AAFA commends the U.S. Food and Drug Administration (FDA) for their investigation into practices that limit choices and pose potential risks for food allergy consumers. Ensuring the accuracy of food labeling is critical for the safety and well-being of people with food allergies. FDA recently sent a warning letter to Bimbo Bakeries, whose product lines include Sara Lee, for violations of the Food, Drug, and Cosmetic Act. Through an inspection, FDA found that Bimbo Bakeries has been labeling some of its products as containing allergens, including sesame and tree nuts, when the allergens are not actually ingredients in the products. AAFA has raised this false labeling practice and the practice of actually adding sesame to product formulations to FDA multiple times since sesame allergen labeling was required in 2021. Manufacturers claim that sesame poses unique challenges for baking. In response, AAFA recently called on FDA to provide specific guidance on how manufacturers can establish effective policies to manage sesame as an allergen. We applaud the FDA’s efforts to hold manufacturers accountable and to protect the health of the over 20 million people in the U.S. living with food allergies. AAFA looks forward to continuing collaboration with the FDA to enhance food safety and ensure that all consumers can access accurate and reliable product information. https://lnkd.in/gkSkETvg
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Litigator and Advisor | Food and Beverage Attorney | Protecting Your Business Interests and Brand in a Complex Regulatory Landscape
Great summary of the issues.
Food industry lawyer and consultant focused on creating a safe, transparent, and accessible food system.
Over-declaration of allergens in food is in the news. When the FASTER Act became law (making sesame the 9th major allergen in the USA), there was an uproar because companies were adding sesame to their formulation to include it in the ingredient list and in the allergen statement. Center for Science in the Public Interest filed a petition with the FDA about it, and the FDA responded, "although the FDA does not encourage the addition of sesame as an ingredient to a food when sesame is not normally an ingredient used to make the food, a company's decision to add sesame and then declare it on the label as required is not violative." It is very difficult, if not impossible to clean up sesame seeds to totally avoid any potential that an FDA inspector may see a sesame seed in an or on a production line after sesame has been used, which could lead to a recall. So, some companies decided to eliminate the regulatory risk, while still trying to protect consumers through proper declaration. And their decision was verified as compliant by the FDA. This was a loss for consumers with an allergy to sesame because the selection of products they could choose was reduced, but somewhat necessary for operations since the FDA tends to take a zero policy approach to allergens and treats "may contains" statements as essentially meaningless to protect against a product recall. Would it be possible to mitigate this situation through written policies on enforcement, allergen thresholds, recognition that for some ingredients even the best manufacturing practices may miss a seed, and providing more education and guidance on "may contain" statements? Maybe, but something should be formalized to help companies avoid regulatory enforcement and recalls while still being able to provide a safe product selection for all consumers. While adding an allergen to a recipe and properly declaring it makes people mad, it won't get you in trouble with the FDA - you know what will? Declaring allergens that are not in the recipe - FDA has issued a warning letter to Bimbo Bakeries USA because they are including allergens in the product "contains" statement and ingredient list that are not in the recipe. It would be nice to know the details, but maybe Bimbo elected to include the allergens in the contains statement while not adding it to the recipe in an effort to protect the severely allergic (that check the "contains" statement) while trying to keep the allergen levels as low as possible (by not intentionally adding it to the formulation) in case a less diligent allergic consumer ate the product without double checking the label. The warning letter does not mention anything about dirty production lines, just that the recipe/ingredient lists don't match the "contains" statement. While it appears Bimbo hasn't had to recall these products for misbranding, I could argue that a warning letter is not much better. #fda #warningletter #foodlaw #recall #foodsafety #allergen #foodlabel
FDA warns top U.S. bakery not to claim foods contain allergens when they don't
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Food industry lawyer and consultant focused on creating a safe, transparent, and accessible food system.
