[Federal Register Volume 65, Number 52 (Thursday, March 16, 2000)]
[Proposed Rules]
[Pages 14219-14223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 00N-0598]


Food Labeling; Dietary Supplement Health Claims; Public Meeting 
Concerning Implementation of Pearson Court Decision and Whether Claims 
of Effects on Existing Diseases May Be Made as Health Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to solicit comments on two topics pertaining to health claims 
in dietary supplement labeling. The first topic concerns implementation 
of the recent court of appeals decision in Pearson v. Shalala 
(Pearson). InPearson, the U.S. Court of Appeals for the D.C. Circuit 
held that FDA's decision not to authorize four health claims for 
dietary supplements violated the First Amendment because the agency did 
not

[[Page 14220]]

consider whether the claims, which failed to meet the ``significant 
scientific agreement'' standard of evidence by which the health claims 
regulations require FDA to evaluate the scientific validity of claims, 
could be rendered nonmisleading by adding qualifying language. The 
second topic on which we are requesting comments is whether claims 
about an effect on an existing disease may be made as health claims, or 
whether such claims should subject the product to regulation as a drug. 
We are holding this meeting to give the public an opportunity to 
provide information and views on these topics.

DATES: The meeting will be held on April 4, 2000, from 10 a.m. to 6 
p.m. Please register by close of business, March 28, 2000. Late 
registrations will be accepted contingent on space availability. Submit 
written comments by April 19, 2000.

ADDRESSES: The meeting will be held at Department of Education, Barnard 
Auditorium (Federal Building 6), 400 Maryland Ave., SW., Washington, 
DC. Building entrances are located on the Maryland Ave., SW. and C 
Street, SW. between 4th and 6th Streets, SW. Federal Building 6 is one 
block east of the L'Enfant METRO Subway Station's Maryland Ave. exit.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, 
MD 20852. You may also send comments to the Dockets Management Branch 
at the following e-mail address: [email protected] or via the FDA 
Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:
    To register for the public meeting contact: Carole A. Williams, 
Office of Consumer Affairs (HFE-88), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4421, FAX 301-827-3052, e-
mail [email protected].
    For general information: Jeanne Latham, Center for Food Safety and 
Applied Nutrition (HFS-800), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-205-4697, FAX 202-205-4594, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA published a number of regulations to implement the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments), which amended 
the Federal Food, Drug, and Cosmetic Act (the act). We set forth 
general requirements for health claims in the labeling of conventional 
foods (58 FR 2478, January 6, 1993); authorized the use of seven health 
claims (58 FR 2665, 58 FR 2787, 58 FR 2820, 58 FR 2739, 58 FR 2537, 58 
FR 2552, and 58 FR 2622); and denied the use of five other claims (58 
FR 2537 [dietary fiber and cancer], 58 FR 2552 [dietary fiber and 
coronary heart disease], 58 FR 2622 [antioxidant vitamins and cancer], 
58 FR 2661 [zinc and immune function in the elderly], and 58 FR 2682 
[omega-3 fatty acids and coronary heart disease]). We also initially 
denied one claim (58 FR 2606 [folic acid and neural tube defects]) that 
was later authorized (59 FR 433, January 4, 1994) and then modified (61 
FR 8750, March 5, 1996). In response to the 1990 amendments and the 
Dietary Supplement Act of 1992, we issued regulations applying the 
general requirements for health claims for conventional foods to 
dietary supplements (59 FR 395, January 4, 1994). The general health 
claims regulations for both conventional foods and dietary supplements 
