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Retailers, suppliers sued over fishy supplement standards

BY Michael Johnsen

The Mateel Environmental Justice Foundation and the founders of FishOilSafety.com—a Web site dedicated to exposing the contamination of fish from such toxins as polychlorinated biphenyl compounds—last month targeted a host of retailers and their supplement suppliers—including CVS/pharmacy, Rite Aid, Pharmavite and specialty supplier Now Foods—in a California lawsuit. The plaintiffs alleged the defendants failed to warn residents of the potential exposure to PCBs in the fish oils they sold, as mandated by California Proposition 65.

The concern that this event will impact sales of fish oils remains slight, one supplement manufacturer maintained. For the three weeks following the filing of the lawsuit, sales of fish oils were still on a traditional upward trajectory.

“Though the [plaintiffs] suggest that the levels of PCBs found in these products far exceed what is acceptable by Proposition 65 standards, the actual levels of PCBs found in the majority of these products do not appear to exceed the Proposition 65 limit [0.09 parts per million per day],” stated Andrew Shao, SVP scientific and regulatory affairs for the Council for Responsible Nutrition, a trade association representing the dietary supplement industry.

CRN believes the suit was filed in California in order to take advantage of Proposition 65, which has conservative standards as compared with the rest of the nation. “Furthermore, [the plaintiffs] fail to mention that the Food and Drug Administration’s tolerance level for PCBs in fish—2 parts per million—far exceeds the levels of PCBs found in fish oil.”

In the test results released by the plaintiffs, none of their results exceeded PCB levels of 0.9 parts per million per day. “It appears that the group performed one test on a single sample from a single bottle of [each] product,” Pharmavite countered in a press release.

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Schnucks’ O’Brien to serve on Department of Agriculture advisory committee

BY Alaric DeArment

ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.

Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.

 

“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”

The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.

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Gilead commences phase 3 trial for single-tablet HIV treatment

BY Alaric DeArment

FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.

Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.

“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”

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