[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Proposed Rules]
[Pages 5367-5374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2006P-0069]
RIN 0910-AF94


Food Labeling: Health Claims; Soluble Fiber From Certain Foods 
and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the regulation authorizing a health claim on the relationship between 
soluble fiber from certain foods and risk of coronary heart disease 
(CHD). The amendment proposes to exempt certain foods from the nutrient 
content requirement of ``low fat.'' The exemption would apply if the 
food exceeds this requirement due to fat content derived from whole oat 
sources. FDA is taking this action in response to a petition submitted 
by the Quaker Oats Company (the petitioner). The amendment would expand 
the use of this health claim to some whole oat products that are 
currently ineligible for the health claim.

DATES: Submit written or electronic comments by April 23, 2007.

ADDRESSES:  You may submit comments, identified by Docket No. 2006P-
0069, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or

[[Page 5368]]

comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Nutrition Labeling and Education Act of 1990

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) (Public Law 101-535) amended the Federal Food, Drug, and 
Cosmetic Act (the act) in a number of important ways. Among other 
changes, the 1990 amendments clarified FDA's authority to regulate 
health claims on food labels and in food labeling. FDA issued several 
new regulations in 1993 to implement the health claim provisions of the 
1990 amendments. Among these were Sec.  101.14 (21 CFR 101.14), Health 
claims: general requirements (58 FR 2478, January 6, 1993), which sets 
out the rules for the authorization and use of health claims, and Sec.  
101.70 (21 CFR 101.70), Petitions for health claims (58 FR 2478, 
January 6, 1993), which sets out a process for petitioning the agency 
to authorize health claims about substance-disease relationships, and 
sets out the types of information that any such petition must include. 
Each of these regulations became effective on May 8, 1993.
    When implementing the 1990 amendments, FDA also conducted a review 
of evidence for a relationship between dietary fiber and cardiovascular 
disease (CVD). Based on this review, FDA concluded that the available 
scientific evidence did not justify authorization of a health claim 
relating dietary fiber to reduced risk of CVD (58 FR 2552 at 2572, 
January 6, 1993). However, the agency did conclude that there was 
significant scientific agreement that the totality of publicly 
available scientific evidence supported an association between diets 
relatively high in foods that are low in saturated fat and cholesterol 
and that naturally are good sources of soluble dietary fiber (i.e., 
fruits, vegetables, and grain products) and reduced risk of coronary 
heart disease (CHD)\1\ (id.). Therefore, FDA authorized a health claim 
about the relationship between diets low in saturated fat and 
cholesterol and high in vegetables, fruit, and grain products that 
contain soluble fiber and a reduced risk of CHD (Sec.  101.77 (21 CFR 
101.77)) (58 FR 2552 at 2572). In the preamble to the 1993 dietary 
fiber and CVD final rule, FDA commented that if a manufacturer could 
document with appropriate evidence that consumption of the type of 
soluble fiber in a particular food has the effect of lowering blood 
(serum or plasma) low density lipoprotein (LDL) cholesterol, and has no 
adverse effects on other heart disease risk factors (e.g., high density 
lipoprotein (HDL) cholesterol), the manufacturer should petition for 
authorization of a health claim specific for that particular dietary 
fiber-containing food (58 FR 2552 at 2567).
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    \1\ Cardiovascular disease means diseases of the heart and 
circulatory system. Coronory heart disease, one form of 
cardiovascular disease, refers to diseases of the heart muscle and 
supporting blood vessels.
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B. Soluble Fiber From Certain Foods and Coronary Heart Disease Health 
Claim (Sec.  101.81 (21 CFR 101.81))

    In 1995, FDA received a petition for a health claim on the 
relationship between oat bran and rolled oats and reduced risk of CHD. 
FDA concluded there was significant scientific agreement that the 
totality of publicly available scientific evidence supported the 
relationship between consumption of whole oat products and reduced risk 
of CHD. FDA further concluded that the type of soluble fiber found in 
whole oats, i.e., beta-glucan soluble fiber, is the component primarily 
responsible for the hypocholesterolemic effects associated with 
consumption of whole oat foods as part of a diet that is low in 
saturated fat and cholesterol (62 FR 3584 at 3597 through 3598, January 
23, 1997). As such, the final rule authorized a health claim relating 
the consumption of beta-glucan soluble fiber in whole oat foods, as 
part of a diet low in saturated fat and cholesterol, and reduced risk 
of CHD (the oat beta-glucan health claim). The source of beta-glucan 
soluble fiber in foods bearing this health claim had to be one of three 
eligible whole oat products, i.e., oat bran, rolled oats, or whole oat 
flour (see Sec.  101.81(c)(2)(ii)(A)). In 2002, FDA amended Sec.  
101.81 to add oatrim as a fourth source of beta-glucan soluble fiber 
eligible for the oat beta-glucan health claim (67 FR 61773, October 2, 
2002). Oatrim is the soluble fraction of alpha-amylase hydrolyzed oat 
bran or whole oat flour.
    In order to bear the oat beta-glucan health claim, a food must, 
among other requirements, provide at least 0.75 grams (g) of soluble 
fiber per reference amount customarily consumed (RACC) and meet the 
nutrient content requirements in Sec.  101.62 (21 CFR 101.62) for a 
``low saturated fat,'' ``low cholesterol,'' and ``low fat'' food (Sec.  
101.81(c)(2)(iii)(C)).

