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Enforcement Accordingly, claims are frequently permitted to proceed under a patchwork of state laws. Recent putative class-action suits have targeted "natural" claims regarding products containing ingredients such as high fructose corn syrup, alkalized cocoa, factory-made ascorbic acid, vegetable glycerin, soybean oil, canola oil, yeast extract, and beta-carotene. Many beverage and snack food products claiming to be "all natural" have been targeted with class action claims. In July 2013, Naked Juice agreed to pay $9 million to settle a consolidated putative class action in California alleging that products' labels and advertising made claims such as "all natural" and non-genetically modified, even though the products contained unnaturally processed and synthetic ingredients, derivatives of genetically modified crops, and chemically processed vitamin substitutes. Naked Juice continues to deny the allegations that the product labels were misleading or false, but has also agreed to redesign the labels to address the representations at issue. There is no clear answer for avoiding trouble, but being overly cautious with regard to "natural" claims may be one of the most effective solutions to help mitigate risk. Even common plant-derived additives and preservatives, as well as genetically modified corn and soybeans or their derivatives, such as corn starch, have been targeted in litigation. Notably, more than 80 percent of the U.S. corn and soybean stock are genetically modified, and these products are two of the most common ingredients in food products. Accordingly, manufacturers should closely scrutinize their ingredients and the way those ingredients are processed before making "natural" claims. And the best solution may be to find alternative marketing strategies to "all natural" claims to avoid being targeted by class-action litigation. Publish in the Mar/Apr Issue of Update Magazine! E. Advice for Manufacturers Until there exists a clear distinction between FDA and FTC authority and what constitutes labeling and advertising in nutraceutical marketing, nutraceutical manufacturers would do well to closely monitor the two agencies' actions and statements, as well as litigation trends involving nutraceuticals. Companies, their marketing teams, and their legal counsel should be proactive in understanding the law and regulatory environment and should consider creating compliance programs that will help ensure marketing efforts are regularly evaluated for conformity. In the meantime, manufacturers and marketers of nutraceuticals should strive for compliance with both FDA and FTC regulations and guidelines, and should expect product websites and social media pages to continue to receive heighted scrutiny by one or both Agencies. When in doubt, the manufacturer should follow a "double dose" of precaution by anticipating overlap between the FDA and FTC. Submit an article by January 16, 2014 The Update issue that covers all FDLI relevant sectors: Food, Drugs, Animal Drugs, Biologics, Cosmetics, Diagnostics, Dietary Supplements, Medical Devices, Tobacco. If you have an idea, we want to hear it! Please send all manuscriPts and inquiries to rachael Vieder at raV@fdli.org Nov/Dec_Published.indd 1 FDLI November/December 2013 Update 11/12/13 11:28 AM 11

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