Fredric Roth V

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The new Rules (for Vending Machines and Menus) are based on changes made as the result of the Affordable Care Act. These changes were made by adding two new sections to Section 403 of the Food, Drug and Cosmetics Act, which describes Mislabeled Foods. The new sections, found under FDCA §403(q)(5)(H), enables the FDA to regulate the labeling requirements for Restaurants, Retail Food Establishments and Vending Machines.

Late last year, the U.S. Food and Drug Administration finalized a new set of Rules pursuant to the new §403 governing how and where caloric content must be displayed. As a result, beginning on Dec. 1, 2015, and Dec. 1, 2016, certain restaurants and vending machine operators, respectively, will be forced to disclose the calorie content of their products to consumers.

Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval.

Smartphones and tablets are quickly becoming the ubiquitous tool for both personal and business activities. The convenience of the platforms, their mobility, and their ability to tie into the Internet means not only is the adoption rate of these devices outpacing the adoption of standard PCs worldwide, but they present a growing opportunity for mobile application developers.