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CRN defends herbal ingredient Ginkgo biloba

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition strongly criticized the Center for Science in the Public Interest earlier this week as that organization petitioned the Food and Drug Administration to prohibit the sale of Ginkgo biloba.

“Ginkgo biloba has literally been used for thousands of years, and this attempt by CSPI to discredit this safe and beneficial dietary supplement demonstrates an irresponsible misinterpretation of both the science and the intent of the National Toxicology Program in reviewing ginkgo," stated Steve Mister, CRN president and CEO. "This premature evaluation from CSPI reveals an abuse of its position, a lack of understanding about the regulation of food by FDA, and presents a true disservice to consumers. 

CSPI’s request to FDA to ban ginkgo is based on an NTP report examining high doses of ginkgo force-fed to mice and rats. However, in the second paragraph of the report’s Foreword, NTP states: "Extrapolation of these results to other species, including characterization of hazards and risks to humans, requires analyses beyond the intent of these reports."  

In response to CSPI’s request FDA responded: "It is not scientifically valid to conclude with certainty that dietary supplement products containing Ginkgo biloba are unsafe based solely on data from the new NTP study.”

 

 

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Actavis seeks approval for two generics

BY Alaric DeArment

PARSIPPANY, N.J. — Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

On Wednesday, Actavis said it had filed for approval with the Food and Drug Administration for a generic version of Bayer’s Safyral (drospirenone, ethinyl estradiol and levomefolate calcium tablets; levomefolate calcium tablets), which prevents pregnancy and acts as a daily folate supplement. The filing prompted a patent-infringement suit by two subsidiaries of Bayer and a subsidiary of Germany-based Merck KGaA. The suit places an automatic stay of approval on the generic for 30 months, or until the companies settle the case.

And on Friday, Actavis filed for approval for a generic version of Fresenius Kabi’s Diprivan (propofol) injection in the 10 mg-per-milliliter strength, a sedative and anesthetic. The filing also prompted a patent-infringement suit from Fresenius Kabi.

Safyral had sales of about $19 million during the 12-month period that ended in April, while Diprivan had sales of about $212 million during the same period, according to IMS Health.


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PacificHealth Laboratories fields ‘all-natural’ energy shot with Body Glove Surge

BY Michael Johnsen

MATAWAN, N.J. — PacificHealth Laboratories recently announced the launch of Body Glove Surge, an energy shot billed as "all natural."

Although 164 million adults are daily consumers of caffeinated products, only 8% of adults regularly purchase energy shots, the company noted. As many as 47% of energy shot users report their consumption would increase if there was a natural alternative. 

"Body Glove Surge provides retailers the opportunity to expand this category and pick up lost sales from the 92% of consumers who are not currently using energy shots," stated PacificHealth CEO Fred Duffner. "With Body Glove Surge, busy health conscious consumers have a safe, all-natural proven energy product to help them perform at their best whether they are exercising, working or playing.”

A recent Montana State University study, which was presented at the recent American College of Sports Medicine’s annual meeting, showed Body Glove Surge was more effective than other energy shots in speeding reaction times, extending endurance, improving alertness and raising mental focus. The Body Glove shot is formulated with protein, honey, green tea, coconut water, pomegranate and other high-antioxidant fruits.

“Body Glove Surge ingredients acts synergistically to raise energy levels and improve mental focus even though it contains 35% less caffeine than the [best] selling shot," stated Robert Portman, developer of the energy shot. "Body Glove Surge gives you fast and long-lasting energy whenever you need it plus … additional immune, antioxidant and electrolyte replenishment benefits.”


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