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

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.

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

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

[[Page 3636]]

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