[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34104-34107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N-0424]


Food Labeling: Health Claims; Chromium and the Risk in Adults of 
Hyperglycemia and the Effects of Glucose Intolerance

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim 
final rule to prohibit the use on foods of a claim relating to the 
relationship between chromium and the risk in adults of hyperglycemia 
and the effects of glucose intolerance. This interim final rule is in 
response to a notification of a health claim submitted under section 
303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed 
statements that the petitioner submitted in that notification, and, in 
conformity with the requirements of FDAMA, the agency is prohibiting 
the claim because the statements submitted as the basis of the claim 
are not ``authoritative statements'' of a scientific body, as required 
by FDAMA; therefore, section 303 of FDAMA does not authorize use of 
this claim. As provided for in section 301 of FDAMA, this rule is 
effective immediately upon publication.

DATES: The interim final rule is effective June 22, 1998; comments by 
September 8, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christine J. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-451), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4168.

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)(2) and 
(r)(3) of the act by adding new paragraphs (r)(2)(G), (r)(2)(H), 
(r)(3)(C), and (r)(3)(D) to section 403 of the act (21 U.S.C. 
343(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D)), which provide for 
the use in food labeling of nutrient content claims and health claims, 
respectively, based on authoritative statements. FDAMA requires that a 
notification of the prospective nutrient content claim or the 
prospective health claim be submitted to FDA at least 120 days before a 
food bearing the claim may be introduced into interstate commerce. 
FDAMA and its requirements are discussed in more detail in a companion 
document in this issue of the Federal Register (see ``Food Labeling: 
Health Claims; Antioxidant Vitamins C and E and the Risk in Adults of 
Atherosclerosis, Coronary Heart Disease, Certain Cancers, and 
Cataracts;'' hereinafter referred to as ``Health Claims; Vitamins C and 
E''). In particular, aspects of the requirements for an ``authoritative 
statement'' that are relevant to this rulemaking and FDA's review 
process for notifications are discussed in sections I.A and I.B, 
respectively, of that document.

II. The Notification

    Section 403(r)(2)(G) and (r)(3)(C) of the act became effective on 
February 19, 1998. On February 23, 1998, the agency received a 
notification from Weider Nutrition International, Inc., containing nine 
prospective claims that were identified in the text of the notification 
as health claims (Ref. 1). The notification included statements that 
the submitter described as authoritative statements and a scientific 
literature review for each claim. FDA has created nine separate 
dockets, one for each of the nine claims and is issuing a separate 
interim final rule responding to each claim.
    This interim final rule addresses the fifth claim in the 
notification. The notification included three statements

[[Page 34105]]

that the petitioner identified as authoritative statements on which the 
following claim is based: ``In adults, chromium may reduce the risk of 
hyperglycemia and the effects of glucose intolerance. Sources of 
chromium include whole grains, brewer's yeast, cheese, and dietary 
supplements.''
    The first sentence of this claim will be discussed in greater 
detail in section III of this document. The agency notes that this 
claim describes the relationship between chromium and two diseases or 
health-related conditions, and thus reflects two prospective health 
claims. The second sentence, ``Sources of chromium include whole 
grains, brewer's yeast, cheese, and dietary supplements,'' is not a 
health claim. Given that the notification indicated that it was 
intended to be a notification for health claims, this statement was not 
reviewed by FDA. The submitter did not separately identify this 
statement as any particular type of claim.
    Nonetheless, as a point of information, the agency wishes to 
highlight that statements that appropriately constitute nutrient 
content claims are allowed on labels and in the labeling of foods and 
dietary supplements. Moreover, statements that constitute dietary 
guidance are also allowed provided the information is truthful and not 
misleading as required by section 403(a) and 201(n) (21 U.S.C. 321(n)) 
of the act. These aspects of nutrient content claims and dietary 
guidance are discussed in more detail in ``Health Claims; Vitamins C 
and E,'' which is published elsewhere in this issue of the Federal 
Register.

