Another Delay for Menu Labeling Enforcement
On May 1, 2017 FDA announced a year long delay of enforcement of menu labeling regulations that were to have become effective May 5, 2017. This is the third delay to regulations that applied to restaurants and other food service businesses with 20 or more outlets.
The Interim Final Rule, which will be published in the May 4, 2017 Federal Register gives several reasons for this delay,which I am excerpting as bullet points for your reading pleasure:
- “We are taking this action consistent with Executive Orders 13777, 13771, and 13563, as well as in response to the diverse and complex set of stakeholders affected by the rule and continued, numerous, and fundamental questions they raise regarding the final rule and its implementation.
- “The continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on these matters.
- “Retailers with many different and diverse business models have raised concerns about how the rule lacks flexibility to permit them to provide meaningful nutrition information to consumers given their type of business and different operations.
- “Moreover, we continue to receive many questions about calorie disclosure signage for self-service foods, including buffets and grab-and-go foods.
- “We do not want to proceed with a rule that might turn out to be too inflexible to support innovation in delivering information to consumers.
- “In addition, we have received questions regarding how to distinguish a menu, which requires the posting of calorie information, from advertisements and other marketing pieces, which do not require calorie information.
- “Many of these menu questions are complex and have highlighted for the agency the need for further consideration and clarification.
- “How to address the natural calorie variations for foods has also been raised by stakeholders as an issue that needs additional guidance and clarity.
- “Finally, some entities with certain business models have stated that they continue to have questions about what provisions of the final rule are applicable to them.
- “We believe questions like this still need to be addressed.”
Indeed. Many restaurant and grocery companies have worked hard and have gone to considerable expense to make sense of the regulation and have even undertaken extensive redesign of their menu boards to meet the now defunct deadline.
May 19, 2016: Menu Labeling Update
Early in May 2016 FDA published their long-awaited guidance on how to comply with menu labeling regulations. The enforcement date for menu labeling regulations is now set as May 5, 2017. The new guidance is in the form of Questions and Answers and appears to use many questions submitted by regulated restaurants. There is nothing in the guidance that makes the process magically easy but many specific circumstances are thoroughly addressed. I will highlight those I found unique, interesting or otherwise noteworthy:
- Prisons and executive dining rooms where the food is not ‘sold’ are not covered under the menu labeling regulations.
- Apps and links to websites may be used to provide the more complete nutrition information that must be available upon request as long as devices to use the apps and links are also available in the ‘covered establishment’/restaurant.
- Any advertising, flyer or even coupon that list a menu item and a price must include calorie information.
It is well known that the menu labeling regulations will require restaurants to list calorie and other nutrition information on alcoholic beverages even though the producers of beers, wines and spirits are not required to provide that information. FDA notes that the restaurants are responsible for determining what a ‘reasonable basis’ is for the caloric/nutrition values. The May 2016 guidance includes this question and answer pair on page 50:
“7.9 If nutrition information on certain alcoholic beverages, such as flavored liqueurs, cordials, ports, or champagne categories, are not available in USDA’s National Nutrient Database or other nutritional databases, how do I get nutrition information for these alcoholic beverages when TTB does not require nutrition labeling for products bearing no nutrition claims? If other databases are not available, is a covered establishment expected to undertake analytical testing?
Answer: As provided in the menu labeling final rule, there are several reasonable bases that can be used to determine calorie and other nutrient content of standard menu items. (See 21 CFR 101.11(c)) Determining calorie and other nutrient contents may require the use of more than one reasonable basis or a combination of two or more reasonable bases or other reasonable means. It is up to the covered establishment to determine the appropriate basis that it uses to determine nutrient values and that the basis is valid for the item and is complete and accurate.”
Two other scenarios are discussed in detail in the guidance and should be reviewed if they apply to your organization.
- For cafeterias, buffets and ‘watch and build’ customer lines, the serving size used to determine calories may be based on the utensil used if the utensil dispenses a uniform serving. However, if tongs or other imprecise utensils are used, the calories must be based on a common household measure, such as a cup or tablespoon or a unit of weight. The guidance gives the example of “200 calories per cup” or “150 calories per 4 ounces.”
- “Grab and go” items sold in grocery stores are to be treated as ‘restaurant foods’ with the calorie and nutrition information reflecting the contents of the entire package or the store could label the food as required for packaged foods.
All restaurants should carefully review the substantiation and certification requirements noted in the menu labeling guidance document (pages 42 -50). First, in addition to having a “reasonable basis” for determining the calorie and nutrient information, the values presented
“must be accurate and consistent with the nutrient values you determined using a reasonable basis. You must take reasonable steps to ensure that how you prepare your product (that is, the types and amounts of ingredients you use, the cooking process, temperatures, etc.) and how you serve your product (that is, the amounts of that item that are offered for sale in a typical serving) are the same as those used to determine the calorie and nutrient declarations. (21 CFR 101.11(c)(2))”
The values should be substantiated by
“keep[ing] records of how you arrive at your nutrient values for standard menu items being offered for sale at your covered establishment. FDA recommends that any such records should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment. Upon request and within a reasonable period of time, you must supply to FDA, information used to substantiate the required calorie and nutrient values that you use for your standard menu items listed on your menus, menu boards or on display, and for your written nutrition information. This information must include both the data and the method you used to derive these nutrient values, as specified in 21 CFR 101.11(c)(3). FDA considers a reasonable period of time to be about 4-6 weeks after the request is made.”
The following certifications are required:
- A statement that is signed and dated by a responsible individual who is employed at the covered establishment, its corporate headquarters, or parent entity who can verify that the information in the nutrient analysis is complete and accurate. (21 CFR 101.11(c)(3)(i)(F)) [This certification may cover multiple establishments—even the entire restaurant chain.]
- A statement that is signed and dated by a responsible individual employed at the covered establishment (such as, the manager of the establishment or someone designated by the establishment manager or owner that is also employed at the specific covered establishment) certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (such as the types and amounts of ingredients used, the recipe, and the cooking times and temperatures) and the amount of the standard menu item offered for sale are the same as that on which the nutrient values were determined. (21 CFR 101.11(c)(3)(i)(G)). For example, such a statement could read “I, (name of the responsible individual), certify that (name of the covered establishment) has taken reasonable steps to ensure that the recipe for (name(s) of standard menu item) that was used to determine the calorie declaration and other nutrient values was followed to prepare (name(s) of standard menu item). The ingredients were properly measured, the specified cook times and temperatures were followed, and the specified portion sizes were served to the customer.” Any other statement or format that includes the required information in 21 CFR 101.11(c)(3)(i)(G) would also be acceptable. [This certification only covers a single establishment/restaurant.]
These guidelines signal the dawn of a new day for the manager and kitchen staff at chain restaurants.
You may also be interested in reading about the new final rules on nutrition labeling, which become effective July 26, 2016 and will apply to the additional menu information restaurants must provide upon request.