HEALTH

FDA announces extension on new labeling requirements for OTCs, supplements

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Friday announced that it has extended by one year the date after which it will begin enforcing new labeling requirements—that labels of over-the-counter medicines and nutritional supplements include contact information, either a complete domestic address or phone number, so that consumers can report serious adverse events associated with the use of those products.

The FDA will begin enforcing those labeling requirements Jan. 1, 2010, now.

“We believe that it is reasonable to allow an additional two-year period for firms whose labels do not yet meet the requirements … to bring their labeling into full compliance,” the agency stated in a guidance. “This period of enforcement discretion should be adequate to enable all firms to meet the new labeling requirements.”

Currently, under FDA’s “Drug Facts” regulations, the labels of OTC drug products may include a telephone number as a source to answer questions about the product, with the heading “Questions?” or “Questions or comments?”

After Jan. 1, 2010, the agency is recommending OTC and dietary supplement manufacturers spell out for consumers that the contact information is for purposes of reporting serious adverse events. “Although [the regulation] does not require the label to include anything other than a domestic address or phone number for the [manufacturer], FDA recommends that the label bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product,” the agency stated in its guidance.

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Mexican product released in U.S. may prevent erectile dysfunction

BY Alaric DeArment

SAN FRANCISCO Hispanic men between the ages of 20 and 50 are two and a half times as likely as men of other races and ethnicities to develop erectile dysfunction, according to a study published in the Archives of Internal Medicine in 2005.

A product on the market in Mexico since 2004 and recently introduced in the United States might address the problem. CRB Ventures said the product, The Sensual Tea, has a rate of effectiveness of 87.3 percent in treating erectile dysfunction and premature ejaculation and has no side effects.

“It is possible to prevent sexual problems from ever occurring,” CRB Ventures president Christian Beasley said in a statement. “The Sensual Tea overcomes low libido and sexual fatigue and enhances the pleasure and intensity of sex.”

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OTC sleep aids get boost from boomers

BY Antoinette Alexander

NEW YORK The market for OTC sleep aids is thriving, thanks in large part to baby boomers, according to a recent research report.

A new report by market research publisher Packaged Facts estimates that the total OTC market for sleep aids alone reached $604 million in 2008, an increase of 9 percent compared with $533 million in 2007. The increase was on par with the 8 percent compound annual growth rate that OTC sleep aids experienced between 2004 and 2008.

Both short-term and long-term success of the market is tied to aging baby boomers, a high-income populace less likely to feel the economic crunch as strongly as consumers with more moderate levels of income, the report states.

Furthermore, women of the baby boomer generation tend to face unique sleep challenges. As women age, more than half entering their menopausal transition years can expect to experience various primary sleep disorders, including sleep apnea, snoring, restless legs syndrome or insomnia.

“Sleep disorders are under-diagnosed in menopausal women, and many experts now recommend special consideration when diagnosing and treating their sleep problems,” stated Tatjana Meerman, publisher of Packaged Facts.

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