[Federal Register Volume 62, Number 155 (Tuesday, August 12, 1997)]
[Rules and Regulations]
[Pages 43071-43075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21156]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 730

[Docket No. 96N-0174]
RIN 0910-AA69


Food and Cosmetic Labeling; Revocation of Certain Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is revoking certain 
regulations that are obsolete. These regulations have been identified 
for revocation as the result of a page-by-page review of the agency's 
regulations. This review is in response to the Administration's 
``Reinventing Government'' initiative which seeks to streamline 
Government to ease the burden on regulated industry and consumers.

DATES: This final rule will become effective September 11, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Felicia B. Satchell, 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: 

I. Background

    On March 4, 1995, President Clinton announced plans for the reform 
of the Federal regulatory system as part of the Administration's 
``Reinventing Government'' initiative. In his March 4 directive, the 
President ordered all Federal agencies to conduct a page-by-page review 
of all of their regulations to ``eliminate or revise those that are 
outdated or otherwise in need of reform.''
    In response to this directive, FDA has revoked a number of 
regulations through notice and comment rulemaking (e.g., 61 FR 58991, 
November 20, 1996; 61 FR 27771, June 3, 1996) and issued proposals to 
revoke additional regulations (e.g., 60 FR 53480, October 13, 1995; 60 
FR 56513 and 56541, November 9, 1995; and 61 FR 29708, June 12, 1996). 
FDA has also issued two advance notices of proposed rulemaking to 
review standards of identity and other existing regulations to 
determine whether these regulations should also be considered for 
revocation or revision (e.g., 60 FR 67492, December 29, 1995; and 61 FR 
29701, June 12, 1996). This document responds to comments submitted to 
its proposal entitled ``Food and Cosmetic Labeling; Revocation of 
Certain Regulations; Opportunity for Public Comment,'' which published 
in the Federal Register of June 12, 1996 (61 FR 29708) (hereinafter 
referred to as the June 12 revocation proposal).
    FDA received 11 letters in response to the June 12 revocation 
proposal. Each letter contained one or more comments. The letters were 
from industry trade associations, academia, and consumer organizations. 
Some comments supported various provisions of the proposal. Other 
comments objected to the revocation of certain regulations. A summary 
of the comments and the agency's responses to the comments follow.

II. Food Labeling Regulations

A. Information Panel of Package Form Food (Sec. 101.2)

    This regulation, in paragraph (a), defines the term ``information 
panel'' as it applies to packaged food, and in paragraph (b) provides 
that all information required to appear on the label of any package of 
food under certain referenced regulations shall appear either on the 
principal display panel or on the information panel, unless otherwise 
specified in the regulations. The referenced regulations are in part 
101 (21 CFR part 101) and part 105 (21 CFR part 105) and are as 
follows: Sec. 101.4 Food; designation of ingredients, Sec. 101.5 Food; 
name and place of business of manufacturer, packer, or distributor, 
Sec. 101.8 Labeling of food with number of servings, Sec. 101.9 
Nutrition labeling of food, Sec. 101.12 Reference amounts customarily 
consumed per eating occasion, Sec. 101.13 Nutrient content claims 
general principles, Sec. 101.17 Food labeling warning and notice 
statements, subpart D of part 101, Specific Requirements for Nutrient 
Content Claims, and Part 105--Foods for Special Dietary Use. Section 
101.2(c) requires that information required by the referenced 
regulations be in letters or numbers of at least one-sixteenth inch in 
height, unless otherwise exempted by regulation. However, Sec. 101.2(c) 
also contains exemptions to this type-size requirement. FDA tentatively 
concluded in the June 12 revocation proposal that several of the 
exemptions are now obsolete and should be revoked.
1. Exemptions for Small Packages
    Specifically, FDA proposed to revoke Sec. 101.2(c)(1), (c)(2), and 
(c)(3). The exemptions set out in these paragraphs are for small 
packages (defined according to the surface area available to bear 
labeling) and were established before the enactment of the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). As fully discussed in the June 12 revocation proposal, these 
exemptions were designed to encourage firms to voluntarily provide 
nutrition information in accordance with Sec. 101.9 and a full list of 
ingredients in accordance with the regulations in part 101, which was 
voluntary on some standardized foods before the enactment of the 1990 
amendments. However, as a result of the 1990 amendments, nutrition 
labeling and full ingredient labeling is now required on most foods, 
and the agency has made specific provision for flexibility in the 
presentation of this information where space is limited.
    For these reasons, the agency tentatively concluded in the June 12 
revocation proposal that the exemptions in Sec. 101.2(c)(1), (c)(2), 
and (c)(3) were now obsolete and should be revoked. Also in that 
document, FDA solicited comments on the need to retain any of these 
exemptions and stated that comments supporting retention of any of 
these exemptions should include information on specific products for 
which other type size exemptions are inadequate.
    1. Two comments addressed the proposed revocation of 
Sec. 101.2(c)(1), (c)(2), and (c)(3). One of these comments supported 
revocation of the exemptions.

