FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for May 2016

Posted on Friday, May 27 2016 at 8:52 pm by -

Today is the Day – Final Regulations on Nutrition and Supplement Facts Labels and Serving Sizes Officially Publish in the Federal Register

By: Carolina M. Wirth and Alyson L. Wooten, PharmD

Today, Friday, May 27, 2016, is the day that the new final regulations on Nutrition and Supplement Facts labeling will officially publish in the Federal Register.  The availability of advanced copies of the final regulations was announced last week by the Food and Drug Administration (FDA or agency).  The new regulations make changes to the content of the “iconic” Nutrition Facts panel found on packaged food labels today, as well as to the serving sizes of certain foods.  Both final regulations were initially published in a prepublication format with the final regulation regarding Nutritional Facts and Supplements Facts labeling totaling 943 pages (the formatted version is now a more manageable 259 pages), and the Serving Sizes final regulation totaling 170 pages (the now formatted version is a manageable 48 pages).[1]

The final regulations have an effective date of July 26, 2016, a compliance date of July 26, 2018 (for manufacturers with more than $10 million in annual food sales), and of July 26, 2019 (for manufacturers with less than $10 million in annual food sales).  The new regulations apply to virtually every packaged food that is manufactured in the United States, as well as those that are imported.


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