[Federal Register Volume 60, Number 181 (Tuesday, September 19, 1995)]
[Notices]
[Pages 48516-48518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23242]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0293]


Guide to Food Labeling Regulations Implementing the Nutrition 
Labeling and Education Act of 1990; Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Food Labeling, Questions and 
Answers Volume II; A Guide for Restaurants and Other Retail 
Establishments'' that addresses various questions concerning the 
regulations that FDA issued to implement the Nutrition Labeling and 
Education Act of 1990 (the 1990 amendments). The agency has received a 
large number of inquiries about how these final rules are being 
implemented in restaurants and other retail establishments, and it has 
prepared ``Food Labeling, Questions and Answers Volume II; A Guide for 
Restaurants and Other Retail Establishments'' to respond generally to 
many of the questions that it has received. Answers to some of the most 
frequently asked questions are included as an appendix to this notice. 
This document is intended to facilitate compliance with the new rules.

DATES: Written comments may be submitted at anytime.

ADDRESSES: Copies of the document ``Food Labeling, Questions and 
Answers Volume II; A Guide for Restaurants and Other Retail 
Establishments'' will be available from the Superintendent of 
Documents, U.S. Government Printing Office, Washington, DC 20402, 202-
512-1800. Please request order No. 017-012-00374-5. Submit written 
comments on ``Food Labeling, Questions and Answers Volume II; A Guide 
for Restaurants and Other Retail Establishments'' to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. ``Food Labeling, Questions and Answers Volume II; A Guide for 
Restaurants and Other Retail Establishments'' and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:  FDA has received a number of inquiries from 
industry, consumers, and others concerning how the regulations it has 
adopted, implementing the Nutrition Labeling and Education Act of 1990 
(the 1990 amendments) apply to retail Food establishments, including 
restaurants. FDA has prepared a document entitled ``Food Labeling, 
Questions and Answers Volume II; A Guide for Restaurants and Other 
Retail Establishments'' to serve as general guidance on the 
regulations. This document provides answers to many of the questions 
that the agency has received. Answers to some of the most frequently 
asked questions are included as an appendix to this notice.
    ``Food Labeling, Questions and Answers Volume II; A Guide for 
Restaurants and Other Retail Establishments'' is intended only to be 
guidance to facilitate compliance with the regulations. It does not 
bind the agency, nor does it create or confer any rights, privileges, 
or benefits for or on any person. While ``Food Labeling, Questions and 
Answers Volume II; A Guide for Restaurants and Other Retail 
Establishments'' represents the best advice of FDA, it does not have 
the force and effect of law. The interpretations presented herein are 
obviously subject to the requirements of law both in the statute and in 
the regulations.
    Interested persons may, submit written comments on ``Food Labeling, 
Questions and Answers Volume II; A Guide for Restaurants and Other 
Retail 

[[Page 48517]]
Establishments'' to the Dockets Management Branch (address above). FDA 
will consider these comments in determining whether revisions to the 
document are warranted. Two copies of any comments should be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The document and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

Appendix--Food Labeling: Questions and Answers, Volume II; A Guide for 
Restaurants and Other Retail Establishments-- Sample Questions

     The Guide presents answers to a range of questions, including 
questions about the application of exemptions and other special 
labeling provisions in restaurants, about the format for nutrition 
labeling when it is required, and about other issues concerning the 
nutrition labeling of retail foods. The Guide also responds to 
questions about the use of nutrient content claims and health claims 
on restaurant and other retail foods. It explains how to determine 
whether there is a reasonable basis for a claim, what foods to use 
as reference foods, and how to determine reference amounts.

