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How to Create Accurate Allergen Declarations and Ingredient Statements with Genesis Foods

Stephanie Ulrich — Wed, 21 Jun 2023 08:00:25 +0000

There are many reasons why clear ingredient statements and allergen declarations are important. For one, consumers want to know what is contained in the food they’re consuming. Creating clear ingredient statements can help establish trust with your customer base and protect their health and wellbeing if they have severe food allergies. Without allergen declarations and ingredient statements, consumers could accidentally ingest an allergen, resulting in severe illness, hospitalization, or death.

For this reason, the Food and Drug Administration (FDA) establishes clear regulatory expectations for food companies to standardized Nutrition Facts labels, ingredient statements, allergen declarations, and other packaging claims and product information when creating packaged food products intended for sale in the U.S. If food companies are found in non-compliance with these regulations, they could face a costly recall due to consumer safety risks and other legal ramifications if consumers incur illness or death due to mislabeled products.

In our recent blog series, we’ve covered how Genesis Foods can help companies accelerate accurate nutrient calculations, launch new food products, and help companies maintain compliance with ever-changing regulations. In this blog, we’ll cover how Genesis Foods built-in compliance tools can simplify the complexity of creating accurate ingredient statements and aligning with government regulations on allergen declarations. Let’s dive in.

Ingredient Statement Requirements

Ingredient statements may seem pretty cut-and-dry. But, unlike your favorite recipe to make at home, ingredient statements have some important distinctions on how they should appear on a food label. According to :

Order: Ingredients must be listed in descending order of predominance (by weight, not volume).
Common Names: Ingredients should be listed using their common names – such as listing “sugar” and not “sucrose.” There are some exceptions for color additives, spices, and incidental ingredients (see ).
Packaging Position: The ingredient list can appear before or after the Nutrition Facts panel but should be on the same label panel as the name and contact information of the manufacturer. (See our Product Packaging 101 blog post or our Food Labeling eBook to learn more.)
Format: The type size should be prominent, easy to read, and at least 1/16^th of an inch in height.
Sub-Ingredients: When a recipe includes sub-ingredients, the sub-ingredients can be listed in one of two ways, either listed parenthetically following the parent ingredient, or dispersed throughout the Ingredient Statement in the proper order of predominance by weight. [Example: if listing sub-ingredients as a parenthetical: “Tomato puree (water, tomato, salt)”, or listing by weight: “water, tomato, salt, etc.…”]

FDA guidelines include other specifications for the ingredient list, such as how to label spices, trace ingredient amounts (and using “Contains less than 2% of”), and more. Just like Nutrition Facts labels, the FDA has created strict rules for food manufacturers to follow so consumers can make educated dietary decisions.

Interestingly, though, the FDA allows when it comes to creating and displaying Nutrition Facts labels on their food packages. However, small businesses are not exempt from displaying the ingredient statement for their packaged food items.

How Genesis Helps with Ingredient Statements

Genesis Foods is pre-built with the government guardrails needed to help food companies align with government regulations when creating Nutrition Fact panels and ingredient statements. So while it may seem overwhelming to read through the entire FDA Food Labeling Guide, the process is a lot easier with Genesis Foods.

As you input your recipe and the system generates a Nutrition Facts label, the ingredient list will also populate and automatically order itself based on the weight of ingredients in the recipe. The system will size the font appropriately, and you can toggle between parenthetical sub-ingredients, or list everything in order of weight. You can further customize the label with alternate ingredient names and a bilingual translation. ��

Allergen Declaration Requirements

Food allergens pose major health risks for consumers with severe food allergies, and as such the FDA enacted the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which went into effect in 2006, 160 foods have been identified as causing food allergies, but the nine major food allergens that must be declared make up about 90% of all food allergy cases in the U.S. Those major allergens include:

Milk
Eggs
Fish*
Crustacean Shellfish*
Tree nuts*
Wheat
Peanuts
Soybeans
Sesame (added in 2023)

*Must identify the species (e.g., for “tree nuts” you must indicate if it’s pecans, almonds, walnuts, etc.)

