FDA Regulatory and Compliance Monthly Recap — December 2015

LOEB & LOEB

Description

KIND Snacks filed a citizen petition asking the FDA to redefine the term, which is currently allowed to be used only as a claim to describe foods that contain three grams or less of total fat and one gram or less of saturated fats per serving. The petition follows a warning letter by the agency saying some of KIND’s snack bars failed to meet these requirements. Redefining what constitutes “healthy” food is a contentious issue among the FDA’s initiatives to modernize the Nutrition Facts panel to reflect new scientific evidence. The agency is also facing pressure to reduce what some see as confusion and misleading information on food labeling. U.S. Sens.

Richard Blumenthal, D-Conn., and Edward J. Markey, D-Mass., along with Reps. Frank Pallone Jr., D-N.J., and Rosa DeLauro, D-Conn., introduced the Food Labeling Modernization Act of 2015.

It would call on the Secretary of the Department of Health and Human Services to establish a standard front-of-package label that would require breaking out added sugar content as well as define terms such as “natural” and “healthy.” Loeb & Loeb LLP’s FDA Regulatory and Compliance Practice Loeb & Loeb’s FDA Regulatory and Compliance Practice comprises an interdisciplinary team of regulatory, corporate, capital markets, patent and litigation attorneys who advise clients on the full spectrum of legal and business issues related to the distribution and commercialization, including marketing and promotion, of FDA-regulated products. Focusing on the health and life sciences industries, including pharmaceuticals, biologics, medical devices, wellness products, dietary supplements and organics, the practice counsels clients on regulatory issues, compliance-related matters and risk management strategies; advises on laws and regulations related to product advertising and labeling; counsels on FDA exclusivity policies and related Hatch-Waxman issues; and provides representation in licensing transactions and regulatory enforcement actions. This report is a publication of Loeb & Loeb LLP and is intended to provide information on recent legal developments. This report does not create or continue an attorney client relationship nor should it be construed as legal advice or an opinion on specific situations. For more information on any of these FDA regulatory and compliance updates, please contact Scott S. Liebman at sliebman@loeb.com. 4 © 2016 Loeb & Loeb LLP.

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