III. Basis for the Action

    FDA has reviewed the notification submitted in support of the 
prospective claim: ``In adults, chromium may reduce the risk of 
hyperglycemia and the effects of glucose intolerance.'' The agency has 
determined that none of the three statements submitted as the basis for 
this claim meets the requirements in section 403(r)(3)(C) of the act to 
be an ``authoritative statement.'' Because the prospective claim is not 
based on an authoritative statement, it is not appropriate for the 
claim to appear on food labels and labeling. Consequently, FDA is 
issuing this interim final rule to prohibit the use of this claim. A 
discussion of the basis for the agency's action on the notification 
follows.
     First, FDA determined that the components required by section 
403(r)(3)(C) of the act were present in the notification submitted to 
support this claim. Second, FDA determined that, as a threshold matter, 
each of the three statements cited in support of the claim may be 
attributable either to an appropriate Federal scientific body or to an 
employee or employees of such a body.
    The notification in support of the claim that is the subject of 
this document cites: (1) Two statements from quarterly reports from the 
U.S. Department of Agriculture's (USDA) Agricultural Research Service 
(ARS) from electronic versions provided on the Internet; and (2) one 
statement from a report issued by the U.S. Surgeon General. Thus, the 
statements in the notification are attributable to USDA's ARS or to the 
Surgeon General. FDA believes that USDA/ARS and the Surgeon General, 
who is housed within the U.S. Department of Health and Human Services 
(DHHS), are scientific bodies of the U.S. Government with official 
responsibility for public health protection or research directly 
relating to human nutrition for the purposes of section 403(r)(2)(G) 
and (r)(3)(C) of the act. Accordingly, the statements provided in the 
notification in support of the claim may be attributable to appropriate 
Federal scientific bodies or to their employees.
    Finally, however, none of the three statements discussed in 
sections III.A through C of this document was found to be an 
authoritative statement.

A. Statement 1

     Statement 1 reads: ``Chromium supplements--in two different 
formulations--lowered blood pressure in rats bred to spontaneously 
develop hypertension * * * the supplements, chromium picolinate and 
chromium nicotinate, also reduced the formation of damaging free 
radicals in the animals' tissues, indicating that chromium can act as 
an antioxidant * * * chromium is essential for insulin to operate 
efficiently and has been shown to reduce diabetic symptoms and restore 
glucose tolerance in studies of humans and animals.'' The notification 
identified Statement 1 as an ``authoritative statement'' for purposes 
of making the claim that is the subject of this rulemaking. The 
statement is found in Human Nutrition (quarterly reports of selected 
research projects, 3d quarter 1997) issued by USDA's ARS and provided 
on the Internet (``http://www.ars.usda.gov/is/qtr/q397/hn397.htm'' 
accessed on 11/26/97). Human Nutrition is a periodic compilation of 
brief (one paragraph) descriptions of ongoing research being conducted 
within the various ARS facilities. The subject statement (submitted to 
the agency as a hardcopy reprint from the Internet) appears in a 
description of research entitled: ``Chromium supplements--in two 
different formulations--lowered blood pressure in rats bred to 
spontaneously develop hypertension.'' The paragraph, which describes 
the nature and outcome of one ARS study and which refers to previous 
studies, is attributed to Richard A. Anderson of the Beltsville Human 
Nutrition Research Center, Beltsville, MD.
    The agency notes that the statement focuses first on hypertension 
in rats, then on the formation of free radicals in rats. The third 
component of the statement suggests that chromium has an effect in 
reducing diabetic symptoms and restoration of glucose tolerance in 
humans as well as animals.
    The agency asked USDA whether the statement is an ``authoritative 
statement'' under FDAMA. USDA responded to FDA that the statement is 
not an authoritative statement of USDA because it was not based upon a 
deliberative review of the scientific evidence regarding a relationship 
between the nutrient and the disease in question (Ref. 2). USDA 
explained that the ARS Quarterly Reports describe progress on 
individual projects without a deliberative review of all relevant 
scientific evidence. Therefore, FDA has concluded that the statement is 
not an ``authoritative statement'' under section 403(r)(3)(C) of the 
act because it is not based on a deliberative review of the scientific 
evidence, as described in section I.A.3 of ``Health Claims; Vitamins C 
and E,'' which is published elsewhere in this issue of the Federal 
Register.

