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2016 Round Up – U.S. FDA Food Regulations

2016 proved to be a landmark year for the U.S. Food and Drug Administration (FDA).  The agency wrapped up the finalization of major rules under the Food Safety Modernization Act (FSMA), as well as finalized long-awaited rules that mandate a complete overhaul of food and beverage labeling.  This article presents an overview of the past year in FDA regulations for food and beverage companies.

FDA Finalized the Sanitary Transportation Rule under FSMA

In April, FDA published its final rule for Sanitary Transportation of Human and Animal Food.  The Sanitary Transportation Rule was the sixth major rule to be finalized under FSMA.  The rule created requirements for shippers, loaders, carriers, and receivers of human and animal food transported by motor or rail vehicle within the United States to use sanitary practices to prevent contamination of food during transportation. Most covered businesses are required to comply by April 6, 2017.   Read here to learn about specific requirements of FDA’s Sanitary Transportation rule.

Canada’s Food Safety Systems were Recognized as Comparable to the US

In May, FDA, the Canadian Food Inspection Agency, and the Department of Health Canada signed a Food Safety Systems Recognition Arrangement.  Canada’s food safety systems are now recognized as providing public health protection comparable to those of the United States.  This means that facilities exporting from Canada and importers importing from Canada benefit from certain modifications and exemptions under FSMA.  For example, importers are exempt from the FSVP requirements of conducting a hazard analysis, approving and verifying suppliers, and conducting FSVP activities for their Canadian suppliers, so long as those suppliers are in good compliance standing with their country.

FDA Finalized Changes to Food Labeling

On May 20, FDA finalized two rules that mandate significant changes to labeling of food and beverages.  Changes range from cosmetic (i.e., a larger font size for calories and serving sizes) to new additions (i.e., adding a line for added sugars and adding vitamin D and potassium as listed nutrients) to data-driven (i.e., new daily value calculations for sodium, dietary fiber, and vitamin D).  Most facilities must comply by July 26, 2018.

FDA Finalized the Intentional Adulteration Rule under FSMA

On May 27, FDA published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major FSMA rules.  FDA’s Intentional Adulteration rule requires facilities registered with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility.  A facility’s Food Defense Plan must include a vulnerability assessment, mitigation strategies for each identified vulnerability, and a plan to continuously ensure proper and effective implementation of those strategies.  Most facilities are required to comply by May 2019.  Read here to learn more.

FDA Finalized Amendments to Food Facility Registration

In July, FDA published a final rule in an effort to improve the accuracy of the agency’s registration database.  The rule, titled “Amendments to Registration of Food Facilities”, made numerous changes to FDA’s registration requirements and codified some rules that were implemented upon the enactment of FSMA (i.e., registration renewal requirements and inspection permissions).  Some amendments were immediate, such as updates to product and activity categories. Others do not take effect until 2020.  In January 2020, FDA will require food facilities to submit their registrations electronically, and in October 2020, FDA will require facilities to list Unique Facility Identifiers (UFI) in their registrations.  Read here to learn more.

FDA Opened Up The Term “Healthy” For Discussion

In September, FDA published a request for information regarding the term “healthy”.   The decision was sparked by the agency’s desire to reflect current nutrition science as well as petitioning by industry.  FDA is accepting comments through January 26, 2017.  Until the agency lands on a new definition, it is using enforcement discretion to allow manufacturers to use the term “healthy” to describe products that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

These are but some highlights in a busy year for FDA food industry regulators.  Registrar Corp will continue to work to keep industry updated through 2017.  For assistance with U.S. FDA regulations, contact Registrar Corp by phone at +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This blog was originally published as an article in Food Online.