[Federal Register Volume 62, Number 16 (Friday, January 24, 1997)]
[Proposed Rules]
[Pages 3635-3636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1785]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 94P-0390 and 95P-0241]


Food Labeling: Health Claims; Availability of FDA Report of 
Effects of Food Label Health Claim Statements; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Consumer Impacts of Health Claims: 
An Experimental Study'' (the FDA Study). The FDA Study is relevant to 
issues under consideration in the rulemaking that FDA instituted on 
December 21, 1995, with a proposal to amend its regulations on nutrient 
content and health claims to provide greater flexibility in the use of 
these claims on food products. FDA is adding this report and two 
related studies on abbreviated health claim statements to the 
administrative record of that rulemaking. In addition, FDA is reopening 
the comment period for the December 21, 1995, proposed rule (60 FR 
66206) to provide interested persons with an opportunity to obtain the 
FDA Study and to submit comments.

DATES: Written comments by March 10, 1997.

ADDRESSES: Submit written requests for single copies of the FDA Study 
``Consumer Impacts of Health Claims: An Experimental Study'' and the 
studies submitted by The Quaker Oats Co. to the contact person listed 
below. Send two self-addressed adhesive labels to assist in processing 
your request. A copy of the FDA Study and received comments are 
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. 
The FDA Study may also be viewed on the FDA World Wide Web site (http:/
/www.fda.gov) by selecting Foods, then Food Labeling from the menus 
presented. Submit written comments to the Dockets Management Branch 
(address above). Comments should be identified with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Alan S. Levy, Center for Food Safety 
and Applied Nutrition (HFS-727), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-9448.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 21, 1995 
(60 FR 66206), FDA published a proposed rule, entitled ``Food Labeling: 
Nutrient Content Claims, General Principles; Health Claims, General 
Requirements and Other Specific Requirements for Individual Health 
Claims'' (the December 1995 proposal), to amend its regulations on 
nutrient content and health claims to provide greater flexibility in 
the use of these claims on food products. The agency proposed to permit 
the use of shortened versions of authorized health claims and to 
eliminate some of the required elements of these claims. The proposed 
rule provided a 90-day period for public comment. The agency extended 
the comment period for an additional 120 days on March 22, 1996. The 
comment period closed on July 18, 1996.
    FDA has recently completed research on the effects of food label 
health claim statements on consumers. This research bears directly on 
the issues involving health claims that were raised in the December 
1995 proposal. FDA believes that it may be appropriate to consider that 
research in developing a final rule in the subject rulemaking. 
Therefore, FDA is placing the FDA Study on this research in the docket 
for the December 1995 proposal and is reopening the comment period on 
the proposal to provide an opportunity for interested parties to 
comment on the FDA Study. FDA is providing 45 days so that interested 
parties have sufficient time to obtain the study and submit comments on 
it.
    Shortly after publication of the December 1995 proposal, FDA 
published a proposed rule to authorize a health claim on the 
association between oat bran and oatmeal and the risk of coronary heart 
disease (61 FR 296, January 4, 1996). In response to that proposal, FDA 
received a comment from The Quaker Oats Co. that included two studies 
on the use of abbreviated health claims. Inasmuch as shortened health 
claims were a primary focus of the December 1995 proposal, the agency 
has submitted these studies to Docket Number 94P-0390 for consideration 
in the rulemaking on the December 1995 proposal. Interested parties may 
submit comments on these studies during the reopened comment period.

I. The FDA Study

A. Background

    The final report of the Keystone National Policy Dialogue on Food, 
Nutrition, and Health (Ref. 1) reviewed several issues raised by the 
food labeling regulations that FDA adopted in response to the Nutrition 
Labeling and Education Act of 1990. This report identified issues 
related to health claims as among those most in need of study. The 
report also noted the lack of research about how consumers respond to 
health claims on food labels and raised a number of specific questions 
about the relative effectiveness of specific language contained in FDA 
model health claim statements. The report strongly recommended that 
consumer research be conducted to evaluate the impact of alternate 
forms of health claim statements on food labels.
    The goal of the regulations governing health claims, to help 
consumers achieve a healthier diet, is one with which virtually 
everyone agrees, but there are many viewpoints, and no small 
controversy, about how to best achieve it. Uncertainty about how best 
to structure health claims arises from the lack of experience with this 
type of claim, but it also reflects the diversity of opinion about how 
health claims will affect consumer behavior.
    The Department of Health and Human Services provided funds to FDA 
to conduct research on the effect of health claims on consumer 
understanding and behavior, so that the agency would have a firm 
empirical basis to evaluate the requirements that it has adopted and 
any revisions that it may contemplate. The agency designed a study to 
investigate the effects of different versions of health claim 
statements on a range of variables chosen to represent some of the 
different possible effects of health claims.
    A preliminary focus group study evaluated a number of proposed 
health claim statements developed by the Keystone Dialogue as 
alternatives to FDA's model health claim statements (Ref. 1, pp. 141 to 
150). The results suggested that FDA's model claims could be improved, 
and it highlighted some basic issues underlying consumer reactions. 
Central to consumer reactions to health claims was the credibility and 
authoritativeness of the claims. The brevity of a claim was seen by 
consumers as a significant element of the effectiveness of health 
claims, but preferences for brevity seemed to depend on the degree of 
familiarity (i.e., amount of prior knowledge) with the given diet/
disease relationship. The focus group results also emphasized the 
importance of looking at several different kinds of health claims, 
because consumer reactions were noticeably different depending on 
familiarity with the claim. FDA used the results from the

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focus groups to identify the independent variables for a larger study.

