[Federal Register Volume 61, Number 23 (Friday, February 2, 1996)]
[Proposed Rules]
[Pages 3885-3891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2153]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95N-0103]


Food Labeling; Nutrient Content Claims and Health Claims; Special 
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
that, in certain circumstances, persons responsible for the labeling of 
foods with nutrient content and health claims maintain records that 
support the claims, and that they make those records available to 
appropriate regulatory officials upon request. FDA has tentatively 
concluded that the proposed requirements are necessary to ensure that, 
in the specified circumstances, when a claim is made on the label or in 
the labeling of a food to characterize the level of a nutrient in that 
food, or to characterize the relationship between a nutrient in the 
food and a disease or health-related condition, the claim is made in 

[[Page 3886]]
accordance with regulations issued by the agency.

DATES: Written comments by April 17, 1996; except that comments 
regarding information collection requirements by March 4, 1996, but not 
later than April 2, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Written comments regarding paperwork burden 
estimates should be sent to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Bldg., rm. 10235, Washington, DC 
20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Center for Food 
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,-
200 C St. SW., Washington, DC 20204, 202-205-4561.

SUPPLEMENTARY INFORMATION:

I. Background

    Nutrition Labeling and Education Act of 1990 (the 1990 amendments) 
(Pub. L. 101-535) amended the act by, among other things, adding 
section 403(r)(21 U.S.C. 343(r)). This section sets out the 
circumstances in which nutrient content claims and health claims can be 
made in food labeling. Under section 403(r) of the act, a food is 
misbranded if a claim made in its label or labeling that characterizes 
the level of a nutrient in the food, or characterizes the relationship 
between a nutrient in the food and a disease or health-related 
condition, unless the claim is made in accordance with regulations 
issued by the agency. FDA has adopted regulations implementing the 1990 
amendments with respect to nutrient content claims in Sec. 101.13 (21 
CFR 101.13) and subpart D of part 101 (21 CFR part 101) of FDA's 
regulations and with respect to health claims in Sec. 101.14 and 
subpart E of part 101.
    One of the purposes of the 1990 amendments was to encourage the 
development of new food technologies. (See 136 Congressional Record S 
16610, October 24, 1990, statement of Senator Hatch: ``[M]anufacturers 
should have the economic incentives they need to be creative and 
innovative so that more and more low-fat, reduced sodium, and high-
fiber foods come onto the market.'') The 1990 amendments also addressed 
``the need to have consistent, enforceable rules pertaining to the 
claims that may be made with respect to the benefits of nutrients in 
foods.'' (See H. Rept. No. 538, 101st Cong., 2d sess., at 8 (1990).) It 
is likely that new, more healthful products that qualify for claims 
will be introduced. Yet newly developed foods can present situations 
that challenge FDA's traditional enforcement tools of inspection and 
sample analysis.
    When FDA issued the regulations implementing the 1990 amendments, 
the agency determined that, in certain situations, adequate enforcement 
of the new regulations would be possible only if the agency could 
review the information that a manufacturer had developed to support the 
statements on its food labels. One such situation is aeration, a 
technique now being used to reduce the fat and calorie content of 
foods. (See the January 6, 1993, final rule on serving sizes (58 FR 
2229 at 2271).) Comments on the proposed rule on serving sizes argued 
that manufacturers of aerated foods should be permitted to substitute a 
volume-based measure for a weight-based reference amount as the basis 
for determining the product's serving size. FDA determined that the 
most reasonable solution was to allow manufacturers to determine a 
``density-adjusted reference amount'' for their aerated foods. Under 
the final regulations, however, manufacturers who choose this approach 
must have available upon request certain information, including a 
detailed protocol and records of all data used to arrive at the 
density-adjusted reference amount (58 FR 2272; Sec. 101.12(e)), 
available for inspection by FDA. -
    FDA also found it necessary to impose a records requirement for 
claims such as ``light,'' which compare the amount or percentage of a 
nutrient in one product to a reference nutrient value derived from one 
of a variety of sources (e.g., a representative valid data base or an 
average value determined from the top three national brands). In 
issuing its final regulation on nutrient content claims, the agency 
required that:

    to fully inform consumers, firms that use a broad based 
reference nutrient value as a basis for a claim must be prepared to 
make information on how they derived the reference nutrient value 
available to consumers on request. In addition, the information must 
also be made available to appropriate regulatory officials on 
request. This additional requirement will assist regulatory 
officials in determining compliance with the requirements for 
appropriate reference nutrient values for products bearing a claim 
to ensure the claim is not false or misleading.

