[Federal Register Volume 71, Number 206 (Wednesday, October 25, 2006)]
[Proposed Rules]
[Pages 62400-62407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 170

[Docket No. 2002P-0122] (formerly 02P-0122)


Conventional Foods Being Marketed as ``Functional Foods''; Public 
Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing on the regulation of certain conventional foods that companies 
are marketing as ``functional foods.'' The purpose of the hearing is 
for the agency to share its current regulatory framework and rationale 
regarding the safety evaluation and labeling of these foods, and to 
solicit information and comments from interested persons on how FDA 
should regulate these foods under the agency's existing legal 
authority.

DATES: The public hearing will be held on Tuesday, December 5, 2006, 
from 9 a.m. to 4:30 p.m. Persons who wish to request an opportunity to 
make an oral presentation must submit a notice of participation by 
November 14, 2006. All other persons must submit a notice of 
participation by November 28, 2006. Persons who request an opportunity 
to make an oral presentation also must submit either the full text of 
the oral presentation, or a comprehensive outline or summary of the 
oral presentation, by November 28, 2006. Written or electronic comments 
(i.e., submissions other than notices of participation and the text, 
comprehensive outline, or summary of an oral presentation) may be 
submitted until January 5, 2007. The administrative record of the 
hearing will remain open until January 5, 2007.

ADDRESSES: The public hearing will be held at Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5100 
Paint Branch Pkwy., Harvey W. Wiley Auditorium, College Park, MD 20740 
(Metro stop: College Park on the Green Line).
    Submit electronic notices of participation to http://
www.cfsan.fda.gov/~comm/register.html. Submit written notices of 
participation and the written full text, comprehensive outline, or 
summary of any oral presentation to Isabelle Howes, U.S. Department of 
Agriculture Graduate School, 600 Maryland Ave., SW., suite 270 
Washington, DC 20024-2520. To submit a notice of participation orally, 
or to submit a notice of participation or the full text, comprehensive 
outline or summary of the oral presentation by e-mail or by fax, see 
FOR FURTHER INFORMATION CONTACT.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
    Instructions: All submissions and comments received must include 
the agency name and docket number found in brackets in the heading of 
this document. All submissions and 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 ``Request for Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Transcripts of the hearing will be available for review at the 
Division of Dockets Management and on the Internet at http://www.fda.gov/ohrms/dockets/default.htm, approximately 30 days after the 
hearing.

FOR FURTHER INFORMATION CONTACT:
    To submit a notice of participation orally, by fax, or by e-mail: 
Isabelle Howes, U.S. Department of Agriculture Graduate School, 202-
314-4713, FAX: 202-479-6801, or e-mail: [email protected].
    For all other questions about the meeting, to request onsite 
parking, or if you need special accommodations due to a disability: 
Juanita Yates, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
301-436-1714, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    FDA is responsible for ensuring that all foods in the American food 
supply (other than meat products, poultry

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products, and egg products that are regulated by the U.S. Department of 
Agriculture) are safe, secure, sanitary, wholesome, and properly 
labeled.
    Section 201(f) of the Federal Food, Drug, and Cosmetic Act (FFDCA 
or the act) (21 U.S.C. 321(f)) defines food to mean: (1) Articles used 
for food or drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article. The act also defines 
several specific types of food and substances that are added to food, 
including: ``raw agricultural commodity'' (section 201(r) (21 U.S.C. 
321(r))), ``food additive'' (section 201(s) (21 U.S.C. 321(s))), 
``color additive'' (section 201(t) (21 U.S.C. 321(t))), ``infant 
formula'' (section 201(z) (21 U.S.C. 321(z))), ``dietary supplement'' 
(section 201(ff) (21 U.S.C. 321(ff))), and ``processed food'' (section 
201(gg) (21 U.S.C. 321(gg))).
    The act does not define the term ``conventional food.'' However, 
the act defines a dietary supplement, in part, as a product that is 
``not represented for use as a conventional food'' (see section 
201(ff)(2)(B) (21 U.S.C. 321(ff)(2)(B))). Products such as beverages, 
baked goods, cheeses, milk products, cereal, grain products, pasta, 
fats and oils, vegetable spreads, snack foods, candy, soups, and infant 
formula are examples of conventional foods. The act includes provisions 
that relate to certain types of conventional food, such as requirements 
for infant formula in section 412 of the act (21 U.S.C. 350a).
    In recent years, the food industry has developed and marketed foods 
that it refers to as ``functional foods.'' Although there is no formal 
definition of what the industry means by ``functional food,'' on March 
24, 2005, the Institute of Food Technologists (IFT) issued a report 
entitled ``Functional Foods: Opportunities and Challenges'' (Ref. 1) 
(the IFT report) in which ``functional foods'' are defined as ``foods 
and food components that provide a health benefit beyond basic 
nutrition (for the intended population). * * * These substances provide 
essential nutrients often beyond quantities necessary for normal 
maintenance, growth, and development, and/or other biologically active 
components that impart health benefits or desirable physiological 
effects.'' Examples of functional foods cited in the report include 
``conventional foods; fortified, enriched or enhanced foods; and 
dietary supplements.''
    Currently, FDA has neither a definition nor a specific regulatory 
rubric for foods being marketed as ``functional foods.'' We regulate 
conventional foods being marketed as ``functional foods'' under the 
same regulatory framework as other conventional foods. Although we are 
confident that the existing provisions of the act are adequate to 
ensure that conventional foods being marketed as ``functional foods'' 
are safe and lawful, we believe that it would be in the best interest 
of public health to begin a dialog with industry, consumers, and other 
stakeholders regarding the regulation of these products. Therefore, in 
this document we announce a public hearing to afford consumers, 
industry, and other interested parties the opportunity to provide 
focused comments on approaches to the regulation of conventional foods 
being marketed as ``functional foods.'' As background relevant to the 
hearing, we describe key provisions of the act regarding the safety and 
labeling of conventional foods.
    For the purpose of this hearing, we are not considering dietary 
supplements to be encompassed by the term ``functional foods.'' Dietary 
supplements have their own detailed regulatory framework prescribed by 
Congress in the Dietary Supplement Health and Education Act of 1994 
(DSHEA) (Public Law 103-417, 108 Stat. L. 4325), which amended the 
FFDCA to define ``dietary supplement'' and to set forth requirements 
for the safety and labeling of dietary supplements. DSHEA specifically 
excludes from the definition of dietary supplement any product that is 
``represented for use as a conventional food or as a sole item of a 
meal or the diet'' (Section 201(ff)(2)(B) of the act (21 U.S.C. 
321(ff)(2)(B)). However, because some labeling provisions of the act 
with respect to dietary supplements are relevant to the issues and 
questions that are part of the scope of this hearing, in this document 
we describe some labeling provisions of the act with respect to dietary 
supplements.

