
[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12761-12762]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0409] (formerly 2006D-0169)


Guidance for Industry: Guidance on the Labeling of Certain Uses 
of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, 
Drug, and Cosmetic Act; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
withdrawal of a guidance entitled ``Guidance for Industry: Guidance on 
the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 
403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, 
that was announced in the Federal Register on May 2, 2006. The guidance 
explained FDA's then current thinking on the labeling of certain uses 
of lecithin derived from soy under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) and was part of FDA's implementation of the Food 
Allergen Labeling and Consumer Protection Act (FALCPA). We are taking 
this action because the policy stated in the guidance regarding FDA's 
consideration of the exercise of enforcement discretion no longer 
reflects our current thinking.

DATES: The withdrawal is effective February 25, 2013.

FOR FURTHER INFORMATION CONTACT:  Steven M. Gendel, Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1056.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 2, 2006 (71 FR 25844), we announced the availability of 
a guidance entitled ``Guidance on the Labeling of Certain Uses of 
Lecithin Derived From Soy Under Section 403(w) of the Federal Food, 
Drug, and Cosmetic Act.'' The guidance explained that, consistent with 
the need to establish enforcement priorities, we would consider the 
exercise of enforcement discretion for a food labeled on or after 
January 1, 2006, in which lecithin derived from soy is used solely as a 
component of a release agent and the label for such food does not 
declare the presence of soy consistent with the requirements of section 
403(w) of the FD&C Act (21 U.S.C. 343(w)). In that guidance, the

[[Page 12762]]

term ``release agent'' referred to an agent used to facilitate the 
release of foods from food contact surfaces, where the agent has been 
applied directly to the food contact surface, rather than incorporated 
into the food. In that guidance, we also stated our intention to 
reconsider our enforcement priorities with regard to the labeling of 
lecithin derived from soy used as a component of a release agent 
approximately 18 months after the issuance of the guidance. Further, we 
stated our expectation that, during the period in which we considered 
the exercise of our enforcement discretion, manufacturers of foods that 
use lecithin derived from soy as a component of a release agent would 
revise as necessary the labels of their relevant food products to 
comply with FALCPA and begin to label their products using the FALCPA-
compliant labels by the end of the enforcement discretion period.
    We believe that there has been sufficient time for all 
manufacturers of foods that use lecithin derived from soy as a 
component of a release agent to revise the labels for such foods to be 
consistent with the requirements of section 403(w) of the FD&C Act. 
Therefore, we no longer believe it is appropriate to consider the 
exercise of our enforcement discretion with regard to foods that use 
lecithin derived from soy as a component of a release agent. For these 
reasons, we are withdrawing the April 2006 guidance entitled ``Guidance 
on the Labeling of Certain Uses of Lecithin Derived from Soy Under 
Section 403(w) of the Federal Food, Drug, and Cosmetic Act.''

    Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04251 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P