(58 FR 2302 at 2365, January 6, 1993; nutrient content claims, general 
principles final rule.) The agency codified this requirement at 
Sec. 101.13(j)(1)(ii)(A).
    Another example of the agency's need to examine supporting 
information arose with respect to the caloric content of new products 
with reduced digestibility, such as novel fats and carbohydrates (58 FR 
2079 at 2111, January 6, 1993; mandatory status of nutrition labeling, 
final rule). The agency stated that it would consider the digestibility 
of new products on a case-by-case basis. FDA also said that those 
manufacturers who wish to declare adjusted values for the energy 
contribution of a substance, based on reduced digestibility, should 
include information on the digestibility of the substance, analytical 
assay procedures for the compound, and data on interference with 
required methods of analysis in a food additive petition or in a 
petition for affirmation that use of the substance is generally 
recognized as safe, or should provide the information to the agency by 
other appropriate means. (See 58 FR 2079 at 2087 and 2111 and 
Sec. 101.9(c)(1)(I)(D).)
    Nutrient content claims for restaurant foods presented FDA with 
difficult compliance questions, as well (58 FR 2302 at 2387). In order 
to provide a way for restaurants to make claims, FDA devised a 
``reasonable basis'' standard, under which restaurateurs who make 
nutrient content claims for their foods on labeling other than menus 
must be prepared to present to regulatory officials the basis for their 
belief that pertinent nutrient levels are present in their foods. (58 
FR 2302 at 2388 and Sec. 101.13(q)(5)(ii).) By requiring access to 
information supporting nutrient content claims, FDA sought to encourage 
the provision of useful dietary information on restaurant foods while 
maintaining its ability to assure consumers that nutrient content 
claims made for restaurant foods reasonably reflect the nutrient 
content of the food (58 FR 2302 at 2387).
    Although in some situations, such as those described above, FDA 
required that access to a manufacturer's information supporting its 
labeling claims be provided to the agency, the agency declined to adopt 
the review of nutritional analyses on file at firms as a general 
investigatory procedure (58 FR 2079 at 2110). The agency set forth 
compliance criteria in Sec. 101.9(g) that explain how its traditional 
investigatory procedures will be applied to mandatory nutrition 
labeling and, by extension, to claims made under section 403(r) of the 
act. A comment on proposed Sec. 101.9 suggested that FDA substantiate 
nutrition label information by verifying laboratory analysis results on 
file at a firm (58 FR 2079 at 2110). The comment cited, as a model for 
FDA 

[[Page 3887]]
to follow, the food labeling regulations proposed (and since made 
final) by the United States Department of Agriculture (USDA) that 
require firms to maintain records to support the validity of nutrient 
declarations contained on product labels and to make these records 
available upon request by USDA. (See 9 CFR 317.309(h)(8) and 
381.409(h)(8).) The agency responded:

    To support a misbranding charge for inaccurate nutrient content 
information, FDA must have accurate, reliable, and objective data to 
present in a court of law. To obtain that information, FDA relies 
upon the work performed by its trained employees because it does not 
have legal authority in most instances to inspect a food 
manufacturing firm's records.

(58 FR 2079 at 2110.)
    This statement reflects the fact that, unlike USDA, FDA does not 
have explicit, broad statutory authority to inspect food manufacturing 
records. However, as discussed in greater detail below, FDA may issue 
regulations for the efficient enforcement of the act, and those 
regulations may require that access to certain records be provided to 
the agency. Thus, although the statement that FDA lacks authority to 
inspect the records of a food manufacturing firm ``in most instances'' 
is generally accurate, it is also true that FDA may legally inspect a 
food manufacturing firm's records when it acts under the authority of a 
regulation that provides for records inspection.