Food manufacturers must include the species-specific common name of any seafood (fish and shellfish) and tree nuts when listing allergens. To learn more about the specific species – as well as common synonyms that might be hiding in allergens – check out our Allergen Synonyms, Species, and Types blog post.

FALCPA labeling requirements apply to any food that includes any of the nine major allergens as an ingredient (including flavoring, coloring, or trace amounts used for processing). Additionally, there are two ways to list allergens that comply with FALCPA regulations. You can either:

Clearly identify the allergen or allergens within the ingredient statement. This can be achieved if the common name of the ingredient itself is the allergen or by use of parenthetical listing the allergen immediately following the common name of the ingredient. [ex: Peanut butter (peanuts), casein (milk), spice mix (sesame)…]
Or list the allergen in a separate “Contains” statement under the ingredient statement. [ex: Contains: peanuts, milk, and sesame]

How Genesis Helps with Allergen Declarations

Genesis Foods offers a variety of compliance checks, and our allergen declaration check is unique and potentially one of the most beneficial features of the system. Across the U.S., one of the are undeclared allergens or mislabeled allergens. While recalls of any kind can , undeclared allergens are considered a significant food hazard that can lead to serious illness or death. Missed allergens can easily turn into a much bigger problem for food manufacturers and consumers.

For those reasons, Genesis Foods automatically assigns all allergens to ingredients in the system to avoid missing this essential step. Recipe developers and compliance experts can then review the recipe or ingredient and remove any allergens that are not present in the formula.��

Companies can add custom names for required allergens, such as a species-specific tree nut (ex: pecans, almonds, walnuts), or any “may contain” allergen warning statements. The system will also show you automatically how the allergen statement will appear on the label, including options to add bilingual translations. To see how easy it is, watch our Allergen Statement Tutorial.

Maintain Compliance and Accuracy with Genesis Foods by Trustwell

For the sake of consumers and your business, it’s important you get food labeling right from the start. With solutions like Genesis Foods from , you can label your products with confidence, align with government regulations, and create clear, accurate ingredient and allergen statements in a matter of minutes.

To learn more about what Genesis Foods has to offer, contact our team to schedule a free demo.

The post How to Create Accurate Allergen Declarations and Ingredient Statements with Genesis Foods appeared first on ��app��.

How to Improve Formulation Accuracy and Labeling Compliance with ��app�� Supplements

Stephanie Ulrich — Thu, 08 Jun 2023 18:19:45 +0000

The dietary supplement industry is on a rapid trajectory for growth, especially as health-conscious consumers focus more on and their dietary choices. But as the industry grows, so does the regulatory oversight that keeps the industry in check. ��

Dietary supplements require the use of Supplement Fact panels to notify customers of what is contained within the supplement, as well as appropriate dosage and other elements. The Food and Drug Administration (FDA) dictates strict guidelines on how Supplement Facts panels appear on a product, how nutrient content is calculated and shown, potential allergens, and other elements required for declaration. Despite the complicated nature of some of these guidelines, the FDA is strict on following them. And companies that fall short or miss a key element could face an FDA warning letter or costly recall.

On top of the FDA’s guidelines, there are also state-specific guidelines that can add layers of difficulty to compliance, like California’s Prop 65. Monitoring compliance across these regulatory bodies can become a full-time job unto itself, which is why a solution that provides the government guardrails for compliance can simplify the entire process. This was the case for one dietary supplement company,��.

In a recent interview with Trustwell, , shared how ��app�� Supplements has transformed their R&D, labeling, and compliance processes.

A Major Formulation Upgrade from Digital Spreadsheets

For many years, Brian used digital spreadsheets to track the ingredients and formulas for over 300 products at Thorne. It took him a few weeks to input all the formulas, and each required strict alignment with FDA guidelines for calculating percent Daily Values (%DVs), using approved units of measure for nutrients, and more. One slight mistype or miscalculation in the spreadsheet could throw off the entire formula. Accuracy is key, Brian noted, but it was a challenge to adjust when formulas or ingredients changed.

