[Federal Register Volume 60, Number 99 (Tuesday, May 23, 1995)]
[Notices]
[Page 27321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12605]



[[Page 27321]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 91P-0186 and 93P-0306]


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

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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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]
BILLING CODE 4160-01-F