II. Recent Enforcement Concerns

    Since the publication of its final regulations implementing the 
1990 amendments, FDA has given further consideration to the 
difficulties it expects to encounter in enforcing the new rules. When 
it issued the final rules, FDA identified and addressed the particular 
problems of which it was aware, such as aeration. Although this 
approach appeared adequate at the time the regulations were developed, 
the agency now recognizes that there may be situations that are not 
provided for in its current regulations in which it will need to have 
access to records in order to enforce the act adequately. -
    For example, circumstances may arise of the sort foreshadowed in 
the final rule authorizing health claims associating calcium with a 
reduced risk of osteoporosis. In that rule, the agency anticipated 
that:

    * * * instances may develop in which the bioavailability of the 
calcium source has not been shown, including the use of new 
fortificants or food products in which the combination of the 
component nutrients raises concerns about the assimilability of 
calcium from the product (e.g., a new bread rich in a novel high 
phytate fiber source and fortified with calcium).

(See 58 FR 2665 at 2667, January 6, 1993). In the Federal Register of 
January 6, 1994, the agency also stated that ``[c]alcium sources whose 
bioavailability has not been shown would be at risk for * * * 
enforcement action.''
    Having further considered this type of situation, the agency 
believes that it would be a far more appropriate and efficient use of 
its resources to require the manufacturer of a new food product labeled 
with a health or nutrient content claim, such as the bread described 
above, to provide the agency with access to the information that the 
manufacturer has developed to support a claim. Where a company has 
developed a product and labeled it with a health or nutrient content 
claim, and elaborate testing is required to provide the basis for the 
claim (e.g., animal tests for bioavailability, 58 FR 2665 at 2667), the 
agency should not have to duplicate those tests. Indeed, it would be 
unlikely that the agency would have the resources to do so. Thus, 
unless FDA were able to review the underlying data, companies could 
make certain claims on newly developed foods that the agency 
effectively would be unable to verify. Companies would then be in a 
position to make false labeling statements with virtual impunity.
    FDA is also concerned that the development and use of new testing 
methods may place it in the position of not having sufficient 
information to assess the accuracy of a claim. The agency has 
recognized that advances are being made in the area of nutrient 
testing. For example, in issuing its final regulation on nutrition 
labeling, the agency noted that testing for certain nutrients is being 
actively researched (see 58 FR 2079 at 2112 (cholesterol)), and that 
new testing methods are being developed (see 58 FR 2079 at 2113 
(sugars)). The agency said that it would not ``preclude [companies'] 
use of emerging technologies * * * as they are developed and 
validated,'' (58 FR 2079 at 2113), but that, for compliance purposes, 
it would continue to use the methods of the Association of Official 
Analytical Chemists (AOAC) International or other validated procedures 
(58 FR 2079 at 2109). However, FDA now expects that there may be 
situations in which this approach is inadequate; for example, where 
there is no AOAC or other validated method applicable to a particular 
food, and a manufacturer has used a new testing method to determine 
that its food qualifies to bear a claim. Such a case might involve a 
novel form of fat that requires the use of unconventional analytical 
methods (58 FR 2079 at 2087).
    New foods and new testing techniques are two matters about which 
the agency has enforcement concerns. The agency does not wish to stand 
in the way of the development of new technology and of new foods by 
limiting companies to conventional manufacturing techniques and 
analytical methods, and FDA believes that to do so would be 
fundamentally inconsistent with the purpose of the 1990 amendments. 
(See 136 Congressional Record, S 16610, October 24, 1990, statement of 
Senator Hatch, stating that Congress ``should not deter'' the benefits 
of new, more healthful foods for the consumer.) However, the only way 
that the agency can avoid doing so, and still enforce the act 
effectively, is if it is able to examine certain relevant records.
    The agency also has concerns about claims that are based on 
information about a food that is available only to the food 
manufacturer and without which the agency would be unable to evaluate 
the truthfulness of the claim. ``Light'' provides an example of this 
type of claim. Without information on what the company has used as its 
reference nutrient value, FDA cannot determine whether the claim 
accurately describes the food. An inflexible approach would be to 
prohibit these claims altogether. However, FDA believes that it is 
consistent with the 1990 amendments to permit certain useful nutrition-
related information in food labeling if the agency can be assured that 
the information accurately describes the labeled food.
    Under section 403(r)(2)(C) and (r)(2)(D) of the act, certain foods 
bearing nutrient content claims as part of their brand names are exempt 
from requirements contained in section 403(r)(2) of the act, if the 
brand name was in use for the food before October 25, 1989 
(Sec. 101.13(q)(1) and (q)(2)). Without access to company records, FDA 
will often not be able to determine whether a food that is asserted to 
qualify for this ``grandfather'' provision actually qualifies; i.e., 
whether the name was in use prior to October 25, 1989, and whether the 
food is unchanged. As with the claim ``light,'' this information may be 
available only to the food manufacturer. FDA's tentative view is that 
companies that take advantage of this exemption should be prepared to 
demonstrate to FDA that the food for which they claim the exemption 
qualifies for it.

