Is Your Company Ready for the FDA's New Allergen Labeling Rules? What You Need to Know About Milk, Egg, and Tree Nuts

Accurate food allergen labeling is a critical component of consumer safety and regulatory compliance. It's so important for the health and safety of consumers and the public that, for some of them, calling it a matter of "life or death" isn't an exaggeration — it's a very good reason to keep up with the latest labeling rules and regulations. Case in point: the Food and Drug Administration (FDA) recently updated its guidance on major food allergen labeling, bringing significant changes to how milk, eggs, and tree nuts must be declared. 

For some food companies, this relatively small change will have a significant impact across dozens or even hundreds of SKUs, so getting it right can feel especially daunting. To make it all a little easier to digest, let's break down the precise changes mandated by the FDA for labeling milk, egg, and tree nut allergens, explore the practical implications for your food products, and introduce some tools that can help you achieve and maintain compliance.

FDA Allergen Regulations: A Brief Explainer

The foundation of modern food allergen labeling in the U.S. rests on the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. This landmark legislation established the concept of "Major Food Allergens" and mandated their clear declaration on food labels. More recently, the FASTER Act of 2021 added sesame as the ninth major food allergen, effective January 1, 2023, showcasing the FDA's ongoing commitment to consumer safety as scientific understanding evolves.

Read More: 5 Tips to Manage Food Allergens in Your Supply Chain

Now, the latest FDA guidance (specifically, Edition 5 of the Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act) zeroes in on more granular details for milk, egg, and tree nut labeling, aiming for greater clarity and precision.

Decoding the Changes: Specifics for Milk, Egg, and Tree Nut Labeling 

These recent updates refine existing requirements, ensuring that consumers have even more precise information about potential allergens. In each instance, the changes are evidence-based. The proteins in chicken eggs and cow's milk are similar to those in eggs and milk from other animals, so adding a little more context to the label can help consumers with those allergies make more informed purchasing decisions.

On the other hand, several tree nuts have been removed from the list due to insufficient evidence to warrant their classification as a major food allergen. Let's take a closer look at what's changed:

Milk Allergen Clarity: Beyond the Cow

Historically, "milk" on a label implicitly referred to cow's milk. However, the FDA's new guidance broadens this scope to prevent confusion and protect consumers with allergies to other milk sources.

The new rule requires an animal source name for milk derived from domesticated ruminants other than cows. This means if you're using goat milk, sheep milk, buffalo milk, or camel milk, your label must specify the animal source. For example, a product containing goat milk would need to state "Contains: Goat Milk" or "Milk (Goat)." Standard cow's milk will continue to be declared simply as "milk."

Egg Allergen Specificity: More Than Just Chicken

Similar to milk, "egg" on a label typically implied chicken eggs. The FDA now requires greater specificity for eggs from other types of fowl.

Under the new guidance, you'll need to specify the animal source name for eggs from ducks, geese, quail, or other fowl. For instance, if your product contains duck eggs, the label should read "Contains: Duck Egg" or "Egg (Duck)." Chicken eggs will continue to be labeled as "egg."

This increased detail is crucial for individuals who may have allergies specific to certain avian eggs.

Streamlined Tree Nut List: What's In and What's Out

Perhaps one of the most significant and anticipated changes comes to the tree nut category. The FDA has revised the list of required tree nuts for labeling, removing several that were previously included but are not typically associated with type I hypersensitivity.

Read More: Genesis Foods Adds AskReg AI Allergen Identification

This revision is based on updated scientific evidence, aiming to provide more accurate and relevant allergen information. It potentially reduces unnecessary allergen avoidance for some consumers while maintaining safety for those with allergies to the defined list.

The following specific tree nuts still require declaration: Almond, Brazil Nut, Cashew, Filbert (also known as Hazelnut), Heartnut, Macadamia Nut (also known as Bush Nut), Pecan, Pine Nut (also known as Pinon Nut), Pistachio, and Walnut. Remember, for these, you must declare the specific nut (e.g., "Contains: Almonds," not just "tree nuts").

