[Federal Register: January 21, 1999 (Volume 64, Number 13)]
[Proposed Rules]
[Page 3250-3255]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja99-17]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 98N-0826]
 
 
Food Labeling: Use on Dietary Supplements of Health Claims Based
on Authoritative Statements
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Proposed rule.
 
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SUMMARY: The Food and Drug Administration (FDA) is proposing to permit
the use on dietary supplements
 
[[Page 3251]]
 
of health claims based on authoritative statements under the
notification procedures in the Food and Drug Administration
Modernization Act of 1997 (FDAMA). FDAMA permits nutrient content
claims based on authoritative statements for both conventional foods
and dietary supplements. FDAMA also permits health claims based on
authoritative statements for conventional foods; however, FDAMA does
not provide for the use of health claims based on authoritative
statements for dietary supplements. FDA believes that, for health
claims, conventional foods and dietary supplements should be subject to
the same standards and procedures, including the notification procedure
provided by FDAMA.
 
DATES: Submit written comments on the proposed rule by April 6, 1999.
Submit written comments on the information collection provisions by
February 22, 1999.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW.,
rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
 
FOR FURTHER INFORMATION CONTACT: Constance B. Henry, 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. The FDA Modernization Act of 1997
 
    On November 21, 1997, the President signed FDAMA into law (Pub. L.
105-115), which amended the Federal Food, Drug, and Cosmetic Act (the
act). Sections 303 and 304 of FDAMA amended section 403(r)(3) and
(r)(2) of the act (21 U.S.C. 343(r)(3) and (r)(2)). Specifically, FDAMA
added new section 403(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D),
which provides for the use in food labeling of nutrient content claims
and health claims based on authoritative statements. FDAMA requires
that a notification of a prospective nutrient content claim or a
prospective health claim be submitted to FDA at least 120 days before a
food bearing the claim may be introduced into interstate commerce.
    The notification must include specific information including: (1)
The exact wording of the prospective nutrient content claim or health
claim; (2) a concise description of the basis upon which the petitioner
relied for determining that the requirements of section 403(r)(2)(G)(i)
of the act for nutrient content claims or section 403(r)(3)(C)(i) of
the act for health claims have been satisfied; (3) a copy of the
authoritative statement upon which the person relied in making the
claim; and (4) a balanced representation of the scientific literature
relating to the nutrient level for a prospective nutrient content claim
or relating to the relationship between the nutrient and the disease or
health-related condition for a prospective health claim. For a
prospective nutrient content claim, the authoritative statement must
identify the nutrient level to which the claim refers. For a
prospective health claim, the authoritative statement must be a
statement about the relationship between a nutrient and a disease or
health-related condition to which the claim refers. For both types of
claims, the authoritative statement must be currently in effect and it
must have been published either by a scientific body of the U.S.
Government that has official responsibility for public health
protection or research directly relating to human nutrition (e.g., the
National Institutes of Health or the Centers for Disease Control and
Prevention) or by the National Academy of Sciences or any of its
subdivisions (hereinafter referred to as a ``scientific body'').
    Under new section 403(r)(2)(H) and (r)(3)(D) of the act, such a
claim may be made until: (1) FDA has issued an effective regulation
that prohibits or modifies the claim; (2) FDA has issued a regulation
finding that the requirements under section 403(r)(2)(G) of the act for
a prospective nutrient content claim or under section 403(r)(3)(C) of
the act for a prospective health claim have not been met; or (3) a
District Court of the United States in an enforcement proceeding under
chapter III of the act has determined that the requirements under
section 403(r)(2)(G) of the act for a prospective nutrient content
claim or under section 403(r)(3)(C) of the act for a prospective health
claim have not been met. During the 120 days following submission of a
notification and before the claim may appear on a food, the agency may
notify any person who is making the claim that the notification did not
include all of the required information.
    Section 304 of FDAMA permits nutrient content claims based on
authoritative statements for both conventional foods and dietary
supplements because section 304 amended section 403(r)(2) of the act,
which provides for nutrient content claims on both conventional foods
and dietary supplements. Section 303 of FDAMA, however, does not
provide for health claims for dietary supplements based on
authoritative statements. In particular, section 403(r)(5)(D) of the
act specifies that health claims for dietary supplements shall not be
subject to section 403(r)(3) of the act, but rather to a procedure and
standard that FDA establishes by regulation. In section 303 of FDAMA,
Congress amended section 403(r)(3) of the act, which provides for
procedures and standards for health claims for conventional foods, to
allow for health claims based on authoritative statements for
conventional foods, but Congress did not amend section 403(r)(5)(D) of
the act. Therefore, FDA believes that section 403(r)(3)(C) of the act
provides only for use of a health claim based on an authoritative
statement on any conventional food that provides an appropriate level
of the nutrient that is the subject of the health claim, but that does
not exceed the disqualifying nutrient levels identified in
Sec. 101.14(a)(5) (21 CFR 101.14(a)(5)), provided that the food and the
claim otherwise comply with section 403(r)(3)(C) of the act and all
other provisions of the act.
 
