HEALTH

Prolatis recalls male-enhancement product

BY Michael Johnsen

SALT LAKE CITY Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under the brand name Prolatis’ after being informed by the Food and Drug Administration that lab analysis has found their male-enhancement products to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction.

That makes Prolatis’ an unapproved drug, as opposed to a dietary supplement.

The active drug ingredient is not listed on the product label. Product manufactured prior to Aug. 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40-count bottles at “GNC and other smarter retailers” according to the company’s website. Prolatis’ had also been sold on CVS.com.

The recall is being conducted as a precautionary measure, the company asserted.

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CRN taps FDA’s Sharfstein as annual symposium’s keynote speaker

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Thursday announced the Food and Drug Administration’s principal deputy commissioner Joshua Sharfstein is slated to return as a keynote speaker at The Conference, CRN’s annual symposium for the dietary supplement industry.

Sharfstein will make the opening address to attendees, providing an update on the FDA’s dietary supplement-related regulatory activities on Sept. 30.

Sharfstein will discuss the impact of the current regulatory landscape of the recently fully implemented dietary supplement good manufacturing practices, as well as the adverse event reporting law. Sharfstein also will provide attendees with advice on what a responsible industry can do to aid the FDA in its mission to protect the public health.

Additionally, Sharfstein will update conference attendees on critical supplement industry issues, such as the new dietary ingredient notification guidance.

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WHO: H1N1 in post-pandemic period, but it’s not over

BY Allison Cerra

NEW YORK The World Health Organization’s director-general Margaret Chan issued a statement on Tuesday that the H1N1 influenza has entered the post-pandemic period, but warned that the virus has not yet gone away.

While WHO has reported marginal levels of H1N1 transmission worldwide as of late, Chan said it expects the H1N1 virus to take on the behavior of a seasonal influenza virus and continue to circulate for some years to come.

 

NEW YORK The World Health Organization’s director-general Margaret Chan issued a statement on Tuesday that the H1N1 influenza has entered the post-pandemic period, but warned that the virus has not yet gone away.

While WHO has reported marginal levels of H1N1 transmission worldwide as of late, Chan said it expects the H1N1 virus to take on the behavior of a seasonal influenza virus and continue to circulate for some years to come.

 

"Pandemics, like the viruses that cause them, are unpredictable," she said. "So is the immediate post-pandemic period. There will be many questions, and we will have clear answers for only some. Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period.

 

"As I said, pandemics are unpredictable and prone to deliver surprises. No two pandemics are ever alike. This pandemic has turned out to be much more fortunate than what we feared a little over a year ago," Chan added.

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