FDA Extended Compliance Dates for Nutrition Facts Label Final Rules to 2020 and 2021

The U.S. Food and Drug Administration is proposing to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.

The FDA is not proposing any other changes to the Nutrition Facts Label and Serving Size final rules.

Written or electronic comments on the extension of the compliance dates are being accepted for 30 days, beginning on October 2, 2017. The FDA is only accepting comments on the extension of the compliance dates and not on the content of the Final Rules published in 2016.

Submit electronic comments to http://www.regulations.gov

The decision was cheered by the industry associations (GMA, Grocery Manufacturer Association), but not so appreciated by consumer’s groups and the CSPI (Center For Science in the Public Interest) which consider the move a danger for public health (added sugars won’t be visible until 2020…) and fear a lack of clarity on the market.

The new Nutrition Facts schemes can be already used on the labels and – in my daily experience – they are requested by many US retailers and importers to foreign clients: therefore, on this last issue, I am totally agree with the CSPI. A co-existence of two different Nutrition Facts schemes on the shelves for 3-4 years cannot help already confused consumers to clear their mind about nutrition information. It is an odd situation also for me that I am used to the convoluted EU legislation making process!

On the other hand, FDA guidance documents on the new labeling schemes will be most welcome in the meantime.

For Additional Information:

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule (Food defense)

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Here you can find also an FDA fact sheet on the final rule on food defense.

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration, on the contrary,  is addressed in the final preventive controls rules for human and animal foods.

We already treated food defense topic in a previous post regarding EU situation.