Transgressions committed by companies within the dietary supplement industry continue to place millions of U.S. consumers at unnecessary risks every day. Recent years have witnessed an exponential increase in the amount of approved pharmaceutical ingredients being added to dietary supplements. As a result, the U.S. Food and Drug Administration (FDA) has taken it upon themselves to initiate a crackdown on suspected companies in violation of the Federal Food, Drug, and Cosmetic Act. In association with international regulatory and law enforcement agencies, the FDA took action this week against more than 4,100 Internet pharmacies that have been accused of illegally distributing potentially dangerous, unapproved drugs to consumers.
The FDA, otherwise known as the U.S. Food and Drug Administration, is an agency of the United States Department of Health and Human Services. As such, the FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation and veterinary products.
The FDA is also tasked with enforcing federal laws to ensure the safety of the public. In a recent crackdown on dietary supplements, the FDA took action this week against more than 4,100 Internet pharmacies that have been accused of illegally distributing potentially dangerous, unapproved drugs to consumers. These actions were announced during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s actions, collectively being referred to as Operation Pangea V, took place between September 25 and October 2. Subsequent results witnessed the shutdown of approximately 18,000 illegal pharmacy websites; resulting in the seizure of nearly $10.5 million worth of pharmaceuticals worldwide.
The initial goal of this collaborative effort, which included customs and regulatory authorities from 100 countries, was to identify producers and distributors of illegal pharmaceutical products and medical devices and remove their services from the supply chain. In doing so, regulatory efforts hope to drastically reduce the presence of dangerous products on the market.
According to a recent FDA News Release, “Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines,” said FDA Commissioner Margaret A. Hamburg, M.D. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”
Operation Pangea V was initiated to rid world markets of potentially dangerous and unapproved medicines that threatened the health of consumers. More often than not, approved pharmaceutical drugs were being masqueraded as dietary supplements. “These products are masquerading as dietary supplements—they may look like dietary supplements, but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”
Among the illegal medicines identified by Operation Pangea V were:
- Domperidone
- Isotretinoin
- Tamiflu
- Viagra
Upon the conclusion of Operation Pangea V, officials at the FDA sent Warning Letters to the operators of more than 4,100 identified websites believed to be in violation of federal law.
“Internet pharmacies that illegally sell unapproved, counterfeit, or potentially adulterated or substandard drugs are an inherently international crime problem,” said John Roth, director of the FDA’s Office of Criminal Investigation. “The FDA is pleased to work with INTERPOL, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”
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