June ___, 2002 PETITIONER: Wellness Lifestyles, Inc. ADDRESS: c/o Emord & Associates, P.C. 5282 Lyngate Court Burke, VA 22015 SUBJECT: Petition for Health Claims: Selenium and Reduction in the Risk of Certain Cancers Food and Drug Administration Office of Nutritional Products, Labeling, and Dietary Supplements HFS-800 5100 Paint Branch Parkway College Park, MD 20740 I. Introduction and Statement of Purpose Wellness Lifestyles, Inc. (hereinafter “Petitioner”), pursuant to Section 403(r)(5)(D) of the Federal Food, Drug and Cosmetic Act (“FDCA”)(21 U.S.C. § 343(r)(5)(D)), submits this petition for health claims concerning the relationship between selenium and reduction in the risk of certain cancers. The proposed claims are contained in section V below. Attached hereto, and constituting a part of this petition, are all of the items specified in 21 C.F.R. § 101.70(f). This petition presents a logical and valid evaluation of the scientific studies and clinical trials concerning selenium’s effect on reducing the risk of certain cancers and its anticarcinogenic effects. Selenium is an essential trace element in human nutrition. Exh. 2 (PDR for Nutritional Supplements) at 416. It is known to have antioxidant and anticarcinogenic activity. Id. The attached scientific studies demonstrate that selenium supplementation may reduce the incidence of colon, prostate, lung, liver, and esophageal cancers. Exhibits 1 at 3-4; 2 at 418-419; and 4 at 290. The scientific evidence justifies permitting a health claim that links selenium with a reduction in the risk of certain cancers and a health claim indicating selenium’s anticarcinogenic effects. See Whanger Report attached as Exhibit (Exh.) 1. The proposed health claims responds to a major public health concern in t thewallachfiles/articles-47-10-25-14-16-97-98-99-100-101-102-103-104-105_cancer.php #RandiantLifeTeachers #DrWallach #Youngevity #90ForLife
Posted on: Sat, 29 Mar 2014 12:58:35 +0000
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