FDA rebukes 17 firms for selling Alzheimer's drugs illegally

The U.S. Food and Drug Administration(FDA) has warned more than a dozen companies against sellingunapproved products which claim to treat Alzheimer's disease andother serious ailments, the agency said on Monday.

Many of these drugs, marketed as dietary supplements andsold online, have not been reviewed by the FDA and their safetyand efficacy remain unproven, the agency said in a statement.

The FDA sent 12 warning letters and five advisory letters toa total of 17 companies, both domestic and foreign, which wereselling such products illegally. The companies have 15 days fromthe receipt of the letters to tell the regulator how they willcorrect the violations.

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 Canadamust have a NPN or a DIN-HMthat 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.

Health Canada already issuesadvisories, warnings and recallsabout natural health products. That's one ofthe moves the U.S. aimsto do introduce with the FDA's announced modernization of dietary supplement regulation and oversight.

Qualified health claims on dietary supplements may lead peopleto 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," Luriesaid.

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. Cohennoted 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 theCanadian Community Health Survey.