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Sesame to become 9th Major Food Allergen

President Biden signed into law the FASTER Act on Friday, which adds sesame to the existing list of eight major food allergens (now nine). This decision has several implications.  First, food manufacturers will need to declare on labels the presence of sesame and will need to verify with suppliers that they are disclosing the presence of sesame. 

In addition, manufacturers will need to revisit their policies and procedures.   For example, under the Food Safety Modernization Act’s current Good Manufacturing Provisions, manufacturers must account for potential cross-contamination; these procedures will now need to account for sesame at the facility.  See cGMP, 21 C.F.R. Subpart B. And of course, FSMA requires that preventive controls be in place to control food allergens – which will now include sesame – leading to the need for updated food safety plans. 

The good news is that there is a runway to enable companies to prepare. These requirements regarding sesame become applicable on January 1, 2023.  At that point, non-compliance can result in serious enforcement actions from FDA as there are serious public health risks that can stem from the failure to declare an allergen.  We recommend that companies revisit their policies and labels now and prepare for early compliance.  The Reed Smith FDA team is here to help companies needing assistance.

SEC. 2. FOOD ALLERGY SAFETY. (a) IN GENERAL.—Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by striking ‘‘and soybeans’’ and inserting ‘‘soybeans, and sesame’’. (b) EFFECTIVE DATE.—The amendment made by subsection (a) shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.

Tags

food, fda, food safety

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