Since the Food Safety Modernization Act (FSMA) was signed into law in January 2011, the Food and Drug Administration (FDA) has published in the Federal Register nearly 800 pages of proposed regulations on the act’s implementation. As stated at the time it passed, the FSMA was the biggest change in food-safety regulations in the past 70 years. Analysis of the written proposals certainly hold true to those words.

The first two proposed rules for implementing FSMA were published by the FDA in January 2013, after a lengthy review and edit by the White House Office of Management and Budget. Before the end of 2013, six more FDA-proposed regulations were published on other parts of FSMA. In March 2014, the FDA published a lengthy proposed regulation on changing the Nutrition Facts labels on all food and dietary supplements.

Regulatory compliance professionals have had a major job of just reading the proposed regulations, determining the feasibility of the proposal and the impact on their food sector and company, and determining how they were going to comply. In some companies, this has become a full-time job for some individuals this past year.

This is an important part of the food business today, however. The FDA hasn’t cornered all of the expertise needed to put together an effective and workable food-safety regulation. Yet the FDA needs to fulfill its responsibility of protecting the nation’s consumers and the food industry from unscrupulous operators. In the end, we both have the same client: A safe consumer.

We are fortunate to live in a country where we can be a part of the regulatory process. The regulatory process provides everyone with an opportunity to voice comments and expertise on the proposed FDA rules to achieve that workable regulation. Thanks to those who have submitted comments; you have made a difference.

Look at the Proposed Rule on Sanitary Transportation of Human and Animal Food by May 31, 2014, and make comments if you see a problem with the proposal. Also, look for the FDA Proposed Updates to the Nutrition Facts Panel on labels of food and dietary supplements. This will affect all labels for these products. Consider what the economic impact will be to your company to implement a new label. Make such information known to the FDA through your comments, which you can submit as outlined in the March 3, 2014, Federal Register.

While compliance deadlines on these regulations maybe not be until late 2015 and 2016, you still need to continue your planning process now.


Author Gale Prince is founder and president of SAGE Food Safety Consultants, LLC, Cincinnati, which offers guidance and solutions to issues such as crisis management, food safety, regulatory compliance and quality assurance.