[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Rules and Regulations]
[Pages 26978-26980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12833]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-0283]
Food Labeling; Nutrient Content Claims--General Provisions
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations for nutrient content claims by revoking the requirement
that the label or labeling of a food for which a nutrient content claim
is made must bear a ``referral statement'' that directs consumers'
attention to the panel on the label or labeling that bears nutrition
[[Page 26979]]
information. FDA is taking this action in response to section 305 of
the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA
also is making some technical conforming amendments to the regulations.
DATES: The regulation is effective May 15, 1998, except for the
amendment to Sec. 101.13(q)(3)(ii) (21 CFR 101.13(q)(3)(ii)) that will
be effective March 23, 1999. Written comments by June 15, 1998.
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: Hilario R. Duncan, Center for Food
Safety and Applied Nutrition (HFS-24), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-8281.
SUPPLEMENTARY INFORMATION: On November 21, 1997, President Clinton
signed into law FDAMA (Pub. L. 105-115). Section 305 of FDAMA amended
section 403(r)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343(r)(2)(B)) to eliminate the requirement that
referral statements be made on food labeling whenever nutrient content
claims are made. Section 305 of FDAMA retained the requirement that
there be disclosure statements when FDA determines that the food for
which the nutrient content claim is to be made contains a nutrient at a
level that increases to persons in the general population the risk of a
disease or health related condition that is diet related, although
section 305 of FDAMA changed how the disclosure statement should be
worded. The act as amended by the Nutrition Labeling and Education Act
of 1990 had previously mandated referral statements whenever nutrient
content claims were made on the label or labeling of a food product.
FDA is revising Sec. 101.13 (21 CFR 101.13) to reflect the
statutory changes of FDAMA. The agency is doing so by removing the
introductory text of Sec. 101.13(g), which requires referral statements
whenever nutrient content claims are made; by redesignating and
amending Sec. 103.13(g)(1), (g)(2), and (g)(3), which specify the size
and placement of referral statements, as paragraphs (h)(4)(i),
(h)(4)(ii), and (h)(4)(iii), respectively, to specify the size and
placement of disclosure statements; by revising Sec. 101.13(h)(1) to
make the disclosure statement language conform to that required by
Section 305 of FDAMA; and by making other conforming revisions.
Under amended section 403(r)(2)(B) of the act, and the conforming
rule set forth in this document, affected food products are misbranded
unless they contain the disclosure statement ``See nutrition
information for ____ content.'' This disclosure statement replaces the
disclosure statement currently set forth in Sec. 101.13(h), which
states: ``See [appropriate panel] for information about [nutrient
requiring disclosure] and other nutrients.'' FDA does not believe that
Congress intended that food producers immediately relabel their
products to include the new disclosure statement, which would create an
unnecessary economic burden on them, especially as the old disclosure
statement is not false or misleading. Accordingly, FDA advises that,
with respect to food products that are subject to the requirements of
Sec. 101.13(h), the agency intends at this time to exercise its
enforcement discretion by refraining from taking regulatory action
against them solely because they continue to use the disclosure
statement ``See [appropriate panel] for information about [nutrient
requiring disclosure] and other nutrients.'' FDA encourages food
producers to revise the labeling for their products that fall under the
requirements of Sec. 101.13(h) to include the new disclosure statement
``See nutrition information for ____ content'' as soon as possible but
no later than the next scheduled redesign of the product's label or
labeling. Finally, FDA advises that food producers may continue to use
the referral statement previously required under Sec. 101.13(g).
Because that referral statement is not false or misleading, such a
referral statement would not be prohibited under the act.
FDA is also taking this opportunity to correct an error that occurs
in the current issue of the Code of Federal Regulations (CFR) in
Sec. 101.13(g)(1). In the Federal Register of August 12, 1997 (62 FR
43071), in the document entitled ``Food and Cosmetic Labeling;
Revocation of Certain Regulations,'' FDA revoked Sec. 101.2(c)(1),
(c)(2), and (c)(3) (21 CFR 101.2(c)(1), (c)(2), and (c)(3)) and
redesignated remaining paragraphs (c)(4) and (c)(5) as paragraphs
(c)(1) and (c)(2), respectively. In making this change, however, FDA
inadvertently neglected to change the citation to Sec. 101.2(c)(5) that
appeared in Sec. 101.13(g)(1). FDA is correcting that inadvertent
omission in Sec. 101.13. Additionally, in a document entitled ``Food
Labeling; General Requirements for Health Claims for Food'' (see 58 FR
2478 at 2534, January 6, 1993), FDA inadvertently used the term
``referral'' instead of the preferred term ``disclosure'', in issuing
Sec. 101.14(e)(3) (21 CFR 101.14(e)(3)). FDA is correcting that error
in Sec. 101.14(e)(3).
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.
FDA has examined the economic implications of this final rule under
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 the regulatory approach that
maximizes net benefits (including potential economic, environmental,
public health and safety effects; 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 or adversely affecting in a
material way a sector of the economy, competition, or jobs, or if it
raises novel legal or policy issues. The agency finds that this final
rule is not a significant rule as defined by Executive Order 12866. No
analysis is required for this rule under the Regulatory Flexibility Act
(5 U.S.C. 601-612) because, as discussed herein, FDA is issuing it
without publishing a general notice of proposed rulemaking.
Finally, in accordance with the Small Business Regulatory
Enforcement Fairness Act, the administrator of the Office of
Information and Regulatory Affairs of the Office of Management and
Budget has determined that this final rule is not a major rule for the
purpose of congressional review.
