Document ID: FDA-2014-D-2275-0001
Agency: fda
Document Type: Notice
Title: Lead in Cosmetic Lip Products and Externally Applied Cosmetics:
Recommended Maximum Level; Draft Guidance for Industry; Availability
Posted Date: 2016-12-22T05:00Z

[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93940-93941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30781]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2275]

Lead in Cosmetic Lip Products and Externally Applied Cosmetics: 
Recommended Maximum Level; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled, ``Lead in 
Cosmetic Lip Products and Externally Applied Cosmetics: Recommended 
Maximum Level.'' This draft guidance provides a recommended maximum 
level of 10 parts per million (ppm) for lead as an impurity in cosmetic 
lip products (such as lipsticks, lip glosses, and lip liners) and 
externally applied cosmetics (such as eye shadows, blushes, shampoos, 
and body lotions) marketed in the United States. We consider the 
recommended maximum lead level to be achievable with the use of good 
manufacturing practices and consistent with the 10 ppm maximum lead 
level for similar products recommended by other countries, and we have 
concluded that the recommended maximum lead level would not pose a 
health risk.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
February 21, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 93941]]

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-2275 for ``Lead in Cosmetic Lip Products and Externally 
Applied Cosmetics: Recommended Maximum Level; Draft Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Cosmetics and Colors, Center for Food Safety and Applied 
Nutrition, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julie N. Barrows, Center for Food 
Safety and Applied Nutrition (HFS-106), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1119.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled, ``Lead in Cosmetic Lip Products and Externally Applied 
Cosmetics: Recommended Maximum Level.'' This draft guidance provides a 
recommended maximum level of 10 ppm for lead as an impurity in cosmetic 
lip products (such as lipsticks, lip glosses, and lip liners) and 
externally applied cosmetics (such as eye shadows, blushes, shampoos, 
and body lotions) marketed in the United States. FDA has concluded that 
a recommended maximum level of 10 ppm for lead as an impurity in 
cosmetic lip products and externally applied cosmetics would not pose a 
health risk. We consider the recommended maximum lead level to be 
achievable with the use of good manufacturing practices. Additionally, 
the recommended maximum level is consistent with the 10 ppm maximum 
lead level for similar products recommended by other countries. This 
draft guidance does not apply to topically applied products that are 
classified as drugs or to hair dyes that contain lead acetate as an 
ingredient.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on ``Lead in Cosmetic 
Lip Products and Externally Applied Cosmetics: Recommended Maximum 
Level.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Cosmetics/GuidanceRegulation/default.htm 
or https://www.regulations.gov. Use the FDA Web site listed in the 
previous sentence to find the most current version of the guidance.

    Dated: December 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30781 Filed 12-21-16; 8:45 am]
 BILLING CODE 4164-01-P