B. Statutory and Regulatory Framework for the Safety of Food 
Ingredients

    In 1958, Congress enacted the Food Additives Amendment (the 1958 
amendment) to the act (Public Law 85-929, 72 Stat. L. 1784). The basic 
thrust of the 1958 amendment was to require ``the processor who wants 
to add a new and unproven additive to accept the responsibility of * * 
* first proving it to be safe for ingestion by human beings'' (S. Rept. 
2422, 85th Cong., 2d Sess.). The 1958 amendment defined the terms 
``food additive'' (section 201(s) of the act (21 U.S.C. 321(s))) and 
``unsafe food additive'' (section 409(a) of the act (21 U.S.C. 
348(a))), established a premarket approval process for food additives 
(section 409(b) through (g) (21 U.S.C. 348(b) through (g)), and amended 
the food adulteration provisions of the act to deem adulterated any 
food that is, or bears or contains, any food additive that is unsafe 
within the meaning of section 409 (section 402(a)(2)(C) of the act (21 
U.S.C. 342(a)(2)(C))).
    Recognizing that the safety of a food additive cannot be 
established with absolute certainty and that safety is dependent on 
dietary intake and other conditions of use, Congress stated that 
``safety'' under the 1958 amendment means a reasonable certainty that 
no harm will result from the intended use of an additive (S. Rept. 
2422, 85th Cong., 2d Sess.). We have incorporated this safety standard 
into our regulation defining the terms ``safe'' and ``safety`` (21 CFR 
170.3(i)). If we find an additive to be safe, based ordinarily on data 
submitted by the manufacturer to the agency in a food additive 
petition, we issue a regulation specifying the conditions under which 
the additive may be safely used in food.
    Many substances intentionally added to food do not require a formal 
premarket review by FDA to assure their safety, either because their 
safety has been established by a long history of use in food or by 
virtue of the nature of the substances, their customary or projected 
conditions of use, and the information generally available to 
scientists about the substances. In enacting the 1958 amendment, 
Congress addressed this category of substances by adopting, in section 
201(s) of the act (21 U.S.C. 321(s)), a two-step definition of ``food 
additive.'' The first step broadly includes any substance, the intended 
use of which results or may reasonably be expected to result, directly 
or indirectly, in its becoming a component or otherwise affecting the 
characteristics of food. The second step, however, excludes from the 
definition of ``food additive'' substances that are generally 
recognized, among experts qualified by scientific training and 
experience to evaluate their safety, as having been adequately shown 
through scientific procedures (or, in the case of a substance used in 
food prior to January 1, 1958, through either scientific procedures or 
through experience based on common use in food) to be safe under the 
conditions of their intended use. Substances that are exempted from the 
food additive definition under this second step are referred to as 
``GRAS'' (generally recognized as safe). The safety standard for a GRAS 
substance is the same as the safety standard for a food additive, i.e., 
reasonable certainty of no harm under the substance's intended 
conditions of use (21 CFR 170.30(i)). However, for the use of a

[[Page 62402]]

substance to be GRAS, it must not only be safe but, unlike for an 
approved food additive, there must also be general recognition of its 
safety among qualified experts.
    We have established regulations governing the food additive 
petition process (21 CFR 171.1). We also have established regulations 
(21 CFR 170.35(c)) governing a voluntary process whereby an interested 
person may petition us to affirm, through rulemaking, that a use of a 
food substance is GRAS. However, more recently we have proposed to 
eliminate the voluntary GRAS affirmation petition process and replace 
it with a voluntary notification procedure in which we respond to a 
notifier by letter rather than conduct rulemaking to affirm GRAS status 
(62 FR 18937, April 17, 1997 (the GRAS proposal)). As announced in the 
GRAS proposal, we are accepting GRAS notices during the interim between 
the proposed rule and any final rule that publishes based on the 
proposed rule. A summary of notices filed under the rubric of the GRAS 
proposal, with links to our letters responding to those notices, is 
available on the Internet (see http://www.cfsan.fda.gov/~rdb/opa-
gras.html).
    We have developed a number of guidance documents relevant to 
evaluating the safety of food ingredients, such as recommendations 
relating to chemical and toxicological considerations. These are 
available at http://www.cfsan.fda.gov/~dms/opa-guid.html.

