FDA advisory committee recommends OTC availability of HIV test
BETHLEHEM, Pa. — OraSure Technologies on Tuesday announced that the Food and Drug Administration’s Blood Products Advisory Committee recommended that the OraQuick In-Home HIV test be made available without a prescription.
“There was broad support expressed by the HIV community at [the] meeting, and we look forward to continuing our work with them in the fight against HIV," stated OraSure president and CEO Douglas Michels. "We believe the OraQuick In-Home HIV Test will make a valuable contribution in this fight.”
The OraQuick In-Home HIV Test is an over-the-counter version of the OraQuick Advance Rapid HIV-1/2 Test, which is currently sold into the professional market. The OraQuick Advance test can detect antibodies to both HIV-1 and HIV-2 in oral fluid within 20 minutes, the company stated.
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Clif Bar wheels out bicycling promotion
NEW YORK — Clif Bar on Tuesday announced its first-ever “Join the Ride” program, which invites consumers to describe how a new bicycle will help them live better. The program will focus on personal health and fitness, community involvement and green living. Individuals with the 50 most compelling entries will receive a Raleigh Route 3.0 bicycle and a Giro Reverb helmet.
Produced in partnership with Bicycling magazine, all winning entries also will be posted on a group blog on Bicycling.com. The program begins May 15 and will be open through June 18. Entries, limited to 100 words or less, can be submitted at Bicycling.com/clifbar.
"Clif Bar believes that life is better on a bicycle," stated Ryan Mayo, Clif Bar environmental activism manager. "We’re committed to supporting the bike movement and feel that riding a bike can bring about profound change in our lives and the world around us, from improving our fitness and lowering our stress, to reducing our carbon footprint by leaving the car keys at home for quick trips around town. ‘Join the Ride’ gives us the opportunity to share the thrill of riding a bike with new and existing cyclists."
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FDA identifies three online products masquerading as dietary supplements
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.
The three products include Boost ultra sexual enhancement formula, VMaxx Rx and Firminite.
FDA laboratory analysis confirmed that Boost ultra sexual enhancement formula contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug used for treatment of erectile dysfunction. VMaxx Rx contained sulfoaildenafil, an analog of sildenafil. Firminite contained tadalafil, the active ingredient in Cialis, another remedy prescribed for the treatment of erectile dsyfunction.
These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels, the FDA said. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the agency added.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a healthcare professional as soon as possible, the FDA noted.
According to the agency, these notifications are part of an initiative to inform the public of a growing trend of products illegally marketed as dietary supplements or conventional foods that actually contain hidden drugs and/or chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building, and are often misrepresented as being “all natural,” the agency said.
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