B. Statement 2

     Statement 2 reads: ``In a 20-week ARS study, rats that daily 
consumed more than 2,000 times the estimated safe limit of chromium for 
people showed no sign of toxicity * * * [the findings] bring into 
question the relevance of a study done 2 years ago * * * that reported 
DNA damage.''
    The notification identified Statement 2 as an ``authoritative 
statement'' for purposes of making the claim that is the subject of 
this rulemaking. The statement is found in Human Nutrition (quarterly 
reports of selected research projects, 3d quarter 1997) (see discussion 
of statement 1 in section III.A of this document), which is issued by 
USDA's ARS and provided on the Internet (``<a href="http://www.ars.usda.gov/is/
qtr/q397/hn397.htm">http://www.ars.usda.gov/is/
qtr/q397/hn397.htm</a>'' accessed on 11/26/97) in a description of research 
entitled: ``There's good news for people concerned about the safety of 
taking chromium supplements.'' The paragraph describes the nature and 
outcome of one ARS study on rats and

[[Page 34106]]

is attributed to Richard A. Anderson of the Beltsville Human Nutrition 
Research Center.
    FDA concludes that the statement focuses on levels of intake 
considered safe in rats and does not identify a relationship between a 
nutrient and a disease or health-related condition in humans, as 
described in section I.A.1 of ``Health Claims; Vitamins C and E,'' 
which is published elsewhere in this issue of the Federal Register. 
Thus, this statement is not an ``authoritative statement'' under 
section 403(r)(3)(C) of the act because it is not about the 
relationship between a nutrient and a disease or health-related 
condition.

C. Statement 3

    Statement 3 reads: ``Scientists must often draw inferences about 
the relationships between dietary factors and disease from animal 
studies or human metabolic and population studies that approach issues 
indirectly.'' The notification identified Statement 3 as an 
``authoritative statement'' for purposes of making the claim that is 
the subject of this rulemaking. The statement is found in a discussion 
on the nature of scientific evidence contained in ``The Surgeon 
General's Report on Nutrition and Health--Summary and Recommendations'' 
that was published by the Public Health Service (PHS) of DHHS (1988).
    FDA concludes that the statement focuses on a general principle of 
scientific inference and is not about the relationship between a 
nutrient and a disease or health-related condition. Thus, this 
statement is not an ``authoritative statement'' under section 
403(r)(3)(C) of the act.
    In summary, FDA has concluded that the notification does not 
include any authoritative statement published by a scientific body as 
required by section 403(r)(3)(C) of the act. Accordingly, the subject 
claim relating to the relationship between chromium and the risk in 
adults of hyperglycemia and the effects of glucose intolerance is not 
authorized under section 403(r)(3)(C) of the act and is, therefore, 
prohibited. The agency notes that, at any future time, a notification 
may be submitted to the agency that bases such a claim or claims on a 
statement that meets the requirements of section 403(r)(3)(C) of the 
act. If there is no authoritative statement that may serve as a basis 
for such claims, an interested person may petition the agency under 
section 403(r)(4) of the act and 21 CFR 10.70 to authorize a health 
claim or claims by regulation under section 403(r)(3)(B) of the act.

