A mislabeled product is a recall waiting to happen. Allergen declaration errors, formula changes that never made it to the artwork file, marketing claims that outpaced what’s actually in the formulation, label mistakes are among the most preventable sources of FDA enforcement action and consumer harm.
In this FSMA Friday session, Tony Lukas, Director of Food Safety and Dietary Supplements at The Acheson Group, walks through what a solid label verification process actually looks like: mandatory vs. optional label elements, how to document formula and label changes so your revision history holds up during an audit, and which departments — R&D, marketing, regulatory, operations — need a seat at the table before anything goes to print.
If your label review process lives in email threads and tribal knowledge, this session is for you.
What You’ll Learn
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Why label errors trigger recalls and FDA action and the specific gaps in documentation and sign-off that leave manufacturers exposed.
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What belongs on every label and what optional claims add risk including how PAL statements and marketing language can create compliance exposure.
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How to document formula and label changes correctly so your revision history holds up when an auditor asks for it.
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Which departments should be involved and when R&D, marketing, regulatory, and operations all touch labels, and misalignment between them is where errors hide.