C. Statutory and Regulatory Framework for the Labeling of Food

1. Provisions regarding false or misleading labeling
    Under section 403(a)(1) of the act (21 U.S.C. 343(a)(1)), a food is 
misbranded if its labeling is false or misleading in any particular. 
Under section 201(n) of the act (21 U.S.C. 321(n)), in determining 
whether the labeling of an article is misleading, ``there shall be 
taken into account (among other things) not only representations made 
or suggested by statement, word, design, device, or any combination 
thereof, but also the extent to which the labeling fails to reveal 
facts material in the light of such representations or material with 
respect to consequences which may result from the use of the article to 
which the labeling relates under the conditions of use prescribed in 
the labeling thereof or under such conditions of use as are customary 
or usual.''
    Sections 403(a)(1) and 201(n) of the act (21 U.S.C. 343(a) and 
321(n)) broadly apply to the labeling of all foods, in addition to any 
specific labeling requirements established by or under authority of the 
act for certain foods or for certain statements on foods. In the 
absence of specific statutory or regulatory requirements for statements 
in the labeling of a food, we apply the standards of sections 403(a)(1) 
and 201(n) of the act (21 U.S.C. 343(a)(1) and 321(n)) to determine if 
the food is misbranded.
2. Provisions for health claims and nutrient content claims
    Section 403(r) of the act (21 U.S.C. 343(r)) lays out the statutory 
framework for the use of labeling claims that characterize the 
relationship of a substance in food to a disease or health-related 
condition (``health claims,'' defined in section 403(r)(1)(B) of the 
act (21 U.S.C. 343(r)(1)(B)), or that characterize the level of a 
nutrient in a food (``nutrient content claims,'' defined in section 
403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A))). We have established 
regulations implementing section 403(r) of the act (21 U.S.C. 343(r)) 
with respect to health claims (21 CFR 101.14 and subpart E) and with 
respect to nutrient content claims (21 CFR 101.13 and subpart D).
    The definition of ``health claim'' identifies two basic elements 
for a health claim: (1) A substance (e.g, a nutrient); and (2) a 
disease or health-related condition (see section 403(r)(1)(B) of the 
act (21 U.S.C. 343(r)(1)(B)) and 21 CFR 101.14(a)(1)). In determining 
whether a particular claim is a health claim, we evaluate, in part, 
whether the claim is about a substance in food (see 21 CFR 
101.14(a)(2)) and whether the claim is about reducing risk for a 
disease or health-related condition (see Whitaker v. Thompson, 353 F.3d 
947 (D.C. Cir.), cert. denied, 125 S. Ct. 310 (2004)).
    There are three ways by which we exercise our oversight in 
determining which health claims may be used in the labeling of 
conventional foods and dietary supplements. First, the Nutrition 
Labeling and Education Act of 1990 (NLEA) (Public Law 101-535, 104 
Stat. L. 2353), which amended the FFDCA, provides for us to issue 
regulations authorizing health claims for conventional foods and 
dietary supplements after our evaluation of the scientific evidence 
relative to the claim under the significant scientific agreement (SSA) 
standard (see section 403(r)(3)(B) of the act (21 U.S.C. 343(r)(3)(B)). 
Health claims authorized through this process are commonly referred to 
as ``SSA claims.'' Second, the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 105-115, 111 Stat. L. 
2296), amended the FFDCA to provide for health claims for conventional 
foods based on an authoritative statement of certain scientific bodies 
of the United States government or of the National Academy of Sciences 
(now the National Academies). Such claims may be used from 120 days 
after submission of a health claim notification to FDA until the agency 
prohibits or modifies the claim by regulation or obtains a court order 
determining that the statutory requirements for an authoritative 
statement notification health claim have not been met (see section 
403(r)(3)(C)-(D) of the act (21 U.S.C. 343(r)(3)(C)-(D))). We have 
issued guidance on the authoritative statement notification procedure 
(see Guidance for Industry: Notification of a Health Claim or Nutrient 
Content Claim Based on an Authoritative Statement of a Scientific Body; 
available at http://www.cfsan.fda.gov/~dms/hclmguid.html) (Ref. 2). 
Third, as a result of court decisions interpreting the first amendment 
of the U.S. Constitution, we exercise enforcement discretion with 
respect to certain qualified health claims (QHC) where there is 
credible evidence to support the proposed claim, but the strength of 
the scientific evidence falls below that required for FDA to issue an 
authorizing regulation based on significant scientific agreement (see, 
e.g., Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). For 
information on qualified health claims for which FDA has issued a 
letter of enforcement discretion, see http://www.cfsan.fda.gov/~dms/
qhc-sum.html).
    A ``nutrient content claim'' is a statement in food labeling that 
explicitly or implicitly characterizes the level of a nutrient in a 
food (see section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)) and 
21 CFR 101.13(b)). Nutrient content claims must be authorized by 
regulation (see section 403(r)(2)(A)(i) and (r)(4)(A)(i) of the act (21 
U.S.C. 343(r)(2)(A)(i) and (r)(4)(A)(i))), through a synonym or brand 
name petition process (see section 403(r)(4)(A)(ii)-(iii) of the act 
(21 U.S.C. 343(r)(4)(A)(ii)-(iii))), or (for conventional foods only) 
through an authoritative statement notification process (see section 
403(r)(2)(G)-(H) of the act (21 U.S.C. 343(r)(2)(G)-(H))) before they 
may be used in food labeling.