Brian’s team was eager for an easier way to manage formulas. Eventually, he reached out to learn more about ��app�� Supplements for formulation and label creation. He found that Genesis not only verified his calculations were correct, but also included all the government guardrails for formulation built directly into the software. Plus, it only took him a few minutes to build formulas, rapidly reducing the time it took for him to verify and manage the product line.

If an ingredient changed, Brian could easily enter the new ingredient and amount, see an instant formula and label adjustment, and double check the work for compliance alignment. This new approach would be a game-changer for streamlining his formulation process.

But they found this wasn’t the only benefit that the software could provide. ��

Instant Label Generation for Faster Speed to Market

While ��app�� Supplements can help with formulations, it also automatically creates Supplement Fact labels that include all the essential elements to aid businesses in maintaining government compliance. This includes allergen declarations, the heavy metal warnings to align with CA Prop 65, and all the essential formatting elements a Supplement Facts panel requires.

Thorne’s R&D team was excited for this streamlined process, but they also found that it ramped up their ability to quickly get products to market. Brian shared:

��“By having the formula built into Genesis and an auto-generated FDA-compliant label being created, we’re able to take the label and give it to our marketing team so they can have an idea upfront of what information should be on the label. They can work with that, which is better than starting out in the dark. This especially helps when we have a new product launch.”

Similar to how Genesis Foods can help companies launch food products faster, the ��app�� Supplements software can provide the same degree of assistance in getting new products on the shelves. With streamlined formulation, automated labels, and built-in guardrails to aid with compliance, supplement companies like Thorne can revolutionize their R&D and compliance process with our gold-standard labeling and formulation software by Trustwell.

Experience the Difference with ��app�� Supplements 2.0

The latest version of ��app�� Supplements (2.0) has been released, which includes regulatory alignments, streamlined menu options, bug fixes, and other product enhancements. You can read the to learn more.

Plus, don’t miss an opportunity to work with our product and compliance experts to learn the benefits of ��app�� Supplements first-hand. Trustwell is offering a professional online training course with complete regulatory review for beginners to the ��app�� Supplements program. With our online events, you can access hands-on training, ask product questions, and learn the fundamentals of ��app�� Supplements, with a primary focus on FDA regulations.

4-Day Online Professional Training

July 17-20, 2023 | 10AM – 1PM (CT) Daily

Earn up to 12 CPE credits.

Register Today

To read a real-life example of how Thorne and Brian Potter found a solution with ��app�� Supplements, today. And to learn more about accurate formulation and labeling with our ��app�� Supplements solution, contact our team to schedule a free demo.

The post How to Improve Formulation Accuracy and Labeling Compliance with ��app�� Supplements appeared first on ��app��.

Simplify Label Compliance with Genesis Foods

Stephanie Ulrich — Tue, 30 May 2023 09:00:26 +0000

Food product labels play a crucial role in conveying vital information about your products and brand. Consumers rely on these labels to gain insights into the ingredients, nutritional value, and allergens present in your products. However, meeting the strict regulations set by governing agencies such as the FDA and USDA can be a daunting task. Every aspect of your food labels, from font sizes to nutrient calculations, must adhere to labeling regulations.

The Importance of Labeling Compliance

Regulations establish standards that ensure fair competition among food companies. By setting uniform guidelines for labeling requirements, such as font size, format, and placement of information, regulations promote consistency and prevent unfair advantages gained through misleading or ambiguous labels. This allows consumers to compare products more easily and make informed choices.

In the U.S., food product Nutrition Facts labels have been regulated since the 1990s, when the Nutrition Labeling and Education Act of 1990 (NLEA) was put into law. The act mandated that all packaged foods must bear a standardized nutrition label, providing consumers with vital information about the contents and nutritional value of the products they purchase. Since its enactment, the NLEA has played a crucial role in empowering consumers to make informed dietary choices and promoting public health awareness.��

Additionally, regulations have gotten tighter over the years. In the last few years alone, we’ve seen proposed changes to packaging claim definitions and regulations passed requiring newly managed allergens.