II. Petition and Grounds

    The Quaker Oats Company (the petitioner), submitted a petition to 
FDA on November 7, 2005, under section 403(r)(4) of the act (21 U.S.C. 
343(r)(4)) (Ref. 1). The petition requested that FDA amend the soluble 
fiber from certain foods and CHD health claim at Sec.  101.81 so that 
foods that exceed the nutrient content requirement in Sec.  101.62 for 
``low fat'' due to fat content derived from whole oat sources (i.e., 
oat bran, rolled oats, whole oat flour, and oatrim) listed in Sec.  
101.81(c)(2)(ii)(A) would be eligible to bear the health claim. On 
February 15, 2006, FDA notified the petitioner that the agency had 
completed its initial review of the petition and that the petition had 
been filed for further action in accordance with section 403(r)(4) of 
the act. If the agency does not act, by either denying the petition or 
issuing a proposed regulation to authorize the health claim, within 90 
days of the date of filing for further action, the petition is deemed 
to be denied unless an extension is mutually agreed upon by the agency 
and the petitioner (section 403(r)(4)(A)(i) of the act and Sec.  
101.70(j)(3)(iii)). On April 28, 2006, FDA and the petitioner mutually 
agreed to extend the deadline to September 30, 2006. On September 25, 
2006, FDA and the petitioner mutually agreed to extend the deadline 
again to March 30, 2007.
    The petition described a problem certain products have in meeting 
the eligibility criteria of the soluble fiber and CHD health claim. 
Quaker Oats Company produces, among other things, flavored varieties of 
reduced sugar instant oatmeal products as well as unmodified (with 
respect to sugar content) instant oatmeal products. The petition stated 
that Quaker Oats Company's flavored, unmodified instant oatmeal 
products are eligible to bear the soluble fiber and CHD health claim, 
but flavored, reduced sugar instant oatmeal products are not because 
the latter products do not meet the nutrient content requirement in 
Sec.  101.62 for ``low fat.''
    The petition stated that the formulation of flavored instant 
oatmeal products with ``reduced sugar'' (the term consistent with 21 
CFR

[[Page 5369]]

101.60(c)(5)) made these products technically ineligible to bear the 
oat beta-glucan health claim because by reducing sugar, the products 
contain more whole oats (and fat from whole oats) per RACC. The 
petition provided the information on the amount of rolled oats, sugar, 
and total fat per packet and total fat content per 55 g RACC for both 
flavored unmodified instant oatmeal and flavored reduced sugar instant 
oatmeal. Both products contain the same amount of rolled oats (28 g) 
and total fat (2 g) per packet but differ in sugar content: 15 g per 
packet of flavored unmodified instant oatmeal and 3 g per packet of 
flavored reduced sugar instant oatmeal. According to the petition, the 
12 g difference in sugar content corresponds with a 12 g difference in 
packet weight (31 g packet weight for the flavored reduced sugar 
instant oatmeal and 43 g packet weight for the flavored unmodified 
product). Therefore, at the RACC for flavored instant oatmeal (55 g), 
the reduced sugar product has more rolled oats than the unmodified 
instant oatmeal. The petition computed total fat per 55 g RACC to be 
2.558 g for flavored unmodified instant oatmeal and 3.548 g for 
flavored reduced sugar instant oatmeal. Because the total fat content 
of the flavored reduced sugar instant oatmeal exceeds 3 g per 55 g RACC 
(even considering permissible rounding), this product is not eligible 
for the health claim.
    The petition requested that FDA amend Sec.  101.81(c)(2)(iii)(C) 
such that the ``low fat'' eligibility standard would not be applicable 
to foods exceeding this standard due to the total fat inherent in whole 
oat sources. The petition stated that such an amendment would have no 
impact on the benefit described in the soluble fiber and CHD health 
claim and discussed that the 2000 Dietary Guidelines for Americans 
modified recommendations regarding total fat intake from a diet low in 
total fat to a diet moderate in total fat. The petition further stated 
that the total fat content and fatty acid composition of whole oats are 
consistent with the current authoritative understanding of dietary 
patterns likely to promote health and reduce risk of CHD, and 
referenced the executive summary of the 2005 Dietary Guidelines for 
Americans for recommending less than 10 percent of total calories from 
saturated fatty acids and 20 to 35 percent of total calories from total 
fat, mostly from sources of polyunsaturated and monounsaturated fatty 
acids. The petition noted that the percent of calories from saturated 
fat and total fat in whole oats is 3 percent and 16 percent, 
respectively, and the ratio of saturated fatty acids to polyunsaturated 
plus monounsaturated fatty acids in whole oats is approximately 1:5.
    The petition stated that amending the soluble fiber from certain 
foods and CHD health claim regulation to allow use of the claim on 
products with greater fat content due to a greater proportion of whole 
oat sources would: (1) Encourage food manufacturers to create products 
that are lower in added sugar while still retaining the heart-
protective qualities of these whole oat-based foods and (2) enhance 
consumer's ability to incorporate beta-glucan soluble fiber into their 
diets while reducing their sugar consumption. The petition also stated 
that the additional level of inherent fat in whole oats would not have 
a negative impact on the benefit of the oat beta-glucan health claim.
    The petition requested the following specific changes in the 
regulation governing the oat beta-glucan health claim:
     Modify Sec.  101.81(c)(2)(iii)(C) to state ``The food 
shall meet the nutrient content requirement in Sec.  101.62 for a `low 
saturated fat' and `low cholesterol' food'' and
     Create a new paragraph (c)(2)(iii)(D) stating ``The food 
shall meet the nutrient content requirement in Sec.  101.62 for a `low 
fat' food, unless it exceeds this requirement due to fat content solely 
derived from whole oat sources listed in paragraph (c)(2)(ii)(A).''