[[Page 62403]]

3. Provisions for structure/function claims
    In the DSHEA, Congress amended section 403(r) of the act (21 U.S.C. 
343(r)) to authorize certain types of claims to be used in the labeling 
of dietary supplements without premarket review by FDA. Among the types 
of claims specifically authorized are statements describing the role of 
a nutrient or dietary ingredient intended to affect the structure or 
function of the body in humans and statements that characterize the 
documented mechanism by which a nutrient or dietary ingredient acts to 
maintain such structure or function. Under section 403(r)(6) of the act 
(21 U.S.C. 343(r)(6)), such statements (as well as two other types of 
claims not relevant to this notice) may be made in the labeling of a 
dietary supplement if the manufacturer of the dietary supplement has 
substantiation that such statement is truthful and not misleading, and 
the statement contains, prominently displayed and in boldface type, the 
following: ``This statement has not been evaluated by the Food and Drug 
Administration. This product is not intended to diagnose, treat, cure, 
or prevent any disease.'' A statement under section 403(r)(6) (21 
U.S.C. 343(r)(6)) may not claim to diagnose, mitigate, treat, cure, or 
prevent a specific disease or class of diseases. The manufacturer of a 
dietary supplement that bears such a statement must notify FDA, no 
later than 30 days after the first marketing of the dietary supplement 
with the statement, that the statement is being made. We have 
established in 21 CFR 101.93 regulations implementing section 403(r)(6) 
of the act (21 U.S.C. 343(r)(6)).
    The act includes no provision analogous to section 403(r)(6) of the 
act (21 U.S.C. 343(r)(6)) for statements made in the labeling of 
conventional food. However, the provision of the act that defines 
``drug'' to include articles intended to affect the structure or 
function of the body contains an exception for foods, which affect the 
structure and function of the body by virtue of providing nutrition to 
sustain life and health (see section 201(g)(1)(C) of the act (21 U.S.C. 
321(g)(1)(C)). As discussed in section I.A of this document, ``food'' 
is defined in section 201(f) of the act (21 U.S.C. 321(f)). Therefore, 
for conventional foods we regulate claims about the effect of a 
substance in food on the structure or function of the body under 
sections 201(f), 201(g), 403(a) and 201(n) of the act, as well as case 
law interpreting these provisions (see, e.g., Nutrilab v. Schweiker, 
713 F.2d 335 (7th Cir. 1983)).

D. Nutrition and Fortification Policy

    The Dietary Guidelines for Americans, 2005 (Dietary Guidelines) 
(Ref. 3), a joint publication of the Department of Health and Human 
Services, FDA's parent agency, and the U.S. Department of Agriculture, 
forms the basis for the Federal Government's nutrition programs and 
policies. The Executive Summary of the Dietary Guidelines states: ``A 
basic premise of the Dietary Guidelines is that nutrient needs should 
be met primarily through consuming foods. Foods provide an array of 
nutrients and other compounds that may have beneficial effects on 
health. In certain cases, fortified foods and dietary supplements may 
be useful sources of one or more nutrients that otherwise might be 
consumed in less than recommended amounts. However, dietary 
supplements, while recommended in some cases, cannot replace a 
healthful diet.''
    FDA's policy on food fortification is set forth in Sec.  104.20 (21 
CFR 104.20), which outlines the circumstances under which FDA considers 
fortification to be appropriate; e.g., to correct a nutritional 
deficiency recognized by the scientific community or to replace 
nutrients lost in storage, handling, or processing. Folic acid-
fortified grain products and milk fortified with Vitamin D are examples 
of fortification under Sec.  104.20.

