[Federal Register Volume 61, Number 246 (Friday, December 20, 1996)]
[Proposed Rules]
[Pages 67243-67260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32124]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 61, No. 246 / Friday, December 20, 1996 / 
Proposed Rules  

[[Page 67243]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 96N-0421 and 94P-0453/CP1]


Food Labeling: Nutrient Content Claims Pertaining to the 
Available Fat Content of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its food labeling regulations to provide for the use of nutrient 
content claims on the food label or in labeling based on the reduced 
availability of fat to the body from the food because of the use of a 
fat substitute ingredient in the food. This proposal responds, in part, 
to a citizen petition on the use of digestibility coefficients in 
determining the quantity of fat declared on a food label. FDA is 
undertaking this action to encourage innovation on the part of food 
manufacturers and to foster a situation that will provide increased 
product choices for consumers in achieving dietary goals.

DATES: Submit written comments by April 21, 1997. Submit written 
comments on the information collection requirements by January 21, 
1997. The agency is proposing that any final rule that may issue based 
upon this proposed rule become effective 30 days after its date of 
publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Submit written comments on the information 
collection requirements to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Washington, 
DC 20503, ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5763.

SUPPLEMENTARY INFORMATION:

I. Background

A. The 1990 Amendments and Implementing Regulations

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) and the final regulations that implement the 1990 
amendments (58 FR 2066, January 6, 1993, as modified at 58 FR 44020, 
August 18, 1993) provided for a number of fundamental changes in how 
food is labeled, including requiring that nutrition labeling appear on 
most foods and establishing that terms that characterize the level of a 
nutrient in a food may not be used in food labeling unless defined by 
FDA.
    The 1990 amendments added section 403(q) to the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 343(q)), which requires that most 
food bear nutrition labeling. In response to this provision, in the 
January 6, 1993, final rule on nutrition labeling (entitled ``Food 
Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content 
Revision, Format for Nutrition Label,'' (the nutrition labeling final 
rule (58 FR 2079)), FDA prescribed how nutrition labeling is to be 
provided on the foods that are regulated by the agency. Among other 
things, the agency required that the nutrition label include 
information on total calories and calories from fat and on the 
quantitative amounts of specified nutrients (e.g., total fat, saturated 
fat, total carbohydrate, and dietary fiber) per serving.
    In the nutrition labeling final rule (58 FR 2079 at 2110), FDA 
recognized that many food ingredients have caloric values substantially 
different from the general factors of 4, 4, and 9 calories per gram (g) 
for protein, carbohydrate, and fat, respectively. Therefore, the agency 
provided a number of options for calculating the energy value of foods. 
For example, FDA stated that calories may be calculated, under 
Sec. 101.9(c)(1)(i)(A) (21 CFR 101.9(c)(1)(i)(A)), by using specific 
Atwater factors given in Table 13 ``Energy Value of Foods-Basis and 
Derivation,'' U.S. Department of Agriculture (USDA) Handbook No. 74; 
under Sec. 101.9(c)(1)(i)(C), by multiplying the general factor of 4 
calories per g by the amount of total carbohydrate less the amount of 
insoluble dietary fiber; under Sec. 101.9(c)(1)(i)(D), by using data 
for specific energy factors for particular foods or ingredients 
approved by FDA through the food additive or generally recognized as 
safe (GRAS) petition processes in parts 170 and 171 (21 CFR parts 170 
and 171) and provided in parts 172 or 184 (21 CFR parts 172 or 184); or 
under Sec. 101.9(c)(1)(i)(E), by using bomb calorimetry data.
    FDA also defined the basic nutrients that are to be declared as 
part of the nutrition label (58 FR 2079 at 2086). In particular, FDA 
defined ``total fat'' as total lipid fatty acids expressed as 
triglycerides (Sec. 101.9(c)(2)) and ``saturated fat'' as the sum of 
all fatty acids containing no double bonds (Sec. 101.9(c)(2)(i) (58 FR 
2079 at 2089)).
    In addition to adding section 403(q) on nutrition labeling to the 
act, the 1990 amendments added section 403(r) on nutrient-related 
claims and, in particular, section 403(r)(1)(A) of the act, which 
states that a food is misbranded if it bears a claim in its label or 
labeling that expressly or implicitly characterizes the level of any 
nutrient of the type required to be declared in nutrition labeling 
unless the claim is made in accordance with section 403(r)(2) of the 
act. Section 403(r)(2)(A)(i) of the act states that a claim may be made 
only if the characterization of the level made in the claim uses terms 
that are defined in regulations of the Secretary of the Department of 
Health and Human Services.
    In the Federal Register of January 6, 1993 (58 FR 2302), FDA 
published a final rule (entitled ``Food Labeling: Nutrient Content 
Claims, General Principles, Petitions, Definitions of Terms; 
Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and 
Cholesterol Content of Food,'' hereinafter referred to as ``the 
nutrient content claims final rule'') that implemented the nutrient 
content claims provisions of the act by establishing general rules for 
how such claims are to be made and defining various terms (e.g., 
``high,'' ``low,'' ``free,'' and ``reduced'') that could be used to 
characterize the level of various nutrients in the food.

[[Page 67244]]

    FDA noted that its approach to developing a system of nutrient 
content claims emphasized three objectives: (1) Consistency among 
definitions, (2) claims that are consistent with public health goals, 
and (3) claims that will help consumers to maintain healthy dietary 
practices (58 FR 2302 at 2319). The agency stated that it is important 
for effective consumer education to establish consistent definitions 
for descriptive terms whenever possible to limit the possibility of 
consumer confusion (58 FR 2302 at 2319).

