The American public relies on the U.S. Food and Drug Administration to help ensure the quality and safety of FDA-regulated products available to consumers, many of which are sourced or manufactured overseas. As the volume of globally produced products and suppliers expands daily, the risk of fraudulent, intentionally adulterated, and/or other illegal products shipping into the U.S. also increases.
Every day, thousands of illicit products are shipped to the U.S. from overseas, across the spectrum of things the FDA regulates, including unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products. These products can be outright forgeries of items produced for the American market, as well as “gray market” products manufactured for use in another country but shipped illegally to the U.S. These products are unsafe: they may contain contaminants or be adulterated, and are not shipped and handled under conditions designed to preserve product stability and sterility.
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