The U.S. Food and Drug Administration (FDA) has released a list of the draft and final guidance topics that the agency is prioritizing for 2022. The list includes guidance on allergens, cell-cultured foods, heavy metals in juice and labeling of plant-based alternatives to milk and animal-derived foods. According to a caveat in the constituent update, "Although the FDA's intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities."
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By Of Counsel John Johnson III The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to control known or reasonably foreseeable food safety hazards. Additionally, the warning reflects that FDA continues to prioritize seeking compliance with preventive controls and sanitation practices to avoid undeclared Major Food Allergens (which we discussed in A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens. The list has been expanded to include sesame, which we discussed in Look Beyond the Label: How the FASTER Act Impacts Food Manufacturing). FDA has been relatively silent about the Preventive Control Rule in 2021, issuing only four Warning Letters directly on that topic. For context, FDA issued at…
By Anna El-Zein and John Johnson III Sesame is the ninth Major Food Allergen with the passage of the Food Allergy Safety, Treatment, Education, and Research Act (FASTER) Act on April 23, 2021. Starting on January 1, 2023, any food “introduced or delivered for introduction into interstate commerce” must appropriately declare the presence of “sesame” as a major food allergen. However, the FASTER Act is more than just updating food labels; it also implicates supplier controls, Food Safety or HACCP Plans, sanitation practices and other procedures. With the compliance deadline looming, companies must start thinking about how FASTER affects their procedures sooner rather than later. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a packaged food is misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. With the addition of sesame to the “Big 8,”…
The U.S. House of Representatives has voted 415-11 to pass the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), a bill that will expand the definition of "major food allergen" to include sesame. The bipartisan bill, which passed the Senate in March 2021, will head to the White House for President Biden's signature. Upon enactment, sesame will become the ninth major food allergen, joining milk, egg, wheat, peanuts, shellfish, tree nuts, fish and soybeans.
The European Food Safety Authority (EFSA) has released several guidance documents to aid stakeholders in complying with EU regulations on food issues implemented on March 27, 2021. The publications provide guidance on: Applying for an exemption from mandatory food allergen labeling; Renewing applications for genetically modified organisms (GMOs) in food and feed; Preparing applications for genetically modified plants; Applying for authorization of a novel food; Preparing applications for substances to be used in food-contact plastics; Applying to make health claims about foods; Preparing an evaluation for infant formula manufactured from protein hydrolysates; and Submitting notifications for traditional foods from third countries.
By Associate Anna El-Zein & Of Counsel John Johnson III Recent actions by the U.S. Food and Drug Administration (FDA) suggest that, in 2021, the Agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food allergens. In a series of high-profile warning letters and press releases, FDA confirmed that it is moving beyond expecting non-compliant food to be recalled and is concentrating on how companies are preventing the issue. Manufacturers and private labelers need to audit their practices and expect an FDA inspection, especially if they have had an allergen-related recall. What the Law Requires The Federal Food, Drug, and Cosmetic Act (FDCA) deems a packaged food misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. This requirement and the list of major food allergens is found…
The U.S. Food and Drug Administration (FDA) has warned Frito-Lay Inc. about "serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" because its investigators found potato chips to be misbranded "in that the finished product labels did not declare a major food allergen (milk)" in addition to being "prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health." The warning applied to Ruffles Cheddar & Sour Cream Potato Chips packaged with labels for the wrong type of chips, the Ruffles Original variety, at one facility. At another facility, the company reportedly failed to implement "allergen preventive control procedures to significantly minimize or prevent allergen cross-contact," which require the company to "verify that all visible evidence of prior seasoning is removed" after producing Lay's Limón Flavored Potato Chips.
The U.S. Food and Drug Administration (FDA) has issued draft guidance "encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels." The guidance notes that "sesame can, in some circumstances (such as when ground and used in a spice blend), be declared in an ingredient statement as simply 'spice' or 'flavor,' so its presence may not be obvious to consumers." While FDA has not required sesame to be labeled, "we recommend that manufacturers, as a voluntary matter, clearly declare sesame in the ingredient list when it is used in foods as a 'flavor' or 'spice' in a parenthetical following the spice or flavor, such as 'spice (sesame),' 'spices (including sesame),' 'flavor (sesame),' or 'flavors (including sesame).' If a term is used for a food that is or contains sesame, such as tahini, we recommend that sesame be included in a parenthesis, e.g. 'tahini (sesame)' in the…
The U.S. Food and Drug Administration (FDA) has issued an update for consumers on its 2018 study examining milk allergies and dark chocolate. "U.S. law requires manufacturers to label food products that are major allergens, as well as food products that contain major allergenic ingredients or proteins," the update notes. "Allergens contained in a food product but not named on the label are a leading cause of FDA requests for food recalls, and undeclared milk is the most frequently cited allergen. Chocolates are one of the most common sources of undeclared milk associated with consumer reactions." FDA advised consumers to interpret "may contain" disclosures as "likely to contain," even if the package is also labeled as dairy-free or vegan. "Unfortunately, you can’t always tell if dark chocolate contains milk by reading the ingredients list. FDA researchers found that of 94 dark chocolate bars tested, only six listed milk as an…
Allergen labeling grabbed headlines in the United Kingdom in 2019 as the country faced pressure from consumers concerned that prepackaged foods lacked mandated ingredient disclosures. Following the 2016 death of a teenager who consumed a premade sandwich packaged without notification of potential exposure to sesame, the U.K. Food Standards Agency launched a public consultation that resulted in the announcement of "Natasha's Law." Under the law, which will take effect in October 2021, restaurants and other food-service entities will be required to provide a full listing of ingredients on prepackaged food. In the United States, sesame is not an allergen that requires labeling, although the U.S. Food and Drug Administration (FDA) requested comments on the allergy's prevalence and severity in 2018. The New York Times called current U.S. regulations incomplete in January, and an August NPR article compared the two systems and found awareness of allergies in the United States lacking.…