[[Page 43072]]

 The other comment opposed revocation of the exemptions and disagreed 
with the rationale the agency presented in the proposal for revoking 
them. The comment contended that nutrition labeling has been mandatory 
for many food products since the early 1970's, often because of the 
addition of a nutrient or use of a nutrition claim. Further, the 
comment argued that the impact of making the disclosure of ingredients 
in standardized food mandatory rather than voluntary has been 
exceedingly small. The comment also pointed out that the type size 
exemptions issued under the 1990 amendments apply only to nutrition 
labeling and not to the other mandatory label information, such as 
ingredient labeling. Consequently, the comment argued, unless the 
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) are retained, 
mandatory information other than nutrition labeling will be required to 
appear in one-sixteenth inch type, even where this cannot realistically 
be accomplished. The comment urged the agency to retain the type-size 
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3).
    The agency has not been persuaded by the latter comment that the 
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) should be retained. 
The comment did not provide any information, as requested in the June 
12 revocation proposal, on specific products for which the other type 
size exemptions provided in FDA's regulations (e.g., Sec. 101.2(c)(5)) 
are inadequate. Nor did the comment point to any specific products that 
could not realistically bear the mandatory information in one-sixteenth 
inch type. Furthermore, the agency has not been presented with 
information suggesting that revocation of these exemptions would cause 
an economic burden on the industry because of the need to redesign 
packaging or print new labels. In the absence of such information, and 
for the reasons cited in the proposal, the agency concludes that the 
exemptions are now obsolete. Accordingly, FDA is revoking 
Sec. 101.2(c)(1), (c)(2), and (c)(3), as proposed.
2. Nonretail Individual Serving Size Packages
    Section 101.2(c)(5) provides that individual serving size packages 
of food served with meals in restaurants, institutions, and on board 
passenger carriers, and not intended for sale at retail, are exempt 
from the type-size requirements of Sec. 101.2(c) under certain 
described conditions. Because declaration of all ingredients in 
standardized foods is now required, reference to Sec. 101.6 is no 
longer appropriate. Consequently, FDA proposed to revise Sec. 101.2 by 
revoking paragraph (c)(5)(iii).
    2. The comments addressing this issue supported revocation of 
Sec. 101.2(c)(5)(iii). Accordingly, FDA is revoking 
Sec. 101.2(c)(5)(iii) and redesignating paragraph (c)(5)(iv) as 
paragraph (c)(5)(iii). The agency points out that revocation of 
existing Sec. 101.2(c)(5)(iii) would not eliminate any ingredient 
listing requirements for nonretail individual serving size packages 
because this proposal does not pertain to any provisions of Sec. 101.4.

B. Labeling of Foods With Number of Servings (Sec. 101.8)

    The regulation in Sec. 101.8(a) requires, among other things, that 
any package of a food that bears a representation as to the number of 
servings contained in the package bear in immediate conjunction with 
such statement, and in the same size type as is used for such 
statement, a statement of the net quantity (in terms of weight, 
measure, or numerical count) of each such serving. However, the latter 
statement may be expressed in terms that differ from the terms used in 
the required statement of net quantity of contents (for example, cups, 
tablespoons) when such differing term is common to cookery and 
describes a constant quantity.
    FDA tentatively concluded in the June 12 revocation proposal that 
this regulation was obsolete in light of the mandatory nutrition 
labeling provisions in Sec. 101.9. As discussed in the June 12 
revocation proposal, Sec. 101.9 defines a ``serving'' or ``serving 
size'' for the purpose of nutrition labeling as the amount of food, 
expressed in a common household measure that is appropriate for the 
food, customarily consumed per eating occasion by persons 4 years of 
age and older. Section 101.9 also gives guidance for determining 
serving size when the food is specially formulated or processed for use 
by infants or by toddlers. Thus, FDA proposed to revoke Sec. 101.8.
    3. All of the comments responding to this issue agreed that FDA's 
regulations governing mandatory nutrition labeling of foods which, in 
Sec. 101.12, establish serving sizes for foods based on the reference 
amounts customarily consumed per eating occasion, render the provisions 
in Sec. 101.8 obsolete. Accordingly, as proposed, FDA is revoking 
Sec. 101.8. FDA advises, however, that manufacturers are expected to 
continue to adhere to its guidance that statements concerning the 
number of servings in a package that are presented in locations other 
than as part of the nutrition information be in the same terms as those 
that are used to express the serving size as part of the nutrition 
information. To do otherwise may render the labeling information 
misleading to consumers.
    To conform its regulations to the revocation of Sec. 101.8, FDA is 
removing the reference to Sec. 101.8 in Sec. 101.2(b) and (f).

