SASMAR announced today that the U.S. Food and Drug Administration (FDA) has approved the full range of SASMAR® Brand of personal lubricant products for sale in the United States of America.
Brussels, Belgium October 01, 2013
SASMAR announced today that the U.S. Food and Drug Administration (FDA) has approved the full range of SASMAR® Brand of personal lubricant products for sale in the United States of America. SASMAR® Brand personal lubricants are formulated for penile and vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and available in eight quality formulations.
The FDA decision provides pre-market approval for SASMAR® Original, SASMAR® Classic, SASMAR® Warming, SASMAR® Strawberry, SASMAR® Cherry, SASMAR® Vanilla, SASMAR® Pina Colada and SASMAR® Melon personal lubricants. Manufactured in France to the highest quality standards, the product range includes a silicone-based, water-based, warming and multiple flavored variants. Each version is formulated without parabens and packaged in 4ml sachets, 50ml Tubes and premium 60ml airless pumps.
The company advises that SASMAR® brand personal lubricants will be available in the U.S. from October this year.
"This is a substantial approval of eight formulations that offers consumers a diverse choice of product offerings, satisfying the demands of a broad demographic," says John-Michael Mancini, group Chief Executive Officer, SASMAR. "The FDA decision is a key milestone for the company as we continue the rollout of our quality products globally and our introduction into the US market."
SASMAR® brand Personal Lubricants are already trusted by millions of consumers in more than sixty countries globally. The comprehensive FDA approval is reliant on results of rigorous clinical testing and other supporting data to prove substantial equivalence with other leading personal lubricant brand in the United States. SASMAR® brand personal lubricants were determined to meet the FDA’s high standards for biocompatibility in accordance with ISO 10993 for cytotoxicity, vaginal irritation, sensitizations and systemic toxicity. Additionally, testing confirmed that all eight formulations are safe for use with natural rubber latex, polyurethane and polyisoprene condoms, the most used condom types worldwide.
The company advises distributors and retailers interested in receiving information and samples of SASMAR® Personal Lubricants to contact their sales department via its website.
About SASMAR:
SASMAR is a pharmaceutical company focused on the categories of fertility, family planning and female health. Founded in 2005, the company is a major manufacturer of personal lubricant and supplier to international governmental organizations in HIV/AIDS prevention and awareness programs in third world and developing countries. The founding purpose of SASMAR in 2005 was to provide high quality personal care products that benefited the lives of consumers in Australia and since then the company has grown its product portfolio and international distribution in a very short period. Headquartered in Brussels, Belgium, the group has operations based in Sydney, London, Hong Kong and Chicago and has a presence in more than sixty countries through a network of distribution partners.