B. Study Design

    The FDA Study was a shopping mall intercept study. Subjects were 
primary food shoppers recruited at a mall with central interviewing 
facilities at eight sites around the country. The sample size was 
approximately 175 persons per site (total sample size was 1,403 
persons), with quotas for age and education to ensure that the full 
range of population characteristics were represented in the sample. 
Subjects were randomly assigned to an experimental condition. In the 
central interviewing facility, an interviewer administered the 
experimental protocol in a 20 to 25 minute session. Subjects were 
presented, one at a time, with realistic product packages. The packages 
were of typical size and organization for the particular type of 
product, including front and back label information appropriate for the 
product category. The product types and health claims represented 
included: Cheese lasagna/saturated fat and cholesterol and risk of 
coronary heart disease; yogurt/calcium and osteoporosis; and breakfast 
cereal/folic acid and risk of neural tube defects.
    The presentation style, authority, and brevity of the health claim 
were experimentally manipulated. Each product label seen represented a 
cell in the experimental design. The order of presentation of the 
products and the type of health claim were counterbalanced to avoid 
confounding effects. A series of questions about each product measured 
purchase intentions and communication effectiveness of the product 
label (e.g., perceived health benefits, compellingness), as well as 
personal and household characteristics. Information search behavior was 
observed and recorded.

C. Conclusions

    The results of the FDA Study (Ref. 2) show that shorter claims are 
more effective than longer claims, that endorsed health claims have 
liabilities compared to nonendorsed claims, and that splitting claims 
between the front and back label makes little difference. The results 
also show that the ability of health claims to accurately communicate 
health information about a product appears to be fairly limited and 
involves tradeoffs between different kinds of valid health information.

II. The Quaker Oats Co. Studies

    The Quaker Oats Co. submitted reports of two studies pertaining to 
the use of abbreviated health claim statements as a comment to Docket 
No. 95P-0197 (61 FR 296). The consumer research in the first report, 
entitled ``Quaker Oatmeal On-Pack Health Claim Survey,'' provided data 
on the question of whether consumers would read the full claim if only 
an abbreviated claim appeared on the front of the label (Ref. 3). The 
data were based on a national telephone survey of 301 consumers. The 
respondents were asked about four types of new highlighted messages on 
the front of a package of breakfast cereal (health or nutrition; 
improvements to the product; price; special offers or rebates). The key 
questions concerned how likely respondents would be to read each of the 
four types of messages on the front of a package, and, if they noticed 
a new highlighted message on the front of the package that was about 
health benefits and that stated that additional information could be 
found on the back of the package, how likely they were to read the 
additional information.
    The second report, entitled ``Consumer Perception Study of a 
Statement Related to Heart Disease on the Label of Quaker Oats,'' 
presented consumer research comparing an abbreviated oatmeal claim (``A 
diet high in oatmeal may help reduce the risk of heart disease.'') with 
a full fiber-heart disease health claim (``Diets low in saturated fat 
and cholesterol and high in grains, fruits and vegetables that contain 
fiber, particularly soluble fiber, may reduce the risk of heart 
disease, a condition associated with many factors.'') (Ref. 4). The 
data were from a national shopping mall intercept study of 826 
consumers. Participants saw one of three mocked-up cereal packages that 
contained the abbreviated claim, the long claim, or no claim (control 
condition).
    The report stated that the presence of either health claim, 
compared to the control condition, increased the number of participants 
who recognized that a diet high in oatmeal may help reduce the risk of 
heart disease. There were no significant differences in terms of the 
impact of the claims on consumers' perceptions of the product or their 
beliefs about the diet-disease relationship.

III. Comments

    Interested persons may by March 10, 1997, submit to the Dockets 
Management Branch (address above) written comments regarding the 
studies being added to this docket. Two copies of any comments are to 
be submitted, 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 office 
above between 9 a.m. and 4 p.m., Monday through Friday.

IV. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. The Keystone Center, ``The Final Report of The Keystone 
National Policy Dialogue on Food, Nutrition, and Health,'' Keystone, 
CO and Washington, DC, March 1996.
    2. Food and Drug Administration, U.S. Department of Health and 
Human Services, ``Consumer Impacts of Health Claims: An Experimental 
Study,'' Washington, DC, December 1996.
    3. The Quaker Oats Co., ``Quaker Oatmeal On-Pack Health Claim 
Survey,'' Chicago, IL, March 1996.
    4. The Quaker Oats Co., ``Consumer Perception Study of a 
Statement Related to Heart Disease on the Label of Quaker Oats,'' 
Chicago, IL, November 1995.

    Dated: January 17, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-1785 Filed 1-23-97; 8:45 am]
BILLING CODE 4160-01-F