II. The Proposal
 
    FDA believes that, for health claims, conventional foods and
dietary supplements should be subject to the same standards and
procedures, including the notification procedure provided by FDAMA.
This approach is consistent with the agency's final rule that makes
dietary supplements subject to the same general requirements that apply
to conventional foods with respect to health claims (59 FR 395, January
4, 1994). This approach is also consistent with the guidance of the
Commission on Dietary Supplement Labels. Although the commission did
not discuss the provisions of FDAMA as enacted, it did state in its
1997 report (Ref. 1) that the process for the approval of health claims
should remain the same for dietary supplements and conventional foods.
    Therefore, FDA is proposing to add a new section to subpart E of
part 101 (21 CFR part 101) to provide for the use of health claims
based on authoritative statements on dietary supplements. The agency
intends this rule to provide for the same process and standard for the
use on dietary supplements of health claims based on authoritative
statements as provided by section 403(r)(3)(C) of the act for
conventional foods.
    This proposed regulation tracks the language of FDAMA section 303
and it
 
[[Page 3252]]
 
 would place dietary supplements on equal footing with conventional
foods with respect to health claims. The agency notes that it has
issued a document entitled ``Guidance for Industry--Notification of a
Health Claim or Nutrient Content Claim Based on an Authoritative
Statement of a Scientific Body'' ((Internet) ``http://
www.cfsan.fda.gov/~dms/guidance.html'') (Ref. 2), as well as
nine interim final rules in response to notifications of health claims
based on authoritative statements (63 FR 34084, 34092, 34097, 34101,
34104, 34107, 34110, 34112, and 34115, June 22, 1998). FDA has received
comments on the nine interim final rules, several of which take issue
with the process and principles outlined in sections I.A and I.B of the
``Food Labeling: Health Claims; Antioxidant Vitamins C and E and the
Risk in Adults of Atherosclerosis, Coronary Heart Disease, Certain
Cancers, and Cataracts'' interim final rule (63 FR 34084 at 34085
through 34087). FDA will respond to those comments in proposing
implementing regulations for sections 303 and 304 of FDAMA, and when it
completes those nine rulemakings. At this time, however, FDA advises
that the process and principles in the guidance and the nine interim
final rules reflect the agency's current thinking with respect to
implementation of sections 303 and 304 of FDAMA. The agency also
advises that, in proposing regulations to implement sections 303 and
304 of FDAMA, it will provide further detail on how the notification
procedures will be implemented with respect to the use of health claims
based on authoritative statements on all foods. The agency expects that
those implementing regulations would maintain the equal treatment
intended by this proposal. Therefore, the agency expects to withdraw
this regulation, if finalized, when that implementing regulation is
issued because this regulation would then no longer be necessary.
 