B. Citizen Petition

    Nabisco Group (Nabisco) (hereinafter ``the petitioner'') submitted 
a citizen petition (filed December 21, 1994, Docket No. 94P-0453/CP1) 
requesting that FDA amend its food labeling regulations to permit the 
use of a ``digestibility coefficient'' or ``food factor'' in 
determining the quantity of fat to be declared on the nutrition label 
and to permit nutrient content claims to be based on the quantity of 
fat declared. According to the petitioner, this action would permit 
claims on a class of products that contain significantly less available 
fat compared to an appropriate reference food but that may not qualify 
to bear a calorie claim or a fat claim based on the total analytically-
determined amount of fat in the food. The petitioner asserted that the 
nutritional benefit of foods with reduced available fat is similar to 
that of foods with reduced total fat, and that providing for claims on 
foods that contain significantly less available fat would further FDA's 
goal of promoting healthier diets by encouraging product innovation. 
The petitioner noted that the costs of development and reformulation 
for the use of manufactured fat substitutes, such as salatrim, make 
them much more expensive to use than fats from traditional sources. The 
petitioner maintained that, unless manufacturers are able to promote 
the beneficial aspects of products containing these ingredients, they 
would have no incentive to develop or use them. Thus, the petitioner 
continued, it is imperative that manufacturers be able to make claims 
for foods containing fat substitutes with reduced availability.
    Specifically, the petitioner requested that FDA 
amendSec. 101.9(c)(2) by inserting the following language at the end of 
the first paragraph in that section:
    Fat content may be calculated by applying a food factor to the 
actual amount of fat present per serving, using specific food 
factors for particular foods or ingredients approved by FDA and 
provided in parts 172 or 184 of this chapter, or by other means as 
appropriate.
The requested change would allow the amount of total fat present per 
serving to be multiplied by a specific factor approved by FDA, to yield 
the quantity of fat that is to be declared in nutrition labeling, even 
though the declared value may be less than the actual amount of fat in 
the food. The approach suggested by the petitioner, that the factor 
used to calculate available fat content be approved by FDA, is similar 
to the approach taken by FDA in Sec. 101.9(c)(1)(i)(D), which provides 
that specific food factors may be used to calculate total caloric 
content declared in nutrition labeling if they have been approved by 
FDA and provided for in part 172, part 184, or by other means as 
appropriate. The petitioner also suggested that the agency could permit 
self-determination of a food factor for calculating nutrient 
availability by a manufacturer, pending agency review of a GRAS 
petition for the ingredient to which the factor applies.
    The petitioner noted, for example, that it had filed a GRAS 
petition for salatrim (GRASP 4G0404) that proposed a food factor of 5/9 
for this ingredient.\1\ The petitioner maintained that the amount of 
available (i.e., absorbed/digestible) fat in an ingredient should be 
reflected in the ``food factor'' or ``digestibility coefficient'' for 
that ingredient. The petitioner went on to suggest that manufacturers 
be permitted to make fat reduction claims for products that claim the 
amount of available fat as opposed to the chemically analyzed quantity 
of fat in the food.
---------------------------------------------------------------------------

    \1\ Dietary fats consist of one, two, or three fatty acid 
molecules attached to a glycerol backbone (i.e., mono-, di-, or 
triglycerides). Salatrim is a manufactured fat substitute in which 
the manufacturer controls the fatty acid composition of the 
triglyceride. Salatrim is the trade name for a family of 
triglycerides that contain one or two long chain fatty acids, 
primarily stearic acid (C18:0, 50 to 60 percent by weight), and one 
or two short chain fatty acids, primarily acetic acid (C2:0) and 
propionic acid (C3:0), randomly attached to the glycerol backbone. 
The stearic acid component is incompletely absorbed, as addressed in 
the current petition. The short chain fatty acids are fully 
absorbed, but they have a lower energy value than long chain fatty 
acids that comprise dietary fats. Thus, the reduction in energy from 
salatrim compared to conventional dietary fats is derived in part 
from the incomplete absorption of stearic acid and, in part, from 
the low energy value of the short chain fatty acids. In combination, 
these two factors have been estimated by the petitioner to result in 
a caloric value that is approximately 55 percent (5/9) of the energy 
value of conventional fats (i.e., a food factor of 55 percent, 
according to the definition of terms in section II.A. of this 
document). The digestibility coefficient, which addresses only the 
availability of fat, would consider only the incomplete absorption 
of stearic acid from this ingredient.
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    Additionally, the petitioner requested that FDA amend 
Sec. 101.9(c)(2) to provide that a food factor be used to calculate the 
quantity of all fatty acids (i.e., saturated fat, polyunsaturated fat, 
and monounsaturated fat) declared on the nutrition label.

II. Agency Response

A. Definition of Terms

    To understand the issues raised by the petition, and the agency's 
response to those issues, it is important to distinguish among three 
terms, ``bioavailability'' or ``availability,'' ``food factor,'' and 
``digestibility coefficient.'' These terms are often used 
interchangeably but have substantially different meanings. The agency's 
approach to how energy and nutrient values are declared in nutrition 
labeling is determined by the differences among these terms.
    FDA notes that bioavailability is the result of a series of complex 
events, i.e., digestion, absorption, and metabolism (Ref. 1). Digestion 
refers to the chemical and physical breakdown of food and its 
macromolecular components in the gastrointestinal tract (e.g., the 
breakdown of triglycerides (fats) into fatty acids and glycerol). 
Absorption refers to the intestinal absorption of the component 
molecules (e.g., fatty acids). The mechanisms of reduced availability 
of a fat substitute may vary for different ingredients. Some products 
are less available because they are resistant to chemical (e.g., 
enzymatic) digestion (e.g., olestra). Other products exploit less 
efficient absorption of certain compounds, such as long chain and very 
long chain fatty acids (e.g., salatrim and caprenin).
    FDA will use the term ``available'' to refer to the portion of a 
fat substitute that is physiologically available from a food, i.e., 
that portion that is digested, absorbed, and metabolized, or, more 
simply, the proportion of the consumed fat substitute that can be 
utilized. The prefix ``bio'' in ``bioavailable'' denotes that a 
biological attribute is being discussed as opposed to, some other type 
of availability, e.g., availability within the marketplace. However, 
based on the context in which the agency expects the term to be used 
(i.e., fat availability), FDA does not anticipate that the term 
``availability'' will be confused with other forms of availability. 
Thus, for the purposes of this rulemaking, and consistent with current 
scientific literature, the term ``available'' will be used as a synonym 
to the term ``bioavailable'' to describe the effects of different 
mechanisms in

[[Page 67245]]

reducing the digestion and absorption of fat substitutes.
    The term ``food factor'' will be used to refer to those factors 
(i.e., Atwater factor, general food factor, and specific food factor) 
that are used to calculate energy value (total caloric content) of a 
food or ingredient (Sec. 101.9(c)(1)(i)) or to calculate the amount of 
calories in a food that it derives from the fat component of the food 
(Sec. 101.9(c)(1)(ii)). It is important to note that energy values vary 
for different classes of nutrients or ingredients and for ingredients 
within a class (e.g., different fats). The general factors of 4, 4, and 
9 calories per g for carbohydrates, protein, and fat, respectively, are 
general factors (i.e., a rule of thumb) that may be used to approximate 
the energy content of foods containing common dietary carbohydrates, 
protein, and fats. The use of more specific factors to calculate the 
energy value of a food increases the accuracy of the value (Ref. 2).
    The term ``digestibility coefficient'' is used extensively in 
scientific literature to refer to the multiplicand used to calculate 
the amount of a nutrient that is physiologically available (Refs. 3 and 
4). In this document, FDA will use the term ``digestibility 
coefficient'' to represent the factor used to calculate fat 
availability.
    Food factors and digestibility coefficients do not necessarily 
refer to the same thing. As noted above, when food factors for specific 
ingredients are available that are more accurate than the general 
factors, their use increases the accuracy of the calculation of the 
total energy value for the food. Specific food factors reflect the 
different parameters, including but not limited to availability, that 
affect the amount of energy that may be derived from a particular food 
or ingredient. It may be possible, under certain circumstances (e.g., 
when a 50 percent reduction in availability of a fat substitute results 
in a proportionate reduction in the energy value of the ingredient), to 
use the same number to calculate both energy value and fat availability 
for a food or an ingredient. However, the energy values of different 
food components may vary because of parameters unrelated to reduced 
availability, such as differences in molecular weight and heat of 
combustion.
    Reduced availability will reduce the amount of calories that derive 
from a particular food component because only part of the component can 
be absorbed. However, different nutrients (e.g., fat, carbohydrate, and 
protein) and different food components within a class (e.g., fats 
composed of different fatty acids) may be essentially 100 percent 
available and still have different energy values. Very short chain 
fatty acids, for example, are at the lower end of the energy value 
range compared to longer chain fatty acids. In fact, a reduced calorie 
fat ingredient can be made by combining fat components that have a 
lower energy value because of reduced availability with components that 
are naturally lower in energy but that are fully available (as is the 
case with salatrim). Therefore, when the energy value and the nutrient 
availability of a fat substitute are reduced, but not proportionately 
(such as when the fat substitute depends on two different mechanisms to 
achieve a lower energy value compared to the average value for fat, but 
only one of the mechanisms relates to the availability of the 
nutrient), the food factor used to calculate available calories would 
be expected to differ from the digestibility coefficient used to 
calculate the availability of the fat.
    Comments are requested on these definitions of terms and the 
tentative conclusions resulting from their use.

