[Federal Register: June 3, 2004 (Volume 69, Number 107)]
[Notices]               
[Page 31395-31397]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn04-68]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0246]

 
Agency Emergency Processing Under OMB Review; Experimental Study 
of Petitioned Health Claims on Glucosamine and Chondroitin Sulfate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information is in response to a petition for health claims for 
glucosamine and chondroitin sulfate. The study examines various 
petitioned health claims about the effect of glucosamine and 
chondroitin sulfate on osteoarthritis. The goal of the study is to 
determine if certain claims about glucosamine and/or chondroitin (the 
``product'') and the reduction of risk of specific outcomes related to 
osteoarthritis, namely joint degradation and cartilage deterioration, 
create misperceptions on the part of consumers about the intended use 
of the product.

DATES: Fax written comments on the collection of information by July 6, 
2004. FDA is requesting approval of this emergency processing by July 
6, 2004.

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The information is critical 
to the agency's mission of regulating health claims on dietary 
supplements. FDA has received petitions for new health claims for 
glucosamine and chondroitin sulfate. Unlike traditional health claims 
that promote the ability of a product to reduce the risk of a 
particular disease, the petitioned claims promote the ability of the 
product to reduce the risk of a specific health outcome without mention 
of an associated disease.
    Traditionally, a health claim states how a product will reduce the 
risk of contracting a particular disease. An example of this type of 
claim would include ``Eating a diet rich in fruits and vegetables may 
reduce the risk of cancer.'' Here, the statement clearly defines the 
product (fruits and vegetables), its risk-reducing effect, and the 
disease upon which it may be effective (cancer). The petitioned claims, 
however, do not employ the standard structure as traditional health 
claims.
    The petitioned claims are designed as health claims, in that they 
promote the risk reducing effect of glucosamine and chondroitin 
sulfate. The claims neglect, however, to mention the specific disease 
risk, or the risk of osteoarthritis, that the product intends to 
reduce. Instead, the claims mention symptoms, modifiable risk factors, 
and surrogate endpoints of the disease. An example of these claims is 
``Glucosamine and chondroitin sulfate may reduce the risk of joint 
degradation.'' The petitioned claims to be examined resemble health 
claims by their use of language concerning the reduction of risk. Yet 
they employ terminology suggestive of modifiable risk factors of the 
disease, which are elements not traditionally found in health claims. 
It is not clear how consumers will interpret these claims. The agency 
is concerned that the label language may cause consumers to interpret 
the claims in such a way that would suggest it has an effect on the 
disease or condition other than risk reduction.
    Consumer research is needed to test consumer's perceptions of 
claims that promote risk reduction of contracting a symptom or a 
modifiable risk factor for a disease. Despite the verbiage within the 
claim about risk reduction, the presence of health conditions without 
mention of a disease may cause consumers to believe that the product 
will treat the health condition rather than reduce risk. If consumers 
disregard language concerning the reduction of risk and interpret the 
claim as one that promotes a treatment effect, then the claim language 
has created a misperception on the part of the consumer. The result is 
that consumer's interpret the claim as a treatment claim rather than a 
health claim.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Experimental Study of Petitioned Health Claims on Glucosamine and 
Chondroitin Sulfate

    FDA is requesting OMB approval of an experimental study of 
petitioned health claims on glucosamine and chondroitin sulfate. The 
study examines various petitioned health claims about the effect of 
glucosamine and chondroitin sulfate on osteoarthritis. The goal of the 
study is to determine if certain claims about glucosamine/chondroitin 
(the ``product'') and the reduction of risk of specific outcomes 
related to osteoarthritis, namely joint degradation and cartilage 
deterioration, create misperceptions on the part of consumers about the 
intended use of the product. Results of the study will inform the 
Center for Food Safety and Applied Nutrition decision making process, 
particularly as it concerns the approval of the use of these claims. 
The results may also assist in future decisions toward other claims 
that bear similar characteristics.
    The need for consumer research on various dietary supplement claims 
arises over a concern that consumer's may misinterpret or misperceive a 
health claim as a treatment claim when the claim does not clearly refer 
to a specific disease. Traditional health claims for dietary 
supplements promote the ability of a product to reduce the risk of a 
particular disease. However, new claims about products promote the 
ability of a product to reduce the risk of

