W.Va. Retailers Association lauds efforts to prevent diversion of OTC drugs for meth
CHARLESTON, W.Va. — Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.
The West Virginia Retailers Association heralded data showing that the National Precursor Log Exchange or NPLEx prevented the sale of about 16,753 boxes from being sold illegally, thus preventing more than 44,400 g from potentially being diverted to making meth. The congestion drug pseudoephedrine is a common ingredient in many OTC products for cold and allergies, but also is a key ingredient in the making of meth. Earlier this month, according to published reports, Rite Aid decided to stop selling OTC products that contain pseudoephedrine as their only active ingredient, though it would continue to sell combination products containing the drug.
"West Virginia’s stop-sale system continues to prove its value in the fight against methamphetamine," West Virginia Retailers Association president Bridget Lambert said. "These most recent results again emphasize the importance of giving this new system time to work. Its benefit to retailers and to law enforcement cannot be overstated."
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.