[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
