[Federal Register Volume 73, Number 85 (Thursday, May 1, 2008)]
[Rules and Regulations]
[Pages 23947-23953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2006-P-0405] (formerly Docket No. 2006P-0069)


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulation authorizing a health claim on the relationship between 
soluble fiber from certain foods and risk of coronary heart disease 
(CHD). The amendment exempts certain foods from the nutrient content 
requirement of ``low fat.'' The exemption will apply if the food 
exceeds the ``low fat'' requirement due to fat content derived from 
whole oat sources. The amendment expands the use of this health claim 
to some whole oat products that are currently ineligible for the health 
claim. FDA is taking this

[[Page 23948]]

action in response to a petition submitted by the Quaker Oats Co.

DATES: This final rule is effective May 1, 2008.

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, 301-436-1774.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 6, 2007 (72 FR 5367), FDA 
published a proposed rule to amend the regulation authorizing a health 
claim on the relationship between soluble fiber from certain foods and 
risk of CHD. FDA proposed to amend the CHD health claim at Sec.  101.81 
(21 CFR 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. Specifically, FDA proposed 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). FDA issued this proposed rule in 
response to a health claim petition submitted by the Quaker Oats Co. 
(the petitioner) on November 7, 2005, under section 403(r)(4) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)). 
Section 403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B)(i)) states 
that the Secretary of Health and Human Services (the Secretary) (and, 
by delegation, FDA) shall issue regulations for health claims if the 
Secretary determines, based on the totality of publicly available 
scientific evidence, that there is significant scientific agreement 
that the claim is supported by such evidence (see also 21 CFR 
101.14(c)). Section 403(r)(4) of the act sets out the procedures that 
FDA is to follow upon receiving a health claim petition. FDA filed the 
petition for comprehensive review in accordance with section 403(r)(4) 
of the act on February 15, 2006.
    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),\1\ 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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    \1\ ``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 reference amount customarily 
consumed (RACC) and per 50 g of food.
    Further, under Sec.  101.62(b)(3), meal products and main dish 
products (as defined in Sec.  101.13(l) and Sec.  101.13(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.
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    Prior to the publication of this final rule, foods such as Quaker 
Oats Co.'s flavored reduced sugar instant oatmeal products were 
ineligible for the soluble fiber from certain foods and CHD health 
claim because these products did not meet the ``low fat'' criterion, 
whereas its flavored, unmodified instant oatmeal product containing the 
same amount of rolled oats and fat, but 12 grams (g) more sugar, per 
packet does meet the criterion. The removal of sugar from the flavored 
unmodified instant oatmeal product resulted in more whole oats (and 
thus fat from whole oats) per RACC. Thus, these food products were not 
eligible to bear the soluble fiber from certain foods and CHD health 
claim because these foods exceed the ``low fat'' criterion due to the 
fat contained in the whole oat source.
    In the proposed rule, FDA stated that a food product that contains 
any fat from ingredients other than whole oat sources would not be 
exempt from the ``low fat'' requirement. However, FDA asked for comment 
on whether 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 types(s) of fat contributed 
by these sources would be acceptable (72 FR 5367 at 5370).
    FDA solicited comments on the proposed rule. The comment period 
closed on April 23, 2007. The agency received eight responses, each 
containing one or more comments, to the proposed rule. The comments 
were from trade associations, industry, a health professional 
organization, a foreign government, and consumers. Most of the comments 
supported the proposed amendment. One comment raised issues that were 
outside the scope of this rulemaking and will not be discussed in this 
document. The remaining comments and the agency's responses are 
discussed below.
    (Comment 1) One comment opposed FDA exempting whole oat food 
products from the ``low fat'' requirement, but did not provide any 
specific information or data in support of its position.
    (Response) The agency disagrees with this comment. FDA believes 
that the consumption of foods containing whole oat products is helpful 
in reducing the risk of CHD, and the amount by which the fat content 
derived solely from whole oat sources may exceed the low fat criterion 
would not be very significant and is not likely to be a health concern. 
Moreover, the exemption does not cover a food product that contains any 
fat from ingredients other than whole oat sources and granting this 
exemption will provide consumers more choices of whole oat products (72 
FR 5367 at 5370). The comment did not provide any information or data 
in support of its position.
    (Comment 2) One comment opposing the proposed rule argued that 
granting the exemption would be the same as saying that full fat whole 
oatmeal cookies could reduce the risk of heart disease.
    (Response) The agency disagrees with the comment. As discussed in 
the proposed rule, only a limited number of products would be newly 
eligible to bear the claim (72 FR 5367 at 5372). Under the new 
exemption, a food must meet the ``low fat'' requirement ``unless the 
food exceeds this requirement due to fat content derived from whole oat 
sources'' (Sec.  101.81(c)(2)(iii)(D)). The products eligible to bear 
the claim would not contain any fat from sources other than the fat 
inherent in the whole oat sources. Food products that are typically 
made with other fat sources, such as cookies, would likely be 
ineligible for the claim.
    (Comment 3) One comment opposing the proposed rule was concerned 
that the exemption allowing an exception to a marketing claim for a 
single food product that has been modified would confuse consumers.
    (Response) FDA disagrees with the comment. Consumers will not be 
confused by this exemption because it does not apply only to a single 
food product. The final rule merely expands the use of this health 
claim to cover any whole oat product that was previously ineligible for 
the claim due to the fat derived from the whole oat source. The food 
product described in the petition only serves as an example of a 
consequence that was not intended

