s approval means nothing because the agency also approves pesticides in our food — which it does not do. Now, the experts on the internet have added cigarettes to the list of harmful things the FDA has purportedly approved (but, in reality, hasn’t). Friendly reminder: Cigarettes are FDA approved, one Facebook post said. Just so everyone is clear .. FDA also approved cigarettes $$$, said another . But the FDA has not approved any tobacco product, cigarettes included. The agency does not have the authority to approve the products, or to ban them. The posts were flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook .) The FDA is responsible for protecting public health by ensuring the safety, efficacy and security of food, drugs, cosmetics, medical devices and other products. The agency regulates the manufacturing, marketing and distribution of tobacco products, including e-cigarettes, but it doesn’t approve them the way it does with drugs and vaccines. FDA doesn’t approve tobacco products, its website says . There’s no such thing as a safe tobacco product, so FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products. Instead, FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole. To legally sell or distribute a new tobacco product in the U.S., manufacturers must receive a written marketing order from the FDA. The agency says it doesn’t have the authority to ban any class of tobacco products, including cigarettes, but does have the charge to reduce their harm. Vaccine regulation is different. Pfizer’s vaccine was tested in multiple clinical trials that included tens of thousands of people before it was given full FDA approval on Aug. 24. The FDA granted emergency use authorization for the vaccine in December 2020 for people 16 and older. In May, the authorization was extended for people between 12 and 15. The COVID-19 vaccines were already deemed safe and effective with the emergency use authorization. Full approval means that businesses and schools may have more leeway to require COVID-19 vaccination, and the Pfizer shot can stay on the market beyond the public health emergency. Pfizer submitted its 340,000-page application for full FDA approval in May 2021, and it was the fastest FDA approval of a vaccine ever. It required data from clinical and non-clinical trials, technical information, labeling information and more. In Pfizer’s case, the application built upon the extensive data submitted to support its application for emergency use authorization. Our ruling Posts on Facebook suggest people shouldn’t trust the FDA’s approval of the Pfizer vaccine because it also approved cigarettes. That’s wrong. The agency regulates the manufacturing, marketing and distribution of tobacco products, including cigarettes, but it doesn’t approve them the way it does with drugs and vaccines. It doesn’t have the authority to ban them, either. We rate this comparison False. (en)
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