B. Current Position

    In its discussion of total fat in the nutrition labeling final rule 
(58 FR 2079 at 2087), FDA responded to a number of comments that 
requested that fat be defined to exclude various types of long chain 
fatty acids because of their poor availability. These comments asserted 
that ``total fat'' should be defined as ``total digestible fat'' to 
allow for the use of fat-type ingredients that have reduced 
digestibility and, therefore, provide fewer calories per g than the 
fats that they replace.
    In response to these comments, FDA acknowledged the effect that the 
use of fats that contain very long chain (longer than 18 carbons) fatty 
acids with reduced digestibility have on the available fat and calorie 
content of foods. FDA stated that, in an effort to encourage innovation 
in the creation of products that provide lower fat and calorie 
contents, it was willing to consider the digestibility of novel fat 
compounds (58 FR 2079 at 2087). In fact, as stated above, 
Sec. 101.9(c)(1)(i)(D) provides for calculating the caloric content of 
foods and ingredients, including fat substitutes, using a specific food 
factor approved by FDA. However, FDA concluded that, because of the 
diversity of possible products, it was not appropriate to modify the 
definition of ``total fat'' in Sec. 101.9(c)(2) (58 FR 2079 at 2087). 
That definition, i.e., ``total lipid fatty acids expressed as 
triglycerides,'' represents all fatty acids obtainable from a total 
lipid extraction (58 FR 2079 at 2087), and, by maintaining this 
definition, FDA not only included all sources of fatty acids that 
provide energy in the amount of fat to be declared in nutrition 
labeling but the nondigestible fatty acids as well.
    Rather than modifying the definition, the agency stated that it 
would address the digestibility of novel fat compounds on a case-by-
case basis. Because the digestibility of a substance is one of the 
identifying characteristics of the substance, the agency requested that 
manufacturers who wish to declare adjusted values of total fat based on 
reduced digestibility include information on the digestibility of the 
compound, analytical assay procedures for the compound, and data on 
interference with required methods of analysis, in food additive 
petitions (part 171) on such substances or in petitions for affirmation 
that the use of such substances is GRAS (Sec. 170.35) (58 FR 2079 at 
2087).
    The agency anticipated including the specific digestibility 
coefficients that could be used in determining the quantitative 
declaration of fats and the caloric contribution from fats as part of 
the statement of identity for the substances in the listing regulations 
for them in part 172 or in the GRAS affirmation regulations in part 184 
for those whose use is affirmed as GRAS. However, FDA also recognized 
that mechanisms other than food additive or GRAS petitions may be 
appropriate to bring issues involving the digestibility of a substance 
to the attention of the agency. Thus, it suggested the mechanism in 
Sec. 101.9(g)(9) as a possible means of requesting the use of specific 
digestibility coefficients (58 FR 2079 at 2087).
    The agency also responded to a number of comments that stated that 
fatty acids with carbon chains longer than 18 (i.e., C20-C24) should 
not be categorized together with those having chain lengths of 12 to 18 
carbons as saturated fatty acids because very long chain fatty acids 
are poorly absorbed and have little or no physiological effect, e.g., 
they will not contribute to raising serum cholesterol. After reviewing 
all the comments, FDA was not persuaded to exclude any fatty acids from 
the definition of saturated fat on the basis of their physiologic 
effects. Rather, FDA defined saturated fat as ``the sum of all fatty 
acids containing no double bonds'' (58 FR 2079 at 2089). FDA did not 
address the issue of digestibility or availability of individual fatty 
acids in its discussion, but the agency noted that an inclusive 
chemical definition avoids controversy about which saturated fatty 
acids are associated with increases in blood

[[Page 67246]]

cholesterol, is consistent with general dietary guidelines recommending 
reduced saturated fat consumption, avoids under-reporting of saturated 
fat, and is more consistent with international definitions (58 FR 2079 
at 2089).
    Thus, while FDA's final regulations provide for the use of food 
factors and other options to calculate more accurately the total energy 
value of a food (Sec. 101.9(c)(1)), they do not provide for the use of 
a mechanism to calculate available fat or available saturated fat for 
nutrition labeling. The regulations require that nutrition labeling and 
claims reflect the total amount of fat and saturated fat in a food 
(i.e., ``all fatty acids obtainable from a total lipid extraction'' (58 
FR 2079 at 2087)). The only exceptions to this general requirement are 
provided in: (1) The voluntary nutrition labeling final rule for raw 
fruit, vegetables, and fish (61 FR 42742, August 16, 1996) with respect 
to total fat in orange roughy and (2) the olestra final rule in 
Sec. 172.867(e)(5).
    In regard to orange roughy, FDA notes that this fish is one of the 
few foods that contains wax esters (i.e., single fatty acids esterified 
to long chain alcohols). Because wax esters are extracted along with 
lipids during analysis, under Sec. 101.9(c)(2), nutrition labeling for 
orange roughy should reflect these wax esters in the total fat 
declaration. However, the value for fat in cooked orange roughy in 
Agricultural Handbook 8-15 (1990 Supplement), upon which FDA relied in 
developing the interim nutrition labeling values for this food, does 
not include the wax esters in the value of total fat because, as stated 
in the Handbook, the wax esters do not provide a metabolizable source 
of energy for humans (Ref. 5). In the Federal Register of July 18, 1994 
(59 FR 36379), FDA proposed to revise its guidelines for the voluntary 
nutrition labeling of raw fruit, vegetables, and fish, stating its 
intention to revise the total fat value for orange roughy to include 
the wax esters should it receive acceptable information in comments on 
its proposal. While such a revision would have made the orange roughy 
declaration of total fat consistent with declarations for other foods, 
FDA did not receive any information that would enable it to change the 
value of fat for orange roughy to include the wax esters. Accordingly, 
the nutrient values for orange roughy in part 101 (21 CFR part 101), 
appendix D continue to exclude the wax esters (61 FR 42742).
    With regard to olestra, FDA recently published a final rule 
establishing conditions of safe use for this substance as a replacement 
for fats and oils (hereinafter referred to as the ``olestra final 
rule'' (61 FR 3118, January 30, 1996)). FDA specified that olestra, a 
sucrose polyester composed of six to eight fatty acids bound to sucrose 
by ester bonds, need not be considered as a source of fat or calories 
for purposes of nutrition labeling or nutrient content claims 
(Sec. 172.867(e)(5)). This holding was based on the fact that nearly 
all ingested olestra remains intact and is not absorbed, but is 
excreted intact in the feces (61 FR 3118 at 3126). Because the fatty 
acids in olestra are not absorbed and, therefore, are unavailable to 
the body, FDA decided not to require that the fatty acids be included 
in the declaration of total fat.