As a result, it has become essential for food companies to comply with label regulations for a few key reasons:��

Ensuring Consumer Health and Safety

Food labeling regulations exist to protect consumers by providing them with accurate and reliable information about the food products they purchase. Labels convey crucial details about the product serving size, nutritional content, ingredients, allergens, and potential health risks associated with the product. Compliance ensures that consumers can make informed choices based on their dietary needs, allergies, or personal preferences.

Building Brand Reputation and Consumer Trust

Consumers expect labels to be accurate, so when they’re not, it can cause serious repercussions for your business. A found that Americans generally place their trust in certain aspects of food labels, particularly the ingredient list, expiration date, and Nutrition Facts label. Any label-related errors or noncompliance can quickly erode consumer trust, resulting in financial losses, damaged reputation, and potential long-term impacts on business sustainability. By prioritizing compliance, businesses demonstrate their commitment to transparency and build a foundation of trust with their customers.

Liability and Legal Consequences

Failure to comply with food labeling regulations can lead to legal consequences, including fines, food product recalls, and (as mentioned above) damage to a company’s reputation. Non-compliance can also result in legal action from consumers who may suffer adverse health effects due to inaccurate or misleading information. Complying with regulations mitigates the risk of legal liability and protects a company’s brand image and consumer trust.

Evolving Food Labeling Regulations and Compliance Challenges

Food labeling regulations are continuously evolving, with updates occurring multiple times each year. For example, the , has the potential to significantly impact labeling regulations. If enacted, it could introduce significant changes to labeling requirements and standards for food labels. Adapting to these modifications can be complex, especially for food companies with a large product portfolio.

Streamlining Label Compliance with Genesis Foods

Fortunately, Trustwell offers a comprehensive solution to simplify label compliance updates through Genesis Foods. With our team of regulatory compliance experts and cutting-edge software, you can effortlessly stay abreast of regulatory changes. Our software integrates updates before the compliance dates, ensuring accurate calculations and adherence to evolving requirements. In addition, Trustwell provides label consulting and compliance reviews to support your business further.

Labels for Compliance and Branding

Genesis Foods provides food manufacturers with a range of Nutrition Facts Labeling formats for the U.S., Canada, Mexico, and European Union. Depending on your product’s contents and packaging size, you can create customized labels. For example, for products needing specific footnotes for added sugar or “not a significant source of [nutrient]”, you can easily toggle the footnote on or off using the format options available.

Comprehensive Compliance Guardrails and Allergen Alerts

Genesis Foods incorporates built-in compliance guardrails to support your team throughout the labeling process. These guardrails include features such as Nutrient Content Claim guidance, calculations nutrition label rounding rules, and allergen alerts. By leveraging these tools, you can avoid overlooking critical compliance checks when reviewing the final product.

Marry Brand Transparency and Regulatory Compliance with Genesis Foods

Complying with food product label regulations is not only crucial for regulatory compliance but also for building strong customer relationships based on trust. Trustwell’s dedicated team of regulatory experts and developers remain up-to-date with the latest regulatory changes, ensuring your business is always prepared. With Genesis Foods as your labeling software, you can navigate label regulation updates seamlessly, relying on our comprehensive compliance checks.

Discover Genesis Foods for Effortless Label Compliance

Don’t let label regulation updates catch you off guard or overwhelm your team. Contact us today to learn more about Genesis Foods Software, our formulation and labeling solution designed to simplify compliance with food product label regulations.

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How to Increase Speed to Market for New Recipes and Food Products

Stephanie Ulrich — Tue, 16 May 2023 08:00:19 +0000

As an R&D leader, you’re likely under constant pressure to evaluate recipes, make changes, and create brand new recipes to grow your product line. However, launching a new food product can be a complex and time-consuming process, requiring a significant amount of planning, research, and investment. On top of that, toggling between different software and systems throughout your company can make the process for getting a new product to market cumbersome and inefficient. Wouldn’t it just be easier if you could formulate, review and approve changes, and create recipes and labels all in one place?

Luckily, you can. In this blog, we’ll uncover the true potential of a food product formulation and labeling software that can do it all and accelerate product launches: Genesis Foods.