E. Reports and Recommendations Regarding ``Functional Foods''

    In July 2000, the General Accounting Office (GAO; now the 
Government Accountability Office) issued a report (the GAO report) 
entitled ``Improvements Needed in Overseeing the Safety of Dietary 
Supplements and `Functional Foods''' (Ref. 4). The GAO report makes 
recommendations to the Congress (regarding statutory amendments) and to 
FDA (regarding the development of regulations and guidance) directed to 
improving Federal oversight of safety for dietary supplements and 
``functional foods'' and to ensuring that these products provide the 
health benefits they claim. The GAO report recommends that Congress 
amend the act to require ``functional food'' manufacturers to meet 
these requirements: Advance notification to FDA regarding ingredients 
that companies have determined are safe; notification to FDA regarding 
the use of labeling claims about effects on the structure or function 
of the human body (structure/function claims); and disclaimers of FDA 
approval on product labels containing structure/function claims. The 
GAO report also recommends that FDA: (1) Develop and promulgate 
regulations or guidance for industry on the safety-related information 
required on labels for ``functional foods'' and (2) develop and 
promulgate regulations or guidance for industry on the evidence needed 
to support structure/function claims.
    In August 2000 the Functional Foods Committee of the International 
Life Sciences Institute (ILSI) issued a report (the ILSI report) 
entitled ``Health Claims on Functional Foods--Proposals on Scientific 
Substantiation and Regulatory Systems'' (Ref. 5). The ILSI report 
emphasizes factors to consider when conducting a clinical study in 
support of a health claim so as to be able to appropriately use the 
data collected during the study. As a basis for its proposals, the ILSI 
report includes information, both domestic and international, regarding 
recent progress in the area of health claims from a regulatory 
perspective and regarding recent developments with ``functional foods'' 
from a commercial perspective.
    In March 2002 the Center for Science in the Public Interest (CSPI) 
submitted a citizen petition making several requests concerning FDA 
regulation of ``functional foods'' (the CSPI petition; Docket No. 
2002P-0122; formerly 02P-0122) (Ref. 6). We describe some of CSPI's 
requests in more detail in section III of this document.
    In March 2005 the IFT issued its report entitled ``Functional 
Foods: Opportunities and Challenges'' (Ref. 1). We describe some of 
IFT's recommendations in more detail in section III of this document.

II. Purpose and Scope of the Hearing

    The purpose of the hearing is for the agency to share its current 
regulatory framework and rationale regarding the safety evaluation and 
labeling of conventional foods being marketed as ``functional foods,'' 
and to solicit information and comments from interested persons on how 
FDA should regulate these foods under the agency's existing legal 
authority. The scope of this hearing is determined by this notice. FDA 
invites information and comments on the issues and questions listed in 
section III of this document as follows:

III. Issues and Questions for Discussion

A. Food Ingredients

     Issue 1: The CSPI petition requests that we require food 
companies to notify us regarding the use of ``novel ingredients'' prior 
to marketing foods

[[Page 62404]]

containing such ingredients. The CSPI petition does not define the term 
``novel ingredients.'' For the purpose of this hearing, we are using 
the term ``functional food'' to mean conventional foods that are being 
marketed as ``functional foods,'' and we are using the term 
``ingredients'' to mean ``functional food'' ingredients that may have a 
purported health benefit and that may be the subject of a label 
statement about this purported health benefit, whether or not the 
ingredient is new to the food supply.
    Question 1a. Is there a need for a regulatory definition and a 
distinct regulatory approach to the evaluation of the safety of 
ingredients added to ``functional foods''? If yes, what would be 
included in this new definition and approach that is not adequately 
addressed under the existing definition of food additive or the 
provisions in the definition for GRAS substances, and what is the 
scientific and legal basis for your position? Under what legal 
authority could FDA create this new definition and distinct regulatory 
approach?
    Question 1b. Should companies that market ingredients for addition 
to ``functional foods'' be required to notify us prior to introducing 
the ingredients into interstate commerce? If yes, what is the 
scientific and legal basis for your position?
     Issue 2: Generally, food additives have been used in 
conventional foods for their technical effects on the food, not for 
their effects on the body. Now, the interest in various uses of certain 
ingredients in conventional foods is due to the marketing of these 
conventional foods as ``functional foods'' with claims about health 
benefits.
    Question 2a. What types of data and information would be 
appropriate to demonstrate that ingredients added to conventional foods 
being marketed as ``functional foods'' meet the safety standard of 
``reasonable certainty of no harm''? What is the scientific and legal 
basis for your position?
    Question 2b. How could we partner with interested stakeholders 
regarding the development of appropriate recommendations or other 
information regarding the safety assessment of ingredients added to 
``functional foods''?