[[Page 31396]]

a specific health outcome without mention of an associated disease. If 
the specific health outcome is mentioned without a disease, consumers 
may misunderstand the claim as one that promotes the product's ability 
to treat, and not reduce the risk of contracting, a particular health 
outcome.
    The larger question of whether or not a consumer interprets a claim 
as a drug treatment claim or as a health claim will be answered by 
comparing the effect of various label claim language on a consumer's 
perceptions of the effect and potency of a product, and the time in 
which the product will be effective. This is accomplished by answering 
a number of smaller research questions about claims concerning 
glucosamine/chondroitin and their relationship to claims that could be 
made about food products, as well as their relationship to claims that 
could be made about an over-the-counter (OTC) or pharmaceutical drug.
    The working hypothesis underlying the study design is that 
consumer's perceive dietary supplements as less potent, less effective, 
and therefore having a weaker effect on a health condition than drugs. 
A parallel hypothesis is that consumer's perceive dietary supplements 
as more potent, more effective, and therefore having a stronger impact 
on a health condition as food. The study is designed to assess the 
relative position of a dietary supplement product, ``DS'', with respect 
to a food and a drug along three dimensions characterizing the impact 
of the DS. These three dimensions include the type of effect the 
consumer believes the DS will have on a health condition, and the 
perceived effectiveness of the substance at achieving the claimed 
effect, and the time in which the consumer believes the effect will 
occur. The study will also assess how various types of claims on food 
products, drugs, and dietary supplements change how consumers perceive 
the relative position of these products with each other. The study will 
determine if the presence of a petitioned claim on the product label 
causes consumers to perceive the product as more treatment-like in its 
effect than when an approved health claim is present.
    FDA will conduct an experimental study using subjects recruited 
from an internet panel of 500,000 households. The internet panel 
methodology allows controlled presentation of visual materials, 
experimental manipulation of study materials, and the random assignment 
of participants to experimental conditions. The experimental 
manipulation of label conditions and random assignment to conditions 
allows for statistical estimates of the effects of different approaches 
to conveying information intended by the health claims. Random 
assignment ensures that mean differences between conditions can be 
tested using established techniques such as analysis of variance and 
multiple regression analysis to yield statistically valid estimates of 
effect size.
    The study design is based on the controlled presentation of 
realistic product labels that carry health claims for glucosamine/
chondroitin, as well as a food product and an OTC drug product. The 
various health claims that are tested vary in terms of the use of 
language concerning treatment or risk-reduction effects, and the use of 
terminology related to a disease or a symptom or risk factor of a 
disease. In addition, on some labels a disclaimer accompanies the 
claims. A number of labels will carry claims about the product's effect 
on a specific disease (osteoarthritis) and will serve as control 
conditions that assess how consumers view the product when the claims 
mention only symptoms of the disease.
    Panel members are recruited by a variety of means designed to 
reflect all segments of the population. They are required to have a 
computer with Internet access. Typical panel members receive three or 
four invitations per month to participate in research projects. 
Incentives of small monetary value are given to panel members for their 
participation periodically.
    Each participant in the study will examine one of the label 
products described earlier. The product may be a food, drug, 
glucosamine, chondroitin sulfate, or glucosamine/chondroitin 
combination. The study may also include an additional dietary 
supplement for comparison with the glucosamine and chondroitin product. 
The label will have a claim about the products effect on the reduction 
of risk of either osteoarthritis, joint degradation, or cartilage 
deterioration. The subject will answer a short set of questions related 
to each of the label products that they have been shown. These 
questions will pertain to the consumer's perception of the effect 
(treat/reduce risk) of the product, the relative effectiveness of the 
product, and the time in which the effect occurs (hours versus years).
    The study includes three conditions, representing important types 
of label claims and label users that constitute benchmarks for 
assessing the direction and magnitude of effects due to the presence of 
symptom-like health conditions: (1) A control that is an approved or 
traditionally worded health claim, i.e., one that mentions risk 
reduction of a specific disease; (2) a petitioned health claim that 
mentions a symptom-like condition, but not the disease; and (3) a 
petitioned health claim with a disclaimer that states that the product 
is not intended to cure or treat a disease. The key measures for this 
study are the perceived effects of the product conveyed by the label 
condition, the effectiveness of the product, and the expected timeframe 
within which the product is expected to be effective.
    FDA will use the information from this study to guide the decision 
making process concerning current and future petitions for health 
claims. The agency acknowledges the lack of empirical data about how 
consumers understand and respond to statements they see in product 
labeling. The information gathered in this study can be used by the 
agency to assess likely consumer responses to various options for 
qualifying health claims based on varied levels of scientific evidence.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency     Total Annual        Hours per
         No. of Respondents              per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
1,560                                                 1              1,560               0.16                250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The approaches and wording options for qualified health claims of 
central interest to the agency requires a complex experimental design. 
To ensure adequate power to identify differences, the minimum cell size 
is 60

[[Page 31397]]

participants. This will be sufficient to identify small to medium 
effects (i.e., r =.15 to .30) for all main effects and first order 
interactions with power = (1-beta), well in excess of .80 at the .05 
significance level.

    Dated: May 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12532 Filed 6-2-04; 8:45 am]

BILLING CODE 4160-01-S