[Federal Register Volume 70, Number 247 (Tuesday, December 27, 2005)]
[Notices]
[Page 76462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0481]


Draft Guidance for Industry: Lead in Candy Likely To Be Consumed 
Frequently by Small Children: Recommended Maximum Level and Enforcement 
Policy; Draft Supporting Document: Supporting Document for Recommended 
Maximum Level for Lead in Candy Likely To Be Consumed Frequently by 
Small Children; 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availability of a draft guidance for industry entitled ``Lead in Candy 
Likely To Be Consumed Frequently by Small Children: Recommended Maximum 
Level and Enforcement Policy.'' This draft guidance provides a 
recommended maximum lead level in candy likely to be consumed 
frequently by small children. FDA considers the recommended maximum 
level to be protective of human health and to be achievable with the 
use of good manufacturing practices in the production of candy and 
candy ingredients. The agency is also announcing the availability of a 
draft supporting document entitled ``Supporting Document for 
Recommended Maximum Level for Lead in Candy Likely To Be Consumed 
Frequently by Small Children.'' These two documents are intended to 
assist candy manufacturers in achieving reduced lead levels in their 
products consistent with the agency's policy of reducing lead levels in 
the food supply to reduce consumers' lead exposure to the lowest level 
that practicably can be obtained.

DATES: Submit written or electronic comments on the draft guidance by 
March 13, 2006. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance and/or draft supporting document to the Division of Plant 
Product Safety (HFS-305), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. Send one self-addressed adhesive label to assist that office in 
processing your requests.
    Submit written comments on the draft guidance and/or draft 
supporting document to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance and draft supporting documents.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Lead in Candy Likely To Be Consumed Frequently by Small 
Children: Recommended Maximum Level and Enforcement Policy.'' This 
draft guidance provides a recommended maximum lead level in candy 
likely to be consumed frequently by small children. FDA considers the 
recommended maximum level to be protective of human health and to be 
achievable with the use of good manufacturing practices in the 
production of candy and candy ingredients. FDA notes that the 
recommended level is not for enforcement purposes. In addition, FDA is 
rescinding previous guidance provided in a 1995 letter to the industry 
regarding an enforcement level. Finally, this draft guidance reiterates 
FDA's enforcement policy toward the use of lead based ink on candy 
wrappers as stated in the 1995 letter to the industry. FDA also is 
announcing the availability of a draft document entitled ``Supporting 
Document for Recommended Maximum Level for Lead in Candy Likely To Be 
Consumed Frequently by Small Children.'' The draft supporting document 
provides additional background and rationale for the recommended 
maximum level. These two documents are intended to assist candy 
manufacturers in achieving reduced lead levels in their products 
consistent with the agency's policy of reducing lead levels in the food 
supply to reduce consumers' lead exposure to the lowest level that 
practically can be obtained.
    The agency has adopted good guidance practices (GGPs) that set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (21 CFR 10.115). The draft 
guidance is being issued as a level 1 draft guidance consistent with 
GGPs. The draft guidance represents the agency's current thinking on 
lead levels in candy that are achievable with the use of good 
manufacturing practices in the production of candy and candy 
ingredients and that also provides for the protection of human health. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such an approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance 
and draft supporting document. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The draft guidance and draft supporting document and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: December 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24494 Filed 12-22-05; 8:45 am]
BILLING CODE 4160-01-S