FDA issues warning about Que She weight-loss supplement
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal weight-loss supplement, actually is an adulterated drug product as it contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.
People who have purchased Que She should stop taking the product immediately and consult a healthcare professional.
Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on such Internet sites as the Bouncing Bear Botanicals website, and at such retail outlets as Sacred Journey in Lawrence, Kan.
An FDA analysis of Que She found that it contained fenfluramine, a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage; propranolol, a prescription beta-blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions; sibutramine, a controlled substance and prescription weight-loss drug, which was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease; and ephedrine, a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.
These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.
Consumers and healthcare professionals are encouraged to report adverse events related to the use of Que She to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: online at FDA.gov/MedWatch/report.htm; by phone at (800) FDA-1088, or (800) 332-1088; or, by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at (800) FDA-0178.
Aisle7 launches Wellness AppStream
PORTLAND, Ore. Aisle7 on Wednesday announced the availability of Aisle7 Wellness AppStream, a set of standards-based Web services enabling digital marketers to create wellness applications for any retail channel environment or any technology platform.
“With the release of Aisle7 Online, we’ve seen how easy it is for customers to leverage our Web services application programming interface to build custom implementations for their website,” stated Jeffrey Beyer, CEO of Aisle7. “Aisle7 Wellness AppStream extends that ability to mobile and in-store delivery formats, as well as social media platforms, so marketers can build new cutting-edge wellness applications for emerging retail platforms such as the iPhone, iPad, Android and many others.”
Aisle7 Wellness AppStream features REST-based Web services that allow retailers to make on-demand requests to any of the Aisle7 databases. Marketers can choose from existing or custom content resources to create applications that highlight wellness recommendations for such high-margin categories as supplements, OTCs, prescriptions, meat and seafood, and produce.
“With its latest set of Web services, Aisle7 has made it really easy for us to deliver a consistent, retail-appropriate wellness message throughout our website,” stated Dan MacKay, director of Web technologies at Albertsons. “The Web services are easy to use and very powerful, allowing us to create a unique wellness experience for our shoppers.”
Five companies join CRN’s roster
WASHINGTON The Council for Responsible Nutrition on Wednesday announced the addition of five members to its roster: voting members Bausch & Lomb, Enzymotec USA, Natural Grocers, CNA HealthPro and Stericycle ExpertRecall.
Bausch & Lomb has a comprehensive portfolio of eye health products, including a full line of eye vitamin and mineral supplements.
Enzymotec USA is a biotechnology company that develops and produces lipid-based biofunctional ingredients for dietary supplements, functional foods and infant nutrition products.
Natural Grocers grew out of Vitamin Cottage, a small family-owned business established in 1955, and now includes more than 32 retail stores around the country that specialize in dietary supplements, organic groceries and personal care products. The company also manufactures a private-label brand of vitamins and supplements of the same name.
CNA HealthPro, a business unit of CNA Insurance companies, offers a full range of insurance coverage written on a claims-made basis for healthcare providers and organizations, including hospitals, large physician practices, nurse practitioners, pharmacists, etc. The company’s comprehensive coverage includes healthcare professional liability, product liability and general liability.
Stericycle ExpertRecall provides business and consulting services with a focus on helping companies promote safety, improve regulatory compliance and manage risk capabilities.