[[Page 3888]]

    The regulations that FDA is now proposing are designed both to 
ensure that the agency's ability to enforce the 1990 amendments is not 
compromised and to avoid significant interference with the development 
of new food technologies and more healthful foods. The circumstances 
described above establish a need for FDA to have access to records in 
particular situations; this rule is intended to address those 
situations. The agency expects that the concerns it has identified will 
arise primarily with respect to foods bearing claims (e.g., a new food 
designed specifically to meet the requirements of a nutrient content 
claim). Therefore, although the proposed regulations are limited in 
scope to health and nutrient content claims, the agency expects that 
they will be sufficient to enable it to enforce the provisions of the 
1990 amendments and the regulations implementing those amendments, and 
it does not at this time anticipate extending these proposed 
requirements to other situations.

III. Legal Authority

     When Congress enacted the 1990 amendments, it sought to ensure 
that the rules pertaining to health and nutrient content claims would 
be enforceable (see H. Rept. 538, 101st Cong., 2d sess. 8, 9 (1990)). 
Health and nutrient content claims are intended to make the consumer 
aware of the nutritional attributes of the labeled food. Because these 
claims are meant to help consumers maintain healthful dietary 
practices, it is of the utmost importance that they accurately reflect 
the nutritional composition of the labeled food. (See 136 Congressional 
Record, H 12953, October 26, 1990, statement of house floor managers: 
``There is a great potential for defrauding consumers if food is sold 
that contains inaccurate or unsupportable health claims.'')
     The agency expects that many advances in food technology will 
occur that will provide the basis for claims, as food products are 
designed to meet the requirements for particular health and nutrient 
content claims. These developments, although beneficial, have the 
potential, as stated above, to outstrip the agency's traditional 
enforcement tools. This proposal is intended to address this problem. 
By enabling manufacturers to provide valuable information to consumers, 
while ensuring that the agency has the ability to verify that 
information, the regulations being proposed will serve the interests of 
both manufacturers and consumers. Food manufacturers will be able to 
profit from the advances that they make by marketing foods with claims 
that make the foods attractive to consumers, yet consumers and 
competitors can be confident that the agency has the tools to ensure 
that the claims appropriately appear on the foods that bear them. Thus, 
consumers will be able to rely on the claims to structure their diet in 
a manner that allows them to achieve their dietary goals.
    FDA may require records to be maintained in specific instances and 
may inspect those required records, despite the act's lack of express, 
general statutory authority to inspect records. The Supreme Court has 
recognized that FDA has authority that ``is implicit in the regulatory 
scheme, not spelled out in haec verba'' in the statute. (See Weinberger 
v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973).)

    Indeed: it is a fundamental principle of administrative law that 
the powers of an administrative agency are not limited to those 
expressly granted by the statutes, but include, also, all of the 
powers that may fairly be implied therefrom. * * * In the 
construction of a grant of powers, it is a general principle of law 
that where the end is required the appropriate means are given and 
that every grant of power carries with it the use of necessary and 
lawful means for its effective execution.