C. Proposal to Allow Nutrient Content Claims Based on Fat Availability

    Having carefully considered the Nabisco petition, FDA tentatively 
concludes that there is merit in providing a generic means of allowing 
for the digestibility of fat substitutes, rather than in addressing 
this issue on a case-by-case basis as stated in the nutrition labeling 
final rule (58 FR 2079 at 2087) and as implemented in the olestra final 
rule (61 FR 3118).
    As noted in the nutrition labeling and nutrient content claims 
final rules, dietary guidance given in various reports, such as the 
Surgeon General's ``Report on Nutrition and Health'' (Ref. 6), the 
National Academy of Sciences' ``Diet and Health: Implications for 
Reducing Chronic Disease Risk'' (Ref. 7), the National Cholesterol 
Education Program's ``Report of the Expert Panel on Population 
Strategies for Blood Cholesterol Reduction'' (Ref. 8), and the 
``Dietary Guidelines for Americans'' (Ref. 9), recommends reducing the 
consumption of fat (especially saturated fat) and cholesterol by 
choosing foods that are relatively low in fat and high in 
carbohydrates. These recommendations have been carried forward in the 
recent publication of the fourth edition of the ``Dietary Guidelines 
for Americans'' (Ref. 10). Read together, these dietary guidance 
reports make clear that reducing the fat content of the American diet 
is an important public health goal.
    The issue presented by the petitioner thus becomes whether fat-
based fat substitutes with reduced availability will play a useful role 
in helping consumers to construct a healthy diet, and, if so, whether 
it is appropriate to authorize nutrient content claims based on the 
amount of available fat from such ingredients. To answer these 
questions, it is useful to understand the physiological functions of 
dietary fats and the metabolic processes necessary to achieve these 
functions. The physiological functions of fats include transporting fat 
soluble vitamins within the body, serving as structural components in 
cell membranes, serving as a source of essential fatty acids, and 
acting as precursors of certain hormones, prostaglandins, and other 
active substances. While dietary fats are insoluble in water, the 
digestion processes convert them into free fatty acids and 
monoglycerides, in which forms they are absorbed from the digestive 
tract. Products of digestion are absorbed from the intestinal lumen 
into the enterocytes (i.e., intestinal cells). The form of transport 
and ultimate fate of fatty acids depends to a large extent on chain 
length and extent of unsaturation (Refs. 11 and 12).
    Long chain fatty acids (>C12) are formed into new triglycerides and 
transported, bound to protein (i.e., lipoproteins), into intercellular 
spaces and thus into the lymphatic system. To pass through the 
capillaries of the organs in which they will ultimately be used or 
stored (e.g., adipose tissue, heart, skeletal muscle, or mammary 
gland), triglycerides must be hydrolyzed into fatty acids and glycerol. 
Shorter chain fatty acids (C18) fatty acids in place of common 
dietary fatty acids (C12-C18)? (5) Are there any safety concerns 
associated with such a shift?
    Additionally, if the proposed action does not become a final rule 
because of objections to the principle of providing for claims and 
nutrition labeling based on availability, are there other, more 
appropriate ways to inform consumers of the amount of available fat in 
a food product? Comments are requested on these issues.
    FDA has, on a number of occasions, raised the issue of nutrient 
availability. For example, in the Federal Register of August 29, 1978 
(43 FR 38575 at 38576), the agency stated that it intended to publish a 
proposal on availability requirements of iron sources used to fortify 
foods. At the time, however, FDA did not have sufficient information on

[[Page 67255]]

availability of iron from different sources or on how to best measure 
iron availability in foods. Consequently, the agency did not publish a 
proposal. Since that time, significant research has been done to 
evaluate availability of different nutrients and food components. 
Basing fat claims on amounts of available fat could set a precedent for 
doing so with other nutrients, such as iron and calcium. Is there 
sufficient data to consider labeling issues based on the availability 
of nutrients other than fat, and, if so, how might consumers be 
affected?

III. Analysis of Impacts

    FDA has examined the economic implications of the proposed rule as 
required by Executive Order 12866 and the Regulatory Flexibility Act (5 
U.S.C. 601-612). 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. If a rule has a significant impact 
on a substantial number of small entities, the Regulatory Flexibility 
Act requires agencies to analyze options that would minimize the 
economic impact of that rule on small entities. FDA finds that this 
proposed rule is not a significant rule as defined by Executive Order 
12866. Similarly, it has been determined that this rule is not a major 
rule for the purpose of congressional review (Pub. L. 104-121).
    FDA is proposing to allow the declaration of available amounts of 
fat and fatty acids in nutrition labeling when fat-based fat 
substitutes are used. FDA also is providing for definitions for claims 
based on amounts of available fat and fatty acids in a food. Currently 
available fat-based fat substitutes include such substances as 
salatrim, caprenin, and olestra. This rule will not result in any 
changes for manufacturers of products containing olestra because, in 
the food additive approval, FDA determined that olestra will not be 
counted as a fat.

A. Benefits

    If finalized, the proposal to provide an expanded definition of fat 
claims based on available fat would give manufacturers a way to promote 
products containing novel fat ingredients, thereby encouraging 
innovation and increasing consumers' product choices in planning 
healthy diets.