FDA concludes that the labeling requirements in this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the
labeling statements are ``public disclosure of information originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
Because FDA is revoking a requirement (referral statements for all
nutrient content claims) that was issued under legal authority that has
been eliminated by Congress in FDAMA, FDA finds, for good cause, that
notice and public procedure on this rule are unnecessary and,
therefore, are not required under 5 U.S.C. 553.
[[Page 26980]]
Nonetheless, under 21 CFR 10.40(e), FDA is providing an opportunity
for comment on whether the regulations set forth below should be
modified or revoked.
Interested persons may, on or before June 15, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this final rule. 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 though Friday.
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, 21 CFR part
101 is 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 101.13 is amended by removing the introductory text of
paragraph (g); by redesignating paragraphs (g)(1), (g)(2), and (g)(3)
as paragraphs (h)(4)(i), (h)(4)(ii), and (h)(4)(iii), respectively and
reserving paragraph (g); by removing the introductory text of paragraph
(h); by revising paragraph (h)(1) and newly redesignated paragraphs
(h)(4)(i), (h)(4)(ii), and (h)(4)(iii); in paragraphs (j)(2)(ii) and
(p)(2) by removing the phrase ``with paragraph (g)(1)'' and adding in
its place the phrase ``with paragraph (h)(4)(i)''; by revising the
second sentence in paragraph (q)(2) and the last sentence in paragraph
(q)(3)(ii); in paragraph (q)(5)(i) by removing the phrase ``in
paragraphs (g) and (h)'' and adding in its place the phrase ``in
paragraph (h)''; and in paragraph (q)(6) by removing the phrase ``of
paragraphs (b), (g), and (h)'' and adding in its place the phrase ``of
paragraphs (b) and (h)'' to read as follows:
Sec. 101.13 Nutrient content claims--general principles.
* * * * *
(h)(1) If a food, except a meal product as defined in
Sec. 101.13(l), a main dish product as defined in Sec. 101.13(m), or
food intended specifically for use by infants and children less than 2
years of age, contains more than 13.0 g of fat, 4.0 g of saturated fat,
60 milligrams (mg) of cholesterol, or 480 mg of sodium per reference
amount customarily consumed, per labeled serving, or, for a food with a
reference amount customarily consumed of 30 g or less or 2 tablespoons
or less, per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50 g criterion
refers to the ``as prepared'' form), then that food must bear a
statement disclosing that the nutrient exceeding the specified level is
present in the food as follows: ``See nutrition information for ____
content'' with the blank filled in with the identity of the nutrient
exceeding the specified level, e.g., ``See nutrition information for
fat content.''
* * * * *
(4) * * *
(i) The disclosure statement ``See nutrition information for ____
content'' shall be in easily legible boldface print or type, in
distinct contrast to other printed or graphic matter, and in a size no
less than that required by Sec. 101.105(i) for the net quantity of
contents statement, except where the size of the claim is less than two
times the required size of the net quantity of contents statement, in
which case the disclosure statement shall be no less than one-half the
size of the claim but no smaller than one-sixteenth of an inch, unless
the package complies with Sec. 101.2(c)(2), in which case the
disclosure statement may be in type of not less than one thirty-second
of an inch.
(ii) The disclosure statement shall be immediately adjacent to the
nutrient content claim and may have no intervening material other than,
if applicable, other information in the statement of identity or any
other information that is required to be presented with the claim under
this section (e.g., see paragraph (j)(2) of this section) or under a
regulation in subpart D of this part (e.g., see Secs. 101.54 and
101.62). If the nutrient content claim appears on more than one panel
of the label, the disclosure statement shall be adjacent to the claim
on each panel except for the panel that bears the nutrition information
where it may be omitted.
(iii) If a single panel of a food label or labeling contains
multiple nutrient content claims or a single claim repeated several
times, a single disclosure statement may be made. The statement shall
be adjacent to the claim that is printed in the largest type on that
panel.
* * * * *
(q) * * *
(2) * * * Such claims are exempt from the requirements of section
403(r)(2) of the act (e.g., the disclosure statement also required by
Sec. 101.13(h)). * * *
(3) * * *
(ii) * * * All such claims shall be accompanied by any disclosure
statement required under paragraph (h) of this section.
* * * * *
Sec. 101.14 [Amended]
3. Section 101.14 Health claims: general requirements is amended in
paragraph (e)(3), in the 15th line by removing the word ``referral''
and adding in its place the word ``disclosure''.
4. Section 101.54 is amended by revising paragraph (d)(2) to read
as follows:
Sec. 101.54 Nutrient content claims for ``good source,'' ``high,''
``more,'' and ``potency.''
* * * * *
(d) * * *
(2) The disclosure shall appear in immediate proximity to such
claim, be in a type size no less than one-half the size of the claim
and precede any disclosure statement required under Sec. 101.13(h)
(e.g., ``contains [x amount] of total fat per serving. See nutrition
information for fat content'').
* * * * *
Sec. 101.62 [Amended]
5. Section 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods is amended in paragraphs (d)(1)(ii)(D),
(d)(2)(iii)(C), (d)(2)(iv)(C), (d)(4)(ii)(C), and (d)(5)(ii)(C) by
removing the phrase ``the referral statement required in
Sec. 101.13(g)'' wherever it appears and by adding in its place the
phrase ``any disclosure statement required under Sec. 101.13(h)''.
* * * * *
Dated: May 6, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12833 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F
