newsletter@youngevity [email protected] YOUNGEVITY URGES FDA TO REQUIRE SELENIUM IN INFANT FORMULA Official Claims Filed to FDA’s Proposed Rule San Diego, CA – June 24, 2013 – Youngevity Essential Life Sciences, a wholly owned subsidiary of Youngevity International Inc., announced that is has filed official Comments in response to the FDA’s Proposed Rule, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements.” If adopted, the Rule would require inclusion of selenium as an essential nutrient in infant formula. When the FDA originally mandated that certain nutrients must be included in infant formula, selenium was not recognized as an essential nutrient. Since then, selenium has been confirmed as an essential nutrient, and the FDA now agrees that selenium is “an essential trace element for humans.” The agency proposed the new rule after agreeing that sufficient scientific evidence confirms that selenium deficiencies “may be of greatest concern in infants and children.” Infant formula is a food that is often intended to be the sole source of nutrition, and must therefore contain proper amounts of all nutrients essential for infants. Infants that are entirely fed through formula may be at risk for developing selenium deficiencies. The FDA relied on studies that associated suboptimal selenium status with “a range of negative health outcomes, including thyroid and immune dysfunction, viral infection, cardiovascular disease, inflammatory conditions, infertility, and an increased risk of some cancers.” Selenium supplementation ensures that infants and young children receive ample amounts of this essential nutritive component. In support of the Proposed Rule, Youngevity and its distributors filed official Comments. The Comments reiterated selenium’s integral role as part of a healthy diet. Youngevity’s Comments also relied on an evaluation by noted researcher, chemist, and scholar, Dr. G.N. Schrauzer, Ph.D who is also a member of the Youngevity Scientific Advisory Board. Citing Dr. Schrauzer’s expert opinion, Youngevity recommended that the FDA require the use of an organic form of selenium, selenomethionine, which provides greater health benefits to humans than does the mineral’s inorganic form, sodium selenate. This is only the latest measure that Youngevity has taken in support of the health benefits derived from supplementation by selenium and other essential nutrients. Youngevity founder, Dr. Joel Wallach, pioneered research concerning the health benefits of selenium. Dr. Wallach’s visionary work with trace elements led to the discovery of the first naturally occurring case of Cystic Fibrosis in non-humans. Dr. Wallach noted that the subject in that case, a young rhesus monkey, suffered from the disease, and selenium deficiency. Youngevity has long been a strong advocate of providing the public with important, truthful information about such health benefits. Although a relatively small percentage have succeeded in petitioning the FDA to allow qualified health claims, Youngevity has obtained multiple such claims. In 2004, Youngevity successfully petitioned the FDA to allow such a claim concerning the consumption of certain omega-3 fatty acids and a reduced risk of coronary heart disease. Youngevity has also twice successfully petitioned the FDA to allow qualified health claims concerning selenium. In 2002, Youngevity submitted a qualified health claim petition concerning selenium and certain site-specific cancers, emphasizing that informed consumers will make more prudent and effective dietary choices. In support, Youngevity cited, among other evidence, six human clinical trials along with epidemiological studies that demonstrated indications that associate reduced selenium levels with increased risk of some cancers. In 2003, the FDA ultimately allowed such qualified claims that acknowledged selenium’s role in reducing the risk of certain cancers. In 2008, Youngevity again successfully petitioned the agency for qualified claims concerning selenium and reduction in the risk of bladder cancer in women as well as prostate and thyroid cancers. In support of its petition, Youngevity furnished the agency over 100 scientific studies, articles, and related media. Youngevity’s 2008 selenium petition was followed by a petition for qualified claims of vitamin C consumption and reduction in risk of stomach cancer, as well as qualified health claims of vitamin E and reduction in the risk of bladder, colorectal, and renal cell cancer. The FDA also allowed qualified claims of those health conditions. Youngevity CEO, Steve Wallach, stated, “My father, and Youngevity founder, Dr. Joel Wallach, has been at the forefront of Selenium research for nearly 40 years and the Proposed Rule would only amplify the importance of mineral supplementation, especially to children who rely on infant formula as their only nutrient source.” The FDA will continue to accept comments on its Proposed Rule until July 1, 2013. Visit youngevity/ for a copy of the Youngevity Comment and supporting documents. About Youngevity® Essential Life Sciences Youngevity Essential Life Sciences (youngevity), headquartered in San Diego, CA, is a nutrition and lifestyle-related services company dedicated to promoting vibrant health and flourishing economics. Founded in 1997 by Drs. Joel Wallach, DVM, ND, and Ma Lan, MD, as AL Global, Inc., the company adopted the name Youngevity in 2006. Youngevity is the only direct selling company to have a qualified FDA Health Claim. Dr. Wallach’s work has been published in more than 70 peer-reviewed and referenced scientific journals and books. About Youngevity International Inc. Youngevity International Inc., (OTCQX: YGYI) (YGYI) is a fast-growing, innovative, multi-dimensional company that offers a wide range of consumer products and services, primarily through person-to-person selling relationships that comprise a "network of networks." The company also is a vertically-integrated producer of the finest coffees for the commercial, retail and direct sales channels. Youngevity International Inc. was formed after the merger of Youngevity Essential Life Sciences (youngevity) and Javalution Coffee Company in the summer of 2011. Safe Harbor Statement This release includes forward-looking statements on our current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law. Youngevity International Inc., Investor Relations John Zervas 800-982-3189 X 6509 [Change Subscription] [Cancel Subscription] Delete Reply Reply to All Forward Move Spam Actions Next Previous
Posted on: Tue, 25 Jun 2013 02:18:48 +0000
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