IV. Issuance of an Interim Final Rule, Immediate Effective Date, 
and Opportunity for Public Comment

    For the reasons described in this section, FDA is issuing this rule 
as an interim final rule, effective immediately, with an opportunity 
for public comment. New section 403(r)(7)(B) of the act, added by 
section 301 of FDAMA, provides that FDA ``may make proposed regulations 
issued under [section 403(r)] effective upon publication pending 
consideration of public comment and publication of a final regulation'' 
if the agency ``determines that such action is necessary * * * to 
enable [FDA] to act promptly to ban or modify a claim'' under section 
403(r) of the act. For purposes of judicial review, ``[s]uch proposed 
regulations shall be deemed final agency action.'' The legislative 
history indicates that the agency should issue rules under this 
authority as interim final rules (H. Conf. Rept. 105-399, at 98 
(1997)).
    As described in section III of this document, FDA has determined 
that the statements submitted in support of the prospective health 
claim do not meet the requirements for authoritative statements in 
section 403(r)(3)(C) of the act. FDA has determined that it is 
necessary to act promptly to prohibit the claim's use under section 
403(r)(3)(C) of the act, and accordingly, is issuing this interim final 
rule to ban its use under section 403(r)(3)(C).
    FDA invites public comment on this interim final rule. The agency 
will consider modifications to this interim final rule based on 
comments made during the comment period. Interested persons may, on or 
before September 8, 1998, submit to the Dockets Management Branch 
(address above) written comments regarding this interim final rule. 
Comments must be received by that date. 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.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(k) 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.

VI. Analysis of Economic Impacts

A. Benefit-Cost Analysis

    FDA has examined the impacts of this interim final rule under 
Executive Order 12866. Executive Order 12866 directs Federal agencies 
to assess the 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). According to Executive Order 12866, a regulatory action is 
``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 in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. FDA 
finds that this interim final rule is not a significant regulatory 
action as defined by Executive Order 12866. In addition, it has been 
determined that this interim final rule is not a major rule for the 
purpose of congressional review.
    If in the future FDA authorizes health claims relating to the 
relationship between chromium and the risk in adults of hyperglycemia 
and the effects of glucose intolerance after finding that there is 
significant scientific agreement about these relationships, the cost to 
consumers of prohibiting this claim at this time would be the cost of 
having kept, in the interim, information from appearing in food 
labeling that would ultimately be shown to be scientifically valid, 
truthful, and not misleading. At this time, the benefit to consumers of 
prohibiting this claim is that a claim that has not been shown to be 
scientifically valid will not appear in food labeling. Accordingly, 
consumers will be able generally to have confidence when they read food 
labeling that any diet/disease relationship information in that 
labeling has been shown to be scientifically valid.
    A health claim related to the association between chromium and the 
risk in adults of hyperglycemia and the effects of glucose intolerance 
has not been authorized under existing regulations. The prohibition of 
this claim in this interim final rule results in no regulatory changes 
for firms, and therefore no costs to firms are attributable to this 
interim final rule.

B. Small Entity Analysis

    FDA has examined the impacts of this interim final rule under the 
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C. 
601-612)

[[Page 34107]]

requires Federal agencies to consider alternatives that would minimize 
the economic impact of their regulations on small businesses and other 
small entities. In compliance with the Regulatory Flexibility Act, FDA 
finds that this interim final rule will not have a significant impact 
on a substantial number of small entities.
    A health claim relating to the relationship between chromium and 
the risk in adults of hyperglycemia and the effects of glucose 
intolerance has not been authorized under existing regulations. The 
prohibition of this claim in this interim final rule results in no 
regulatory changes for firms, and therefore this rule will not result 
in a significant increase in costs to any small entity. Therefore, this 
interim 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. 601-612), the agency certifies that this 
interim final rule will not have a significant economic impact on a 
substantial number of small entities.

C. Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of this interim final rule under the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This 
interim final rule does not trigger the requirement for a written 
statement under section 202(a) of UMRA because it does not impose a 
mandate that results in an expenditure of $100 million or more by 
State, local, and tribal governments in the aggregate, or by the 
private sector, in any 1 year.

VII. The Paperwork Reduction Act of 1995

    This interim final rule contains no collections of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

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. Notification to Donna E. Shalala, DHHS, from Jonathan W. 
Emord et al., Emord & Associates, P.C., Counsel for Weider Nutrition 
International, Inc., February 23, 1998.
    2. Letter to Christine Lewis, CFSAN, FDA, from Eileen Kennedy, 
USDA, May 7, 1998.

    Dated: June 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-16458 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F