FDA Law Blog: FDA Issues Draft Guidance Regarding Menu Labeling Requirements

FDA Law Blog: FDA Issues Draft Guidance Regarding Menu Labeling Requirements

FDA Issues Draft Guidance Regarding Menu Labeling Requirements

Posted: 14 Sep 2015 07:47 PM PDT

By Riëtte van Laack & Etan J. Yeshua –

As we previously reported, when FDA announced a new compliance date for the menu labeling rule, it also announced that it would issue guidance.

On Friday, September 11, FDA issued the promised draft guidance.  The draft guidance is a mix of clarifications of the rule, and answers to certain questions.  Overall, the draft guidance appears to include little “new” information, though. A few noteworthy statements:

• The rule requires that covered establishments provide FDA, “within a reasonable period of time upon request,” with information substantiating nutrient values.  According to the draft guidance, FDA considers “4-6 week” a reasonable period of time to respond to such a request;
• If there is an inconsistency between declaration of nutrient values under the menu labeling rounding rules and under the TTB’s rounding rules for the voluntary Serving Facts on the label, covered establishments may use the value provided in the voluntary Serving Facts statement for an alcoholic beverage labeled consistent with TTB’s rather than with FDA’s rounding rules.
• The guidance includes a helpful table that lists types of establishments and identifies which establishments would and would not be considered “covered establishments.”  In response to questions, FDA clarifies that in-patient only food service facilities in hospitals and prisons are not covered establishments.  Also, complementary hotel breakfast buffets are not subject to the menu labeling rule.

The draft guidance is labeled as Part II.  FDA previously issued Part I.  However, that guidance is not available because the Agency is “revising this guidance document in order to make changes in light of FDA’s issuance of final rules.”  It is unclear when an updated version of Part I will be available.

Stakeholders would be well-advised to review the draft guidance and submit remaining questions.  FDA invites comments to the draft guidance but, at this time, has not provided a deadline for comments to be considered in finalizing the guidance.  In the constituent update, FDA indicates that it will consider updates to the guidance as needed.  Likely as a result of critical reviews of the final rule and the threat of amending legislation, the Agency states that it is “committed to working collaboratively with establishments covered by the menu labeling final rule , . . . now and in the future, to answer additional questions” and FDA will “work flexibly and cooperatively with individual companies making a good faith effort to comply.”  FDA also plans to provide “educational and technical assistance for covered establishments and for our state, local, and tribal regulatory partners to support consistent compliance nationwide.”