B. Costs

    There are two different ways in which the rule imposes costs: (1) 
Revising existing labels to reflect the new regulations; and (2) data 
gathering and premarket notification.
    Any food manufacturer currently using claims based on available fat 
for foods containing fat-based fat substitutes may have to change their 
labels to reflect the new regulations. Such labels may be changed to 
reflect proper wording of the claim as allowed by FDA. To continue to 
use the claims, manufacturers will have to alter the nutrition facts 
panel on their products so that the amount of fat that is reported 
reflects the amount that is available. FDA is aware of very few 
products containing fat-based fat substitutes on the market. FDA is 
aware of two manufacturers marketing products containing a fat-based 
fat substitute (other than olestra) for which claims are made. However, 
because of recent emphasis on reducing intakes of fat, FDA expects that 
many products containing fat-based fat substitutes will be marketed in 
the future. Because of the small number of such products currently in 
existence, few if any labels will be modified as a result of this 
proposed regulation if made final. Therefore, the label revision costs 
of this proposed regulation will be minimal.
    The second way in which the rule imposes costs is in the premarket 
notification requirements for the digestibility coefficient. If this 
proposal is adopted, producers of fat substitutes will be required to 
notify FDA of their intent to market fat substitutes that could provide 
the basis for nutrient content claims based on availability and to 
provide the agency with data supporting a digestibility coefficient. 
Thus, the fat substitute will be tested to determine the digestibility 
coefficient. FDA estimates that the cost of testing a fat substitute to 
determine digestibility will be in excess of $100,000 and perhaps as 
high as $1 million. It is not clear that the costs of the initial 
notification will be significantly more than the current cost of FDA 
approval of a substitute. However, FDA is also proposing to require the 
notifier to continue to submit any information related to the 
availability of the fat substitute of which it becomes aware to FDA as 
long as the ingredient is marketed. Therefore, producers will continue 
to bear the costs of informing FDA of any new information pertaining to 
the digestibility of the fat substitute that becomes available. FDA is 
not proposing to require that firms continue to generate or actively 
seek out new data, only that they provide FDA with any data of which 
they become aware. Therefore, although not zero, the costs will not be 
significant.

C. Regulatory Options

1. Approval of the Nutrient Content Claim
    One option available to FDA is to deny the petition for nutrient 
content claims based on the availability of fat. Because the 
marketability of fat-based fat substitutes depends on the manufacturers 
ability to market the food containing them as lower in fat, if FDA were 
to select this option, firms would not have any reason to develop fat 
substitutes that are less bioavailable. Therefore, FDA would be 
stifling innovation. Also, if FDA were to deny the petition, consumers 
would not benefit from the availability of lower available fat foods.
2. Premarket Approval
    As an alternative to premarket notification, FDA considered the 
options of premarket approval of the digestibility coefficient and 
postmarket notification. A premarket approval of the digestibility 
coefficient would result in the manufacturer not being able to market a 
food containing a fat-based substitute until FDA has published in the 
Federal Register its approval of the coefficient. This option could 
result in great delays in marketing a product and would be more costly 
to all parties involved--the firms, the consumer, and the government. 
However, this option would provide all parties with greater certainty 
about the information provided on the label.
3. Postmarket Notification
    In contrast to a premarket notification, under a postmarket 
notification requirement the manufacturer can market the food prior to 
notifying FDA. However, although a postmarket notification clearly does 
not cause a delay in placing the product in the marketplace, it is not 
clear that a premarket notification requirement would cause any delay 
in marketing the food because manufacturers would account for the FDA 
review period in their timeframes. FDA requests comments on whether the 
options of postmarket notification and premarket notification are 
significantly different

[[Page 67256]]

with respect to delays in marketing foods.
    A postmarket notification might result in greater uncertainty about 
the nutritional content of the food. Also, if FDA were to determine 
that the digestibility coefficient is inaccurate or inappropriate after 
the product is marketed, then the manufacturer will incur significant 
costs to remove the product from the market, reanalyze the 
digestibility, revise the labeling, and try again to market the 
product. Similarly, if the digestibility coefficient is wrong, then 
consumers could be harmed if the foods they believe are low fat are not 
in fact low fat.
4. Sunset Provision
    Another regulatory option available to FDA would be to limit the 
length of the time for which the notifier is required to continually 
submit information to FDA. This option would reduce costs by reducing 
the amount of information that must be provided to FDA. Although 
significant information may be generated with experience in marketing 
the product, at some point in time, the marginal cost of that 
information may exceed the marginal benefit. FDA requests comments on 
this option, including how long the manufacturer should be required to 
update the notification.
5. Multiple Digestibility Coefficients
    FDA is raising questions about whether it is appropriate to 
establish one digestibility coefficient for fat and its fatty acid 
subcomponents for all approved uses of a fat substitute, or whether 
different digestibility coefficients should be established for each 
fatty acid subcomponent and for different uses. If different food 
components and different processing methods significantly affect the 
digestibility of fat, then different coefficients may be appropriate 
for different foods or different conditions of use. If one 
digestibility coefficient is appropriate for all approved uses, then 
the necessary tests will be conducted once as a part of the initial 
development and approval of the fat substitute.
    The ability to make a nutrient content claim based on the 
availability of the fat then will apply to all producers of foods that 
include the fat substitute. However, if FDA determines that one 
digestibility coefficient for all uses is not appropriate, then the 
digestibility of the fat substitute will need to be tested, and a new 
notification submitted, as appropriate when the fat substitute is used 
under conditions that would change its digestibility. Because there are 
no official methods for determining the digestibility of a fat 
substitute, FDA cannot estimate the costs of performing new tests for 
each use. The agency is aware however that, animal tests are relatively 
costly, in excess of $100,000 per test and perhaps as high as $1 
million. The digestibility of the fat substitute is likely to be tested 
only for those uses for which the expected revenues will exceed the 
costs of the tests and premarket notification. Because testing is a 
high fixed cost, digestibility coefficients would only be determined 
for products with a sufficiently high volume.

D. Regulatory Flexibility

    FDA has also considered the impact of the premarket notification on 
small entities. None of the firms currently marketing fat-based fat 
substitutes, or the foods that contain them, are small. Therefore, the 
only potential for impact on small entities would be if this rule 
creates barriers to entry into markets for either fat-based fat 
substitutes or the products that contain them. The incremental cost of 
developing digestibility data and submitting it to FDA is not expected 
to be large relative to the cost of seeking approval for fat 
substitutes. In fact, because fat-based fat substitutes are developed 
specifically because of their reduced digestibility, digestibility 
testing for the initial intended uses may be a part of the development 
of the fat substitute. FDA requests comments on whether the incremental 
costs of the notification requirements themselves are likely to create 
barriers for the ability of small firms to develop or manufacture fat-
based fat substitutes.
    However, whether or not the notification requirements will create 
barriers for the ability of small entities to develop or manufacture 
foods that contain fat-based fat substitutes depends on whether or not 
one digestibility coefficient is determined to be appropriate for all 
approved food uses. If one coefficient is appropriate, then this rule 
is not expected to create any significant difficulties for small firms. 
However, if a separate digestibility coefficient is required for each 
approved use of a fat substitute, then this rule may create barriers to 
entry for small firms. As stated previously, the cost of testing the 
fat-based fat substitute for a particular use and submitting a 
notification will be prohibitive if the potential use is of 
sufficiently low volume. This situation will primarily occur in niche 
markets, which are dominated by small firms. Certain small firms might 
not be able to take advantage of the opportunity to market their 
product based on the amount of available fat. FDA cannot predict how 
many small firms, if any, might be prevented from using nutrient 
content claims based on available fat should different digestibility 
coefficients be required for each approved use of a fat substitute. 
However, given recent interest in reducing intakes of fat, it is likely 
that many small firms will have a desire to use fat-based fat 
substitutes and make claims based on available fat.
    FDA requests comments, especially from small firms, on the economic 
implications of this proposal, specifically with respect to barriers to 
entry that might be created by a provision for different coefficients 
for each approved use.
    Because of concerns regarding potential barriers to entry, if 
different digestibility coefficients are necessary for different uses 
of a fat-based fat substitute, it may cause a significant impact on 
small entities.