III. Decision To Amend the Health Claim

    In regulations authorizing CHD-related health claims, FDA has 
required, with a few exceptions, that foods bearing such claims meet 
the ``low fat'' criterion defined by Sec.  101.62(b)(2),\2\ the ``low 
saturated fat'' criterion defined by Sec.  101.62(c)(2), and the ``low 
cholesterol'' criterion defined by Sec.  101.62(d)(2) (see authorized 
claims in 21 CFR 101.75, 101.77, 101.81, 101.82, and 101.83) rather 
than applying the total fat, saturated fat, and cholesterol content 
disqualifying levels specified in the general requirement for health 
claims (Sec.  101.14(a)(4)). The ``low fat'' criterion is currently 
applied to the soluble fiber from certain foods and CHD health claim in 
Sec.  101.81(c)(2)(iii)(C).
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    \2\ ``Low fat'' food is defined in Sec.  101.62(b)(2) as 
follows: (1) A food that has a RACC greater than 30 g or greater 
than 2 tablespoons and contains 3 g or less of fat per RACC or (2) a 
food that has a RACC of 30 g or less or 2 tablespoons or less and 
contains 3 g or less of fat per RACC and per 50 g of food. Further, 
meal products and main dish products, as defined in 21 CFR 101.13(l) 
and (m), respectively, are ``low fat'' if they contain 3 g or less 
of total fat per 100 g and not more than 30 percent of calories from 
fat (Sec.  101.62(b)(3)).
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    As set out in Sec.  101.62(b)(2), for purposes of the requirements 
for ``low fat,'' the measure of a food's total fat is the total fat per 
RACC (if the food has a RACC of 30 g or less or 2 tablespoons or less, 
the total fat measure is also based per 50 g of food). Hot dry 
breakfast cereals have two separate RACCs: 55 g for flavored, sweetened 
dry cereal and 40 g for plain dry cereal (21 CFR 101.12(b)). Thus, 
flavored, sweetened dry cereal has to contain 3 g or less of fat per 55 
g, whereas plain dry cereal has to contain 3 g or less of fat per 40 g 
to meet the ``low fat'' criterion.
    The petition discussed that the Quaker Oats Company's flavored 
reduced sugar instant oatmeal products are ineligible for the oat beta-
glucan health claim because these products do not meet the ``low fat'' 
criterion, whereas its flavored, unmodified instant oatmeal product 
containing the same amount of rolled oats and fat, but 12 g more sugar 
per packet does meet the criterion. The petition stated that removing 
sugar from the flavored unmodified instant oatmeal product results in 
more whole oats (and thus fat from whole oats) per RACC. The petition 
requested an exemption to the requirement of ``low fat'' for foods that 
exceed this requirement due to fat contained in whole oat soluble fiber 
sources listed in Sec.  101.81(c)(2)(ii)(A) (i.e., oat bran, rolled 
oats, whole oat flour, and oatrim).
    To determine if the requested amendment is appropriate, the agency 
examined the amount of fat in the whole oat soluble fiber sources 
(i.e., whole oat flour, rolled oats, oat bran, and oatrim) eligible to 
bear the claim. The total fat content is about 6.9 g per 100 g for 
whole oats (same as whole oat flour) (Ref. 2), 6.3 g per 100 g for 
rolled oats (Ref. 2), 7.0 g per 100 g for oat bran (Ref. 2), and 2.1 g 
per 100 g for oatrim (Ref. 3). Whole oats contain a higher amount of 
total fat than barley (2.3 g per 100 g) or other cereal grains such as 
whole wheat (1.9 g per 100 g whole wheat flour), rice (2.9 g per 100 g 
brown rice), or corn (1.2 g per 100 g dry corn grits) (Ref. 2). As a 
result, it is possible that a product could exceed the maximum total 
fat permitted under the ``low fat'' requirement solely due to fat from 
whole oat sources. However, most whole oat products that are 
essentially all whole oats meet the ``low fat'' requirement unless fat 
from other sources are added. For some products that do not meet the 
``low fat'' requirement due to fat from whole oat sources, the amount 
of fat exceeding the ``low fat'' requirement may be small. For