Over-declaration of allergens in food is in the news. When the FASTER Act became law (making sesame the 9th major allergen in the USA), there was an uproar because companies were adding sesame to their formulation to include it in the ingredient list and in the allergen statement. Center for Science in the Public Interest filed a petition with the FDA about it, and the FDA responded, "although the FDA does not encourage the addition of sesame as an ingredient to a food when sesame is not normally an ingredient used to make the food, a company's decision to add sesame and then declare it on the label as required is not violative." It is very difficult, if not impossible to clean up sesame seeds to totally avoid any potential that an FDA inspector may see a sesame seed in an or on a production line after sesame has been used, which could lead to a recall. So, some companies decided to eliminate the regulatory risk, while still trying to protect consumers through proper declaration. And their decision was verified as compliant by the FDA. This was a loss for consumers with an allergy to sesame because the selection of products they could choose was reduced, but somewhat necessary for operations since the FDA tends to take a zero policy approach to allergens and treats "may contains" statements as essentially meaningless to protect against a product recall. Would it be possible to mitigate this situation through written policies on enforcement, allergen thresholds, recognition that for some ingredients even the best manufacturing practices may miss a seed, and providing more education and guidance on "may contain" statements? Maybe, but something should be formalized to help companies avoid regulatory enforcement and recalls while still being able to provide a safe product selection for all consumers. While adding an allergen to a recipe and properly declaring it makes people mad, it won't get you in trouble with the FDA - you know what will? Declaring allergens that are not in the recipe - FDA has issued a warning letter to Bimbo Bakeries USA because they are including allergens in the product "contains" statement and ingredient list that are not in the recipe. It would be nice to know the details, but maybe Bimbo elected to include the allergens in the contains statement while not adding it to the recipe in an effort to protect the severely allergic (that check the "contains" statement) while trying to keep the allergen levels as low as possible (by not intentionally adding it to the formulation) in case a less diligent allergic consumer ate the product without double checking the label. The warning letter does not mention anything about dirty production lines, just that the recipe/ingredient lists don't match the "contains" statement. While it appears Bimbo hasn't had to recall these products for misbranding, I could argue that a warning letter is not much better. #fda #warningletter #foodlaw #recall #foodsafety #allergen #foodlabel
FDA warns top U.S. bakery not to claim foods contain allergens when they don't
npr.org
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FDA Updates Recalled Noodles To Highest Risk Level The U.S. Food and Drug Administration (FDA) recently updated its risk level for recalled instant noodles. Manufactured by Sun Noodle, the packages have been labelled as a Class 1 recall - the highest risk level that the FDA can give. Recall Initiated in May Sun Noodle began recalling many of its instant noodle products last month. The manufacturer, located in Hawaii, voluntarily recalled many of the products because of an undeclared ingredient. Egg, one of the most common food allergens, must be disclosed on food labels. The recalled items are S&S Cup Saimin -Noodles with Soup $ Garnishes. Why the Products Must Be Pulled From Shelves The FDA requires all ingredients, especially potential allergens, to be labelled correctly on packages. In May, Sun Noodle products were recalled from grocery store shelves after the company became aware that the items were improperly labelled. The FDA Increases the Risk Level After a thorough investigation, the FDA has increased the risk level of the instant noodles to Class 1, the most severe classification. Class 1 is only issued when there is a "reasonable probability" that eating the product might "cause serious adverse health consequences or death." Although the company previously noted that the egg is only added to powdered form, the ability for someone with an egg allergy to become deathly ill is high.
FDA Updates Recalled Noodles To Highest Risk Level
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Allergens What are Food Allergies? Food allergies occur when our immune systems mistake harmless food proteins as threats and respond with antibodies known as Immunoglobulin E(IgE). The "Big Eight" Food Allergens Food allergens most frequently known as "The Big Eight" include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soy. Identifying Allergens In Labeled Foods In many jurisdictions, allergens must be highlighted on an ingredients list in order to distinguish them from the rest of the text - typically through bold font or using italics; alternatively, allergens could be listed separately under "Contains." Follow link below for detailed information on allergen management and control as a manufacturer:
en
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Manager Quality Assurance | ISO, FSSC, HACCP certified | Microbiologist | quality and compliance | Product development Professional.
🌟Food Allergens and Labeling Requirements: What You Need to Know🌟 Food allergies can be life-threatening, and proper labeling is crucial for consumer safety. In the US, the Food and Drug Administration (FDA) requires food manufacturers to declare major food allergens on packaging. What are major food allergens?🧐 - Peanuts (21 CFR 101.62)🥜 - Tree nuts (21 CFR 101.62)🌰 - Milk (21 CFR 101.62)🥛 - Eggs (21 CFR 101.62)🥚 - Fish (21 CFR 101.62)🐟 - Crustacean shellfish (21 CFR 101.62)🦞 - Wheat (21 CFR 101.62)🌾 - Soybeans (21 CFR 101.62)🫘 ♦️Labeling requirements:♦️ ▪️Use plain language to identify the allergen (e.g., "Contains peanuts") ▪️Use a font size no smaller than 6 points ▪️Declare allergens in both the ingredient list and a separate "Contains" statement ▪️Use a clear and concise format to avoid confusion ♦️Additional considerations:♦️ ▪️Be aware of cross-contact during processing and manufacturing ▪️Use Good Manufacturing Practices (GMPs) to minimize allergen exposure ▪️Consider labeling for potential allergens that may be present due to shared equipment or facilities ▪️Keep accurate records of allergen testing and labeling ♦️Regulatory updates:♦️ ▪️The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires labeling for major allergens ▪️The FDA's Food Safety Modernization Act (FSMA) emphasizes prevention and risk-based approaches to food safety ♦️Best practices:♦️👍 ▪️Use allergen management plans to identify and control hazards ▪️Train personnel on allergen awareness and labeling requirements ▪️Collaborate with suppliers and manufacturers to ensure accurate labeling ♦️References:♦️ - FDA: Food Allergens (21 CFR 101.62) - FDA: Guidance for Industry: Food Allergens - FALCPA - FSMA By following these regulations and guidelines, food manufacturers can help ensure the safety of consumers with food allergies.