[[Page 23949]]

(reduction of sugar leading to ineligibility for the claim) in the 
authorization of the original health claim. The agency wishes to 
eliminate this unintended consequence and allow consumers access to 
information about the health benefits of whole oat sources.
    (Comment 4) One comment stated that any health claim related to CHD 
should meet requirements of ``low soluble fibre, low saturated fat, and 
low cholesterol.'' The comment did not provide any specific information 
or data in support of its position.
    (Response) Foods eligible for CHD-related health claims are 
currently required to meet the definition of ``low fat,'' ``low 
saturated fat,'' and ``low cholesterol,'' unless specifically exempted 
(see 21 CFR 101.75 (dietary saturated fat and cholesterol and CHD)), 21 
CFR 101.77 (fruits, vegetables, and grain products containing fiber and 
CHD), Sec.  101.81 (soluble fiber and CHD), 21 CFR 101.82 (soy protein 
and CHD), and 21 CFR 101.83 (plant sterol/stanol esters and CHD)). This 
final rule does not change the nutrient content requirements for ``low 
saturated fat,'' ``low fat,''or ``low cholesterol'' found in these CHD-
related health claims. The agency notes that the soy protein and CHD 
health claim also contains an exemption for the ``low fat'' 
requirement. Specifically, the soy protein and CHD health claim 
requires the food to meet the nutrient content requirement for ``low 
fat'' found in Sec.  101.62 ``unless it consists of or is derived from 
whole soybeans and contains no fat in addition to the fat inherently 
present in the whole soybeans it contains or from which it is derived'' 
(Sec.  101.82(c)(2)(iii)(C)).
    Contrary to what the comment infers, foods are not required to meet 
any soluble fiber requirements to bear a CHD-related health claim 
except in the specific case where fiber has been declared as the 
substance that is the subject of the claim (i.e., the fruits, 
vegetables, and grain products containing fiber and CHD-related health 
claim found at Sec.  101.77 and the health claim discussed in this 
rule). Even in these cases, the fiber requirement is to meet certain 
fiber levels, not to keep the fiber (soluble or otherwise) ``low.'' The 
agency has determined in these CHD-related health claims that diets 
that are low in saturated fat and cholesterol and that include soluble 
fiber from certain foods may reduce the risk of CHD (see Sec. Sec.  
101.77(a) and 101.81(a) for explanations of the relationship between 
diets low in saturated fat and cholesterol that contain fiber). 
Therefore for these CHD-related health claims, the goal is to encourage 
the consumption of fiber-rich foods, and not to limit the amount of 
fiber in the food as the comment suggests.
    (Comment 5) Two comments requested that FDA extend the exemption 
from the ``low fat'' requirement to other beta-glucan-containing food 
products, specifically whole grain barley, dry milled barley, and other 
barley products.
    (Response) FDA is not now exempting other beta-glucan-containing 
food products from the ``low fat'' nutrient content requirement. As 
discussed in the proposed rule, 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. The total fat 
content of whole oat sources can be as high as 7.0 g per 100 g, whereas 
other cereal grain products are lower in fat. ``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)'' (72 FR 5367 at 5369). As a result of these nutrient 
compositions, it is likely that additional cereal grain food products 
on the market consisting of other cereal grains (and not including 
other sources of fat) would already meet the ``low fat'' requirement 
for the soluble fiber claim and would not require any exemption to this 