IV. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3506 and 3507). Therefore, in accordance with 5 CFR part 
1320, a description of the information collection requirement 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 information, and completion and submission of the 
notice. Also included is the time necessary for retaining records and 
making them available to appropriate regulatory officials.
    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: Notification of fat substitute digestibility coefficient.
    Description: Section 403(r) of the act requires that food bearing 
nutrient content claims be labeled in compliance with regulations 
issued by FDA. FDA

[[Page 67257]]

has issued regulations in Sec. 101.62(b) and (c) for nutrient content 
claims that may be used to characterize the level of fat and fatty 
acids in food products. Among other things, Sec. 101.62(b) and (c) 
define specific levels of fat that may not be exceeded for a food 
product to bear specific nutrient content claims concerning fat or 
fatty acids.
    The regulations set forth in this proposed rule provide that the 
digestibility of fat or fatty acids can be used as a basis for 
determining whether a food complies with the level requirements 
established in Sec. 101.62(b) and (c) for nutrient content claims for 
fat or fatty acids. The proposed rule requires that manufacturers that 
intend to market a fat-based substitute whose reduced availability can 
be relied upon as the basis for nutrient content claims for fat or 
fatty acids notify FDA at least 120 days before marketing the 
substance. Such notification shall include data and other appropriate 
information to establish the appropriateness of the digestibility 
coefficients to be used for the substance and a certification that all 
data of which the firm is aware that pertains to the digestibility of 
the fat-based fat substitute is being submitted, with assurances that 
any new data will also be promptly submitted as it becomes available. 
Firms that use the substance in their food products may proceed to use 
claims based on the digestibility coefficient for the substance if FDA 
does not object to the digestibility coefficient within the 120-day 
review period. The proposed rule also requires that manufacturers of 
food products whose labeling bears nutrient content claims based in 
part or whole on digestibility of a fat-based fat substitute retain the 
all records that support the quantitative declaration of fat and any 
fatty acid components declared for as long as the product is marketed. 
The manufacturer of such a food product would be required to make those 
records available for review and copying by appropriate regulatory 
officials upon request.
    Descriptions of Respondents: Persons and businesses, including 
small businesses.

                               Estimated Annual Reporting and Recordkeeping Burden                              
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
101.63(c)                               2               1               2             100             200       
101.9(g)(10)                           25               1              25               1              25       
Total                                                                                                 225       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.                  

FDA believes that the information that would be submitted in a 
notification would be that information that a prudent business would 
obtain as a normal part of doing business.
    The agency has submitted copies of the proposed rule to OMB for its 
review of these requirements. Interested persons are requested to 
submit written comments regarding information collection requirements 
by January 21, 1997, to the Office of Information and Regulatory 
Affairs, OMB (address above), ATTN: Desk Officer for FDA.

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(b)(1) 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. Comments

    Interested persons may by April 21, 1997, submit to the Dockets 
Management Branch (address above) written comments regarding this 
proposal and may by January 21, 1997, submit comments on the 
information collection requirements. 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.

VII. 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. Bender, A. E., ``Nutritional Significance of 
Bioavailability,'' in Nutrient Availability: Chemical & Biological 
Aspects, edited by D. Southgate, I. Johnson, and G. R. Fenwick, The 
Royal Society of Chemistry, Thomas Graham House, Cambridge, England, 
pp. 3 to 9, 1989.
    2. Merrill, A. L., and B. K. Watt, ``Energy Value of Foods--
Basis and Derivation,'' U.S. Department of Agriculture, Agriculture 
Handbook No. 74, U.S. Government Printing Office, Washington, DC, 
revised February 1973.
    3. Allison, R. G., and F. R. Senti, ``A Perspective on the 
Application of the Atwater System of Food Energy Assessment,'' Life 
Sciences Research Office, FASEB, Bethesda, MD, 1983.
    4. Apgar, J. L., C. A. Shively, and S. M. Tarka, ``Digestibility 
of Cocoa Butter and Corn Oil and Their Influence on Fatty Acid 
Distribution in Rats,'' Journal of Nutrition, 117:660-665, 1987.
    5. U.S. Department of Agriculture, ``Composition of Foods: 
Finfish and Shellfish Products,'' Agriculture Handbook Number 8-15, 
Human Nutrition Information Service, USDA, page 91, 1987.
    6. U.S. Department of Health and Human Services, The Surgeon 
General's Report on Nutrition and Health, DHHS (Public Health 
Service) Publication No. 88-50210 (Government Printing Office Stock 
N. 017-001-00465-1), U.S. Government Printing Office, Washington, 
DC, 1988.
    7. National Research Council, Diet and Health--Implications for 
Reducing Chronic Disease Risk, National Academy Press, Washington, 
DC, pp. 206-210, 654-656, 669-672, 1989.
    8. National Heart, Lung, and Blood Institute, ``Report of the 
Expert Panel on Population Strategies for Blood Cholesterol 
Reduction,'' NCEP, PHS, National Institutes of Health, DHHS, 
Washington, DC; NIH Publication No. 90-3046, 1990.
    9. U.S. Department of Agriculture and U.S. Department of Health 
and Human Services, ``Nutrition and Your Health, Dietary Guidelines 
for Americans,'' Washington, DC, Home and Garden Bulletin No. 232, 
3d edition, U.S. Government Printing Office, 1990.
    10. U.S. Department of Agriculture and U.S. Department of Health 
and Human Services, ``Nutrition and Your Health, Dietary Guidelines 
for Americans,'' Washington, DC, Home and Garden Bulletin No. 232, 
4th edition, U.S. Government Printing Office, 1995.
    11. Brindley, D. N., ``Absorption and Metabolism of Fats,'' in 
Health Effects of Dietary Fatty Acids, edited by G. L. Nelson, The 
American Oil Chemists' Society, Champaign, IL, pp. 35-47, 1991.
    12. Carey, M. C., D. M. Small, and C. M. Bliss, ``Lipid 
Digestion and Absorption,'' Annual Review of Physiology, 45:651-677, 
1983.
    13. Vanderveen, J. E., N. D. Heidelbaugh, and M. J. O'Hara, 
``Study of Man During a 56-day Exposure to an Oxygen-Helium

[[Page 67258]]