[[Page 5370]]

example, if a flavored, sweetened instant oatmeal product were made 
almost entirely of whole oats, the total fat content of this product 
would exceed the 3 g per RACC maximum to meet the ``low fat'' 
requirement, but would not exceed 4 g per RACC.
    FDA also evaluated the type of fat in whole oats. Whole oats 
contain 1.2 g saturated fatty acids, 2.2 g monounsaturated fatty acids, 
and 2.5 g polyunsaturated fatty acids per 100 g (Ref. 2). Thus, 
polyunsaturated and monounsaturated fatty acids are the predominant 
types of fat in whole oats. Whole oats do not contain cholesterol. The 
2005 Dietary Guidelines for Americans (Ref. 4) recommended that total 
fat intake be kept between 20 and 35 percent of calories, with most 
fats coming from sources of polyunsaturated and monounsaturated fatty 
acids, that less than 10 percent of calories come from saturated fatty 
acids, and that cholesterol intake be less than 300 milligrams (mg) per 
day. Thus, the fat profile of whole oats is consistent with the 2005 
Dietary Guidelines for Americans recommendation of consuming a moderate 
amount of total fat with most sources coming from polyunsaturated and 
monounsaturated fatty acids, and limiting intake of saturated fatty 
acids and cholesterol.
    FDA tentatively concludes that, for purposes of the oat beta-glucan 
health claim, it is appropriate to exempt foods that exceed the ``low 
fat'' criterion due to fat contained in whole oat sources listed in 
Sec.  101.81(c)(2)(ii)(A) (i.e., oat bran, rolled oats, whole oat 
flour, and oatrim) from the requirement of ``low fat'' because: (1) The 
fat profile in whole oats is consistent with the 2005 Dietary 
Guidelines for Americans; (2) the consumption of foods containing beta-
glucan soluble fiber, such as whole oat products, is helpful in 
reducing the risk of CHD; and (3) the amount by which the fat content 
from whole oat sources may exceed the criterion of 3 g of fat per RACC 
(e.g., by no more than 1 g) is not likely to be a health concern.
    FDA agrees with the petitioner that foods eligible for the oat 
beta-glucan health claim should meet the nutrient content requirement 
for a ``low fat'' food, unless it exceeds this requirement due to fat 
content solely derived from whole oat sources. The agency is aware that 
some whole oat products contain a small amount of fat from ingredients 
other than whole oat sources. Examples of the sources of fat included 
in these products are vitamin A palmitate, hydrogenated soybean oil, 
and soy lecithin. The petition has only requested that an exemption to 
the ``low fat'' requirement be given to foods that exceed this 
requirement ``due to fat content solely derived from whole oat sources 
listed in paragraph (c)(2)(ii)(A).'' Therefore, a food product that 
contains any fat from ingredients other than whole oat sources would 
not be exempt from the ``low fat'' requirement. The agency has not been 
given any justification why whole oat foods that contain sources of fat 
other than whole oat sources should be exempt from the ``low fat`` 
requirement. However, the agency would like to ensure that this 
proposed rule achieves its intent of providing consumers with more 
choices of whole oat products. Therefore, FDA asks for comment on 
whether or not whole oat food products that contain sources of fat 
other than whole oat sources should be exempt from the ``low fat'' 
requirement and, if so, how much and what type(s) of fat contributed by 
these sources would be acceptable.

IV. Description of Amendments to Sec.  101.81

    In light of the FDA's tentative decision to accept the petitioner's 
request, the agency is proposing to amend Sec.  101.81(c)(2)(iii)(C) by 
removing the phrase, ``low fat'' food and creating a new Sec.  
101.81(c)(2)(iii)(D) to specify that the food shall meet the ``low 
fat'' food requirement, unless the food exceeds this requirement due to 
fat content derived from whole oat sources listed in Sec.  
101.81(c)(2)(ii)(A).

V. Environmental Impact

    FDA has determined under 21 CFR 25.32(p) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

A. Preliminary Regulatory Impact Analysis

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 does not 
believe that this proposed rule is an economically significant 
regulatory action as defined by the Executive order.
1. The Need for Regulation
    Current Sec.  101.81 authorizes a health claim on foods for the 
relationship between soluble fiber from certain foods and reduced risk 
of CHD. One of the requirements for the claim is the nutrient content 
requirement for ``low fat.'' In order to bear the claim, foods must 
contain no more than 3 g of fat per RACC. The RACC for plain oatmeal is 
40 g dry weight and the RACC for flavored, sweetened oatmeal is 55 g 
dry weight, assuming that 15 g of sugar is added. The amount of fat in 
40 g of rolled oats is just below 3 g, mostly polyunsaturated fatty 
acids and monounsaturated fatty acids. A recently introduced flavored 
reduced-sugar oatmeal does not meet the criterion of 3 g or less of fat 
per 55 g dry weight. Because the amount of added sugar in this reduced-
sugar oatmeal is less than 15 g, the proportional amount of fat, 
essentially all from whole oats, is slightly more than 3 g of fat per 
55 g of the product compared to the sweetened oatmeal, even thougth the 
total amount of fat in both the sweetened and reduced-sugar oatmeal 
products is the same.
    The ineligibility of reduced-sugar oatmeal for this health claim, 
due to less added sugar, is an uninitended consequence of the 
regulation. The current regulation, without amendment, causes 
distortion in the market, where products are essentially penalized for 
adding less sugar or filler. In certain instances where two products 
are identical at the package level, except for the amount of sugar 
added, only the product with more sugar is able to carry the CHD health 
claim because the product with less sugar has more oats per RACC and 
exceeds the ``low fat'' requirement. The proposed rule is needed to 
remove this unintended consequence.
2. Regulatory Options Considered
    The proposed rule would amend the regulation authorizing a health 
claim on the relationship between soluble fiber from certain foods and 
risk of CHD. The amendment would exempt certain foods from the nutrient 
content requirement of ``low fat.'' The exemption applies if the food 
exceeds this requirement due to fat content derived from oat sources.
    In drafting this document, FDA considered two regulatory 
alternatives in addition to these proposed amendments. The agency 
considered: (1) No additional regulatory action and (2) general 
relaxation of the total fat requirement, while keeping in place