C. Labeling of Kosher and Kosher-Style Foods (Sec. 101.29)

    Section 101.29 of FDA's regulations is a statement of informal 
agency policy regarding the use of the terms ``kosher'' and ``kosher-
style'' in the labeling of food products. Because this section only 
provides guidance and was not established through rulemaking, it does 
not have the force and effect of law. Furthermore, because the use of 
the terms ``kosher'' and ``kosher-style'' is, in fact, governed under 
the general misbranding provisions of the act, FDA proposed in the June 
12 revocation proposal to remove this section. In addition, the agency 
solicited comments on whether it should prepare a Compliance Policy 
Guide (CPG) (an FDA informal guidance document used for efficient 
enforcement of the act) that reflects the policy that has been codified 
in Sec. 101.29.
    4. Six comments addressed the proposed revocation of Sec. 101.29. 
Two of these comments supported the removal of Sec. 101.29. Both 
comments noted that FDA has not traditionally sought to regulate kosher 
food labeling. These comments opined that religious authorities are 
well-equipped to police the use of ``kosher'' and other religious 
terminology in food labeling. Furthermore, these two comments 
questioned the constitutionality of any FDA action in this area. 
Finally, the comments urged that the agency not republish Sec. 101.29 
or any other policy regarding kosher labeling as a CPG.
    Several other comments supported maintaining a written policy on 
the use of these terms. These comments contended that it is appropriate 
for the agency to concern itself with the proper use of the terms 
``kosher'' and ``kosher-style'' on food labels because without such 
guidance, the potential for misuse of these terms would undoubtedly 
increase, resulting in significant consumer deception. Two of these 
comments supported retaining this policy in the form of a CPG. Further, 
one comment suggested that even as a CPG, Sec. 101.29 did not go far 
enough in providing guidance to the industry or in providing adequate 
information to the consumer. Accordingly, the comment requested that as 
a part of a CPG, FDA create and maintain a certificate for

[[Page 43073]]

domestic and imported products that contains information regarding the 
manufacturer, certifying Rabbi and organization, effective dates of the 
certificate, and symbols used in product labeling. The comment opined 
that such a certificate, publicly available upon request, could greatly 
assist consumers in deciding whether the food in question meets their 
personal needs, because they would have access to information 
identifying not only the manufacturer but also the certifying 
organization. The comment further suggested that having a certificate 
on file could reduce difficulties currently experienced by persons 
wishing to import kosher products into the United States.
    Another comment argued that the proper course for FDA is not to 
remove from the Code of Federal Regulations (CFR) its only 
pronouncement on kosher labeling but to assume a higher profile and 
initiate rulemaking that explicitly states its enforcement authority 
with regard to use of the terms ``kosher'' and ``kosher-style,'' 
thereby providing the kosher food consumer with effective and 
meaningful protection. The comment contended that such action was 
needed because misbranding of kosher foods is not uncommon. The comment 
further argued that such a regulation should prohibit the use of 
``kosher-style'' on all food items, whether or not they conform to 
religious dietary standards. The comment stated, however, that if FDA 
would not prohibit the use of the term ``kosher-style,'' then FDA 
should establish a regulation consistent with the U.S. Department of 
Agriculture's (USDA's) policy and allow use of the term ``kosher-
style'' only when the product is produced under ``rabbinical 
supervision.'' A second alternative suggested by the comment to 
prohibiting the term is to permit the term but require that the product 
label also bear a disclaimer if the product does not conform to 
religious dietary standards. The comment argued that such a regulation 
is necessary to adequately protect the kosher consumer and to reduce 
the potential for misbranding, fraud, error, and confusion as the 
kosher food industry grows.
    FDA has evaluated the comments and finds that, while there is 
support for maintaining specific guidance on use of the terms 
``kosher'' and ``kosher-style,'' FDA is not persuaded by the comments 
that such guidance should be retained in the CFR. The comments 
presented no compelling reason why this statement of policy should not 
be converted to a CPG, the form in which most agency policy statements 
are maintained. The goal of the President's Initiative is to develop a 
more efficient regulatory regime, and that goal is advanced by 
minimizing the number of policy statements in the CFR.
    Nor have the comments persuaded the agency that a rulemaking on the 
use of the terms ``kosher'' and ``kosher-style'' is warranted. The use 
of the terms ``kosher,'' ``kosher-style,'' and any other term 
suggesting that a food has been prepared in accordance with certain 
religious practices is subject to the general misbranding provisions of 
section 403(a) of the act (21 U.S.C. 343(a)). Aside from providing this 
basic level of protection, FDA has no role in determining what food is 
kosher.
    In light of the issues raised in the comments, however, the agency 
is concerned that if it did not maintain some statement on kosher 
labeling, there would be confusion and misinformation in the kosher 
food industry, which could result in a proliferation of misbranded 
products, and thus consumers could be adversely affected. Therefore, 
FDA will maintain a statement of its policy on labeling foods that 
conform to religious dietary laws but do so through the use of a CPG.
    Accordingly, FDA is revoking Sec. 101.29 as proposed. It intends to 
prepare a CPG in accordance with the Good Guidance Principles published 
in the Federal Register of February 27, 1997 (62 FR 8961). In 
developing the CPG, the agency will fully consider the alternatives 
suggested in the comments and will provide an opportunity for comment. 
The agency believes that this approach will provide the kosher food 
industry with the guidance needed to minimize false or misleading 
labels.