requirement. The agency is aware, however, that advances in food 
technology (such as the reduction of sugar in oatmeal products) can 
lead to consequences unintended by the original health claim, and in 
those cases, the agency can be petitioned under section 403(r)(4) of 
the act to address the issue in rulemaking.
    (Comment 6) Two comments requested that FDA eliminate the ``low 
fat'' requirement for this health claim based on the latest 2005 
Dietary Guidelines for Americans science and dietary recommendations. 
The comments recommended that a ``moderate'' level of fat should be the 
requirement that foods eligible for the claim should have to meet. This 
change, the comments noted, could allow food products eligible to bear 
the claim to contain as much as 13 g total fat (the total fat 
disqualifying level). In support of their position, the comments 
pointed out that the 2005 Dietary Guidelines for Americans do not 
require that diets be low in fat.
    (Response) FDA is not revising the rule as requested by the 
comment. Section 101.81(c)(2)(iii)(C) states that a food eligible to 
bear a soluble fiber and CHD health claim must meet the nutrient 
content requirements in Sec.  101.62 for a ``low saturated fat,'' ``low 
cholesterol,'' and ``low fat'' food. ``Low saturated fat,'' ``low 
cholesterol,'' and ``low fat'' are nutrient content claims defined by 
regulation (Sec.  101.62). ``Moderate fat'' is not defined by 
regulation nor was defining this term foreshadowed in the proposal. 
However, any interested person can petition the agency to define and 
authorize a new nutrient content claim for ``moderate fat'' under 
section 403(r)(4) of the act.
    (Comment 7) One comment requested that FDA exempt fat from 
fortificants (e.g., vitamin A palmitate) from the ``low fat'' 
requirement because the amount of fat from fortificants would likely be 
``inconsequential.''
    (Response) FDA is not granting the requested exemption. The agency 
asked for comment in the proposed rule about whether to exempt whole 
oat products that contain sources of fat other than whole oat sources 
and, if so, how much and what type(s) of fat contributed by these 
sources would be acceptable. However, FDA did not receive, nor does it 
have, sufficient data regarding fortificants, such as vitamin A 
palmitate, to determine if whole oat foods that contain sources of fat 
from fortificants should be exempted from the ``low fat'' requirement.
    Although FDA is not now revising the rule to include fat from 
fortificants as a source of fat eligible for the exemption from the 
``low fat'' requirement, any interested person can petition the agency 
for such an exemption under section 403(r)(4) of the act.
    (Comment 8) One comment requested that FDA confirm the nutrient 
composition values for total fat because the USDA National Nutrient 
Database has been updated since the proposal was published in February 
2007.
    (Response) The agency has confirmed that the values for fat 
composition of the grains cited in the proposed rule (i.e., about 6.9 g 
per 100 g for whole oats (same as whole oat flour), 6.3 g per 100 g for 
rolled oats, and 7.0 g per 100 g for oat bran) have remained unchanged 
in the newest release of the USDA National Nutrient Database for 
Standard Reference, Release 20 (Ref. 1).
    (Comment 9) One comment suggested that FDA also provide exemptions 
to the per 50 g provision of the ``low fat'' requirement for foods with 
small serving sizes. The comment stated that products should not need 
to meet the ``low fat'' criteria on a per 50 g basis in addition to a 
per RACC and labeled serving size basis since products with small 
serving sizes (e.g., ready-to-eat cereals) would not be eligible for 
the health claim.