B. Food Labeling

     Issue 3: The CSPI petition requests that we require food 
companies to notify us within 30 days of marketing a conventional food 
bearing a structure/function claim if such food contains a ``novel 
ingredient,'' and to include the disclaimer currently required on 
dietary supplements making structure/function claims on the label and 
in labeling of such foods.
    Question 3. If our statutory authority permits, should we require 
food companies to notify us within 30 days of marketing a conventional 
food bearing a structure/function claim and to include the disclaimer 
currently required on dietary supplements making structure/function 
claims in labeling of such foods? If yes, what is the scientific (e.g., 
consumer studies) basis for your position? Under what existing legal 
authority could FDA require notification of these claims? Under what 
legal authority could FDA require inclusion of such a disclaimer with 
these claims?
     Issue 4: The IFT report recommends that companies wishing 
to make label claims regarding the effects of ``functional foods'' or 
ingredients convene panels of independent experts qualified to evaluate 
the efficacy of the functional food component under consideration. 
According to IFT's recommendations, the findings of these Generally 
Recognized as Efficacious (GRAE) panels would be submitted to FDA under 
a process that is similar to the notification program that we proposed 
for GRAS substances. If the GRAE panel report found that the proposed 
label claim was supported by the available scientific evidence, the 
agency would have 90 days to object to the use of the notified GRAE 
label claim, and in the absence of such objection the label claim would 
be permitted at the end of the 90 days.
    The act limits FDA's ability to accept this recommendation with 
regard to certain health claims and nutrient content claims (assuming 
that the recommendation applies to nutrient content claims, which is 
unclear because the IFT report does not specify). First, the act 
requires health claims and nutrient content claims for conventional 
foods to be submitted to FDA for review through a petition process (see 
section 403(r)(4)(A) of the act (21 U.S.C. 343(r)(4)(A))), unless the 
proposed claim is based on an authoritative statement. Second, even 
though claims based on an authoritative statement are submitted to FDA 
for review through a notification process, the act limits the 
``scientific bodies'' that can be sources of such an authoritative 
statement to certain Government agencies and the National Academy of 
Sciences (now the National Academies) (see sections 403(r)(2)(G)(i) and 
(r)(3)(C)(i) of the act (21 U.S.C. 343(r)(2)(G)(i) and (r)(3)(C)(i))). 
The GRAE panels recommended in the IFT report do not qualify as 
scientific bodies for this purpose. FDA can and does consider the 
findings of outside groups that do not qualify as ``scientific bodies'' 
as part of the totality of publicly available scientific evidence 
evaluated in support of a health claim petition, however.
    In an advance notice of proposed rulemaking (ANPRM) on food 
labeling, including health claims (68 FR 66040 at 66044; November 25, 
2003 (the 2003 ANPRM on food labeling)), we previously asked for public 
comment on a question about whether the evaluations of non-governmental 
groups should be given weight in evaluating the strength of the science 
supporting a health claim. In that ANPRM, we asked: ``If the agency 
should give weight to the evaluations of these groups, how should this 
weight be determined?'' That question is related to IFT's 
recommendations regarding the agency's acceptance of the findings of 
GRAE panels for ``functional food'' label claims. We are asking the 
question below, which is similar to the question we asked in the 2003 
ANPRM on food labeling, because we would like additional input on this 
topic.
    Question 4. Within our statutory authority, how (if at all) should 
FDA utilize the findings of non-governmental groups, such as the IFT 
recommended GRAE panels, in support of health claims, nutrient content 
claims, and other labeling claims about the effects of a ``functional 
food'' or ingredient, such as structure/function claims? What is the 
scientific and legal basis for your position? Should FDA institute a 
premarket notification process for review of the scientific evidence 
for structure/function claims for ``functional foods'' and ingredients, 
as recommended by IFT? What is the scientific basis for your position? 
Under what existing legal authority could FDA institute a premarket 
notification process for review of the scientific evidence for 
``functional foods'' and ingredients?
     Issue 5: Under Nutrilab v. Schweiker (713 F.2d 335 (7th 
Cir. 1983)), structure/function claims on the label or in labeling of 
conventional food make the product a drug if they promote the product 
for a structure/function effect (e.g., blocking the digestion of 
starch) that is unrelated to the product's ``food'' attributes of 
taste, aroma, and nutritive value. FDA has interpreted this court 
decision to limit structure/function claims for conventional foods to 
claims about effects that derive from the taste, aroma, or nutritive 
value of the food or food ingredient that is the subject of the claim. 
FDA's health claim regulations also require that the substance that is 
the subject of the claim contribute taste, aroma, nutritive value,

[[Page 62405]]

or a technical effect recognized in FDA's food additive regulations (21 
CFR 101.14(b)(3)(i)). Because we recognize that food substances may 
confer health benefits through a number of processes, we have provided 
significant flexibility in determining whether a substance possesses 
nutritive value. Nutritive value is defined at 21 CFR 101.14(a)(3) as a 
value in sustaining human existence by such processes as promoting 
growth, replacing lost nutrients, or providing energy, and we have 
discussed this definition in many of our health claim reviews. Listings 
of health claims reviewed to date can be found at http://
www.cfsan.fda.gov/~dms/lab-ssa.html (SSA claims) and http://
www.cfsan.fda.gov/~dms/qhc-sum.html (QHCs).
    The IFT report criticizes the approach of requiring that the health 
benefit be derived from the food's nutritive value as too restrictive 
to allow for claims on foods being marketed as ``functional foods.'' 
Instead, the IFT report recommends that FDA permit a labeling claim for 
a ``functional food'' if the claimed benefit is based either on 
nutritive value or on ``the provision of a physical or physiological 
effect that has been scientifically documented or for which a 
substantial body of evidence exists for plausibility'' (Ref. 1).
    Question 5. Given the agency's interpretation of the definition of 
nutritive value as reflected in 21 CFR 101.14(a)(3) and our decisions 
on the health claims reviewed to date, does or will the agency's 
interpretation of Nutrilab v. Schweiker to limit structure/function 
claims and health claims to those that are based on nutritive value (or 
other food attributes such as taste and aroma) adequately allow for 
claims in the labeling of ``functional foods''? If no, how is the 
agency's approach inadequate? What is the scientific and legal basis 
for your position? If you favor a change in the agency's approach, do 
you recommend that FDA adopt the IFT report's recommendation on this 
issue, or some other alternative? What legal rationale would support 
your preferred change in approach?
     Issue 6: The IFT report recommends that research into 
``functional foods'' be stimulated using incentives to the food 
industry, including market exclusivity for their bioactive food 
components and government research grants for the investigation of 
these components. There is currently no statutory provision for 
exclusivity of the use of a substance added to food (whether this be a 
food additive or a GRAS substance) or for the use of a health claim 
(whether a health claim has been authorized under NLEA or FDAMA or 
whether FDA has issued a letter of enforcement discretion for a QHC).
    In the 2003 ANPRM on food labeling, we previously asked ``How can 
FDA more effectively develop public-sponsored research on substance/
disease relationships?'' (68 FR 66040 at 66043). We are asking the 
question below, which is similar to the question we asked in the 2003 
ANPRM on food labeling, because we would like additional input on this 
topic.
    Question 6. Should FDA provide incentives to manufacturers to 
conduct further research on emerging substance/disease relationships? 
If yes, how? If yes, what is the scientific (e.g., consumer research) 
basis for your position? (For example, in the case of exclusivity, we 
are interested in consumer data concerning the use of a health claim on 
one product but not on other similar products by other manufacturers, 
and in how such data show that such claims are or are not misleading.) 
Under what existing legal authority could FDA provide such incentives?

