BioRay Dietary Supplements Not Proven Safe or Effective

With no medical or pharmacy degrees and no compelling scientific data, BioRay’s owners—Timothy and Stephanie Ray—tout their <"http://www.yourlawyer.com/practice_areas/product_liability">dietary supplements as being able to help with sexual problems, allergies, speech delays, weight issues, even liver and autism problems; virtually any health malady, said The LA Times.

Not only does BioRay not provide scientific evidence to back its claims, there is no evidence that the products are safe. As a matter-of-fact, wrote the LA Times, BioRay’s online forum is rife with customer complaints about, for instance, “fever, rashes, boils,” racing heart rates “cold and flu symptoms, canker sores …high fever, itching, aggressive behavior, constipation, headaches, brain fog, reduced energy, coughing, and insomnia,” to name some.

Experts were asked to take a look at some of BioRay’s claims. They are concerned. For instance, liver specialist Dr. Daniel Ganger, said he is worried that consumers would take BioRay’s Liver Life, which, on BioRay’s website, indicates can “normalize liver enzymes.” “It’s a joke,” said Ganger, an associate professor of medicine at Northwestern University’s Feinberg School of Medicine. Ganger said people could read these claims and forego medical care.

BioRay, located in Laguna Hills, California, claims, quoted the LA Times from the BioRay website, that “At BioRay we have married ancient Chinese Medicine with science to bring you the most effective all natural products.” After being questioned by the Tribune, BioRay closed its public forums and Wiki and amended website wording.

For its part, the website contains a disclaimer saying that neither its products nor content have been evaluated by the U.S. Food and Drug Administration (FDA) 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,” quoted the LA Times.

We’ve writing that in recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

We’ve also previously explained that lawful dietary supplements contain minerals, vitamins, or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Also, FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products. Unlike drugs, dietary supplements do not require FDA approval prior to marketing.

In 2010, the LA Times pointed out, the agency sent warning letters to eight firms for illegally selling supplements as chelators, drugs that help remove metals from the body. Despite that BioRay had advertised on its website that two of its products—NDF and NDF Plus—were “full spectrum organic chelators,” it was not included in the mailing, said the LA Times. The two products are sold on the BioRay website for $269.95 for four ounces, but are no longer described as chelators after BioRay was contacted by the Tribune.

Over 16,000 companies manufacture, package, label, or hold supplements sold in the U.S. During fiscal year 2009, the FDA completed 184 inspections of supplement firms in the U.S. said its spokeswoman Pat El-Hinnawy, who noted that the agency 1,800 inspectors who monitor device and drug safety and efficacy as well as ensuring laws concerning food, supplements, and cosmetics are maintained, said the LA Times.

Even when action is taken, products can turn up on the Internet. We’ve been writing about the dangers of purchasing medications and supplements over the Internet, explaining, for example, that some supplements tout incredible benefits while not fully disclosing ingredients, some dangerous.

This entry was posted in Pharmaceuticals and tagged , , , , , . Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.