[[Page 23950]]

    (Response) FDA advises that the exemption to the ``low fat'' 
requirement is not restricted by this final rule to food products with 
typical serving sizes. If a whole oat food product with a small serving 
size of 30 g or less or 2 tablespoons or less exceeds the ``low fat'' 
requirement on a 50 g basis due to fat derived solely from the whole 
oat source, it is exempted from the ``low fat'' requirement as well.
    Given the information discussed in the preamble to the proposed 
rule and the absence of contrary information in the comments, FDA is 
adopting as a final rule, without change, the proposed amendment to 
Sec.  101.81 to exempt certain foods from the nutrient content 
requirement of ``low fat'' if the food exceeds this requirement due to 
fat content derived from whole oat sources.

II. Analysis of Economic Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, 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 final rule is an economically significant regulatory 
action as defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule allows new voluntary 
behavior and imposes no additional restrictions on current practices, 
the agency certifies that this final rule will not have a significant 
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before finalizing ``any rule that 
includes any 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 $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. The Need for Regulation

    Current 21 CFR 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 though 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 unintended consequence of the regulation. 
The current regulation, without amendment, causes a 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 final rule is needed to remove this unintended 
consequence.

B. Regulatory Options Considered

    The final rule amends the regulation authorizing a health claim on 
the relationship between soluble fiber from certain foods and risk of 
CHD. The amendment exempts 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 certain oat sources.
    In drafting this rule, FDA considered two regulatory alternatives 
in addition to the final rule. The agency considered the following 
alternatives: (1) No additional regulatory action and (2) general 
relaxation of the total fat requirement, while keeping in place 
restrictions on saturated fat and cholesterol. This final rule will not 
be an economically significant regulatory action. FDA is not 
quantitatively estimating the benefits and costs of the regulatory 
alternatives to the final rule. In what follows, FDA qualitatively 
compares the costs and benefits of the regulatory options to the costs 
and benefits of the final rule.
    1. Option one. The first option considered is no action. As stated 
earlier, 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.
    2. Option two. A second alternative to the final 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. 
1), 6.3 g per 100 g for rolled oats (Ref. 1), 7.0 g per 100 g for oat 
bran (Ref. 1), and 2.1 g per 100 g for oatrim (Ref. 2). 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. 1). 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 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

[[Page 23951]]

polyunsaturated fatty acids per 100 g (Ref. 1), 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. 3) 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/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. 
3). 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 final rule.

C. The Final Rule

    This section details the costs and benefits of the final rule. The 
baseline in this case is the current rule, option one listed above, so 
the benefits of the final rule are derived from an increase in the 
number of products consumers have to choose from that carry the CHD 
claim. The costs of the final 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.\2\
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    \2\ As discussed in detail in section C.3 of this regulatory 
impact analysis, a firm will not choose to label its product with 
the CHD claim if the firm can not make up the cost in higher margins 
for its product, increased volume of sales, or a combination of the 
two. Further, consumers will not pay the higher margin, or CHD claim 
premium, if they do 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.
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1. Coverage of the 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 label, FDA does not know with certainty how many products 
currently marketed will be affected by the final rule.\3\ Furthermore, 
FDA cannot predict how many new products will be introduced because of 
the final rule.
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    \3\ For example, the source of the fat content is not required 
on the Nutrition Facts label.
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    In estimating the baseline number of products, FDA identified five 
products in the 2001 Food Label and Package Survey (FLAPS) (Ref. 4) 
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 final 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 final 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 6 cold cereals sampled 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.
    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 final 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 final 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 one and ten current and future 
products will be affected by this final rule.
2. Benefits
    The principal benefits of the final rule are derived from an 
increase in the number of products consumers have to choose from that 
carry the CHD claim. Society benefits from the increased number of CHD 
claim products in two ways: (1) Increased consumer information and (2) 
a potential health benefit.
    a. Increased consumer information. Consumers place a premium on 
products bearing a reduced CHD 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,\4\ This 
is where you want the beginning of your text to appear instantly gives 
the consumer a lot of information about the product and therefore 
reduces search costs. The final 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.
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    \4\ In section B.2 of this regulatory impact analysis, 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.
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    b. Potential health benefit. If consumers substitute the new CHD 
claim products for less healthy alternatives, the final rule will 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

