[Federal Register Volume 73, Number 159 (Friday, August 15, 2008)]
[Rules and Regulations]
[Pages 47828-47829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18863]

[[Page 47828]]



Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


SUMMARY:  The Food and Drug Administration (FDA) is adopting as a final 
rule, without change, the provisions of the interim final rule (IFR) 
that amended the regulation authorizing a health claim on soluble fiber 
from certain foods and risk of coronary heart disease (CHD), to add 
barley betafiber as an additional eligible source of beta-glucan 
soluble fiber. FDA is taking this action to complete the rulemaking 
initiated with the IFR.

DATES:  This final rule is effective August 15, 2008.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, 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.


I. Background

    In the Federal Register of February 25, 2008 (73 FR 9938), FDA 
published an IFR to amend the regulation in part 101 (21 CFR part 101) 
that authorizes a health claim on the relationship between soluble 
fiber from certain foods and CHD (Sec.  101.81), to include barley 
betafiber as an additional eligible source of beta-glucan soluble 
fiber. Under section 403(r)(3)(B)(i) and (r)(7) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i) and 
343(r)(7)), FDA issued the IFR in response to a petition filed under 
section 403(r)(4) of the act. On June 20, 2006, Cargill Inc. (the 
petitioner), submitted a health claim petition to FDA requesting that 
the agency expand the ``Soluble fiber from certain foods and coronary 
heart disease'' health claim (Sec.  101.81) to include barley betafiber 
as an eligible food ingredient source of beta-glucan soluble fiber. The 
petitioner requested that FDA grant an IFR by which foods containing 
barley betafiber could bear the health claim prior to publication of 
the final rule.
    Section 403(r)(3)(B)(i) of the act states that the Secretary of 
Health and Human Services (and, by delegation, FDA) shall issue a 
regulation authorizing a health claim if he or she ``determines, based 
on the totality of publicly available scientific evidence (including 
evidence from well-designed studies conducted in a manner which is 
consistent with generally recognized scientific procedures and 
principles), that there is significant scientific agreement, among 
experts qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by such evidence.'' (See also 
Sec.  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. Section 
403(r)(7) of the act permits FDA to make a proposed regulation issued 
under section 403(r) effective upon publication pending consideration 
of public comment and publication of a final regulation if the agency 
determines that such action is necessary for public health reasons. FDA 
filed the petition for comprehensive review in accordance with section 
403(r)(4) of the act on September 28, 2006.
    As part of its review of the scientific literature on barley 
betafiber and CHD, FDA considered the scientific evidence presented in 
the petition as well as information previously considered by the agency 
on CHD risk reduction and the effects of beta-glucan soluble fiber 
containing food ingredients on lowering serum total and low density 
lipoprotein (LDL) cholesterol. The agency summarized this evidence in 
the IFR (73 FR 9938 at 9941 to 9943). Based on the available evidence, 
FDA concluded that barley betafiber, like the other whole oat and 
barley products listed in Sec.  101.81(c)(2)(ii)(A), lowers serum total 
and LDL cholesterol. Consequently, FDA amended Sec.  
101.81(c)(2)(ii)(A) to broaden the health claim to include barley 
betafiber as an additional eligible source of beta-glucan soluble 

II. Summary of Comments and the Agency's Response

    FDA solicited comments on the IFR. The comment period closed on May 
12, 2008. The agency received five letters of response, three from 
consumers, one from academia, and one from the Commonwealth of 
Kentucky. One consumer comment and the comment from academia supported 
the IFR. The Commonwealth of Kentucky advised the agency that FDA's 
ruling on the health claim would not adversely affect the State's 
actions or conflict with any State laws. The remaining consumer 
comments addressed issues that are outside the scope of this rulemaking 
and will not be addressed here.
    Given the absence of contrary evidence on the agency's decisions 
announced in the IFR, FDA is adopting as a final rule, without change, 
the IFR that amended Sec.  101.81 to include barley betafiber as an 
additional eligible source of beta-glucan soluble fiber.

III. Analysis of Impacts

    FDA has examined the impacts of the final 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 believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule allows new voluntary 
behavior and imposes no additional restrictions on current practices, 
the agency certifies that the final rule will not have a significant 
economic 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 proposing ``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 $127,000,000, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any one-year expenditure that would meet or 
exceed this amount.
    FDA received no comments relevant to economic impact. The costs and 
benefits of available regulatory alternatives analyzed in the IFR (73 
FR 9938 at 9944 and 9945) are adopted, without change, in this final 
rule. By now affirming that IFR, FDA has not imposed any new 
requirements. Therefore, there are no additional costs and benefits 
associated with this final rule.

[[Page 47829]]

IV. Environmental Impact

    The agency 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.

V. Paperwork Reduction Act

    FDA concludes that the labeling provisions of this final rule are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food 
labeling health claim on the association between consumption of barley 
betafiber and reduced risk of coronary heart disease is a ``public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 

VI. 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--* * * 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). * * *''
    On February 25, 2008, FDA published an IFR which imposed 
requirements under section 403(r) of the act. This final rule affirms 
the February 25, 2008, amendment to the existing food labeling 
regulations to add barley betafiber to the authorized health claim for 
soluble fiber from certain foods and CHD. Although this rule has a 
preemptive effect in that it precludes States from issuing any health 
claim labeling requirements for barley betafiber and 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 
December 12, 2007, FDA's Division of Federal and State Relations 
provided 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 
intent to amend the health claim regulation authorizing health claims 
for soluble fiber from certain foods and CHD (Sec.  101.81).
    In addition, the agency sought input from all stakeholders through 
publication of the IFR in the Federal Register on February 25, 2008. 
FDA received one comment from the Commonwealth of Kentucky, which noted 
that FDA's ruling on the health claim would not adversely affect the 
State's actions or conflict with any State laws.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements of Executive Order 13132 and has determined 
that the preemptive effects of this rule are consistent with the 
Executive order.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

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


Accordingly, the interim final rule amending Sec.  101.81 that was 
published in the Federal Register of February 25, 2008 (73 FR 9938), is 
adopted as a final rule, without change.

    Dated: August 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18863 Filed 8-14-08; 8:45 am]