Gluten-Free Labeling Under the Current Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and Beyond

Why Should You Attend:

Recent federally-adopted requirements mandate the declaration of major food allergens, as defined by FALCPA. While these requirements mandate FDA’s action in the area of gluten-free labeling, and despite the activity in this area, the Agency has had difficulty in adopting a final rule to date. However, this difficulty does not necessarily prevent the FDA from using other regulatory tools, such as the misbranding provisions, to limit the use of “gluten-free” in food labeling. Thus, it is important for manufacturers and labelers to be aware of the meaning attached to “gluten-free,” including how and when this distinction may be used.

This session is designed for food manufacturers and labelers and is focused towards helping both domestic and foreign entities in ensuring compliance with FDA regulations. This session will cover the requirements of FALCPA, particularly in the context of gluten-free labeling, and will highlight FDA action taken to date in this area.

Areas Covered in the Webinar:

• Brief overview of FALCPA, highlighting provisions pertaining to gluten-free labeling.
• Overview of the products subject to FALCPA and FDA’s gluten-free requirements – including those foods prohibited from using the declaration in product labeling.
• Examination of how the FDA defines the term “gluten-free”.
• How to properly declare gluten free foods in labeling, including recognized synonyms of the term.
• Regulatory status of the gluten-free declaration and timeline of Agency action
• What FDA expects from manufacturers and labelers.
• How failure to comply with the guidelines may affect the manufacturing unit.

Who will Benefit:

Food manufacturers and facilities responsible for packaging/labeling food products will benefit from this training.

• Regulatory affairs
• Food packaging suppliers and manufacturers
• Labeling
• Documentation
• Food technologists
• Food safety
• Food inspectors
• Marketing
• QA/ QC

Instructor Profile:

Ms. Giannamore, serves as principal attorney at the Law Office of Katherine Giannamore, P.A. In her position, she helps individuals and companies resolve a wide range of regulatory issues. In addition to helping clients ensure compliance with the laws and regulations pertaining to food labeling, she serves an international clientele in the development of an array of compliant marketing materials, including websites, brochures, infomercials and more. In addition to these services, Ms. Giannamore helps companies who have been targeted as a result of non-compliance by working on their behalf to secure the release of seized goods, submission of reconditioning requests, effectuating removals from import alerts and providing responses to warning letters. In addition to foods, Ms. Giannamore provides regulatory assistance to the many different FDA-regulated industries, including medical devices, cosmetics and drugs. Katherine Giannamore is currently licensed to practice law in the State of Florida and is admitted to practice before the United States Courts of Appeals for the Third Circuit and the Eleventh Circuit.

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