Sarah Roller, Kristi Wolff, and Donnelly McDowell co-authored this blog post.

The Food and Drug Administration (FDA) published yesterday two long-awaited and lengthy proposed rules related to food safety standards–“Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” FDA is required to promulgate rules related to preventive controls for human food and produce safety standards under the 2011 Food Safety Modernization Act (FSMA).

Summaries of the two proposed rules are provided below. This publication is the first of several industry-focused posts that Kelley Drye intends to issue in the coming days regarding the proposed FSMA rules. Both of the proposed rules include numerous exemptions, requests for comment, and details that will be of interest to food industry stakeholders.


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On November 15, 2012, the City Council of Cincinnati passed a resolution “expressing the support of Council for the mandatory labeling of genetically engineered products.” The Council was petitioned by the consumer advocacy group, Food & Water Watch, as part of its campaign to require “genetically engineered” labeling for foods developed with the use of

Californians voted against Proposition 37 yesterday, the California ballot initiative that would have compelled labeling for foods developed with the use of recombinant DNA and related technologies, as well as prohibited “natural” claims for certain processed foods. With 98.5 percent of precincts reporting, Californians had voted against Proposition 37 by a margin of 53 to

On March 27, 2012, the House Energy and Commerce Committee held a hearing entitled “Examining the Current State of Cosmetics,” which considered existing FDA authority over cosmetics and calls to modernize that authority to address technological advances and globalization of the cosmetics industry. The hearing provided regulators and stakeholders an opportunity to voice their perspective on the future of the regulatory landscape governing cosmetics, with most expressing approval for adapting existing FDA authority to meet new industry needs while emphasizing extensive safeguards already put in place by industry. Witnesses further noted that maintaining FDA regulatory authority would help prevent individual state regulations which could deter innovation and disrupt interstate commerce.
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Protecting the US food supply from intentional adulteration requires coordination at all levels of government and throughout the private sector. Companies engaged in the manufacture, importation, distribution or storage of food for the U.S. market will be interested in a new article published by the Food and Drug Law Institute that provides an introduction to

On November 9, 2011, the Committee for the Right to Know, a consumer advocacy group that focuses on consumer, public health, environmental, and food issues, submitted the California Right to Know Genetically Engineered Food Act to the California state attorney general for title and summary–a necessary step needed to place citizen-created initiatives on the California

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food supply. Many of the items on FDA’s “to do” list require significant and swift action. Over the next two years, FDA must

In a previous post we discussed the “preliminary vote” by the Santa Clara County, California, Board of Supervisors to institute a new ordinance which prohibits restaurants from “providing” toys, coupons, or other “incentive items linked to the purchase” of any product containing “excessive” calorie, fat, saturated fat, sodium, added sugars, or prohibited levels of trans