FDA Revisions to the 2016 Nutrition Labeling Regulations

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FDA Revisions to the 2016 Nutrition Labeling Regulations

A nutrition labeling technical amendment was published in the Federal Register on Dec. 21, 2018, effective immediately. In this amendment, the FDA made some corrections and added clarifications to the 2016 Nutrition Facts and Supplement Facts labeling regulations.

What does this mean for ESHA software?

We have been expecting this amendment for some time. Basically, the document corrects some inconsistencies in the final 2016 regulations; CFR 101.9 (Nutrition Facts) and 101.36 (Supplement Facts). Corrections included fixing graphical errors in the labeling examples that the FDA provided, adding back the Fat regulations that were inadvertently deleted from the final regulations, revising some references, and adding a few clarifications. It is important to note that no new regulations were added. Upon reviewing the amendment, we have determined that ESHA software already implements the correct regulations.

A few highlights from the FDA technical amendment:

Corrected errors in the label graphics
We have been in close contact with the FDA since the release of the 2016 labeling regulations, especially when the regulation text did not match the graphic label examples. When the graphics and text do not match, we always side with the regulation text. In the technical amendment, inaccurate label graphic examples were corrected to reflect the text. So labels in our software continue to reflect the current FDA regulations.

Adding back the Fat regulations
CFR section 101.9 c2 of the final rule was missing sections i through iv that talked about saturated fat, trans fat, polyunsaturated fat, and monounsaturated fat. The technical amendment adds these sections back to the regulations. Since these regulations did not change from the 1990 labeling rules, we continued to use the 1990 rules for 2016 label creation. So the labels in our software continue to reflect the current FDA regulations.

  • Italicized “trans”
    The word “trans” may be italicized to indicate its Latin Origin. ESHA already provides that option, however, it is not mandatory.

Correcting the font size for Calories on the Supplement Facts label
CFR section 101.36e specified a larger font size for Calories on the Supplement Facts label. This was not consistent with other documentation at the time however and after clarifying with the FDA we did not implement this. The amendment removes mention of the larger font size for Calories. So the labels in our software continue to reflect the current FDA regulations.