2016 Roundup: FDA And CFIA Food Regulations

By David Lennarz, Co-Founder & VP, Registrar Corp

2016 proved to be a landmark year for the FDA. The agency wrapped up the finalization of major rules under 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.

FSMA’s Sanitary Transportation Rule Becomes Final
In April, the 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 U.S. 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 Recognized as Comparable To The U.S.
In May, the FDA, the Canadian Food Inspection Agency (CFIA), 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 U.S. This means 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 Finalizes Changes To Food Labeling
On May 20, the 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.  

FSMA’s Intentional Adulteration Rule Becomes Final
On May 27, the FDA published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major FSMA rules. The 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.  

The FDA Finalizes Amendments To Food Facility Registration
In July, the 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 the 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, the 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.

The FDA Opens Up The Term "Healthy" For Discussion
In September, the 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. The 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 10 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.

About The Author
David Lennarz acts as vice president of Registrar Corp, an FDA consulting firm that helps companies comply with FDA regulation. Mr. Lennarz has worked for over 22 years in FDA-regulated industries in the U.S. and Europe. He has conducted seminars on U.S. Food and Drug Administration regulations for trade associations, trade shows, and governments in more than 30 countries around the world. He served as a Technical Expert for the FDA Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. He co-founded Registrar Corp in 2003. Mr. Lennarz can be reached by e-mail at dlennarz@registrarcorp.com.