III. Analysis of Economic Impacts
 
A. Benefit-Cost Analysis
 
    FDA has examined the economic implications of this proposed 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 a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. The administrator of the Office of
Information and Regulatory Affairs of the Office of Management and
Budget (OMB) has determined that this proposed rule is a significant
regulatory action as defined by Executive Order 12866.
    The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), requiring
cost-benefit and other analyses, in section 1531(a) defines a
significant rule as ``a Federal mandate that may result in the
expenditure by State, local, and tribal governments in the aggregate,
or by the private sector, of $100 million (adjusted annually for
inflation) in any 1 year.'' FDA has determined that this rule does not
constitute a significant rule under the Unfunded Mandates Reform Act.
    The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million; a major
increase in costs or prices; significant effects on competition,
employment, productivity, or innovation; or significant effects on the
ability of U.S.-based enterprises to compete with foreign-based
enterprises in domestic or export markets. In accordance with the Small
Business Regulatory Enforcement Fairness Act, OMB has determined that
this proposed rule is not a major rule for the purpose of congressional
review.
    In this rule, FDA is proposing to permit the use on dietary
supplements of health claims based on authoritative statements under
the notification procedures in FDAMA. The proposed rule potentially
affects the entire dietary supplement industry.
    There are several types of products that may be considered to be
dietary supplements. These products include, but are not limited to,
vitamin and mineral supplements, herbal products, and products that
contain other similar nutritional substances. Estimates of the number
of dietary supplements are approximate because no one source collects
information on all types of dietary supplements. Some sources include
only dietary supplements of vitamins and minerals, others include
herbals or botanicals, and still others include types of products that
may or may not be dietary supplements, such as sports nutrition
products and ``functional foods,'' a term for which there is no
definition. FDA tentatively estimates the number of dietary supplement
products to be 29,000. FDA estimates the number of stockkeeping units,
a count of the number of labels, to be approximately 75,000.
    In its analysis of the proposed rule to establish regulations on
statements made for dietary supplements concerning the effect of the
product on the structure or function of the body (63 FR 23624 at 23628
and 23629, April 29, 1998), FDA estimated that approximately 850 firms
manufacture dietary supplements. For purposes of determining the
benefits and costs of this regulation, FDA will use 850 as an estimate
of the number of dietary supplement firms.
    Because the notification procedure established by FDAMA is
voluntary, the only dietary supplement firms likely to take advantage
of this procedure will be those firms who anticipate that private
benefits will exceed private costs. Consequently, FDA will not attempt
to estimate the internal benefits and costs for individual dietary
supplement firms. Those firms who anticipate that the benefits will
exceed the costs will make health claims based on authoritative
statements. The number of health claim notifications submitted can,
therefore, measure the effects of the proposed rule. Since the
notification procedures for statements on dietary supplements were
established in October 1997, FDA has received more than 3,000
notifications of nutritional support statements (structure-function
claims). FDA believes that dietary supplement firms will continue to
rely mainly on structure-function rather than health claims. FDA
expects the number of health claim notifications to be a small fraction
of the number of nutritional support statement notifications. Based on
FDA's experience with health claims and with other similar notification
procedures that fall under its jurisdiction, FDA has estimated that 12
firms per year may submit an average of 5 health claim notifications
each, for a total of 60 notifications. The agency specifically invites
comments on this estimate.
    In addition to the benefits and costs internal to dietary
supplement firms, FDA expects this proposed rule to generate benefits
and costs to society. Most of the benefits from this proposed rule will
come from the increased availability of the information provided by
health claims. FDA cannot quantify those benefits. To the extent that
the
 
[[Page 3253]]
 
lack of these claims has caused consumers to seek out the information
from other sources, this rule will benefit consumers by reducing the
cost of searching for information and by ensuring that the information
provided to consumers is appropriate. The proposed rule will also
impose additional costs on FDA and on the scientific bodies of the U.S.
Government whose authoritative statements form the basis for the
claims. FDA is unable to quantify those costs at this time, however.
 
