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FDA Clarifies 'Free From' Claims on Product Labels, Paving the Way for Certified Free From®
Allergen-free declarations can now only be made if a product is absolutely free of an allergen, paving the way for Certified Free From® seals on packaged goods.
According to the FDA, a product can only use an allergen-free claim if it truly does not contain the named allergen, including any unintended traces from cross-contact. The FDA also states that a product claiming to be "free-from" should not include an advisory statement for the same allergen. For example, a product labeled "milk-free" should not also have a "may contain milk" statement.
With this statement, the FDA is looking to clear up labeling confusion for consumer packaged goods (CPG).
“What this means for CPGs is they now must back up their statements through third-party validation of allergen-free claims. This is much like what we saw a decade ago with the gluten-free industry providing more transparency into what goes into their products, thus opening the door to more consumer trust,” said Betsy Craig, founder and CEO of MenuTrinfo®.
Based on a 2024 study conducted by FARE, 85 million Americans seek out products that are free from at least one of the Major 9 allergens.
“For brands, adding a seal that holds as much credibility as Certified Free From makes their product a no-brainer purchase for these consumers who seek out goods and dining facilities that have achieved certification,” Craig said. “This is especially true for CPG foods that are manufactured at times in a shared environment. Testing to confirm the free from status to achieve a Free-From certification delivers confidence to the consumer and means assurance for the CPG brand.“
Since 2017, MenuTrinfo has been providing Certified Free From®(CFF) seals to consumer-packaged brands and manufacturers looking to validate their products as free from anywhere from one to all nine of the major allergens.
In 2022, the MenuTrinfo CFF program was recognized by the American National Standards Institute (ANSI) National Accreditation Board (ANAB) as meeting the rigorous International Standards Organization (ISO) 17065 standards for certification bodies. They are the first certification of their kind to reach this level of accreditation.
“We are 100% aligned with FDA regulations and strategically poised to support brands ready to add the CFF seal to their products," Craig said. "Our seal helps to ensure strict compliance with FDA standards through rigorous audits and testing, it also boosts consumer trust and significantly reduces the volume of ingredient-related inquiries to manufacturers. Not to mention it eliminates the potential threat of product recalls and lawsuits. It's a win-win for everyone—brands, consumers and the industry as a whole.”
The FDA now clearly states that food and household products that claim to be free from one or more allergens must:
Not contain that allergen as either a direct or indirect ingredient; and
Not pose any risk of cross-contact with an allergen during the manufacturing process.
Additionally, in their Jan. 6, statement, the FDA outlined robust standards and requirements for food manufacturers, which will:
A. Ensure that "allergen-free" truly means allergen-free;
B. Support any validated allergen-free claims made by manufacturers;
C. Open the door for more validation and verification through third-party auditing and testing;
D. Build consumer trust around Certified Free From seals on packaged goods.
“This is the perfect time for brands to jump on board and add the CFF seal to their product packaging,” Craig said. “It also will help the manufacturing community because verifying and substantiating claims through our audit process will help reduce allergen-related recalls in their facilities. Our scheme brings allergen safety even further down the winning path and provides a more robust backbone to the products brands want to certify.”
ABOUT CERTIFIED FREE FROM®
Certified Free From® by MenuTrinfo® (CFF) is committed to delivering safe, reliable and transparent solutions for individuals with food allergies, intolerances and sensitivities. The ISO17065 CFF program, offered by MenuTrinfo, provides a vital and trusted certification for consumer-packaged goods (CPG) and food manufacturers looking to offer allergen-free products. This comprehensive program involves rigorous testing of both products and facilities to ensure they are free from one or more of the top nine major food allergens: peanuts, milk, eggs, shellfish, wheat, sesame, soy, fish, and tree nuts. As the only certification of its kind in the world, CFF offers unmatched third-party in-person verification, testing, and validation, ensuring the accuracy and integrity of allergen-free claims on consumer-packaged products.
Valerie Gritton
MenuTrinfo
valerie@menutrinfo.com
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