C. Overall Framework for Foods Being Marketed as ``Functional Foods''

     Issue 7: The FFDCA does not recognize ``functional foods'' 
as a distinct category of food, either by definition or through 
establishing specific requirements for ``functional foods.'' The IFT 
report recommends that we establish, by regulation, a definition of, 
and labeling requirements for, ``functional foods.'' The IFT report 
asserts that these regulations are necessary because consumer interest 
in the relationship between diet and health has increased the demand 
for these foods. According to the IFT report, this increased consumer 
demand is causing the food industry to add more and larger amounts of 
substances to food and this competitive pressure has shifted the focus 
of food fortification from carefully orchestrated and closely monitored 
interventions for addressing specific dietary deficiencies to a focus 
on meeting market demands.
    Question 7. Can the conventional foods being marketed (now or in 
the future) as ``functional foods'' be adequately addressed through the 
current regulations for food additives, GRAS substances, and labeling 
claims? If no, how are these regulations insufficient to address these 
products, and what is the scientific and legal basis for your position?

IV. Notice of Hearing Under 21 CFR Part 15

    By delegation from the Acting Commissioner of Food and Drugs (the 
Acting Commissioner) (Staff Manual Guide 1420.21, section 1(b)), the 
Associate Commissioner for Policy and Planning finds that it is in the 
public interest to permit persons to present information and views at a 
public hearing regarding the regulation of conventional foods marketed 
as ``functional foods,'' and is announcing that the public hearing will 
be held in accordance with part 15 (21 CFR part 15). The presiding 
officer will be the Acting Commissioner or his designee. The presiding 
officer will be accompanied by a panel of FDA employees with relevant 
expertise.
    Persons who wish to participate in the hearing must file a notice 
of participation (see ADDRESSES, DATES, FOR FURTHER INFORMATION 
CONTACT, and ``Notices of Participation'' in section V of this 
document). By delegation from the Acting Commissioner (Staff Manual 
Guide 1420.21, section 1(b)), the Associate Commissioner for Policy and 
Planning has determined under Sec.  15.20(c) that advance submissions 
of oral presentations are necessary for the panel to formulate useful 
questions to be posed at the hearing under Sec.  15.30(e), and that the 
submission of a comprehensive outline or summary is an acceptable 
alternative to the submission of the full text of the oral 
presentation. We request that individuals and organizations with common 
interests consolidate their requests for oral presentation and request 
time for a joint presentation through a single representative. After 
reviewing the notices of participation and accompanying information, we 
will schedule each oral presentation and notify each participant of the 
time allotted to the presenter and the approximate time that the 
presentation is scheduled to begin. If time permits, we may allow 
interested persons attending the hearing who did not submit a notice of 
participation in advance to make an oral presentation at the conclusion 
of the hearing. The hearing schedule will be available at the hearing. 
After the hearing, the schedule will be placed on file in the Division 
of Dockets Management (see ADDRESSES) under the docket number listed in 
brackets in the heading of this notice.
    To ensure timely handling of any mailed notices of participation, 
presentations, or comments, any outer envelope should be clearly marked 
with the docket number listed in brackets in the heading of this notice 
along with the statement ``Conventional Foods Being Marketed as 
`Functional Foods' Public Hearing.''
    Under Sec.  15.30(f), the hearing is informal, and the rules of 
evidence do

[[Page 62406]]