are in 21 CFR 101.14 and 101.70. The regulations on individual health 
claims are in 21 CFR 101.71 through 101.82.
    Our general health claim regulations for dietary supplements and 
our decision not to authorize health claims for four specific 
substance/disease relationships were challenged in Pearson v. Shalala 
(Pearson). These four substance/disease relationships include: Dietary 
fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids 
and coronary heart disease, and the claim that 0.8 milligram of folic 
acid in dietary supplement form is more effective in reducing the risk 
of neural tube defect than a lower amount in conventional food form.
    In 1998, the district court ruled for FDA in all respects (14 F. 
Supp. 2d 10 (D.D.C. 1998)). In January 1999, however, the U.S. Court of 
Appeals for the D.C. Circuit reversed the lower court's decision (164 
F.3d 650 (D.C. Cir. 1999)). The appeals court held that, based on the 
administrative record compiled in the challenged rulemakings, the First 
Amendment does not permit FDA to reject health claims that we determine 
to be potentially misleading unless we also reasonably determine that 
no disclaimer would eliminate the potential deception. As a result of 
the decision, we must reconsider our approach to authorizing health 
claims for dietary supplements. The court further held that the 
Administrative Procedure Act (the APA) requires FDA to clarify the 
``significant scientific agreement'' standard for authorizing health 
claims, either by issuing a regulatory definition of significant 
scientific agreement or by defining it on a case-by-case basis.
    On March 1, 1999, the Government filed a petition for rehearing en 
banc (reconsideration by the full court of appeals). The U.S. Court of 
Appeals for the D.C. Circuit denied the petition for rehearing on April 
2, 1999 (172 F.3d 72 (D.C. Cir. 1999)). We announced in the Federal 
Register of December 22, 1999 (64 FR 71794), the availability of a 
guidance clarifying the significant scientific agreement standard. The 
guidance is available on the Internet at http://vm.cfsan.fda.gov/dms/ssaguide.html.
    In the Federal Register of December 1, 1999 (64 FR 67289), we 
published a notice informing the public of the steps we plan to follow 
to carry out the Pearson decision. This notice announced plans to hold 
a public meeting before initiating rulemaking to consider what changes 
to the general health claims regulations for dietary supplements may be 
warranted in light of Pearson (64 FR 67289 at 67290). We believe that 
our reevaluation of these regulations will benefit from a public 
meeting and an open discussion of all possible approaches to 
implementing the court's decision.
    Also in December 1999, we declined to issue a proposed rule for a 
health claim relating dietary supplements containing saw palmetto 
extracts and symptoms associated with benign prostatic hyperplasia 
(BPH). The petition requesting authorization for the claim was denied 
by operation of law on December 1, 1999, and we issued a letter 
explaining our decision on the same day. Our basis for not proposing a 
rule was that we were unable to resolve, within the timeframe required, 
the novel policy issue, which the petition entailed. This issue is 
whether a health claim may include claims about mitigation or treatment 
of disease. To date, the health claims that we have authorized have 
been for reducing the risk of a disease. While this issue was not 
considered in Pearson, as a topic that also relates to the regulation 
of health claims, it is being included for discussion in this public 
meeting.
    On December 7, 1999, the agency was sued by the petitioners who had 
requested FDA to authorize a health claim for saw palmetto extract and 
BPH (Whitaker v. Shalala, No. 1:99CV0247 (D.D.C. December 7, 1999)). 
The plaintiffs alleged that our denial of the petition violated the 
First Amendment to the Constitution, the 1990 amendments, and the APA. 
The plaintiffs asked the court to order the