[[Page 5371]]

restrictions on saturated fat and cholesterol. This proposed rule would 
not be an economically significant regulatory action. FDA is not 
quantitatively estimating the benefits and costs of the regulatory 
alternatives to the proposed rule. In the following paragraphs, FDA 
qualitatively compares the costs and benefits of the regulatory options 
to the costs and benefits of the proposed rule.
    a. Option one. The first option would be no action. As stated 
earlier in this document, the current rule as it stands causes an 
unintended distortion in the market. Consumers have a higher than 
necessary search cost to find products that are both reduced in sugar 
and that have similar attributes of those currently carrying the CHD 
claim. Furthermore, taking no action stifles the innovation of new 
products that have all of the attributes of those with the CHD claim 
and that are reduced in sugar.
    b. Option two. A second alternative to the proposed rule is a 
general relaxation of the total fat requirement from all fat sources 
for all products covered by the rule, while keeping in place 
restrictions on saturated fat and cholesterol. Relaxing the restriction 
for total fat from whole oat sources will not dampen the signal of the 
CHD claim (i.e., it will not reduce the clarity of the message that 
products bearing that claim in their labeling may reduce the risk of 
CHD), whereas a general relaxation of total fat from all fat sources in 
such products may have a deleterious effect in that the fat content may 
be excessive and increase the risk of CHD and negate the health 
benefits from the beta-glucan soluble fiber sources. The total fat 
content is about 6.9 g per 100 g for whole oats (same as whole oat 
flour) (Ref. 2), 6.3 g per 100 g for rolled oats (Ref. 2), 7.0 g per 
100 g for oat bran (Ref. 2), and 2.1 g per 100 g for oatrim (Ref. 3). 
Whole oats contain a higher amount of total fat than barley (2.3 g per 
100 g) or other cereal grains such as whole wheat (1.9 g per 100 g 
whole wheat flour), rice (2.9 g per 100 g brown rice), or corn (1.2 g 
per 100 g dry corn grits) (Ref. 2). However, most whole oat products 
that are essentially all whole oats meet the ``low fat'' requirement 
unless fat from other sources is added. For some products that do not 
meet the ``low fat'' requirement due to fat from whole oat sources, the 
amount of fat exceeding the ``low fat'' requirement may be small. For 
example, if a flavored sweetened oatmeal product were made almost 
entirely of whole oats, the total fat content of this product would not 
exceed 4 g per 55 g of RACC.
    Further, whole oats contain 1.2 g saturated fatty acids, 2.2 g 
monounsaturated fatty acids, and 2.5 g polyunsaturated fatty acids per 
100 g (Ref. 2), and thus, polyunsaturated and monounsaturated fatty 
acids are the predominant types of fat in whole oats. Whole oats do not 
contain cholesterol. The 2005 Dietary Guidelines for Americans (Ref. 4) 
recommends total fat intake be kept between 20 to 35 percent of 
calories, with most fats coming from sources of polyunsaturated and 
monounsaturated fatty acids, and less than 10 percent of calories from 
saturated fatty acids, and cholesterol intake be kept at less than 300 
mg per day. Thus, the fat profile of whole oats is consistent with the 
2005 Dietary Guidelines for Americans recommendation of a moderate 
amount of total fat with most sources coming from polyunsaturated and 
monounsaturated fatty acids, and limiting intake of saturated fatty 
acids and cholesterol. Relaxing the total fat requirement for fat from 
whole oats will not have a negative health effect and will allow the 
CHD claim to retain clarity when directing consumers to products 
consistent with a diet that is low in saturated fat and cholesterol, 
and high in soluble fiber.
    Relaxing the total fat requirement for fat from all fat sources in 
whole oat products may weaken the CHD claim signal that products 
bearing that claim in their labeling may reduce the risk of CHD. Under 
this scenario, products carrying the CHD claim could contain up to 13 g 
of fat per 55 g serving (i.e., the total fat disqualifying level for an 
individual food). The total fat disqualifying level is the level of 
total fat in a food above which the food will be disqualified from 
making a health claim (Sec.  101.14(a)(4)). Unlike whole oat sources, 
other products may have significantly more than the 3 g of fat per RACC 
that is the current total fat allowance for products carrying the CHD 
claim, and some may even approach the 13 g per RACC. Consumers using 
these products could easily increase their fat intake to levels above 
those recommended by the 2005 Dietary Guidelines for Americans (Ref. 
4). Furthermore, under current regulation that only stipulates 
disqualifying levels for saturated fat, cholesterol, and total fat, 
some of the increased fat intake could include trans fat.
    The potential health benefits would therefore be lower and the 
costs higher under this option than under the proposed rule.
3. The Proposed Rule
    This section details the potential costs and benefits of the 
proposed rule. The baseline in this case is the current rule, option 1 
listed earlier in this section. Thus, the benefits of the proposed rule 
are derived from an increase in the number of products that carry the 
CHD claim from which consumers may choose. The costs of the proposed 
rule are the health effects associated with the potential net increase 
in fat intake and the new labeling costs if a manufacturer decides to 
voluntarily use the health claim.\3\
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    \3\ As discussed in detail in section VI.A.3.c of this document, 
firms will not choose to label their product with the CHD claim if 
they could not make up the cost in higher margins for their 
products, increased volume of sales, or a combination of the two. 
Further, consumers would not pay the higher margin, or CHD claim 
premium, if they did not value the product relatively more than 
other products not carrying the claim. This increase in consumer 
willingness to pay for the CHD claim, though not to be confused with 
health benefits, will offset the private cost of the new labels.
---------------------------------------------------------------------------

