Proposed Warning Labels for Iron-Containing Products; FDA Report on Consumer Research; Availability

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a report entitled ``Consumer Research on Proposed

Warning Labels for Iron-Containing Products,'' which describes the

results of research conducted by the agency to evaluate consumer

understanding of the proposed warning labels for iron-containing

products. FDA is inviting comments on the findings in this report.

DATES: Written comments by July 24, 1995.

ADDRESSES: Submit written comments and requests for single copies of

``Consumer Research on Proposed Warning Labels for Iron-Containing

Products'' to the Dockets Management Branch (HFA-305), Food and Drug

Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

Comments and requests should be identified with the docket number found

in brackets in the heading of this document. Send two self-addressed

adhesive labels to assist that office in processing your requests.

After the comment period shown above, copies of the document will be

available at cost from the Freedom of Information Staff (HFI-35), Food

and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD

20857. ``Consumer Research on Proposed Warning Labels for Iron-

Containing Products'' and received comments are available for public

examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Raymond E. Schucker, Center for Food

Safety and Applied Nutrition (HFS-725), Food and Drug Administration, -

200 C St. SW., Washington, DC 20204, 202-205-5657.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 6, 1994

(59 FR 51030), FDA issued a proposal (``the initial proposal'') on

actions that it tentatively concluded were necessary to stop the recent

epidemic of pediatric poisonings from over consumption of iron-

containing products. In the Federal Register of February 16, 1995 (60

FR 8989), the agency issued a supplementary proposal to clarify changes

in its legal authority with the passage of the Dietary Supplement

Health and Education Act (Pub. L. 103-417).

In the initial proposal, FDA announced that it may conduct focus

group research to evaluate consumer understanding of the proposed

warning messages and to ensure that the messages are not misleading.

FDA has conducted this research. Consumers provided feedback as to

their understanding of the proposed warnings and the degree to which

the specific wording of the messages was believable, relevant,

confusing, or irritating. Additional warning messages were created as a

result of public comment on the proposed rule, and these messages were

also evaluated in the focus groups.

FDA stated in the initial proposal that it would make a report of

the results of this research available for public comment before it

issued the final regulations. The research report is now available for

public comment.

Dated: May 18, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95-12605 Filed 5-22-95; 8:45 am]

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