(Morrow v. Clayton, 326 F.2d 35, 44 (10th Cir. 1963).)
    Under section 701(a) of the act (21 U.S.C. 371(a)), the agency may 
issue regulations for the efficient enforcement of the act. Courts have 
recognized that FDA may impose recordkeeping requirements where they 
effectuate the act's goals. (See Toilet Goods Association v. Gardner, 
387 U.S. 158, 163-64 (1967); and National Confectioners Association v. 
Califano, 569 F.2d 690, 693 & n.9 (D.C. Cir. 1978).) The agency has 
required that records be maintained and made available for inspection 
by FDA employees in a number of situations. (See, e.g., 21 CFR 
108.25(g) and 114.100 (acidified foods); 108.35(h) and 113.100 (thermal 
processing of low-acid foods); part 129 (21 CFR part 129) (bottled 
drinking water); 172.320 (amino acids); 176.170 (components of paper 
and paperboard in contact with aqueous and fatty foods); and 179.25(e) 
(food irradiation).)
    FDA has tentatively determined that the proposed requirements, 
which would cover only those health and nutrient content claims that 
pose particular enforcement difficulties, are necessary for the 
efficient enforcement of the act. Ensuring the accuracy of claims was 
an overriding concern of Congress in passing the 1990 amendments. 
Congress envisioned that, under the act as amended, ``only truthful 
claims may be made on foods'' (136 Congressional Record H 12953, 
October 26, 1990, statement of Representative Waxman. See also 136 
Congressional Record H 12954, statement of Representative Moakley: 
``This bill will help curb misleading claims * * *.''; and H. Rept. 
538, 101st Cong., 2d sess. 21 (1990): ``The [health] claim on the food 
label or labeling would have to be stated in a manner which accurately 
represented the substance of the regulation * * *.'') By its terms, 
section 403(r) of the act (21 U.S.C. 343(r)(1)) applies to claims made 
``for'' a food ``in the label or labeling of the food.'' In order for a 
claim ``for'' a food to be truthful, it must accurately describe the 
labeled food. A food labeled ``low fat'' must meet the definition of 
``low fat'' in 21 CFR 101.62(b) and any other applicable requirements. 
Similarly, a food bearing a health claim relating calcium intake to the 
risk of osteoporosis must, among other things, actually provide the 
consumer with a ``high'' amount of calcium (Sec. 101.72(c)(2)(ii)).
    It is implicit in the 1990 amendments that a manufacturer who 
places a health or nutrient content claim in food labeling must have 
knowledge that the food qualifies to bear the claim. Congress expected 
that manufacturers would have to ascertain the nutritional attributes 
of their food products, through laboratory analysis or otherwise, in 
order to label those products properly. (See H. Rept. 538, 101st Cong., 
2d sess. 14 (1990), stating that nutrient definitions will enable 
manufacturers to ``know the type of analysis to conduct on the food.'') 
FDA has previously stated that a food manufacturer is responsible for 
the accuracy of its food labels (58 FR 2079 at 2163 and 2165). Indeed, 
placing a claim in food labeling that calls the consumer's attention to 
the food's nutritional characteristics is a representation that the 
manufacturer has evidence that the food meets the requirements for the 
claim.\1\ Thus, making a claim without such a basis 

[[Page 3889]]
would be misleading, in violation of section 403(a) of the act.

    \1\ Cf. Aerosolized food, drug, and cosmetic products, proposed 
rule; 38 FR 6191 at 6192, March 7,, 1973, (``[W]ith respect to the 
safety of cosmetics, [the act] necessarily contemplates that the 
manufacturer or distributer has obtained all data and information 
necessary and appropriate to substantiate the product's safety 
before marketing. Any cosmetic product whose safety is not 
adequately substantiated prior to marketing may be adulterated and 
would in any event be misbranded unless it candidly and prominently 
warns that the safety of the product has not been adequately 
determined.'') Thompson Medical Co., Inc. v. FTS, 791 (1987) (``[I]n 
general an advertisement is considered deceptive if the advertiser 
lacks a `reasonable basis' to support the claims made in it.''
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    The agency anticipates, and hopes, that in some instances companies 
will be amenable to demonstrating to FDA how particular values were 
calculated, regardless of the existence of these regulations. In the 
mandatory status of nutrition labeling final rule, the agency noted 
that: ``A few comments expressed the position that FDA should not 
declare a product misbranded until the manufacturer has had an 
opportunity to establish that the variations are reasonable under the 
circumstances'' (58 FR 2079 at 2162). Moreover, the agency considers 
that, when a product bears a claim based on information available 
solely to the manufacturer, it is reasonable for the agency to have 
access to that information. (See United States v. An Article of Device, 
731 F.2d 1253, 1261-62 (7th Cir. 1984) (upholding regulation requiring 
makers of prescription devices to be able to prove that their devices 
work safely for their intended purposes and stating that ``[w]here the 
government's access to the necessary information may be limited * * * 
it seems not inappropriate to put the burden of persuasion on the party 
who * * * presumably has better access to the relevant information''.) 
(See also Trans-American Van Service, Inc. v. United States, 421 F. 
supp. 308, 331 (N.D. Tex. 1976).)-
    In section 3(b) of the 1990 amendments, Congress specifically 
directed FDA to issue regulations implementing section 403(r) of the 
act, and FDA has done so. Congress clearly contemplated that, in these 
regulations, the agency would not only define certain terms used in 
claims but would also determine the circumstances when claims can be 
made (see 136 Congressional Record H 5841, July 30, 1990, (``[T]he 
secretary is required, in the regulations, to define the circumstances 
under which statements disclosing the amount and percentage of 
nutrients in food will be permitted.''); 136 Congressional Record H 
12953, October 26, 1990, (defined terms ``will have to be used in a 
manner that is consistent with the FDA's definition.''); and 136 
Congressional Record S 16609, October 24, 1990, statement of Senator 
Metzenbaum:

    [T]he bill does not specify how the term `light' should be 
defined or how the Secretary should permit the term to be used. 
However, the bill gives the Secretary broad authority to develop an 
appropriate definition, so the Secretary certainly could consider 
permitting the term `light' to be used in the manner * * * 
describe[d].)

FDA is now proposing to amend the general requirements for nutrient 
content and health claims in Sec. Sec. 101.13 and 101.14 so that 
manufacturers who choose to place certain claims on the food label or 
in labeling may do so only if they keep the information on which the 
claim is based and make it available to appropriate regulatory 
officials upon request. Failure to meet the requirements by maintaining 
appropriate records and complying with an agency request to examine 
those records will be a violation of section 403(r) of the act, 
misbranding the food bearing the claim.

IV. The Proposal

    FDA is now proposing that manufacturers who place certain types of 
claims on the labels or labeling of food be required to maintain the 
information upon which they have relied in determining that the food 
meets the requirements for the claims and to make it available to the 
agency upon request. The agency proposes that the claims covered by 
this requirement will be those based on new food technology (e.g., 
novel ingredients such as fat substitutes) or a new use of a food 
technology (e.g., manufacturing methods such as aeration), those based 
on the results of novel or nonstandardized testing procedures (e.g., 
where there is no applicable AOAC or other validated method), and those 
which the agency cannot evaluate without such information (e.g., 
because they are based on information available only to the 
manufacturer). The agency believes that these three categories 
encompass the areas of enforcement difficulty that it has already 
encountered in developing its new food labeling regulations and those 
that it can expect in the future, as advances in food technology are 
made.
    Compliance with the proposed regulations would not entail the 
creation of any new information or the compilation of any special 
records. Rather, the proposed recordkeeping requirement would obligate 
manufacturers simply to keep and provide FDA with information that they 
should already possess. Adequate records may consist of results of 
direct product analyses, data base values or recipe calculations, or a 
combination of direct analyses, data base values, and recipe 
calculations.
    The agency anticipates that manufacturers may have concerns about 
the confidentiality of the information inspected by the agency under 
this regulation. Manufacturers should be assured that FDA does not and 
would not release information that would provide a competitive 
advantage to another manufacturer (21 CFR 20.61). For example, if a 
company's records that support the validity of a labeling statement 
contain confidential information describing product formulation, 
manufacturing processes, or unique testing methods, the agency would 
protect this information from public disclosure (21 CFR 20.61). (See 
also 5 U.S.C. 552(b)(4); 18 U.S.C. 1905; and 45 CFR 5.65.)

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) 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. Analyis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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). The agency estimates 
that this proposed rule would cause some incremental cost of 
developing, maintaining, and storing information above what food firms 
would normally experience. However, the agency anticipates these costs 
will be small. Therefore, the agency finds that the proposed rule is 
not a significant regulatory action as defined by the Executive Order 
and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because any records or necessary documents would be 
ones that any responsible firm would create and maintain in the normal 
course of business, the agency certifies that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains record retention requirements that are 
subject to public comment and to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 
and 3507). 

