[Federal Register Volume 71, Number 226 (Friday, November 24, 2006)]
[Notices]
[Pages 67881-67882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0481]


Guidance for Industry: Lead in Candy Likely to Be Consumed 
Frequently by Small Children; Recommended Maximum Level and Enforcement 
Policy, Availability; and Supporting Document: Supporting Document for 
Maximum Recommended 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 final guidance for industry entitled ``Guidance for 
Industry: Lead in Candy Likely to Be Consumed Frequently by Small 
Children; Recommended Maximum level and Enforcement Policy,'' and a 
supporting document entitled ``Supporting Document for Maximum 
Recommended Level for Lead in Candy Likely to Be Consumed Frequently By 
Small Children.'' The guidance provides a maximum recommended 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 
guidance states FDA's commitment to take enforcement action against 
candy containing lead at levels that may pose a health risk. 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 can practicably be obtained.

DATES: The guidance and supporting documents are final upon the date of 
publication. However, you may submit written or electronic comments 
concerning the guidance and/or supporting document any time.

ADDRESSES: Submit written requests for single copies of the guidance 
and/or supporting document to the Office of Plant and Dairy Foods (HFS-
300), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Parkway, College Park, MD 20740. 
Include a self-addressed adhesive label to assist that office in 
processing your request.
    Submit written comments concerning the guidance and/or 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. To 
ensure a timelier processing of comments, FDA is no longer accepting 
comments submitted to the agency by e-mail. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance and 
supporting document.

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 20740-3835, 301-436-2022, FAX 
301-436-2651, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 27, 2005 (70 FR 76462), FDA 
made available a draft guidance for industry entitled ``Lead in Candy 
Likely to Be Consumed Frequently by Small Children; Recommended Maximum 
Level and Enforcement Policy'' and a draft supporting document entitled 
``Supporting Document for Maximum Recommended Level for Lead in Candy 
Likely to Be Consumed Frequently By Small Children'' and gave 
interested parties an opportunity to submit comments by March 13, 2006. 
The agency considered received comments as it finalized this guidance 
and supporting document.
    This guidance provides a recommended maximum lead level in candy 
likely to be consumed frequently by small children. FDA considers the 
maximum recommended 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. In response to comments on 
the draft guidance, this guidance clarifies FDA's commitment to take 
enforcement action against candy containing lead at levels that may 
pose a health risk. FDA notes that it is rescinding previous guidance 
provided in a 1995 letter to the industry regarding an enforcement 
level for lead in candy because the level cited in the 1995 letter is 
no longer regarded as consistent with the agency's policy of reducing 
lead levels in the food supply to reduce consumers' lead exposure to 
the lowest level that can practically be obtained. In addition, this 
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 supporting document 
entitled ``Supporting Document for Maximum Recommended Level for Lead 
in Candy Likely to Be Consumed Frequently by Small Children.'' The 
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 can practically be obtained.
    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This guidance represents FDA'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 provide 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. You may use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations. 
If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance (see FOR FURTHER INFORMATION 
CONTACT). If you cannot identify the appropriate FDA staff, call the 
telephone number listed in the title page of the guidance.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic

[[Page 67882]]

comments regarding this guidance and/or supporting document at any 
time. 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 guidance and supporting 
documents 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 guidance and 
supporting documents at http://www.cfsan.fda.gov/guidance.html.

    Dated: November 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19809 Filed 11-22-06; 8:45 am]
BILLING CODE 4160-01-S