FDA
rebukes 17 firms for selling fake Alzheimer's drugs
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[February 12, 2019]
(Reuters) - The U.S. Food and Drug
Administration (FDA) has warned more than a dozen companies against
selling unapproved products which claim to treat Alzheimer's disease and
other serious ailments, the agency said on Monday.
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Many of these drugs, marketed as dietary supplements and sold
online, have not been reviewed by the FDA and their safety and
efficacy remain unproven, the agency said in a statement.
The FDA sent 12 warning letters and five advisory letters to a total
of 17 companies, both domestic and foreign, which were selling such
products illegally. The companies have 15 days from the receipt of
the letters to tell the regulator how they will correct the
violations.
Separately on Monday, the FDA also announced plans to improve the
regulation of dietary supplements. The plans include communicating
as soon as possible when there is a concern about a supplement and
improving how the FDA evaluates the safety of such drugs.
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"As the popularity of supplements has grown, so have the number of
entities marketing potentially dangerous products or making unproven
or misleading claims about the health benefits they may deliver,"
FDA Commissioner Scott Gottlieb said.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Sai
Sachin Ravikumar)
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