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.
Look for Natural Health Product number: Health Canada
In the U.S., dietary supplements are considered to be food products. Supplement makers can make claims similar to what’s found on cereals in the U.S. such as “calcium builds strong bones.” But they can’t contain drug ingredients or make claims about treating diseases like Alzheimer’s, cancer or diabetes.
In contrast in Canada, Health Canada said it assesses natural health products “for safety and efficacy, so claims made about their use to diagnose, prevent, mitigate, or treat a specific disease can be substantiated.”
If Health Canada considers a product to be safe, effective and of high quality then it will issue a licence.
“All [natural health products] products for sale in Canada must have a NPN or a DIN-HM that consumer can look for to assure the product is approved for sale in Canada,” Maryse Durette, a spokeswoman for Health Canada, said in an email.
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Health Canada already issues advisories, warnings and recalls about natural health products. That’s one of the moves the U.S. aims to do introduce with the FDA’s announced modernization of dietary supplement regulation and oversight.
Qualified health claims on dietary supplements may lead people to think they’re more effective than they are, said Peter Lurie, a former FDA official who now heads the U.S. Center for Science in the Public Interest.
“It’s very hard to take on this industry comprehensively when the law shackles the agency to the extent that it does,” Lurie said.
Dr. Pieter Cohen, an associate professor at Harvard Medical School, said dietary supplements are unnecessary for most people unless a doctor recommends them for a specific reason. Cohen noted there are exceptions, such as women who may be planning to become pregnant.
About 40 per cent of adult Canadians said they took supplements, according to a 2009 study based on the Canadian Community Health Survey.