[[Page 3890]]
Therefore, in accordance with 5 CFR part 1320, a description of the 
record retention requirements is given below with an estimate of the 
annual collection of information burden. Included in the estimate is 
the time for reviewing instructions, gathering necessary data, and 
maintaining the required records.
    FDA is soliciting comments to: (1) Evaluate whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information will 
have practical utility; (2) evaluate the accuracy of the agency's 
estimate of the burden of the proposed collection of information; (3) 
evaluate the quality, utility, and clarity of the information to be 
collected; and (4) minimize the burden of the collection of information 
on those who are to respond, including through the use of automated 
collection techniques or other forms of information technology, when 
appropriate.
    Title: Record Retention Requirements for Nutrient Content Claims 
and Health Claims.
    Description: FDA has previously issued regulations that prescribe 
nutrient content claims (Sec. 101.13 and subpart D) and health claims 
(Sec. 101.14 and subpart E) that may be used on the label or labeling 
of a food. The proposed rule would establish a requirement that, in 
certain circumstances, persons responsible for the labeling of foods 
with nutrient content claims and health claims maintain the records 
upon which they rely as the basis for those claims. The proposal would 
also require that those records be made available to appropriate 
regulatory officials upon request. The proposed regulation does not 
specify the records that must be retained or the format in which they 
must be retained but proposes that they be the ones which form the 
basis for the claims. Thus, the agency believes that the proposed 
provisions will add only a minor additional record retention burden for 
firms subject to the proposed provisions.
    Description of Respondents: Persons and businesses, including small 
businesses.

                                                                                                                                                        
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                                                   Estimated Annual Reporting and Recordkeeping Burden                                                  
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                        No. of Responses Per                                                                                Total Operating/ Maintenance
   21 CFR Section            Respondents         Total Annual Responses     Hours Per Response       Total Annual Hours                Costs            
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101.13 and 101.14     10                        1,000                    1                        1,000                    $46,000                      
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    The agency has submitted copies of the proposed rule to OMB for its 
review of these recordkeeping requirements. Interested persons are 
requested to send comments regarding information collection by March 4, 
1996, but not later than April 2, 1996 to the Office of Information and 
Regulatory Affairs, OMB, rm. 1035, New Executive Bldg., Washington, DC 
20503, ATTN: Desk Officer for FDA.

VIII. Comments

    Interested persons may, on or before April 17, 1996, 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.

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: 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).

    2. Section 101.13 is amended by revising paragraph (o) and by 
adding new paragraph (s) to read as follows:


Sec. 101.13  Nutrient content claims--general principles.-

* * * * *
    (o) Except as provided in Sec. 101.10 and in this paragraph, 
compliance with requirements for nutrient content claims in this 
section and in the regulations in subpart D of this part will be 
determined using the analytical methodology prescribed for determining 
compliance with nutrition labeling in Sec. 101.9. With respect to those 
foods covered by paragraph (s) of this section, compliance may be 
determined by reviewing the records required to be kept under paragraph 
(s) of this section.
* * * * *
    (s) Each person responsible for the labeling of a food that bears a 
nutrient content claim defined in subpart D of this part that is based 
on:
    (1) A new food technology (e.g., novel ingredients such as fat 
substitutes) or a new use of a food technology (e.g., manufacturing 
method such as aeration);
    (2) Novel or nonstandardized testing procedures (e.g., where there 
is no applicable Association of Official Analytical Chemists method or 
other reliable and appropriate analytical procedure); or
    (3) Information available only to the person responsible for the 
labeling, and which the agency cannot evaluate without such 
information, shall maintain, for as long as the food is marketed, all 
records that demonstrate that the food meets the requirements in this 
section and in the applicable regulation in subpart D of this part. 
These records shall be made available for authorized inspection and 
copying by appropriate regulatory officials and shall be submitted to 
those regulatory officials upon request.
    3. Section 101.14 is amended by adding new paragraph (h) to read as 
follows:


Sec. 101.14   Health claims: general requirements.

* * * * *
    (h) Records. Each person responsible for the labeling of a food 
that bears a health claim provided for in subpart E of this part that 
is based on:
    (1) A new food technology (e.g., novel ingredients such as fat 
substitutes) or a new use of a food technology (e.g., manufacturing 
method such as aeration);
    (2) Novel or nonstandardized testing procedures (e.g., where there 
is no applicable Association of Official Analytical Chemists method or 
other 

[[Page 3891]]
reliable and appropriate analytical procedure); or
    (3) Information available only to the person responsible for the 
labeling, and which the agency cannot evaluate without such 
information, shall maintain, for as long as the food is marketed, all 
records that demonstrate that the food meets the requirements in this 
section and in the applicable regulation in subpart D of this part. 
These records shall be made available for authorized inspection and 
copying by appropriate regulatory officials and shall be submitted to 
those regulatory officials upon request.

    Dated: December 12, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-2153 Filed 2-1-96; 8:45 am]
BILLING CODE 4160-01-F