[[Page 23952]]

oat bran consumed daily (Ref. 5). 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.
3. Costs
    The principal costs of the final 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.
    a. 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 Labeling Cost Model (Ref. 6) to calculate the 
potential new labeling costs produced by the final 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. Since 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 $4,900 and $10,600 (mean = $6,800) 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 final rule will not 
incur new labeling costs due to the CHD claim label. They will simply 
work the claim into their initial label development. Since 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 
final rule, the one time new labeling costs are estimated to be between 
zero and $10,600.
    b. 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 final rule. 
Under the final 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. 3). 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 final rule with respect to fat intake will probably be 
positive.
4. Summary of Benefits and Costs
    Benefits and costs of the final rule are likely to be small because 
few products will be affected. Voluntary labeling costs for those 
manufacturers who choose to use the health claim are small (less than a 
one-time cost of $11,000) and necessarily less than the consumer 
premium placed on the products. Furthermore, 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.

III. Environmental Impact

    FDA has determined under 21 CFR 25.32(p) that this action is of the 
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.

IV. Paperwork Reduction Act of 1995

    FDA concludes that labeling provisions of this 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)).

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
will 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 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) made in the label 
or labeling of food that is not identical to the requirement of section 
403(r). * * *''
    This final rule amends existing food labeling regulations to 
provide an exemption for certain foods from the nutrient content 
requirement of ``low fat.'' Although this rule has 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 final 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. (Riegel v. 
Medtronic, 128 S. Ct. 999 (2008)).
    FDA believes that the preemptive effect of this final rule 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.'' On 
February 5, 2007, FDA's Division of Federal and State Relations 
provided notice by fax and e-mail transmission to State health 
commissioners, State agriculture commissioners, food program directors, 
and drug program directors as well as

[[Page 23953]]

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).
    In addition, the agency sought input from all stakeholders through 
publication of the proposed rule (72 FR 5367). FDA received no comments 
from any states on the proposed rulemaking.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under the Executive Order and has 
determined that the preemptive effects of this final rule are 
consistent with Executive Order 13132.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday. (FDA has verified all 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. U.S. Department of Agriculture, Agricultural Research 
Service. 2007. USDA National Nutrient Database for Standard 
Reference, Release 20. Nutrient Data Laboratory Home Page, http://www.ars.usda.gov/ba/bhnrc/ndl.
     2. The Quaker Oats Co. and Rhodia, Inc., ``Oatrim [Beta 
Trim\TM\] Health Petition,'' HCN1, vol. 1, Docket No. 01A-0313, 
April 12, 2001.
    3. U.S. Department of Health and Human Services and U.S. 
Department of Agriculture, Dietary Guidelines for Americans, 2005, 
6\th\ Edition, Washington, DC: U.S. Government Printing Office, 
(http://www.health.gov/dietaryguidelines/dga2005/document/), January 
2005.
    4. 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.
    5. 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, DC, 2005, pp. 367-368.
    6. RTI International, FDA Labeling Cost Model, Final Report, 
(http://www.foodrisk.org/exclusives/FDA_LCM/), October 2004.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
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.

0
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: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9590 Filed 4-30-08; 8:45 am]
BILLING CODE 4160-01-S