Last week, the FDA issued a warning letter to Bimbo Bakeries USA. The FDA's "constituent update" described that: "...during two inspections in late 2023, FDA found that some of the company’s bakery products included ingredients that are or contain major food allergens on their labels, but those ingredients were not included in the product formulations." FARE released a two-part comment in response from Sung Poblete, PhD, RN, CEO of FARE and Robert Earl, Vice President of Regulatory Affairs: "We thank FDA for its efforts to protect the food allergy community. Just as FARE finds the practice of intentionally adding sesame flour to avoid thorough cleaning or segregating lines to be an act of malicious compliance, including sesame and other food allergens in an ingredient list and ‘Contains statement’ also does a disservice to those with food allergies. Our community relies on accurate product labeling for their health and safety and these findings about Bimbo Bakeries’ products undermine their trust and further limit choices." - Robert Earl, MPH, RDN, FAND, Vice President of Regulatory Affair "Given the size and reach of Bimbo Bakeries to American consumers, FARE expects better. Losing the food allergy community's respect also extends to the restaurants and institutions that buy their products, beyond retail packaged products. The food allergy community shouldn’t have to deserve less.” - Sung Poblete, PhD, RN, CEO of FARE Associated Press reporter, JoNel Aleccia broke the story: https://lnkd.in/gkSkETvg
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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
FDA warns maker of Sara Lee and Entenmann's not to claim foods contain allergens when they don't
apnews.com
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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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Founder | MIT Sloan | TradeTech | CPG Imports Compliance | Global Food Strategic Sourcing| International Trade
Today, the U.S. Food and Drug Administration (FDA) dropped significant news with its updated draft guidance, a step forward in shaping the landscape of food safety for millions of Americans with food allergies. Here's a breakdown of this development: What's New? The FDA's draft focuses on helping food facilities adhere to current good manufacturing practices (CGMPs) and preventive controls for human food. A highlight? A chapter dedicated to food allergens, explaining how food businesses can ensure food is both protected from major allergen cross-contact and properly labeled. Why It Matters: Earlier this year, sesame joined the list as the ninth major food allergen. While this was a monumental stride for the sesame-allergic community, there's a twist. Some manufacturers are now adding sesame to products, merely indicating its presence to comply with regulations rather than preventing cross-contact. The FDA isn't thrilled and encourages adherence to its guidance instead. Words from the Top: FDA Commissioner Robert M. Califf, M.D. states, "The FDA is looking for opportunities that could help consumers allergic to sesame and other major food allergens find safe foods... We're committed to finding solutions within our powers that cater to consumers with food allergies.” Deep Dive: Chapter 11, "Food Allergen Program", offers an array of ways to minimize or prevent allergen cross-contact. Notably, most FDA food allergen recalls stem from labeling errors. So, this chapter elucidates how to verify that food allergens are aptly declared. Chapter 16 focuses on acidified foods, guiding manufacturers on how to meet requirements both in the acidified foods regulations and the preventive controls for human food rule. This move by the FDA exemplifies a proactive approach to ensuring the safety of consumers with food allergies. However, while guidelines can steer the industry, the real change depends on food businesses' commitment to adhere. As we await further developments, one thing's for sure: the FDA is keen on making allergic reactions due to food a thing of the past. https://lnkd.in/gdfAxqaZ #FDA #FoodAllergens #FoodSafety #SesameAllergy #PublicHealth
An Update on Sesame Allergen Labeling on Food Packages
fda.gov
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What Do Restaurant Servers Need to Know About Milk Allergies? What Do Restaurant Servers Need to Know About Milk Allergies? How Can Restaurant Servers Ensure Safe Dairy Allergen Documentation? Can Restaurant Servers Spot Dairy Allergens? How Can Restaurant Servers Best Serve Customers with Dairy Allergies? How Can Restaurant Servers Spot Real Milk Allergies? How Can Restaurant Servers Protect Against Dairy Allergic Reactions? There are several things that restaurant servers must know if they want to take care of customers who are allergic to milk and other milk-related products. This includes knowing what each dish contains, how the ingredients are prepared, and where potential cross-contamination may occur. In addition, servers must follow their company's policy when dealing with customers with allergies. To read the rest of this article, please click on the link below: https://lnkd.in/ej4y_DAk
What Do Restaurant Servers Need to Know About Milk Allergies? - 6TopCharlie
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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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I started taking Food Allergy training on the Food Standards Agency site , where I came across information about cross-contamination, the associated risks, and the importance of labeling. This triggered a memory journey that I would like to share with you. I love trying out new things and am naturally curious. While shopping one day, I came across a package of almonds. Wondering if they would taste like almond milk, I picked them up. As is my habit, I turned the package to check the ingredients and any other information, even though I knew it was a single-ingredient product. Thank God I did. The package had a warning for people with food allergies and sensitivities. It read something like this: "Cross-contamination might have occurred due to processing and packing in a factory where wheat, milk, eggs, and other nuts are also processed." I almost dropped the package immediately when I saw the mention of wheat. However, my inner voice whispered that the key word was "might," implying a 50/50 chance. So, I decided to take the risk and bought it. What is cross-contamination? According to food allergy organizations, cross-contamination occurs when one food comes into contact with another food, and their proteins mix. This makes each food contain small amounts of the other, which can trigger reactions in people with food allergies. Imagine a factory that processes both oats and wheat in the same section with the same workers handling both products. Cross-contamination is almost inevitable. Food industries can try their best to limit it, but the most responsible action is to put a warning label on the package. The problem is, will restaurants do the same? Will they make consumers aware that the food they are eating might have come into contact with an #allergen? An allergen is a harmless substance that triggers an immune response, leading to an allergic reaction. So, what happened to me after ignoring the cross-contact warning? I learned my lesson the hard way and became much more aware of cross-contamination risks. ________________________________________ I am a biochemist with a keen interest in nutrition, primarily concerned with food safety. As someone who is watchful of what I eat due to allergies and sensitivities, I am particularly concerned about the production, labeling, and packaging of food and drink products. Join the family as I talk about food safety, quality and other food related things. #newweek #allergy #biochemist #fmcg #foodsafety #crosscontact #foodallergy #monday #qualityassurance #foodhygiene #foodlabelling #quality
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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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Food safety is becoming more and more critical in food manufacturing, and this article provides some insight into the various food allergies which are becoming increasingly prominent. This means traceability and zero touch automation solutions are being adopted amongst others by manufacturers to provide consumers with confidence in their products.
2.4m UK adults suffer from food allergies
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