not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members may question 
any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, 
representatives of the electronic media may be permitted, subject to 
the procedures and limitations in Sec.  10.206, to videotape, film, or 
otherwise record FDA's public administrative proceedings, including 
presentations by participants. The hearing will be transcribed as 
stipulated in Sec.  15.30(b). The transcript will be available on the 
Internet at http://www.fda.gov/ohrms/dockets/default.htm, and orders 
for copies of the transcript can be placed at the meeting or through 
the Division of Dockets Management (see ADDRESSES).
    Any handicapped persons requiring special accommodations to attend 
the hearing should direct those needs to the contact person (see FOR 
FURTHER INFORMATION CONTACT).
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of these provisions as specified in Sec. Sec.  
10.19 and 15.30(h). In particular, Sec.  15.21(a) states that the 
notice of hearing will provide persons an opportunity to file a written 
notice of participation with the Division of Dockets Management within 
a specified period of time. If the public interest requires, e.g., if a 
hearing is to be conducted within a short period of time, the notice 
may name a specific FDA employee and telephone number to whom an oral 
notice of participation may be given. If the public interest requires, 
the notice may also provide for submitting notices of participation at 
the time of the hearing. In this document, the conditions for the 
hearing specify that notices of participation be submitted 
electronically to an agency Internet site, to a contact person (outside 
of FDA) who will accept notices of participation by mail, telephone, 
fax, or e-mail, or in person on the day of the hearing (as space 
permits). We are using these procedures for submitting notices of 
participation, rather than provide for the submission of notices of 
participation to the Division of Dockets Management, because the 
hearing is to be conducted within a short period of time and these 
procedures are more efficient. In addition, these procedures provide 
more flexibility to persons who wish to participate in the hearing than 
would be provided if participants were required to submit the notice of 
participation in writing to the Division of Dockets Management. By 
delegation from the Acting Commissioner (Staff Manual Guide 1420.21, 
section 1(f)(2)(i)), the Associate Commissioner for Policy and Planning 
finds under Sec.  10.19 that no participant will be prejudiced, the 
ends of justice will thereby be served, and the action is in accordance 
with law if notices of participation are submitted by the procedures 
listed in this notice rather than to the Division of Dockets 
Management.

V. Notice of Participation

    Pre-registration by submission of a notice of participation is 
necessary to ensure participation. The notice of participation may be 
submitted electronically or by mail (see ADDRESSES). The notice of 
participation also may be submitted orally, by fax, or by E-mail (see 
FOR FURTHER INFORMATION CONTACT). We encourage you to submit your 
notice of participation electronically. See DATES for the dates by 
which you must submit your notice of participation. A single copy of 
any notice of participation is sufficient.
    The notice of participation must include your name, title, business 
affiliation (if applicable), address, telephone number, fax number (if 
available), and e-mail address (if available). If you wish to request 
an opportunity to make an oral presentation during the open public 
comment period of the hearing, your notice of participation also must 
include the title of your presentation, the sponsor of the oral 
presentation (e.g., the organization paying travel expenses or fees), 
if any; and the approximate amount of time requested for the 
presentation. Presentations will be limited to the questions and 
subject matter identified in section III of this document.
    Under Sec.  15.20(c), if you request an opportunity to make an oral 
presentation you must submit two copies of your presentation (either as 
the full text of the presentation, or as a comprehensive outline or 
summary), except that individuals may submit one copy. See DATES for 
the dates by which you must submit your presentation. See ADDRESSES and 
FOR FURTHER INFORMATION CONTACT for information on where to send your 
presentation.
    Registration will be accepted on a first-come, first-served basis. 
Individuals who request an opportunity to make an oral presentation 
will be notified of the scheduled time for their presentation prior to 
the meeting. Depending on the number of oral presentations, we may need 
to limit the time allotted for each oral presentation (e.g., 5 minutes 
each). We request that interested persons and groups having similar 
interests consolidate their requests for oral presentation and present 
them through a single representative. If you need special 
accommodations due to a disability, please inform us (see FOR FURTHER 
INFORMATION CONTACT). We will also accept registration onsite; however, 
space is limited and registration will be closed when the maximum 
seating capacity is reached. Individuals and organizations that do not 
pre-register to make an oral presentation may have the opportunity to 
speak if time permits.
    Persons pre-registered or wishing to register onsite should check 
in between 8:30 and 9:00 a.m. We encourage all participants to attend 
the entire day. Because the meeting will be held in a Federal building, 
meeting participants must present photo identification and plan 
adequate time to pass through the security system.

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments for consideration at or 
after the hearing in addition to, or in place of, a request for an 
opportunity to make an oral presentation (see DATES). Submit two paper 
copies of any written comments, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

VI. References

    1. Institute of Food Technologists, ``Functional Foods: 
Opportunities and Challenges,'' 2005. (Available at http://members.ift.org/IFT/Research/IFTExpertReports/functionalfoods_report.htm. Accessed and printed on September 25, 2006.)
    2. Food and Drug Administration, ``Guidance for Industry: 
Notification of a Health Claim or Nutrient Content Claim Based on an 
Authoritative Statement of a Scientific Body,'' 1998. (Available at 
http://www.cfsan.fda.gov/~dms/hclmguid.html)
    3. Department of Health and Human Services and Department of 
Agriculture, Executive Summary, Dietary Guidelines for Americans, 
2005. (Available at http://www.healthierus.gov/dietaryguidelines. 
Accessed and printed on September 25, 2006.)
    4. General Accounting Office, ``Improvements Needed in 
Overseeing the Safety of Dietary Supplements and `Functional 
Foods,''' 2000. (Available at

[[Page 62407]]

http://www.gao.gov/new.items/rc00156.pdf. Accessed and printed on 
September 25, 2006.)
    5. International Life Sciences Institute, ``Health Claims on 
Functional Foods--Proposals on Scientific Substantiation and 
Regulatory Systems,'' 2000.
    6. Center for Science in the Public Interest, Citizen petition 
2002P-0122, Petition for Rulemaking on Functional Foods and Request 
to Establish an Advisory Committee, 2002.

    Dated: October 19, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-8895 Filed 10-20-06; 3:48 pm]
BILLING CODE 4160-01-S