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FDA Releases Proposed Rules under FSMA

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On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety Modernization Act (FSMA) of 2011. The four new rules open for public comment set guidelines for the following food safety issues: Enhanced produce safety Preventative controls for human food Best practices and guidelines for animal food The foreign supplier verification program The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to…
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FDA’s CFSAN Announces Plan for Program Priorities

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On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain goals and objectives that CFSAN intends to achieve to improve food and cosmetic safety. You can read the 2013-2014 Plan for Program Priorities on the FDA’s website, available here. More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best…
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FDA Publishes Overview of Regulatory Requirements for Food Businesses

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On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA regulations. You can read the article here. As the FDA explains, the Public Health Security and Bioterrorism Preparedness and Response Act amended the FDCA to require that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where…
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FDA Actions Highlight New Authority under FSMA

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On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number of recalls spurred after Salmonella was discovered in the Company’s peanut processing facility. More information about the affected products and the ongoing action against Sunland, Inc. may be accessed here. After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing…
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