III. Cosmetic Regulations

    Parts 710 and 720 (21 CFR parts 710 and 720) of FDA's regulations 
provide for the Voluntary Cosmetic Reporting Program (VCRP) under which 
cosmetic firms voluntarily register cosmetic product establishments 
(part 710) and cosmetic product ingredient and raw material composition 
statements (part 720). Part 730 (21 CFR part 730) provides for the 
voluntary filing of cosmetic product experience reports (VCPE) by the 
cosmetics industry.
    During the 23 years the VCPE has been in place, companies have 
submitted information about adverse reactions that consumers have 
reported to them. FDA has performed a statistical assessment of the 
data to calculate the ``baseline'' adverse reactions (expected number 
of reactions per million units distributed) that occur for the 
different cosmetic product categories identified in the program.
    While the VCPE has provided useful information regarding relative 
adverse reaction baseline rates, it has suffered from some serious 
limitations. As fully discussed in the June 12 revocation proposal, 
this program no longer provides any new information about cosmetic 
adverse reactions, and it no longer serves the important purpose of 
helping to find harmful cosmetics and to remove them from the 
marketplace. Thus, FDA proposed to revoke part 730. However, the agency 
solicited comments on whether this section should be eliminated in its 
entirety, reduced in scope, or some other alternative.
    5. Three comments addressed the proposed revocation of part 730. 
Two comments supported the proposal to revoke this part in its 
entirety. One comment suggested, however, that FDA replace the 
voluntary program by: (1) Enhancing its MEDWATCH program to include 
cosmetic adverse reactions; (2) referring consumers with adverse 
reactions directly to the cosmetic company; and (3) maintaining a 
process for voluntary industry analysis of product experience and 
reporting of any serious reactions to FDA.
    The third comment asserted that, although the VCPE program had 
failed, part 730 should not be revoked but completely revised to 
require cosmetic companies to file with FDA all consumer adverse 
reaction reports. The comment suggested that a mandatory reporting 
system would provide data that would be useful in increasing the safety 
of cosmetics and protecting the public health. Further, the comment 
recommended that FDA mandate the registration of cosmetic manufacturing 
establishments and product formulations, continue with the 
establishment of a toll-free telephone hotline for consumers to report 
adverse reactions, and enhance its MEDWATCH program to include cosmetic 
products.
    The agency rejects the assertion in the latter comment that the 
VCPE has failed. During the years that this program has been in effect, 
it has provided FDA with useful information and data. Using these data, 
FDA has been able to establish baseline adverse reaction rates. Thus, 
the function for which the program was intended has been achieved, and 
from the point of view of establishing a baseline level, any further 
data would be of little value. The comment has not persuaded the agency 
to change this view. Accordingly, FDA is revoking part 730 in its 
entirety.
    However, the agency recognizes that there may be some merit to the 
other arguments made in this and another comment. As suggested by one

[[Page 43074]]

comment, the agency will consider enhancing its MEDWATCH program to 
include cosmetic products and will maintain the availability of adverse 
reaction reporting forms, which may be submitted to the agency. 
Further, FDA intends to perform a thorough evaluation of the cosmetic 
adverse reaction information that it has received over the years and to 
prepare an indepth report that will be useful to both the cosmetic 
industry and the public in understanding adverse reaction trends for 
different product categories and the baseline rates of adverse 
reactions. However, the comment did not provide a factual basis for 
making an adverse reaction reporting system or a registration system 
mandatory for cosmetics.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) and (a)(8), 
respectively, that the actions to revoke or revise several food 
labeling regulations in part 101 and to eliminate or modify part 730 of 
the cosmetic regulations are of a type that do not individually or 
cumulatively have a significant effect on the environment. Therefore, 
neither an environmental assessment nor an environmental impact 
statement is required.