    a. Coverage of the rule. FDA asks for comment on the number of 
products currently on the market that will qualify for the CHD claim if 
FDA finalizes the rule to permit the relaxation of the total fat 
requirement for fat from whole oat sources. FDA also requests comment 
on the number of new products that may be introduced due to the 
proposed rule. Because much of the information required to assess 
whether a product will qualify for the CHD claim is not required on the 
Nutrition Facts panel (NFP), FDA does not know with certainty how many 
products currently marketed will be affected by the proposed rule.\4\ 
Furthermore, FDA cannot predict how many new products will be 
introduced because of the proposed rule.
---------------------------------------------------------------------------

    \4\ For example, the source of the fat content is not required 
on the NFP.
---------------------------------------------------------------------------

    In estimating the baseline number of products, FDA identified 5 
products in the 2001 Food Label and Package Survey (FLAPS) (Ref. 5) 
that use the fiber related CHD claim. Of these products, three are hot 
cereals, one is a cold cereal, and one is wheat germ. Wheat germ 
products will not be affected by the proposed rule. Other types of 
products containing whole oats, such as cereal and snack bars, muffins, 
and cookies, will also not likely be affected by the proposed rule, as 
these products typically contain fat from sources other than whole oat 
sources, and would not be eligible to carry the CHD claim.
    FLAPS is only a sample of all of the products available on the 
market. The five hot cereal products sampled made up 90 percent of all 
hot cereal sales in 2001. Therefore, it is possible that one or two 
products on the market that carry the CHD claim in 2001 were missed by 
the survey. The six cold cereals sampled

[[Page 5372]]

made up only 18 percent of all cold cereal sales in 2001. Assuming the 
sample is representative implies that six or more products carrying the 
CHD claim were not included in the survey. Since 2001, new products 
carrying the claim may have entered the market and some products may 
have dropped out. FDA requests comment on the baseline number of 
products carrying the CHD claim.
    Through a search of the web and local grocery stores, FDA 
identified a single ``lower sugar'' hot cereal product that does not 
currently qualify for the CHD claim, but might under the proposed rule. 
The company that produces this product also produces two other ``lower 
sugar'' hot cereal products that qualify for the claim under the 
current rule. Beyond this single product, it is difficult to accurately 
predict how many products will be developed that would qualify for the 
claim under the proposed rule. Other ``lower sugar'' flavors might be 
developed. Furthermore, ``no sugar added'' products could be developed 
that could qualify for the CHD claim. Based on the current, limited 
information FDA estimates that between 1 and 10 current and future 
products will be affected by this proposed rule. FDA requests comment 
on this estimate.
    b. Benefits. The principal benefits of the proposed rule are 
derived from an increase in the number of products that carry the CHD 
claim from which consumers may choose. Society benefits from the 
increased number of CHD claim products in two ways: (1) Increased 
consumer information and (2) a potential health benefit.
    i. Increased consumer information. Consumers place a premium on 
products bearing a reduced CDH risk claim. That is, they value these 
products more than similar products not carrying the CHD claim. Part of 
this premium is due to a perceived health benefit. Part of it is also 
due to the fact that the CHD claim on the label, if consistent,\5\ 
instantly gives the consumer a lot of information about the product and 
therefore reduces search costs. The proposed rule, for example, will 
greatly increase the efficiency of a consumer's search for a product 
that is lower in sugar and also has all the qualities of a product 
carrying the CHD claim. FDA requests comment on the magnitude of this 
benefit.
---------------------------------------------------------------------------

