HEALTH

Natural Nutrition introduces pain-relief cream

BY Michael Johnsen

OTTAWA Natural Nutrition on Tuesday announced that it will launch an all-natural pain-relief cream in November under the brand name Blue Lightning Fast Pain Relief.

Blue Lightning will be first introduced through the Web site www.naturalnutritioninc.net in early November. This will be followed byproduct availability through infomercials in the second phase and will be made available in health stores and supermarkets in the final phase of the launch.

“The fitness demands of baby boomers sometimes result in sore muscle and joint pains,” stated Tim Connolly, chief executive officer of Natural Nutrition. “We see a huge demand for this product in the market.”

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HEALTH

FDA committee to review OTC decongestants

BY Michael Johnsen

ROCKVILLE, Md. The Nonprescription Drugs Advisory Committee will consider the possibility of a revision to the final monograph for over-the-counter decongestants following a review of the safety and efficacy of phenylephrine in a Dec. 14 meeting, FDA said in a notice prepared for the Oct. 24 Federal Register, according to the Tan Sheet.

The meeting is one day after the FDA considers the potential switch of Merck’s Mevacor for the third time.

At the Dec. 14 meeting, the committee will discuss questions on the safety and effectiveness of PE hydrochloride and PE bitartrate in nonprescription decongestants raised in a Feb. 1 citizen petition.

The petitioners—University of Florida pharmacy professors Leslie Hendeles and Randy Hatton—assert that available data does not support the adult and pediatric dosing levels recognized as safe and effective in the monograph for OTC cough, cold, allergy, bronchodilator and antiasthmatic drug products. They requested FDA revise the monograph to increase the adult dose of PE hydrochloride from 10 mg to 25 mg and PE bitartrate from 15.6 mg to 40 mg.

Last week a pair of FDA advisory committees voted to discontinue the recommendation of children’s cough-and-cold remedies for children under the age of six. 

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NPA to hold Web conference on adverse-event reporting law

BY Michael Johnsen

WASHINGTON The Natural Products Association on Monday announced the scheduling of a Web conference this Friday at 2 p.m. featuring two experts—Rick Kingston, president, regulatory and scientific affairs, SafetyCall International and Daniel Fabricant, vice president of scientific and regulatory affairs, Natural Products Association—to help companies understand both the broad and technical aspects of the new adverse-event reporting law.

“As the largest trade association representing both retailers and manufacturers, I can say there are a lot of questions and confusion about how these new rules will work,” Fabricant stated. “Every company needs to know and understand this new law and its ramifications, which is why we are conducting this special session. We will also use the knowledge gained from this session to inform our official comments that we submit to the FDA.”

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