Atmosphere at 258 mm. Hg Total Pressure IX. Nutritional Evaluation 
of Feeding Bite-size Foods,'' Aerospace Medicine, 37:591-594, 1966.
    14. Emken, E. A., R. O. Adolf, W. K. Rohwedder, and R. M. 
Gulley, ``Influence of Linoleic Acid on Desaturation and Uptake of 
Deuterium-labeled Palmitic and Stearic Acids in Humans,'' Biochimica 
et Biophysica Acta, 1170:173-181, 1993.
    15. Chen, I. S., S. Subramaniam, G. V. Vahouny, M. M. Cassidy, 
I. Ikeda, and D. Kritchevsky, ``A Comparison of the Digestion and 
Absorption of Cocoa Butter and Palm Kernel Oil and Their Effects on 
Cholesterol Absorption in Rats,'' Journal of Nutrition, 1569-1573, 
1989.
    16. Erdman, J. W., C. L. Poor, and J. M. Dietz, ``Factors 
Affecting the Bioavailability of Vitamin A, Carotenoids, and Vitamin 
E,'' Journal of Food Technology, 42(10):214-221, 1988.
    17. Letter from Stephen A. Brown to Dr. F. Edward Scarborough, 
Office of Food Labeling, FDA, May 29, 1996.
    18. Memo from John Wallingford, Office of Special Nutritionals 
to the Director, Office of Food Labeling, FDA, September 30, 1996.
    19. Labels of Hershey's Reduced Fat Baking Chips and Snackwell's 
Fudge Dipped Granola Bars.
    20. The American Dietetic Association, ``1995 Nutrition Trends 
Survey, Executive Summary,'' Chicago, IL, 1995.
    21. Food and Agriculture Organization of the United Nations and 
the World Health Organization, ``Fats and Oils in Human Nutrition, 
Report of a Joint Expert Consultation,'' FAO Food & Nutrition Paper 
57, Rome, October 19 to 26, 1993.

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 101.9 is amended by revising paragraph (c)(2), and by 
adding new paragraphs (d)(15) and (g)(10) to read as follows:

Sec. 101.9  Nutrition labeling of food.

* * * * *
    (c) * * *
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat in a serving defined as total lipid fatty acids and 
expressed as triglycerides, except that, for a food that bears a claim 
that is made in compliance with Sec. 101.63, a statement of the grams 
of available fat may be declared instead in accordance with paragraph 
(d)(15) of this section. Amounts shall be expressed to the nearest 0.5-
gram increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number 
of grams of saturated fat in a serving defined as the sum of all fatty 
acids containing no double bonds, except that, for a food that bears a 
claim that is made in compliance with Sec. 101.63, a statement of the 
grams of available saturated fat may be declared instead in accordance 
with paragraph (d)(15) of this section. However, a label declaration of 
saturated fat content is not required for products that contain less 
than 0.5 gram of total fat in a serving if no claims are made about fat 
or cholesterol content, and if ``calories from saturated fat'' is not 
declared. Except as provided for in paragraph (f) of this section, if a 
statement of the saturated fat content is not required and, as a 
result, not declared, the statement ``Not a significant source of 
saturated fat'' shall be placed at the bottom of the table of nutrient 
values in the same type size. Saturated fat content shall be indented 
and expressed as grams per serving to the nearest 0.5-gram increment 
below 5 grams and to the nearest gram increment above 5 grams. If the 
serving contains less than 0.5 gram, the content shall be expressed as 
zero.
    (ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat in a serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids 
may be declared voluntarily, except that when monounsaturated fat is 
declared or when a claim is made on the label or in labeling about 
fatty acids or cholesterol, label declaration of polyunsaturated fat is 
required. When a food bears a claim that is made in compliance with 
Sec. 101.63, the grams of available polyunsaturated fat may be 
declared, in accordance with paragraph (d)(15) of this section, as the 
amount of polyunsaturated fat. Polyunsaturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5-gram 
increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat in a serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily 
except that when polyunsaturated fat is declared or when a claim is 
made on the label or in labeling about fatty acids or cholesterol, 
label declaration of monounsaturated fat is required. When a food bears 
a claim that is made in compliance with Sec. 101.63, the grams of 
available monounsaturated fat may be declared, in accordance with 
paragraph (d)(15) of this section, as the amount of monounsaturated 
fat. Monounsaturated fat content shall be indented and expressed as 
grams per serving to the nearest 0.5-gram increment below 5 grams and 
to the nearest gram increment above 5 grams. If the serving contains 
less than 0.5 gram, the content shall be expressed as zero.
* * * * *
    (d) * * *
    (15) For food products that bear a claim that is made in compliance 
with Sec. 101.63, and that contain an ingredient for which a 
digestibility coefficient is used to calculate the number of grams of 
total fat or fatty acids that are available from the ingredient, there 
shall be, in the nutrition label, following the quantitative 
declaration of fat (and saturated fat, polyunsaturated fat, or 
monounsaturated fat, if declared) and again immediately preceding the 
footnote required by paragraph (d)(9) of this section, an asterisk (*) 
or other similar cross-reference symbol. The asterisk or other symbol 
shall be followed by a statement that the declared amount of ``total 
fat'' has been adjusted to reflect reduced digestibility of the 
ingredient (e.g., ``*Total fat content adjusted for reduced 
availability of fat from [name of ingredient]''). The footnote required 
by paragraph (d)(9) of this section shall be separated by a hairline 
from the footnote required under this paragraph.
* * * * *
    (g) * * *
    (10) Each person responsible for the labeling of a food that bears 
a claim that is made in compliance with Sec. 101.63, and for which 
available fat is declared in accordance with paragraph (d)(15) of this 
section, shall retain, for as long as the food is marketed, all records 
that support the quantitative declaration of fat and any fatty acid 
subcomponents declared. Such 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 101.13 is amended by revising paragraph (o) to read as 
follows:


[[Page 67259]]




Sec. 101.13  Nutrient content claims--general principles.

* * * * *
    (o) Except as provided in Secs. 101.10 and 101.63, 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.
* * * * *
    4. Section 101.62 is amended by revising paragraphs (b)(1)(i), 
(b)(2)(i)(A), (b)(2)(i)(B), (b)(3)(i), (b)(4)(i), (b)(5)(i), (c)(1)(i), 
(c)(2)(i), (c)(3)(i), (c)(4)(i), and (c)(5)(i) to read as follows:

Sec. 101.62  Nutrient content claims for fat, fatty acid, and 
cholesterol content of foods.