[[Page 14221]]

agency to evaluate their petition under the health claims regulations. 
The case is stayed through May 26, 2000, while we consider whether 
claims of effects on an existing disease may be made as health claims 
rather than drug claims.

II. Scope of Discussion

    We are holding the public meeting on April 4, 2000, in part to 
identify and discuss possible changes, in light of the Pearson 
decision, to our general health claim regulations as they apply to 
dietary supplements. Unlike the statutory provision for the use of 
health claims on dietary supplements (section 403(r)(5)(D) of the act 
(21 U.S.C. 343(r)(s)(D))), section 403(r)(3)(B)(i) of the act provides 
that FDA may authorize health claims on conventional foods only when 
there is significant scientific agreement among qualified experts that 
the totality of publicly available scientific evidence supports the 
claim. As a result of this statutory requirement for conventional foods 
and because the Pearson case involved only dietary supplements, this 
portion of the public meeting will be restricted to health claims on 
dietary supplements.
    A second topic open for discussion is whether claims about 
mitigation or treatment of diseases and their symptoms may be 
appropriately made as health claims.
    We anticipate that both discussions will include presentations from 
people whom we invite to participate as well as from members of the 
public.

A. Implementation of the Pearson Court Decision

    We are requesting comment on how to implement the element of the 
Pearson decision addressing the use of qualified health claims on 
dietary supplements when the evidence supporting the claim does not 
meet the ``significant scientific agreement'' standard. In general, we 
request public comment on whether qualified health claim statements for 
dietary supplements can be made that would not mislead consumers, and, 
if so, what types of disclaimers or other qualifying language would be 
appropriate. We would specifically request that persons commenting in 
person and in writing consider and provide input on the questions 
listed below. Comments recommending a particular regulatory approach 
should explain how that approach is consistent with the constitutional 
and statutory requirements to which FDA is subject.
    1. What is the best regulatory approach for protecting and 
promoting the public health? Specifically, what approach to regulating 
health claims will: (a) Protect consumers from fraudulent and 
misleading claims; and (b) provide reliable, understandable information 
that will allow consumers to evaluate claims intelligently and identify 
products that will in fact reduce the incidence of diseases? By what 
criteria should implementation options be judged?
    2. Can qualifying language (including disclaimers) be effective in 
preventing consumers from being misled by health claims based on 
preliminary or conflicting evidence? If so, what are the 
characteristics of effective qualifying language? How should the agency 
determine what constitutes an appropriately qualified claim? If the 
available information is not sufficient to answer these questions, what 
research needs to be done, and who should be responsible for doing it? 
The agency encourages those commenting to submit empirical data on the 
effectiveness of qualifying language.
    3. Is there a way to preserve the existing regulatory framework for 
health claims consistent with the First Amendment?
    4. If health claims are permitted based on a standard less rigorous 
than significant scientific agreement, what is the best way to 
distinguish among claims supported by different levels of evidence so 
that consumers are not misled? Does the word ``may'' in existing health 
claims accurately communicate the strength of the evidence supporting 
claims that meet the significant scientific agreement standard, or 
should other language be used?
    5. If health claims are permitted based on a less rigorous 
standard, what actions can be taken to provide incentives to 
manufacturers to conduct further research on emerging substance-disease 
relationships?
    6. The Pearson opinion mentions circumstances in which FDA might be 
justified in banning certain health claims outright (e.g., where the 
evidence in support of the claim is outweighed by evidence against the 
claim, or where the evidence supporting it is qualitatively weaker than 
the evidence against it) (Pearson, 164 F.3d at 659 and n.10).
    a. How should FDA determine when evidence supporting a health claim 
is outweighed by evidence against the claim?
    b. How should FDA determine when evidence supporting a health claim 
is qualitatively weaker than the evidence against the claim?
    c. Are there other circumstances in which health claims are 
inevitably misleading and cannot be made nondeceptive by qualifying 
language?
    7. What safety information is necessary to prevent a health claim 
from being misleading? For example, such information might include side 
effects, drug and food interactions, and segments of the population who 
should not use the product or should consult a physician before doing 
so. When a product may have adverse effects unrelated to the subject of 
a scientifically valid health claim, is the claim misleading? Under 
what circumstances, if any, should the product be allowed to bear the 
claim?
    8. What actions should the agency take to ensure that consumers 
receive all relevant information about the safety of products that bear 
health claims and about research on product safety?

B. Whether Claims of Effects on Existing Diseases May Be Made as Health 
Claims

    All health claims that we have authorized since passage of the 1990 
amendments have been claims about reducing the risk of a disease. 
However, the saw palmetto extract health claim petition (Docket Number 
99P-3030) requests authorization to make a claim about effects on an 
existing disease. Thus, the petition proposes a significant expansion 
of the scope of health claims beyond those that are currently 
authorized.
    The issue of whether health claims may be about effects on an 
existing disease arose in the context of a petition for a dietary 
supplement health claim. For this reason and because the other issue to 
be discussed at the public meeting concerns health claims for dietary 
supplements, the focus of discussion will be the use of claims on 
labels or labeling of dietary supplements about effects on an existing 
disease. However, we recognize that this issue is likely to arise in 
the context of health claims for conventional foods as well. Any 
decision we make on this issue with respect to dietary supplements, 
therefore, will also affect the use of such claims for conventional 
foods.
    The health claims provisions of the act were enacted as part of a 
statutory scheme that already included extensive regulatory 
requirements for drugs. Before the 1990 amendments, the drug provisions 
had been applied to foods, including dietary supplements, that made 
claims about effects on disease. Arguably, if Congress had intended to 
permit any kind of disease claim for foods, it could have exempted all 
foods bearing authorized health claims from the drug definition in 
section 201(g)(1)(B) of the act (21 U.S.C. 321(g)(1)(B)), which 
provides that an article ``intended for use in the diagnosis, cure, 
mitigation, treatment, or

