Why is more than half a microgram of lead in a single dose of some supplements sold by Iovate Health Sciences, Inc.? Do their cold remedies really increase resistance to cold symptoms by 312%? Questions the company failed to answer, which resulted in a $1.5 million California fine.Who is Iovate Health Sciences, Inc.?Iovate is a Canadian company that for many workout enthusiasts and those looking for weight loss aids may be more familiar under its former handle, MuscleTech Research and Development, Inc. Under that moniker, Iovate still sells products called "Anator P70", "Anabolic Hardcore Halo", "naNO Vapor" and many others, not the least of them the weight loss aid "Hydroxycut".Hydroxycut, in its original incarnation based on ephedra and caffeine, was Iovate's biggest success and biggest debacle. Selling one million units per year, it was marketed as being created and endorsed by medical doctors: advertisements featured an osteopath named Dr. Jon Marshall and Professor Marvin Heuer of the University of Florida - who concidentally also was Iovate's Chief Scientific Officer at the time.That endorsements by medical professionals, especially those holding an interest in the endorsed product, don't translate to a product being safe, was shown soon after, when scientific evidence of serious side effects due to ephedra accumulated, including at least one death. This led to the 2004 ban of ephedra and Iovate went to "reformulate" their Hydroxycut products.But in 2009, it came to the FDA's attention that people using the "new" Hydroxycut products were still suffering from serious side effects, including severe liver damage. The agency issued a warning to consumers to stop using Hydroxycut immediately. Iovate reformulated Hydroxycut - again. It is still being sold today.Creatively testing out boundaries seems to be one of the company's hobbies: Already in 2003 the New York Times reported that internal Iovate documents indicated that they tried to hide studies showing that Hydroxycut was ineffective, attempted to cover up side effects, and even tampered with documents submitted as evidence in an Oklahoma lawsuit.Aren't Supplements Quasi-Medications?Now it's 2012 and it seems Iovate is still trying to find out how far they can go before being seriously threatened: In a settlement that became public on Wednesday, the company agreed to pay $1.5 million to end a lawsuit filed by ten California counties. The reason for the suit? Misleading advertising and failing to inform customers that some of their cold remedies contained more than half a microgram of lead per dose.In the settlement, Iovate did not admit to fault or liability. Or as CBS' Jim Edwards put it:
In a normal world a company like Iovate Health Sciences (...) shouldn't exist. Twice its products have killed people. Twice its products have been removed from the market by the FDA. Twice the company has "reformulated" the product to replace its active ingredient with a completely different substance. Yet Iovate continues to sell its snake oil, making the same "clinically proven" claims for each generation of its product, often with identical wording.One wonders how far things have to go before this changes. As it is right now, the supplement market is largely unregulated and companies can push their products with the most outrageous claims. Customers, consumer protection and governmental agencies then have to prove them wrong.Why isn't it the other way around? Any medication has to run through heaps of clinical trials before being allowed to be used on patients. That process can still be tampered with, but the mind boggles when imagining what would happen if medications could be sold with the same freedom as dietary supplements.Picture courtesy of "Lara604".