Action Plan for Compliance: Leveraging Genesis Foods

The date to comply with these changes has already passed: January 13, 2025. However, the FDA understands the implications of label changes and offers some flexibility, stating,

"While firms must be in compliance with major food allergen requirements of the FD&C Act, we understand the implications of making label changes and that firms have been relying on previous guidance. Given those circumstances, the FDA recognizes that product labels might be corrected the next time they are printed. Alternatively, the firm may choose to use a sticker to cover the outdated labeling.”

Source: Frequently Asked Questions: Food Allergen Labeling Guidance for Industry

While that gives companies some leeway, being proactive is always the best policy when it comes to consumer safety and avoiding potential issues. Here's how to navigate these changes, especially if you're a Genesis Foods user:

Step 1: Review and Update Your Ingredient Pantry in Genesis Foods

This is your crucial first step. Previously declared allergens will remain on your food items until you are ready to make the necessary updates. You will not be able to approve new ingredients or recipe versions without making the required changes. You'll need to go into each relevant ingredient within your Genesis Foods system.

• For removed tree nuts: Manually deselect the old allergen designations (e.g., Coconut, Chestnut).

• For milk and eggs: Select the specific animal source from the new Genesis Foods designations (e.g., "Goat Milk" instead of just "Milk" if applicable; "Duck Egg" instead of just "Egg").

Remember, for newly created food items, Genesis Foods has already updated the allergen selection list to only include the current regulatory required allergens, preventing you from adding the removed ones.

Step 2: Bulk Update Your Recipes in Genesis Foods

Once your ingredients are updated, you'll want to apply those changes across your product portfolio. Genesis Foods offers a powerful tool for this: Find and Replace.

After updating your ingredient, use the Find and Replace tool to update some or all of your recipes to use the updated ingredient. The allergens will also be automatically updated at the recipe level after the Replace action is complete. This feature is a game-changer for businesses with numerous recipes containing the affected ingredients, ensuring efficiency and accuracy in your updates.

Step 3: Revise Product Labels and Packaging

With your Genesis Foods data accurate, you can now generate new labels. Consider your current inventory. For immediate compliance, you can choose to print new labels or use compliant stickers to cover outdated labeling on existing stock. For products with longer shelf lives or less immediate impact, you can incorporate the label changes during your next scheduled print run.

Always prioritize clear, legible allergen declarations that meet the new FDA requirements.

Step 4: Internal Training and Communication

Finally, ensure that your entire team is aware of these changes. Educate staff involved in product development, procurement, manufacturing, quality control, and sales, so that everyone understands the importance of precise allergen management and labeling in maintaining compliance and upholding your brand's commitment to consumer safety.

Beyond the Label: Maintaining Allergen Control

While these labeling updates are significant, remember that proper labeling complements, but does not replace, robust Good Manufacturing Practices (GMPs). Continue to focus on preventing cross-contact in your facilities.

Listen In: Food Safety & Quality Assurance: Protect Your Brand by Protecting Consumers with Dr. Stephen Sims

Always verify allergen information with your suppliers for all incoming ingredients. The regulatory landscape is dynamic, and continuous monitoring of FDA guidance documents is essential to stay compliant. These updates aren't just about ticking boxes; they're about enhancing consumer safety and building unwavering trust in your products.

The FDA's updated guidance for milk, egg, and tree nut allergen labeling marks another step forward in consumer protection. By understanding these specific changes and proactively leveraging tools like Genesis Foods, food manufacturers can efficiently adapt, ensure compliance, and continue to deliver safe, accurately labeled products to the market.

Are you ready to make these crucial updates? Genesis Foods makes meeting regulatory and compliance rules more efficient and less painful. Try our hands-on demo, or get in touch today to set up a customized walkthrough of the gold standard in food formulation and labeling software.