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*Allergens As a Cross -contamination* Allergens can indeed be a type of cross-contamination. Cross-contamination occurs when allergens are unintentionally transferred from one food product to another, which can happen at various stages of food handling, such as during manufacturing, packaging, cooking, or serving. This unintentional transfer can cause serious health risks for individuals with food allergies. * Examples of Allergen Cross-Contamination 1. Food Preparation Surfaces: Using the same cutting board, knife, or other kitchen tools for multiple foods without proper cleaning can lead to cross-contamination. For instance, chopping nuts and then vegetables on the same board without cleaning it can transfer nut residues to the vegetables. 2. Cooking Equipment: Fryers, grills, and other cooking equipment can cause cross-contamination if the same equipment is used to cook different foods. For example, frying shrimp and then fries in the same oil can transfer shellfish allergens to the fries. 3. Processing Facilities: In food manufacturing, if the same machinery is used to produce different products without thorough cleaning, allergens from one product can contaminate another. For instance, a machine used to process both peanut butter and chocolate can lead to peanut allergens in the chocolate. 4. Storage: Storing allergenic foods near non-allergenic foods can result in cross-contact foods. For example, placing an open bag of nuts next to flour in a pantry can lead to nut particles contaminating the flour. *Preventing Allergen Cross-Contamination - Strict Cleaning Protocols:Thoroughly clean all equipment and surfaces between handling different foods. - Dedicated Equipment:Use separate utensils and equipment for allergenic and non-allergenic foods. - Clear Labeling:Clearly label foods that contain allergens and store them separately. - Staff Training: Ensure that food handlers are trained in allergen awareness and cross-contamination prevention. *Importance for Allergic Individuals For individuals with food allergies, even trace amounts of an allergen can trigger severe reactions. Therefore, understanding and preventing cross-contamination is crucial in food safety practices to protect those with food allergies.
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Over time, the food and drink industry and the legislation affecting it have progressed in a positive direction of increased awareness and control of substances or products causing allergies or intolerances. However, the occurrences of news headlines relating to real-life stories of the serious implications of some allergic reactions still continue. In her blog, Helen Arrowsmith, Regulatory Affairs Manager and Allergen Specialist reflects on the industry’s evolution with respect to allergen management, and where we are now. Read the blog here ➡️ https://okt.to/LEdGYZ Our NEW training courses provide guidance and best practice on control of food allergens, testing for food allergens, validation of cleaning for the removal of food allergens and communicating information on food allergens to consumers. To view and book the Allergen Training Courses that we are running in October 2023 follow this link ➡️ https://okt.to/n5VE8r #CampdenBRI #FoodandDrinkIndustry #Regulatory #FoodLaw #Allergens #Labelling #FoodandDrink #FoodInnovation #FoodTechnology #FoodandDrinkScience
Food allergen management and labelling - the food industry's evolution
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What Restaurant Servers Should Know About Nut Allergies? What Restaurant Servers Should Know About Nut Allergies? In the fast-paced world of restaurant service, catering to customers with nut allergies is a critical responsibility that should never be taken lightly. The consequences of mishandling allergens can be severe, from legal liabilities to jeopardizing the health and safety of patrons. As a restaurant owner or manager, educating yourself and your staff on food allergies is paramount. Understanding common allergens, investing in proper training, and implementing clear protocols for handling allergy-related incidents are essential steps in creating a safe and inclusive dining experience for all. By prioritizing communication, education, and attention to detail, you can ensure that your establishment is allergy-friendly and your customers are well taken care of. Remember, when it comes to food allergies, there is no room for error. Stay informed, stay vigilant, and most importantly, stay safe. Your customers will thank you for it. To read the rest of this article, please click on the link below: https://lnkd.in/gx9VK7fR
What Restaurant Servers Should Know About Nut Allergies? - 6TopCharlie
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Veteran | Texas Aggie | Transformational Leader | CEO | Board Member | Future of Food Allergy Management | Patient Care, Quality, & Engagement | Intersection of Business, Health, & Humanity | Advisor | Coach
Estimates suggest that 33 million Americans, among them 5.6 million children under the age of 18, contend with food allergies. This equates to approximately one in 13 children and one in 10 adults. Despite the ongoing push to find new treatments and preventative measures, these numbers just keep rising. The FDA, in response, has gone on to create new labeling measures and food safety laws… But we still need more. Changing the laws is one thing, now we need better help at enforcing these laws which, in turn, will lead to fewer reactions and recalls of major brands. This will be a major topic of discussion at this year's Food Safety Summit and I'm glad it's getting some of the spotlight. #FoodAllergies #VC #AllergyDiagnostics #FoodSafetySummit
'When a Food Allergen is Your Enemy' to be presented at the Food Safety Summit
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