USPLabs agrees to recall and destroy dietary supplement following FDA actions
SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
"As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention," Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs stated. "Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
"Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law," Fabricant said. "Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed."
Trigg Laboratories to help raise awareness in support of World AIDS Day
LOS ANGELES — Trigg Laboratories, makers of Wet personal lubricants, will be supporting World AIDS Day on Dec. 1 through the donation of more than 5,000 safe-sex kits and samples to local clinics across nine cities to help raise awareness around HIV/AIDS, the company announced Tuesday.
“We’re proud to support World AIDS Day,” stated Michael Trigg, CEO of Trigg Labs. “We hope our safe sex kits will increase public awareness to reduce the stigma associated with HIV. It’s so important to get educated, tested and to know your current HIV status," he said.
Study: Top quit-smoking apps not employing tried and true smoking-cessation strategies
WASHINGTON — Many of the most popular anti-smoking apps for iPhones or Androids lack some basic strategies that are known to help smokers quit, according to a new study in the American Journal of Preventive Medicine released Tuesday.
“Quit-smoking apps are an increasingly available tool for smokers,” stated lead author Lorien Abroms, an associate professor of prevention and community health at the George Washington University School of Public Health and Health Services. “Yet our study suggests these apps have a long way to go to comply with practices that we know can help people stub out that last cigarette.”
The researchers found apps for smartphones were in high demand around the world, with more than 700,000 such apps downloaded every month for Android phones alone. The popularity of such apps may speak to the high level of desire smokers have to quit. According to the Centers for Disease Control and Prevention, more than half of all smokers tried to quit in 2010, the most recent year that statistics were available.
The researchers identified 414 quit-smoking apps for iPhones and Androids and then zeroed in on 50 of the most popular ones from each operating system. The team analyzed each app’s approach to smoking cessation, including their adherence to guidelines established by the U.S. Public Health Service on treating tobacco use. The guidelines review decades of scientific studies and offer recommendations on the most effective ways to beat a tobacco habit.
Overall, the study found that the most popular apps were not giving smokers the best treatment options — at least from a clinical practice standpoint. For example, none of the apps in this study recommend that smokers call a quit-line, usually a toll free number that has trained public health counselors on hand that provide advice on quitting smoking. According to the U.S. Public Health Service, such counseling can more than double a smoker’s chance of successfully ending their habit.
And less than one-in-20 apps recommended that smokers try medication to help them resist the cravings for a smoke. Researchers know that nicotine replacement therapy can be a highly effective tool, especially when used in conjunction with a quit-line. In fact, the use of such counseling along with medication can more than triple a smoker’s chances of joining the ranks of former smokers. Most apps also lacked basic advice on how to quit smoking and did not provide assistance in setting up a quit plan, the authors said.
This study had some limitations, including the fact that it does not offer any insight on how the apps are being used once downloaded and whether people are using them in combination with other effective methods.
Abroms suggested smokers might want to consider taking the new technology a step back by using their phone not just to download an app but to make a call. “They should simply pick up their smartphone and call a quit-line now to get proven help on how to beat a tobacco addiction.”
The study, “A Content Analysis of Popular Smartphone Apps for Smoking Cessation,” will be in the December print edition of the American Journal of Preventive Medicine.