FDA seizes tainted product from Florida’s Globe All Wellness
SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.
“Companies that distribute products containing undisclosed drugs are not only breaking the law, they also are putting consumers at risk,” stated Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking.”
“Two important protections for the public are that a firm may not sell new drugs unless they have been tested and approved by the FDA and a firm may not make false or unsubstantiated claims about drugs they sell,” said Melinda Plaisier, acting associate commissioner for regulatory affairs. “The FDA must and will take aggressive enforcement action.”
Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Meridia. In December 2010, Meridia was withdrawn from the U.S. market after clinical data demonstrated that the drug increased the risk of heart attack and stroke.
Globe All markets its products with claims that its products can lower blood pressure and cholesterol, among others. Under the Federal Food, Drug and Cosmetic Act, products offered for such use are considered to be drugs, since they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
During inspections of Globe All conducted in October 2012 and February 2013, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice requirements for dietary supplements.
GAO issues report on the impact PSE sales restrictions have on meth labs
WASHINGTON — According to a report filed to Congress by the Government Accountability Office on Wednesday, the seizures of methamphetamine-producing labs declined following state and federal sales restrictions on pseudoephedrine. And while electronic tracking systems help enforce PSE sales limits, those efforts have not reduced meth lab incidents and have limitations related to smurfing, the GAO added.
The report also found that the prescription-only approach to regulating PSE sales "appears to have contributed to reductions in lab incidents with unclear impacts on consumers and limited impacts on the healthcare system," GAO reported in its summary. "Prescription-only status appears to have reduced overall demand for PSE products, but overall welfare impacts on consumers are unclear because of the lack of data, such as the cost of obtaining prescriptions. On the basis of the limited information available from health care providers in Oregon and Mississippi, there has not been a substantial increase in workload demands to provide and dispense prescriptions for PSE products.
That suggests consumers are foregoing scheduling a doctor’s appointment for a PSE subscription and instead suffering their congestion.
”Maintaining access to nonprescription pseudoephedrine is important to the 18 million American families who rely on these medicines,” stated Scott Melville, president and CEO of the Consumer Healthcare Products Association. “The NPLEx [electronic reporting] system serves as a responsible alternative to a prescription requirement for cold and allergy medicines containing pseudoephedrine, and the GAO’s findings strengthen our resolve to ensure that this technology provides law enforcement with the right tools to stop methamphetamine-related crime," he said. “Consumers value medicines containing pseudoephedrine because they are effective, they keep consumers productive, and they reduce unnecessary and costly visits to the doctor."
The impact of a prescription-only approach on the reduction of meth labs was not fully discernible, the GAO reported.
"Even as declines were observed in Oregon and Mississippi after implementing the prescription-only approach, declines were also observed in neighboring states that did not implement the approach, possibly because of other regional or reporting factors," the report noted. "For example, all states bordering Oregon also experienced significant declines in meth labs from 2005 through 2011, ranging from a 76% decline for California to a 94% decline for Washington state. In Mississippi’s case, except for Tennessee, all bordering states also experienced declines in lab incidents from 2009 through 2011, ranging from a 54% decrease in Arkansas to a decline of 57% in Louisiana."
That’s because the reporting of meth labs might have as much to do with budgetary constraints as it does with sales restrictions. "One potential factor for the declines observed from 2010 through 2011 is the exhaustion of DEA funds to clean up labs," the report noted. "According to DEA officials, as the funds provide an incentive to state and local agencies to report meth lab incidents to DEA, the lack of funds from February 2011 to October 2011 may have resulted in fewer lab incidents being reported during this time period."
The recent rise in the number of meth labs has been attributed to two trends: the emergence of a new technique for smaller-scale production and smurfing, the technique used to obtain large quantities of PSE by recruiting groups of individuals to purchase the legally allowable amount of PSE products at multiple stores that are then aggregated for meth production.
Smurfing is the practice that electronic reporting systems help identify and discourage. "To that end, CHPA has supported NPLEx since its inception and worked with lawmakers across the country to launch the proven system in 25 states," the CHPA stated in a release responding to the GAO report. "NPLEx is helping states fight methamphetamine-related crime, not only by blocking thousands of illegal sales but also by providing law enforcement with critical information that has led to numerous lab seizures, convictions and arrests."
Vitamin Shoppe closes deal on 31-store acquisition in Northwest
NORTH BERGEN, N.J. — The Vitamin Shoppe on Thursday announced that it has closed on the previously announced purchase of Super Supplements — a specialty retailer of vitamins, minerals and supplements — for approximately $50 million.
Super Supplements is headquartered in Seattle and operates 31 stores in the Pacific Northwest.
Stifel Nicolaus Weisel acted as financial advisor to the Vitamin Shoppe and Latham & Watkins LLP served as legal counsel. Cascadia Capital acted as financial advisor to Super Supplements and Dorsey & Whitney LLP served as legal counsel.
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