Comment period extended to March 5, 2007.
[Federal Register: October 25, 2006 (Volume 71, Number 206)]
[Proposed Rules]
[Page 62400-62407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc06-12]
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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: isabelle_howes@grad.usda.gov.
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: Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
FDA is responsible for ensuring that all foods in the American food
supply (other than meat products, poultry
[[Page 62401]]
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
<bullet> 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?
<bullet> 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
<bullet> 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?
<bullet> 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?
<bullet> 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?
<bullet> 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''
<bullet> 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
Public Meeting on Conventional Foods Being Marketed as 'Functional Foods'