Sales of herbal supplement Fruta Planta, a self-proclaimed "All Natural Chinese Weight Loss Solution," have been halted after the U. S. Food and Drug Administration (FDA) discovered an undisclosed drug in the product during recent laboratory analyses. The lab tests came after a raft of consumer complaints filtered into FDA linking Fruta Planta with heart health issues and one death. In a December 23 press release, FDA reported that the product contains sibutramine, an appetite suppressant withdrawn from the U.S. market in October 2010. The press release urges consumers to discontinue use of the product and then "throw it away."
FDA interrupted the manufacture and sale of sibutramine, sold under the brand name Meridia, in October, after a clinical study revealed an increased risk of heart attack and stroke for people taking the drug. Since discovery of the drug in Fruta Planta (manufactured by Chinese biotech company GuangZhouYanxiang), its U.S. distributor—Florida-based PRockMarketing—has issued a nationwide recall and has halted new consumer orders.
NBJ Bottom Line
Supplement manufacturers and distributors be warned: the surest way to invoke FDA's wrath is to sell products tainted with undeclared pharmaceuticals. In a recent interview with NBJ, Steve Mister, president and CEO of the CouncilforResponsibleNutrition (CRN), asserted that FDA commissioner Joshua Sharfstein, MD, has tainted dietary supplements in his direct line of fire. "The number one priority for the agency is products that are contaminated with prescription drug ingredients," said Mister. "Dr. Sharfstein talked to us about this at one of our conferences, and I've had conversations with him since then. If you asked him what keeps him up at night, this is it."
The problem is compounded by the fact that—despite new identity testing requirements now in force with FDA's latest list of GMPs—supplement distributors like PRock are under less scrutiny and impugned less often than manufacturers. As issues of contamination often radiate from the distribution level, distributors and marketers—especially in the oft-targeted sexual enhancement, sports nutrition and weight loss spaces—are urged to institute identity testing of all products.
"And when you start to think about it," said Mister, "that's not a lot to ask of the industry. If you're putting something out there for the consumer and you're telling them that it's vitamin D, every drum that comes in, you should test it to be sure it's vitamin D." According to FrutaPlanta's website, the product's active ingredients are limited to herbs and super fruits like lemon, bitter melon, papaya, mangosteen and spirulina, and it "does not contain added stimulants or controlled substances of any kind." Such statements now come at a premium, especially when consumers are at risk of heart attack and stroke.
Said Mister, "Everybody knows prescription drugs have side effects, have interactions, have all kinds of precautions. Some people shouldn't take certain drugs because of other things they take or conditions that they have. If you're putting a product out there in the market and you're putting a prescription drug in it and not telling the consumer that's what it is, you are creating a potential health hazard just waiting to happen."
For the full interview with Steve Mister, as well as other insights from leaders in the industry, be sure to read NBJ's January 2011 Industry Awards issue. To order or become a subscriber, please visit the NBJ subscription page. For a deeper discussion of supplement-drug interactions and their implications for industry, please see our 2010 Integrative Medicine & Condition-Specific Supplements Double Issue and sign up early for NBJ's upcoming Integrative Medicine Web Seminar.
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