B. Small Entity Analysis
 
    FDA has examined the economic implications of this proposed 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. FDA finds that this proposed rule would have a
significant economic impact on a substantial number of small
businesses.
    According to the Regulatory Flexibility Act, the definition of a
small entity is a business independently owned and operated and not
dominant in its field. The Small Business Administration (SBA) has set
size standards for most business categories through use of four-digit
Standard Industrial Classification (SIC) codes. Dietary supplements
fall into several codes, including Food Preparations Not Elsewhere
Classified (SIC 2099), Industrial Inorganic Chemicals Not Elsewhere
Classified (SIC 2819), Medicinal Chemicals and Botanical Products (SIC
2833), Pharmaceutical Preparations (SIC 2834), and Industrial Organic
Chemicals Not Elsewhere Classified (SIC 2869). According to SBA size
standards, dietary supplement firms are small entities if they have
fewer than 500 employees in SIC codes 2099 and 2899, fewer than 750
employees in SIC codes 2833 and 2834, and fewer than 1,000 employees in
SIC codes 2819 and 2969. Based on these standards, FDA has previously
estimated that approximately 95 percent of dietary supplement
manufacturers could be considered small under SBA size standards (63 FR
23624 at 23631).
    As discussed earlier, FDA estimates that about 12 firms per year
will submit health claims notifications based on authoritative
statements. Because most businesses in the dietary supplement industry
would be classified as small under SBA standards, FDA assumes that many
businesses potentially affected by this proposed rule will be small.
FDA, therefore, concludes that the proposed rule will affect a
substantial number of small entities. The proposed rule would, however,
impose no involuntary costs and would benefit small businesses wishing
to make health claims based on authoritative statements.
    The Regulatory Flexibility Act requires agencies to examine
regulatory alternatives that would minimize the impact on small
entities. FDA believes that the proposed rule will impose no
involuntary burdens on small entities. Other regulatory options were
nevertheless considered, including taking no new regulatory action and
waiting until the implementing regulation for section 303 of FDAMA to
propose that health claims based on authoritative statements be
permitted for dietary supplements. FDA rejected the option of taking no
new regulatory action because it would make conventional foods and
dietary supplements subject to different standards for health claims.
As stated previously in this document, the agency expects to withdraw
this rule, if finalized, when the implementing regulation for section
303 of FDAMA is issued.
 
IV. Environmental Impact
 
    The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
 
V. Effective Date
 
    FDA is proposing that any final rule that may be issued based upon
this proposal become effective upon publication in the Federal
Register. Under section 553(e) of the Administrative Procedure Act (5
U.S.C. 553(e)) and FDA's procedural regulations at 21 CFR
10.40(c)(4)(i), the agency may make a final substantive rule effective
immediately upon publication if the rule ``grants or recognizes an
exemption or relieves a restriction.'' If it becomes final, this rule
would not place an affirmative requirement on anyone but rather would
relieve a restriction on the dietary supplement industry. As more fully
discussed previously, FDAMA makes the streamlined notification
procedures for health claims available only to the conventional food
industry. The agency is proposing to relieve this restriction in FDAMA
to make health claims based on authoritative statements also available
for use by the dietary supplement industry.
 
VI. Paperwork Reduction Act of 1995
 
    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). A description of these provisions is
given below with an estimate of the annual reporting burden. Included
in the estimate is the time for reviewing the instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Title: Notification Procedures for Dietary Supplement Health Claims
Based on Authoritative Statements.
    Description: This proposed rule would permit producers of dietary
supplements to market a product whose label or labeling bears a health
claim based on authoritative statements of certain scientific bodies of
the Federal Government or the National Academy of Sciences, or any of
its subdivisions, using the same process and standard established for
conventional foods by the provisions of section 403(r)(3)(C) of the
act. Under this proposed rule, a dietary supplement producer may use
such a health claim in the labeling of an appropriate product 120 days
after a complete notification of the claim is submitted to FDA, unless:
(1) The agency has issued an effective regulation that prohibits or
modifies the claim, (2) the agency has issued a regulation finding that
the requirements of proposed Sec. 101.90(a) have not been met, or (3) a
Federal District Court in an enforcement proceeding under chapter III
of the act (21 U.S.C. 301-310) has determined that the requirements of
proposed Sec. 101.90(a) have not been met. This proposed rule would
prescribe the type of information that a dietary supplement producer
must include in a notification that it would submit to the agency.
 
[[Page 3254]]
 
    As noted previously, FDA recently announced the availability of a
guidance on the submission of a notification of a nutrient content
claim or health claim based on an authoritative statement of a
scientific body under the provisions of section 403(r)(2)(G) or
(r)(3)(C) of the act. In estimating the annual reporting burden under
this proposed rule, FDA has assumed that submitters of notifications
will follow that guidance.
    Description of Respondents: Persons and businesses, including small
businesses.
 
