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.
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.
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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.
“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.