V. Benefit-Cost Analysis

    FDA has examined the economic implications of this final rule as 
required by Executive Order 12866. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). Executive Order 12866 classifies a 
rule as significant if it meets any one of a number of specified 
conditions, including: Having an annual effect on the economy of $100 
million; adversely affecting some sector of the economy in a material 
way; adversely affecting jobs or competition; or raising novel legal or 
policy issues.
    In the proposal, FDA based the economic impact analysis on the 
effects of revoking the following: Certain type-size exemptions, 
labeling with number of servings other than as specified in the 1990 
amendments, the statement of informal agency policy regarding the terms 
``kosher'' and ``kosher-style,'' and the Voluntary Cosmetic Experience 
Program. None of the comments on the proposal directly addressed the 
economic impact analysis. The one comment that opposed revocation of 
the current minimum type-size exemptions did not mention costs 
directly, but implied (``can not realistically be accomplished'') that 
the revocation could impose additional labeling costs for some 
products. The net effect of revoking the type-size and serving-size 
exemptions will be to reduce compliance costs for businesses. In the 
absence of evidence that the revocation would impose significant 
labeling costs, the agency has not altered its conclusion that the net 
economic benefits of this final rule are positive.
    FDA finds that this final rule does not constitute a significant 
rule as defined by Executive Order 12866. Furthermore, it has been 
determined that this final rule is not a major rule for purposes of 
Congressional Review (Pub. L. 104-121).

VI. Small Business Analysis

    FDA has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities.
    No comments dealt with the proposal's statement that the rule would 
not have a significant impact on a substantial number of small 
businesses. One comment that came from an organization representing 
entrepreneurial cosmetic firms supported terminating the Voluntary 
Cosmetic Experience Program. The comment agreed with the agency's 
conclusion that the program's benefits had already been realized. 
Terminating the program will impose no costs on participating small 
firms.
    Although it is possible that revoking the type-size exemptions 
could impose costs on some small entities, the reduced costs of 
interpreting labeling regulations and determining how they apply to 
individual products will more likely, if anything, reduce the costs of 
labeling for small entities. The removal of the kosher and kosher-style 
labeling guidance, because it is a guidance, will impose no additional 
costs on small entities.
    FDA finds that under the Regulatory Flexibility Act, this final 
rule will not have a significant economic impact on a substantial 
number of small entities. Accordingly, under the Regulatory Flexibility 
Act (5 U.S.C. 605(b)), the Commissioner of Food and Drugs certifies 
that this final rule will not have a significant economic impact on a 
substantial number of small entities.

VII. The Paperwork Reduction Act of 1995

    In the June 12 revocation proposal, FDA solicited comment on 
whether the proposed rule to revoke certain regulations that the agency 
believes are obsolete imposes any paperwork burden. FDA did not receive 
any comments on this issue. Thus, FDA concludes that this final rule 
contains no reporting, recordkeeping, labeling, or other third party 
disclosure requirements. Thus there is no ``information collection'' 
necessitating clearance by the Office of Management and Budget.

List of Subjects

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 730

    Cosmetics, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
101 and 730 are amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:
    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).


Sec. 101.2  [Amended]

    2. Section 101.2 Information panel of package form food is amended 
in paragraphs (b) and (f) by removing the reference to Sec. 101.8; by 
removing paragraphs (c)(1) through (c)(3) and paragraph (c)(5)(iii); by 
redesignating paragraph (c)(5)(iv) as paragraph (c)(5)(iii); and by 
redesignating paragraphs (c)(4) and (c)(5) as paragraphs (c)(1) and 
(c)(2), respectively.


Sec. 101.8  [Removed]

    3. Section 101.8 Labeling of food with number of servings is 
removed.


Sec. 101.29  [Removed]

    4. Section 101.29 Labeling of kosher and kosher-style foods is 
removed.

PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES

PART 730--[REMOVED]

    5. Part 730 is removed.


[[Page 43075]]


    Dated: July 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-21156 Filed 8-11-97; 8:45 am]
BILLING CODE 4160-01-F