The US Food and Drug Administration (FDA) has warned more than a dozen companies against selling unauthorized products claiming to treat Alzheimer's disease and others. Serious ills, announced Monday the agency.
Many of these drugs, marketed as dietary supplements and sold online, have not been reviewed by the FDA, nor are they safe or effective. stay unprovensaid the agency in a statement.
The FDA sent 12 warning letters and five letters of advice to 17 national and foreign companies in total, who were selling these products illegally. Companies have 15 days from receipt of letters to inform the regulator how they will correct the violations.
In addition, the FDA also announced Monday plans to improve the regulation of food supplements. The plans include communicating as early as possible in the event of a supplement concern and improving the way the FDA assesses the safety of these medications.
"The popularity of supplements has increased, as well as the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they can bring," said the Commissioner. from the FDA, Scott Gottlieb.
Look for the Natural Health Product Number: Health Canada
In the United States, dietary supplements are considered food products. Supplement manufacturers can make statements similar to those found on cereals in the United States, such as "calcium strengthens bones." But they can not contain medicinal ingredients or claim to treat diseases such as Alzheimer's disease, cancer or diabetes.
In Canada, on the contrary, Health Canada has stated that it evaluates natural health products "in terms of safety and efficacy, so that claims of their use to diagnose, prevent, mitigate or treat a specific disease can be justified ".
If Health Canada considers that a product is safe, effective and of high quality, it will issue a license.
"All [natural health products] Products sold in Canada must have an NPN or DIN-HM that the consumer can research to ensure that the product is approved for sale in Canada, "said Health Canada spokesperson Maryse Durette. an email.
Health Canada already publishes advisories, warnings and recalls regarding natural health products. This is one of the initiatives that the United States aims to introduce with the FDA's announced modernization of dietary supplement regulation and monitoring.
According to Peter Lurie, a former FDA official who currently heads the US Center for Science in the Public Interest, qualified health claims on dietary supplements may make people think they're more effective than they are. are.
"It is very difficult to tackle this industry in a comprehensive way when the law hinders it so much that it does," Lurie said.
Dr. Pieter Cohen, an associate professor at Harvard Medical School, said dietary supplements were useless for most people unless a doctor recommended them for a specific reason. Cohen noted that there were exceptions, such as women who might have the intention of becoming pregnant.
About 40% of Canadian adults reported taken supplements, according to a 2009 study based on the Canadian Community Health Survey.