"Lost your essence after excessive lovemaking?" BioRay said it has a supplement for you.
Autism? Allergies? Liver problems? BioRay said it can help.
In fact, the supplement company established by Timothy and Stephanie Ray said it has products for just about anything that ails you or your family — from speech delays to weight issues.
It might sound like the world's best apothecary, but neither Timothy nor Stephanie Ray is a licensed medical doctor or pharmacist. There's no strong scientific evidence that their products work or that they are safe. In BioRay's online forum, customers have linked its products to fever, rashes, boils, heart palpitations and more.
Medical experts who were asked to look at some of BioRay's product claims expressed concerns. Dr. Daniel Ganger, a liver specialist, said he worried that people would opt for products like Liver Life, which BioRay's website said can "normalize liver enzymes," instead of getting medical attention.
"It's a joke," said Ganger, associate professor of medicine at Northwestern University's Feinberg School of Medicine.
BioRay, which is located in Laguna Hills, Calif., defended its products, its claims about them and their safety.
"At BioRay we have married ancient Chinese Medicine with science to bring you the most effective all natural products," the company website states.
The company, after questioning by the Tribune, changed wording about its products and staff on its website. The company also shut its public forums and Wiki.
The website also has a disclaimer noting, in part, that its products and content have not been evaluated by the U.S. Food and Drug Administration and that "no action or inaction should be taken based solely on the contents of this information; readers should consult appropriate health professionals on any matter relating to their health and well being."
BioRay is a cautionary tale for consumers whose hope and money fuel the $25 billion supplement industry. Federal law on supplements doesn't require companies to prove products work or are safe. And the law is only intermittently enforced by an overwhelmed FDA.
Last year, the FDA sent warning letters to eight companies for illegally selling supplements as chelators — drugs that help remove metals from the body. But the agency did not send one to BioRay, which, until recently, advertised two of its products as "full spectrum organic chelators" on its website.
The company stopped referring to NDF and NDF Plus, both sold on the BioRay website for $269.95 for 4 ounces, as "chelators" after being contacted by the Tribune. According to BioRay, NDF is its most popular product.
"They don't have enough people (at the FDA)," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "It's grossly inadequate."
Now the FDA has even more to do — ensuring that the more than 16,000 companies that manufacture, package, label or hold supplements sold to U.S. customers comply with a lengthy list of what are known as "Current Good Manufacturing Practices" guidelines. The guidelines, rules governing the manufacturing and testing of supplements for quality, have been phased in over several years, with the last group — very small supplement companies like BioRay — required to comply starting in June 2010.
"They have their hands full," said Duffy MacKay, vice president of scientific and regulatory affairs for the supplement industry trade association Council for Responsible Nutrition. "We really support the full enforcement of current laws and regulations. …We lose consumer confidence with those late-night commercials making false claims."
In fiscal year 2009, the FDA conducted 184 inspections of domestic supplement establishments, according to FDA spokeswoman Pat El-Hinnawy. The agency has about 1,800 inspectors responsible for monitoring the safety and efficacy of medical devices and drugs and enforcing laws pertaining to food, supplements and cosmetics.
"While we cannot inspect every manufacturing facility, we use a risk-based system to determine the best candidates for inspection," El-Hinnawy wrote in an e-mail. The agency considers the company's history of violations, adverse event reports associated with the product, length of time since last inspection and other factors, she said.
Even when the FDA takes action, illegal and recalled products can pop up for sale online.
Supplements lack science, safety proof
Medical experts say they're concerned with claims by BioRay
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