HEALTH

Wet Lubricants gain 510(k) clearance as a class II medical device

BY Michael Johnsen
VALENCIA, Calif. – Trigg Laboratories on Monday announced that its Wet Original Personal Lubricant, which includes the Wet Flavored line, has been 510(k) cleared as a class II medical device by the U.S. Food and Drug Administration.
 
“It’s a good thing the FDA has been cracking down on the lubricant industry, requiring every lubricant on the market to submit a 510(k) application to the FDA in order to legally be marketed," stated Michael Trigg, CEO Trigg Laboratories. "Consumers need to understand that personal lubricants are applied to mucous membranes (our most intimate areas) and are very easily absorbed into the body, so it’s important to make sure they are classified as medical devices by the FDA before purchasing and using them.” 
 
Water-based, Wet Original is safe and effective as personal lubricant or vaginal moisturizer and is compatible with latex, polyisoprene and polyurethane condoms. 
 
“We will continue to meet the clinical standards that have made our products doctor-recommended and adult-preferred, and we are pleased to have the FDA regulating our ingredients and facility, to ensure we are meeting all safety guidelines so our customers can know with certainty that the Wet lubricants they trust to go on and inside are being made to the highest possible standards," Trigg added. "Trigg has many more applications in the works with the goal of having our entire line of lubricants 510(k) cleared by the end of 2016."
 
 
 
 

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Female Health Company donates FC2 Female Condoms to promote STD Awareness Month

BY Michael Johnsen
CHICAGO – The Female Health Company on Monday announced that it has donated FC2 Female Condoms to both the CDC Foundation and UNFPA and pledged education and training efforts as part of its participation in Sexually Transmitted Disease Awareness Month, which occurs every April.  
 
This year's STD Awareness campaign focused on two critical current medical issues: 1) the rising number of cases of STDs – chlamydia, gonorrhea and syphilis, the first increase in STD cases since 2006; and 2) the Zika virus, a critical new threat that has been added to the STD list. 
 
"The Female Health Company has a long history as an advocate for women with regard to their sexual health," stated O.B. Parrish, chairman and CEO of The Female Health Company. "The FC2 Female Condom is a highly effective option that protects women from STDs, including the Zika virus. We are proud to donate our FC2 Female Condoms to both United Nations Population Fund and the CDC Foundation to help prevent the transmission of STDs. In addition, we intend to continue our work with the CDC and the National Coalition of STD Directors to bring greater awareness of this critical health issue and provide education and training on how to use FC2 to prevent the spread of these infections."
 

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Optimum Nutrition ‘Leads the Whey’ with new protein mix flavors

BY Michael Johnsen
DOWNERS GROVE, Ill. – Optimum Nutrition on Thursday announced that chocolate-dipped banana is the winner of its "Lead the Whey" flavor contest, which took place in the fall of 2015. The contest featured three flavors – chocolate-dipped banana, mango and blueberry cheesecake – vying to become the newest permanent addition to the array of flavors already offered by Optimum Nutrition. 
 
The fan voting results were so close, Optimum Nutrition will also release the second most popular flavor – Blueberry Cheesecake. Optimum Nutrition fan votes online and product purchase at GNC stores nationwide determined the contest's outcome.
 
"Great taste is a signature of our ON Gold Standard Whey product – and our fans could experience that commitment with every flavor in our Lead the Whey contest," stated Saverio Spontella, director of North America marketing for Optimum Nutrition. "We love to get feedback directly from fans of the product and deliver exactly what they want."
 
Gold Standard 100% Whey delivers 24 grams of high-quality protein, primarily from whey protein isolates. The product is formulated to mix easily and dissolve quickly in water, milk or milk alternatives like soy or almond milk. The addition of Chocolate-Dipped Banana and Blueberry Cheesecake to the Gold Standard 100% Whey™ line brings the total available roster of flavors to 24.
 
2015 marked the second annual Optimum Nutrition "Lead the Whey" contest. In 2014, the contest marked the addition of salted caramel and key lime pie to the ON Gold Standard 100% Whey flavor collection.
 
 
 
 

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