[[Page 14222]]

prevention of disease'' is a drug. Instead, Congress provided that a 
product that bears an authorized health claim shall not be classified 
as a drug solely because of the presence of the claim (21 U.S.C. 
321(g)(1)(B)). Congress' decision to proceed in this manner, rather 
than by creating an unconditional exemption, suggests that it may have 
wanted the drug provisions to continue to apply to foods in certain 
circumstances. Similarly when the Dietary Supplement Health and 
Education Act (DSHEA) was enacted in 1994, Congress did not provide 
that dietary supplements are deemed to be foods in all circumstances; 
rather, it provided that dietary supplements are deemed to be foods 
``except for purposes of section 201(g)'' of the act, the drug 
definition.
    In interpreting the health claim provisions of the act and their 
relationship to the drug provisions of the act, FDA has tried to strike 
a balance between recognizing that foods, including dietary 
supplements, can influence disease outcomes without ceasing to be 
foods, and honoring the statutory distinction between drugs and foods. 
To that end, we included in our health claims regulations the 
requirement that a product that bears a health claim must establish 
that it is a food by demonstrating nutritive value (21 CFR 
101.14(b)(3)). Moreover, in the preambles to the regulations, we 
distinguished between nutritional effects of food substances, which we 
said would be an appropriate subject for a health claim, and effects 
that are therapeutic, medicinal, or pharmacological, which would not. 
(See, e.g., 56 FR 60537 at 60545 to 60546, November 27, 1991; 58 FR 
2478 at 2501, January 6, 1993; and 59 FR 395 at 408, January 4, 1994.) 
FDA also emphasized that the relationship of a food or a food component 
to a disease is different from that of a drug because of genetic, 
environmental, and behavioral factors that affect the development of 
chronic diseases in addition to diet, and because of the complexity of 
foods themselves (58 FR 2478 at 2501). Therefore, we explained, some 
claims that would be appropriate as drug claims under section 
201(g)(1)(B) would not be appropriate as health claims for foods 
because they ``imply a degree of association between the substance and 
the disease that is not supportable for any food'' (56 FR 60537 at 
60552).
    Further, we commented that it would be necessary for a health claim 
petitioner to ``show that the claimed effect on disease is associated 
with the normal functioning of the human body'' and that claims to 
``correct an abnormal physiological function caused by a disease or 
health-related condition'' would be drug claims rather than health 
claims (59 FR 395 at 407 to 408). With respect to claims about effects 
on symptoms of a disease, we said:

    [T]here is no provision in the act for the agency to exempt 
statements about symptoms of disease from causing products to be 
regulated as drugs. Although such statements may not be claims that 
the product will treat the disease that causes the symptoms, the 
statements clearly pertain to the mitigation of disease by 
addressing the symptoms caused by the disease. Section 201(g)(1)(B) 
of the act provides, in part, that articles intended for use in the 
mitigation of disease are drugs.

(59 FR 395 at 413)
    Another relevant part of the statutory scheme is the medical foods 
definition, enacted as part of the Orphan Drug Amendments of 1988. The 
statutory definition of a medical food is ``a food which is formulated 
to be consumed or administered enterally under the supervision of a 
physician and which is intended for the specific dietary management of 
a disease or condition for which distinctive nutritional requirements, 
based on recognized scientific principles, are established by medical 
evaluation'' (21 U.S.C. 360ee(b)(3)). Thus, medical foods are a 
category of foods intended for dietary management of disease through a 
nutritional mechanism.
    By their very nature, claims about effects on an existing disease 
are aimed at people who are ill. To date, authorized health claims have 
been aimed either at the general population or at a population subgroup 
whose members are at risk for a particular disease but are not yet 
sick. Since there are already two categories of ingested products that 
bear claims targeted to people suffering from a disease, drugs and 
medical foods, the agency believes there is reason to question whether 
Congress also intended health claims to encompass such claims.
    FDA is open to reexamining its past statements on this issue in 
light of subsequent developments, such as advances in science and 
technology, changes in the marketplace, and the passage of DSHEA. In 
considering the scope of the health claims provisions of the act, we 
will seek an interpretation that is consistent with the statutory 
provisions governing drugs and medical foods and that gives effect to 
each part of the statute.
    We are inviting public comment on this issue, and in particular we 
are seeking input on the following questions. Comments recommending a 
particular regulatory approach should explain how that approach is 
consistent with the legal requirements to which FDA is subject.
    1. Does the language and structure of the act restrict the 
permissible types of substance-disease relationships that can be 
described in a health claim? How should FDA interpret the health claim 
and drug provisions of the act and the medical food provision of the 
Orphan Drug Amendments in relationship to each other?
    2. If FDA were to permit at least some claims about effects on an 
existing disease as health claims, what criteria should be used to 
determine when a claim is a permissible health claim and when it is a 
drug claim under section 201(g)(1)(B) of the act?
    3. If FDA were to permit at least some disease treatment or 
mitigation claims as health claims, what about claims that are covered 
by an existing over-the-counter (OTC) drug monograph? For example, if 
there is an existing drug monograph on the use of a dietary ingredient 
in an OTC drug product to treat or mitigate disease, and the monograph 
concludes that the substance is not safe and effective for the intended 
use, should FDA still consider authorizing a health claim for the 
substance-disease relationship?