    \5\ In section VI.A.2.b of this document, we assert that the 
relaxation of the total fat requirement for products made primarily 
of whole oats does not decrease the consistency or strength of the 
signal given by the CHD claim.
---------------------------------------------------------------------------

    ii. Potential health benefit. If consumers substitute the new CHD 
claim products for less healthy alternatives, the proposed rule would 
have a positive health effect. If a consumer is currently eating a 
product daily that is ``lower in sugar'' but happens to be relatively 
high in saturated fat and cholesterol, that consumer could potentially 
enjoy better health by switching to the new ``lower in sugar'' product 
that also carries the CHD claim. For example, some evidence suggests 
that the risk of CHD may be decreased by more than 2 percent for every 
1 g of oat bran consumed daily (Ref. 6). Without data allowing a 
prediction of consumer response, FDA cannot quantify this effect. 
Because the number of new products is likely to be small and the total 
dietary intake of consumers across the population is not likely to 
change drastically due to substitution between breakfast cereals, the 
health benefit is expected to be small.
    c. Costs. The principal costs of the proposed rule are the new 
labeling costs, if a manufacturer decides to voluntarily use the health 
claim, and the possible negative health effect due to a potential 
increase in fat intake.
    i. Labeling costs. Although voluntary labeling costs are 
necessarily less than the consumer premium placed on the products, it 
is useful to estimate the costs. Doing so gives a better idea of the 
costs generated and provides a lower bound to the total consumer 
utility gained from such products.
    FDA used the 2004 FDA Labeling Cost Model (Ref. 7) to calculate the 
potential new labeling costs produced by the proposed rule. The model 
calculates the cost of a new label based on the product type, label 
type, type of analytical and market tests necessary to develop the new 
label, compliance time, and inflation. Because the label is voluntary, 
firms can choose when to add the CHD label to their packaging and 
therefore can control the cost of the new label. If the firm chooses to 
immediately add the new label to the packaging, the full cost of 
redoing the label can be attributed to the CHD claim. Costs in this 
case will fall between $4.9 thousand and $10.6 thousand (mean = $6.8 
thousand) per unique product. Firms typically update their label about 
every 3 years. If firms add the CHD claim when they would normally 
update their label, the cost of adding the new information on the 
package approaches zero.
    New products that are developed because of the proposed rule will 
not incur new labeling costs due to the CHD claim label. They will 
simply work the claim into their initial label development. Because FDA 
only identified one current existing product that may qualify for the 
CHD claim because of the relaxation of the total fat requirement in the 
proposed rule, the one-time new labeling costs may fall between zero 
and $10.6 thousand.
    ii. Potential increase in fat intake. One other potential cost 
arises if total fat intake increases as a result of this claim. Total 
fat intake could either increase or decrease due to the proposed rule. 
Under the proposed rule, products carrying the CHD claim will, on 
average, contain more total fat than under the current rule. If there 
is no substitution between CHD claim products and other products, then 
the total intake of mostly polyunsaturated and monounsaturated fats 
would increase slightly in the population currently consuming CHD claim 
products. There is no evidence that a small increase in unsaturated 
fatty acids due to increased consumption of whole oat sources, even for 
a person eating multiple servings daily, would cause a negative health 
effect. In fact, a person with such a diet would still easily fall 
within the recommended fat intake (Ref. 4). If there is substitution 
between other products and CHD claims products (for example, between 
CHD claims cereal and other cereals that are higher in fat), it is 
possible that new CHD claims products might actually cause a decrease 
in total fat consumption.
    Due to the small number of products likely to make the CHD claim in 
the future, the health effect is likely to be small, but because some 
substitution from higher fat products is likely to occur, the health 
effect of the proposed rule with respect to fat intake will probably be 
positive.
    d. Summary of benefits and costs. Benefits and costs of the 
proposed rule are likely to be small because few products will be 
affected. Voluntary labeling costs for those manufacturers who choose 
voluntarily to use the health claim are small (less than a one-time 
cost of $11 thousand) and necessarily less than the consumer premium 
placed on the products. Futhermore it is likely that, with more product 
choices available bearing the CHD claim, there will be a net shift 
towards these products carrying the claim and away from other products. 
Although the size of this shift cannot be estimated with available 
data, it would result in a public health benefit.

B. Small Entity Analysis

    FDA has examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires

[[Page 5373]]

agencies to analyze the regulatory options that would lessen the 
economic effect of the rule on small entities. This proposed rule 
relaxes the total fat content requirement in the soluble fiber and CHD 
health claim for products whose fat content is derived solely from 
whole oat sources. Without this proposed rule, the more restrictive 
total fat content requirement would disqualify some products from being 
marketed with a CHD health claim. The proposed rule will not generate 
any compliance costs for any small entities because it does not require 
small entities to undertake any new activity. FDA therefore certifies 
that this proposed rule will not have a significant economic impact on 
a substantial number of small entities.

C. Unfunded Mandate Analysis

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rulemaking 
if the rule would include a ``Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $118 million, using the most current (2004) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this proposed rule, if finalized, to result in 1-year 
expenditures that would meet or exceed this amount and has determined 
that this proposed rule does not constitute a significant rule under 
the Unfunded Mandates Reform Act of 1995.

VII. The Paperwork Reduction Act of 1995

    FDA tentatively concludes that labeling provisions of this proposed 
rule are not subject to review by the Office of Management and Budget 
because they do not constitute a ``collection of information'' under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the 
food labeling health claim on beta-glucan soluble fiber and CHD risk is 
a ``public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the 
public.'' (see 5 CFR 1320.3(c)(2)).