                                  Table 1.--Estimated Annual Reporting Burden<SUP>1
----------------------------------------------------------------------------------------------------------------
                                                      No. of
         21 CFR Section               No. of       Responses per   Total Annual      Hours per     Total Annual
                                    Respondents     Respondent       Responses       Response          Hours
----------------------------------------------------------------------------------------------------------------
101.90                                 12               5              60              40           2,400
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
 
    These estimates are based on FDA's experience with health claims
and with other similar notification procedures that fall under its
jurisdiction. Because the claims are based on authoritative statements
of certain scientific bodies of the Federal Government or the National
Academy of Sciences, or any of its subdivisions, FDA believes that the
information submitted with a notification will be either provided as
part of the authoritative statement or readily available to anyone
wishing to submit a notification.
    In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
the agency has submitted the information collection provisions of this
proposed rule to OMB for review. Interested persons are requested to
send written comments regarding information collection by February 22,
1999, to the Office of Information and Regulatory Affairs, OMB (address
above), Attn: Desk Officer for FDA.
 
VII. Comments
 
    Interested persons may, on or before April 6, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to 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. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
 
VIII. References
 
    The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Commission on Dietary Supplement Labels, ``Report of the
Commission on Dietary Supplement Labels,'' p. vii, November 1997.
    2. ``Guidance for Industry--Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body,'' FDA, DHHS, June 11, 1998.
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
 
PART 101--FOOD LABELING
 
    1. The authority citation for 21 CFR part 101 continues to read as
follows:
 
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
 
    2. Section 101.90 is added to subpart F to read as follows:
 
 
Sec. 101.90  Notifications for health claims based on authoritative
statements.
 
    (a) A claim of the type described in Sec. 101.14(a)(1) which is not
authorized by the Food and Drug Administration (FDA) in a regulation
found in this part shall be authorized and may be made with respect to
a dietary supplement if:
    (1) A scientific body of the U.S. Government with official
responsibility for public health protection or research directly
relating to human nutrition (such as the National Institutes of Health
or the Centers for Disease Control and Prevention) or the National
Academy of Sciences or any of its subdivisions has published an
authoritative statement, which is currently in effect, about the
relationship between a nutrient and a disease or health-related
condition to which the claim refers;
    (2) A person has submitted to FDA, at least 120 days (during which
FDA may notify any person who is making a claim as authorized by
paragraph (a) of this section that such person has not submitted all
the information required by this paragraph) before the first
introduction into interstate commerce of the dietary supplement with a
label containing the claim:
    (i) A notice of the claim, which shall include the exact words used
in the claim and shall include a concise description of the basis upon
which such person relied for determining that the requirements of
paragraph (a)(1) of this section have been satisfied;
    (ii) A copy of the statement referred to in paragraph (a)(1) of
this section upon which such person relied in making the claim; and
    (iii) A balanced representation of the scientific literature
relating to the relationship between a nutrient and a disease or
health-related condition to which the claim refers;
    (3) The claim and the dietary supplement for which the claim is
made are in compliance with Sec. 101.14(a)(5) and (e)(3) and are
otherwise in compliance with sections 403(a) and 201(n) of the act (21
U.S.C. 343(a) and 21 U.S.C. 321(n)); and
    (4) The claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred to in
paragraph (a)(1) of this section and so that the claim enables the
public to comprehend the information provided in the claim and to
understand the relative significance of such information in the context
of a total daily diet. For purposes of this paragraph, a statement
shall be regarded as an authoritative statement of a scientific body
described in paragraph (a)(1) of this section only if the statement is
published by the scientific body and shall not include a statement of
an employee of the scientific body made in the individual capacity of
the employee.
    (b) A claim submitted under the requirements of paragraph (a) of
this section may be made until:
    (1) Such time as FDA issues a regulation under the standard in
Sec. 101.14(c):
    (i) Prohibiting or modifying the claim and the regulation has
become effective; or
    (ii) Finding that the requirements of paragraph (a) of this section
have not
 
[[Page 3255]]
 
been met, including finding that the petitioner has not submitted all
the information required by such clause; or
    (2) A District Court of the United States in an enforcement
proceeding under chapter III of the act (21 U.S.C. 301-310) has
determined that the requirements of paragraph (a) of this section have
not been met.
 
    Dated: October 7, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 99-1365 Filed 1-20-99; 8:45 am]
BILLING CODE 4160-01-F