* * * * *
    (b) * * *
    (1) * * *
    (i) The food contains less than 0.5 g of total fat or, as provided 
in Sec. 101.63, available fat per reference amount customarily consumed 
and per labeled serving or; in the case of a meal product or main dish 
product, less than 0.5 g total fat, or as provided in Sec. 101.63, 
available fat per labeled serving; and
* * * * *
    (2) * * *
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 3 g or less of 
total fat or, as provided in Sec. 101.63, available fat per reference 
amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less, or 2 tablespoons or less, and contains 3 g or less of total fat 
or, as provided in Sec. 101.63, available fat per reference amount 
customarily consumed and per 50-g of food (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); 
and
* * * * *
    (3) * * *
    (i) The product contains 3 g or less of total fat or, as provided 
in Sec. 101.63, available fat per 100 g and not more than 30 percent of 
calories from fat; and
* * * * *
    (4) * * *
    (i) The food contains at least 25 percent less total fat or, as 
provided in Sec. 101.63, available fat per reference amount customarily 
consumed than an appropriate reference food as described in 
Sec. 101.13(j)(1); and
* * * * *
    (5) * * *
    (i) The food contains at least 25 percent less total fat or, as 
provided in Sec. 101.63, available fat per 100 g of food than an 
appropriate reference food as described in Sec. 101.13(j)(1); and
* * * * *
    (c) * * *
    (1) * * *
    (i) The food contains less than 0.5 g of saturated fat or, as 
provided in Sec. 101.63, available saturated fat and less than 0.5 g 
trans fatty acid per reference amount customarily consumed and per 
labeled serving, or in the case of a meal product or main dish product, 
less than 0.5 g of saturated fat or, as provided in Sec. 101.63, 
available saturated fat and less than 0.5 g trans fatty acid per 
labeled serving; and
* * * * *
    (2) * * *
    (i) The food contains 1 g or less of saturated fat or, as provided 
in Sec. 101.63, available saturated fat per reference amount 
customarily consumed and not more than 15 percent of calories from 
saturated fat; and
* * * * *
    (3) * * *
    (i) The food contains 1 g or less of saturated fat or, as provided 
in Sec. 101.63, available saturated fat per 100 g and less than 10 
percent of calories from saturated fat; and
* * * * *
    (4) * * *
    (i) The food contains at least 25 percent less saturated fat or, as 
provided in Sec. 101.63, available saturated fat per reference amount 
customarily consumed than an appropriate reference food as described in 
Sec. 101.13(j)(1); and
* * * * *
    (5) * * *
    (i) The food contains at least 25 percent less saturated fat or, as 
provided in Sec. 101.63, available saturated fat per 100 g of food than 
an appropriate reference food as described in Sec. 101.13(j)(1); and
* * * * *
    5. New Sec. 101.63 is added to subpart D to read as follows:

Sec. 101.63  Nutrient content claims for fat and fatty acids based on 
use of ingredients formulated to reduce amount of available fat.

    (a) Coverage. This regulation defines the circumstances in which 
nutrient content claims for fat and fatty acids can be made for foods 
that contain manufactured fat-based fat substitutes that have been 
formulated to provide functional characteristics of fat but to limit or 
eliminate absorption and digestion of the fat from the substance by the 
body, thereby restricting the availability of the fat to the body.
    (b) Claims. The terms defined in Sec. 101.62 may be used on the 
label or in the labeling of foods that contain an ingredient that is 
covered under this paragraph, provided that:
    (1) There has been compliance with the notification provisions of 
paragraph (c) of this section, and FDA has not objected (see paragraph 
(d) of this section);
    (2) The level of available fat or available saturated fat in the 
food meets the applicable level in Sec. 101.62; and
    (3) The food is nutrition labeled in accordance with paragraph (e) 
of this section.
    (c) Notification. The manufacturer of an ingredient covered under 
paragraph (a) of this section shall notify FDA at least 120 days before 
such ingredient is introduced into or delivered for introduction into 
interstate commerce. Such notification shall be signed by a responsible 
person and shall include:
    (1) The name and address of the manufacturer and a contact person;
    (2) The common or usual name of the fat substitute that is the 
subject of the claim (i.e., the notified substance);
    (3) Descriptive information that characterizes the substance, 
including its chemical structure and physical characteristics, its 
purity and homogeneity, and a detailed description of the analytical 
methodology for determining the amount of the substance present in a 
food or a statement that refers the agency to where this analytical 
methodology can be found in its records (e.g., in a filed food additive 
petition or in a petition for affirmation that use of a substance is 
generally recognized as safe). Where the substance is part of a family 
of similar structured fats, information should be submitted on the 
applicability of the digestibility coefficient to other forms of the 
substance;
    (4) The digestibility coefficient that is expected to be used to 
adjust the amount of total fat or of fatty acids contributed by such an 
ingredient to reflect the amount of fat and fatty acids available from 
the finished food product;
    (5) Data that establish the appropriateness of the digestibility 
coefficient to be used including, but not limited to:
    (i) Evidence demonstrating the reduced absorption of the substance 
or its components, such as:

[[Page 67260]]

    (A) An estimate of the biologic variability in the availability of 
the substance in humans and in the relationship between the amount of 
the substance ingested and the rate of absorption (i.e., dose-
response);
    (B) A statement of the relevance, and limit to relevance to the 
human, of any animal model used to estimate human digestion and 
absorption of the substance; and
    (C) For any clinical studies that are relied on to demonstrate 
reduced absorption or digestion, information on the characteristics of 
the subjects studied and the manner in which they are representative of 
the population for whom the substance is intended. For example:
    (1) An accounting of subjects enrolled in the study including those 
who did not complete the study, reasons for any noncompletion, and an 
assessment of the effect that noncompletion of subjects had on the 
results of the study; and
    (2) A description of any adverse events that occurred during the 
study, and a comparison of the frequency and type of effects as a 
function of the feeding of the substance;
    (ii) Information about foods or diets that may affect the 
digestibility coefficient, such as:
    (A) Interactions of the substance with other components of foods or 
the diet that could significantly affect the digestibility coefficient;
    (B) Steps in processing of the types of foods expected to contain 
the fat substitute that could affect the digestibility coefficient;
    (C) The amount of the substance used in feeding studies, the 
relationship of that amount to expected levels of intake, and the dose-
response relationship between the amount of the substance and the 
digestibility coefficient; and
    (D) The duration of feeding studies and changes in the 
digestibility coefficient with continued exposure;
    (6) A certification that all data of which the firm is aware that 
pertain to the digestibility of the fat substitute have been submitted, 
and that any new data will be promptly submitted as it becomes 
available for as long as the ingredient is marketed; and
    (7) Such notification shall be submitted to the Office of Food 
Labeling (HFS-150), Food and Drug Administration, 200 C St., SW., 
Washington, DC 20204.
    (d) FDA review. Upon receipt, FDA will notify the submitting firm 
that it has received the notification and will commence its review. If 
firms do not receive written objections from FDA within 120 days of 
FDA's receipt of the notification, nutrient content claims based on the 
digestibility coefficient submitted may be used.
    (e) Nutrition labeling. When a claim is made for fat or saturated 
fat under this section, the nutrition label shall declare the amount of 
available fat or saturated fat in accordance with Sec. 101.9(d)(15).
    (f) Misbranding. Any food product containing ingredients that are 
covered under paragraph (a) of this section that bears a claim based on 
available levels of fat for which supporting data have not been 
provided to FDA in accordance with this section or to which FDA has 
objected in response to the notification filed in accordance with 
paragraph (c) of this section will be deemed to be misbranded under 
section 403(a) and (r)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act.

    Dated: December 11, 1996.
William B. Schultz,
Deputy Commissioner for Policy
[FR Doc. 96-32124 Filed 12-19-96; 8:45 am]
BILLING CODE 4160-01-F