Sample Questions

     Question: How does FDA define ``restaurants''?
    Answer: ``Restaurants'' include conventional full service 
restaurants and other establishments where food is sold for 
immediate, on-site consumption (e.g., institutional food service, 
delicatessens, and catering where there are facilities for immediate 
consumption on the premises) and establishments where foods are 
generally consumed immediately where purchased or while walking away 
(e.g., lunch wagons, cookie counters in a mall, and vending machines 
including similar foods sold from convenience stores); and food 
delivery systems or establishments where ready-to-eat foods are 
delivered to homes or offices for immediate consumption.
    Question: If a restaurant makes a claim for one item, does it 
need to provide nutrition information for all the foods it serves?
     Answer: No. The exemptions from nutrition labeling set out in 
Secs. 101.9(j)(2)(i) through (iii) apply to individual food items 
that are served or sold in a restaurant or similar establishment, 
not to the establishment. A restaurant need only provide nutrition 
information for those items that bear a claim. The restaurant may 
voluntarily provide nutrition information for foods that do not bear 
a claim.
     It should be noted that the January 6, 1993, final regulations 
implementing the NLEA currently apply to all forms of restaurant 
labeling except for menus. Thus, a claim on a menu does not trigger 
FDA's nutrition labeling or claims requirements. However, States are 
not prohibited from enforcing these requirements with respect to 
menus. Furthermore, in the Federal Register of June 15, 1993 (58 FR 
33055), FDA published a proposal to remove the exemption for claims 
on menus. Should the agency publish a final regulation deleting the 
menu exemption, the requirements discussed herein for non-menu 
labeling (e.g., signs, posters, placards, brochures, banners, etc.) 
will apply to all forms of labeling, including menus.
    Question: A restaurant serves a food that is commercially 
manufactured and packaged and labeled. The food is served to 
consumers in the form it was purchased by the restaurant, e.g., 
individual serving size packages of condiments are placed in a bowl 
for consumer use. Would FDA hold the restaurant that serves the food 
responsible if the label of the food does not meet FDA's 
requirements, for example, if a package of salad dressing bears a 
``lowfat'' claim but fails to bear nutrition information?
    Answer: FDA requires that the label of a food sold in packaged 
form identify conspicuously the name and place of business of the 
manufacturer, packer, or distributor (Sec. 101.5). The firm that is 
so identified is generally the firm that is responsible for insuring 
that the food is properly labeled.
    Question: Does a restaurant have to use the Nutrition Facts 
format to provide nutrition information for a food that bears a 
claim?
    Answer: No. FDA is not requiring full nutrition labeling for 
restaurant foods, nor is it requiring that nutrition information be 
presented in the Nutrition Facts format. Because restaurant foods 
tend to be prepared or sold differently from foods from other 
sources, FDA is providing flexibility for restaurants in how they 
determine the nutrient content of a food (e.g., using a cookbook, 
reliable nutrient data base, or other reasonable bases) and in how 
this information may be presented to consumers. Information on the 
nutrient amounts that are the basis for the claim (e.g., ``low fat, 
this meal provides less than 10 grams of fat'') may serve as the 
functional equivalent of complete nutrition labeling (Sec. 101.10).
    Question: Does nutrition information have to appear on the same 
labeling that bears the claim?
    Answer: No. Nutrition information for restaurant foods may 
appear on the same or different labeling from that which bears the 
claim. Nutrition information may be presented in various forms, 
including those specified in Sec. 101.9 (Nutrition Facts), 
Sec. 101.45 (e.g., displayed at point of purchase by an appropriate 
means, such as affixing it to the food, by posting a sign, or by 
making the information readily available in a brochure, notebook, or 
leaflet, in close proximity to the foods), and by other reasonable 
means, such as orally by waiters or waitresses. (The agency notes, 
however, that to ensure that the information is presented accurately 
by waitpersons the nutrition information should also be maintained 
in written form by the restaurant management.)
    Question: When making a claim for a food, does a restaurateur 
have to have the food that bears the claim analyzed by a lab to 
determine its nutrient content?
    Answer: No. A restaurant food may bear a nutrient content claim 
or health claim if the restaurateur has a ``reasonable basis'' for 
believing that the food meets the definition for the claim. If a 
restaurateur labels a food ``low fat,'' for example, he or she must 
have a reasonable basis for believing that the food complies with 
FDA's definition for ``low fat,'' i.e., that it contains no more 
than 3 g of fat per reference amount customarily consumed or, in the 
case of meals and main dishes, no more than 3 g of fat per 100 g.
      Question: Will FDA require prior approval for labeling that 
bears a claim?
    Answer: No. FDA does not have the authority to require prior 
approval of restaurant labeling that bears a nutrient content claim, 
health claim, or other nutrition information.
    Question: Will restaurants be required to have claim bearing 
foods ``certified'' by a third party or an independent dietary 
professional?
    Answer: No. FDA has provided broad flexibility in establishing 
the ``reasonable basis'' criterion for restaurant foods. Thus, while 
some restaurateurs may choose to work with a third party to modify 
recipes or revise labeling, there is no requirement to do so. 
Restaurants should be able to make their own determinations once 
they are familiar with the claims requirements.
    Question: Many food service items are partially or wholly 
processed when they are purchased for use in a restaurant or similar 
establishment. Thus, it is difficult for the restaurant to keep 
track of the sodium content of foods. It may also be difficult for a 
restaurant to monitor the use of sodium in the cooking process and 
to develop recipes for ``low sodium'' foods that taste good. How 
will these problems be addressed in implementing the new 
requirements?
    Answer: FDA does not intend to impose an unrealistic regime 
(e.g., to require exacting measurements or strict portion controls) 
in restaurants. However, the agency is requiring that a restaurant 
have a reasonable basis for believing that a food meets the nutrient 
requirements for a claim, and that it be able to provide reasonable 
assurance that the preparation of the food adheres to the basis for 
the claim. If a restaurateur has no knowledge of, or control over, 
the sodium content of a food, or some other aspect of its nutrient 
content, he/she should not attempt to make a sodium content or other 
claim about the nutrient levels in that food.
    Question: What is a ``reference amount''? Do restaurants need to 
alter their serving size to be equal to the reference amount?
    Answer: The reference amount or reference amount customarily 
consumed (RACC) is the amount of a food item customarily consumed 
per eating occasion as determined by FDA for the purpose of 
establishing realistic and consistent serving sizes for use in food 
labeling. Reference amounts for 139 different food categories are 
set out in 21 CFR 101.12. (Reference amounts for meat and poultry 
products are listed in 9 CFR 317.312.)
    Restaurants do not need to alter the size of the portions they 
serve to be the same as the reference amount, nor does the serving 
size used in the labeling for a particular food need to be the same 
as the reference amount. However, in order to make certain nutrient 
content claims or health claims, an 

[[Page 48518]]
individual food must meet the definition for the claim based on the 
amount of the subject nutrient in an amount of the food equal to its 
reference amount, e.g., a ``low fat'' food may contain up to 3 grams 
of fat per reference amount. When a food's reference amount is small 
(i.e., 30 g or less or 2 tablespoons or less), the food (e.g., a 
sauce or condiment) must also meet the requirements for the claim 
based on its nutrient content per 50 grams.
    Question: Must a restaurant develop recipes for, analyze, and 
market, a reference food for every food that bears a relative claim?
    Answer: No. The reference food may be the restaurant's regular 
product, or that of another restaurant, that has been offered for 
sale to the public on a regular basis for a substantial period of 
time. Nutrient values for a reference food may also be derived from 
such sources as a valid data base, an average of top national or 
regional brands, or a market basket norm (Sec. 101.13(j)(1)(ii)).

    Dated: September 14, 1995
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23242 Filed 9-18-95; 8:45 am]
BILLING CODE 4160-01-F