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized as proposed, would have a preemptive 
effect on State law. Section 4(a) of the Executive Order requires 
agencies to ``construe * * * a Federal statute to preempt State law 
only where the statute contains an express preemption provision or 
there is some other clear evidence that the Congress intended 
preemption of State law, or where the exercise of State authority 
conflicts with the exercise of Federal authority under the Federal 
statute.'' Section 403A of the act (21 U.S.C. 343-1) is an express 
preemption provision. Section 403A(a)(5) of the act (21 U.S.C. 343-
1(a)(5)) provides that: ``* * *no State or political subdivision of a 
State may directly or indirectly establish under any authority or 
continue in effect as to any food in interstate commerce--* * *(5) any 
requirement respecting any claim of the type described in section 
403(r)(1) of the act made in the label or labeling of food that is not 
identical to the requirement of section 403(r) * * *''.
    Currently, this provision operates to preempt States from imposing 
health claim labeling requirements concerning soluble fiber from 
certain foods and reduced risk of CHD because no such requirements had 
been imposed by FDA under section 403(r) of the act. This proposed 
rule, if finalized as proposed, would amend existing food labeling 
regulations to provide an exemption for certain foods from the nutrient 
content requirement of ``low fat.'' Although the final rule would have 
a preemptive effect in that it would preclude States from issuing any 
health claim labeling requirements for soluble fiber from certain foods 
and a reduced risk of CHD that are not identical to those required by 
this proposed rule, this preemptive effect is consistent with what 
Congress set forth in section 403A of the act. Section 403A(a)(5) of 
the act displaces both state legislative requirements and state common 
law duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., 
concurring in part and concurring in judgment); id. at 510 (O'Connor, 
J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring 
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505 
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., 
joined by Thomas, J., concurring in judgment in part and dissenting in 
part).
    FDA believes that the preemptive effect of the proposed rule, if 
finalized as proposed, is consistent with Executive Order 13132. 
Section 4(e) of the Executive order provides that ``when an agency 
proposes to act through adjudication or rulemaking to preempt State 
law, the agency shall provide all affected State and local officials 
notice and an opportunity for appropriate participation in the 
proceedings.'' FDA's Division of Federal and State Relations is 
inviting the States' participation in this rulemaking by providing 
notice via fax and e-mail transmission to State health commissioners, 
State agriculture commissioners, food program directors, and drug 
program directors as well as FDA field personnel of FDA's publication 
of the proposed amendment to the health claim regulation authorizing 
the health claim for soluble fiber from certain foods and CHD (Sec.  
101.81). The notice provides the States with further opportunity for 
input on the rule. It advises the States of FDA's publication of this 
proposed rule and encourages the States and local governments to review 
the notice of proposed rulemaking and to provide any comments to the 
docket (Docket No. 2006P-0069).
    In conclusion, the agency has determined that the preemptive 
effects of this proposed rule, if finalized as proposed, are consistent 
with Executive Order 13132.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

    1. The Quaker Oats Company, ``Petition for Amendment of Health 
Claim Regulation (21 CFR Sec.  101.81)--Beta-Glucan Soluble Fiber 
from Whole Oat Sources and Risk of Coronary Heart Disease,'' Item 
CP1, Docket 2005P-0449, November 7, 2005.
    2. U.S. Department of Agriculture, Agricultural Research 
Service, USDA National Nutrient Database for Standard Reference, 
Release 18, Nutrient Data Laboratory Home Page (http://www.ars.usda.gov/Services/docs.htm?docid=13747), 2005.
    3. The Quaker Oats Company and Rhodia, Inc., ``Oatrim [Beta 
Trim\TM\] Health Petition,''

[[Page 5374]]

HCN1, vol. 1, Docket No. 01A-0313, April 12, 2001.
    4. U.S. Department of Health and Human Services and U.S. 
Department of Agriculture, Dietary Guidelines for Americans, 2005, 
6th Edition, Washington, D.C.: U.S. Government Printing Office, 
(http://www.health.gov/dietaryguidelines/dga2005/document/), January 
2005.
    5. U.S. Food and Drug Administration, CFSAN/Office of 
Nutritional Products, Labeling, and Dietary Supplements, Food Label 
and Package Survey 2000-2001, (http://www.cfsan.fda.gov/~dms/lab-
flap.html), May 2006.
    6. Institute of Medicine of the National Academies, Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids, the National Academies Press, 
Washington, D.C., pp. 367-368, 2005.
    7. RTI International, FDA Labeling Cost Model, Final Report, 
(http://www.foodrisk.org/lcm.htm), October 2004.

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, and 
redelegated to the Deputy Director for Regulatory Affairs, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

    2. Section 101.81 is amended by revising paragraph (c)(2)(iii)(C) 
and by adding new paragraph (c)(2)(iii)(D) to read as follows:


Sec.  101.81   Health claims: Soluble fiber from certain foods and risk 
of coronary heart disease (CHD).

* * * * *
    (c) * * *
    (2) * * *
    (iii) * * *
    (C) The food shall meet the nutrient content requirement in Sec.  
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (D) The food shall meet the nutrient content requirement in Sec.  
101.62(b)(2) for a ``low fat'' food, unless the food exceeds this 
requirement due to fat content derived from whole oat sources listed in 
paragraph (c)(2)(ii)(A) of this section.
* * * * *

    Dated: January 30, 2007.
Michael M. Landa,
Deputy Director, Regulatory Affairs, Center for Food Safety and Applied 
Nutrition.
[FR Doc. E7-1849 Filed 2-5-07; 8:45 am]
BILLING CODE 4160-01-S