III. Registration and Requests to Make Oral Presentations

    If you would like to attend the meeting, we request that you 
register in writing with the contact person by March 28, 2000, by 
providing your name, title, business affiliation, address, telephone 
and fax number. To expedite processing, this registration information 
also may be sent to the contact person by fax to 301-827-3052, or sent 
by e-mail to [email protected]. If you need special accommodations due 
to disability, please inform the contact person when you register. A 
permanent assistive listening device (ALD) is installed in Barnard 
Auditorium. The ALD can be used with either a hearing aid T-coil or a 
headset/receiver available at the auditorium. If, in addition to 
attending, you wish to make an oral presentation during the meeting, 
you must so inform the contact person when you register and submit: (1) 
A brief written statement of the general nature of the views you wish 
to present; (2) the names and addresses of all persons who will 
participate in the presentation; and (3) an indication of the 
approximate time that you request to make your presentation. Depending 
upon the number of people who register to make presentations, we may 
have to limit the time allotted for each presentation. We anticipate 
that, if time permits, those

[[Page 14223]]

attending the meeting will have the opportunity to ask questions during 
the meeting.

IV. Comments

    You may submit, on or before April 19, 2000, written comments to 
the Dockets Management Branch (address above). You may also send 
comments to the Dockets Management Branch via e-mail to 
[email protected] or via the FDA Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. 
You should annotate and organize your comments to identify the specific 
issues to which they refer. Please address your comment to the docket 
number given at the beginning of this notice. You must submit two 
copies of comments, identified with the docket number found in brackets 
in the heading of this document, except that you may submit one copy if 
you are an individual. You may review received comments in the Dockets 
Management Branch between 9 a.m. and 4 p.m. Monday through Friday.

V. Transcripts

    You may request a transcript of the meeting in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, approximately 15 
working days after the meeting, at a cost of 10 cents per page. You may 
also examine the transcript of the meeting after April 14, 2000, at the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday, as well as on the FDA Internet at http://www.fda.gov.

VI. Reference

    We have placed the following reference on display in the Dockets 
Management Branch. You may see it at that office between 9 a.m. and 4 
p.m., Monday through Friday.
    1. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).

                            Registration Form
 
Public Meeting on Implementation of Pearson Court Decision and Expansion
    of Health Claims to Cover Claims of Effects on Existing Diseases
 
Instructions: To register, complete this form and mail or fax it to 301-
                       827-3052 by March 28, 2000.
 

Name------------------------------------------------------------------

Title-----------------------------------------------------------------

Company---------------------------------------------------------------

Address---------------------------------------------------------------

Telephone-------------------------------------------------------------

Fax-------------------------------------------------------------------

E-mail----------------------------------------------------------------
Please indicate the type or organization that you represent:

Industry ______

Government ______

Consumer Organization ______

Media ______

Healthcare Professional ______

Law Firm ______

Educational Organization ______
Other (specify)____
Do you wish to make an oral presentation?
Yes____
No____
If yes, you also must submit the following:
1. A brief statement of the general nature of the views you wish to 
present,
2. The names and addressed of all persons who will participate in the 
presentation, and
3. An indication of the approximate time that you request to make your 
presentation.

    Dated: March 10, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6509 Filed 3-13-00; 2:34 pm]
BILLING CODE 4160-01-F