Step 1: Testing Ingredients and Recipes

As with any new product, the first step in your launch is to test recipes and determine ingredients. But when you are looking to stay compliant with regulations, you also must take into consideration the nutrient profile of the food products made in your test kitchen. This process often takes a lot of time as you determine what you want to include in the recipe.

Genesis Foods offers a flexible, intuitive way to add or compare ingredients in a recipe using the Genesis Nutrition Analysis database. The Genesis Foods database has collected over 90,000 ingredients from government and proprietary sources, which food manufacturers can use to create test recipes and perform quick nutritional analysis. You can also add unique ingredients from supplier’s spec sheet or from previous lab analysis.

Additionally, tools like versioning allow R&D leaders to create multiple versions of a recipe to submit for approval or compare during the formulation process. Once a recipe is approved and finalized, the system will capture the date, time, and version number, and locks the record from further changes.

With a nationally recognized, gold-standard nutrition database, the testing and formulation period can happen in minutes instead of hours.

Step 2: Nutrient Calculations and Refining Recipes

As you are testing ingredients, you may also want to test the nutrient value of your recipe. Again, the nutritional database built into Genesis Foods can simplify this process in a matter of minutes.

Once you have added your ingredient, or found it within the nutrition database, and selected it for your recipe Genesis Foods automatically updates your nutrition facts and shows the nutrient profile for your ingredient. As you build your recipe, the system will compile the ingredients and their nutrient values, which include government-compliant calculations for caloric amount, nutrient rounding rules, and other essential datapoints necessary for the recipe. That means no more managing calculations in spreadsheets or doing things by hand.

Genesis Foods also has built-in compliance checks for allergen declarations, ingredient statements, and more. As you add or change ingredients in your recipe, the collected information is displayed on a compliant Nutrition Facts label for the tested product.

Step 3: Labeling and Compliance Review

You’ve compared recipes, chosen a winner, and determined the nutrient values for the final approved recipe. The next step is to get the recipe ready for the shelves.

While a lot goes into a product’s packaging, from sizing and placement of information, to color choices, brand image, front-of-package labels, and more – you also need to create an FDA compliant Nutrition Facts label. Luckily, Genesis Foods takes that step for you, automatically creating a Nutrition Facts panel and ingredient statement that meets the FDA’s requirements for calculations, rounding rules, font sizes, allergen declarations, and essential nutrient declarations. It even knows where to place footnotes, ingredient statements, and the order of nutrients, as defined by FDA regulations.

When the FDA releases new regulations on calculations or formatting, as it often does, our regulatory and development team are quick to update Genesis Foods with the latest guidance before a compliance date arrives.

By having a Nutrition Facts panel generated for your food product, you can easily pass the accurate label from your compliance review to your graphic design team within a few minutes. Again, this turns a normally cumbersome process into a streamlined, efficient hand off from team to team. By the time your product is ready for the shelves, you’ve saved hours in testing, formulation, calculation, and labeling.

Send Your Product Development into Hyper Drive

Launching a new food product can be complex and challenging, but with the right tools and approach, you can simplify, streamline, and optimize your recipe development process. Genesis Foods was created specifically to refine the steps from formulation to labeling, giving R&D and compliance experts a quick and easy way to make their processes more efficient. With quicker recipe creation, instant nutrient analysis, and automated label creation, food companies can launch their product development team into hyperdrive.

If you’re eager to see Genesis Foods in action or want to learn more about �հ��ܲ��ٷɱ��’s suite of compliant, food-centric solutions, today.

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How Genesis Foods Can Accelerate Accurate Nutrient Calculations

Stephanie Ulrich — Wed, 10 May 2023 09:00:45 +0000

As a food and beverage manufacturer, it’s important for your product labels to not only include accurate ingredient information, but that they also include accurate nutrient values. For consumers, reviewing a label may seem rather straightforward – they consider the ingredients, any potential allergens, calorie counts, nutrient values, and maybe health claims. But from an insider’s perspective, Nutrition Facts labels are a bit more complicated than they seem.

The Food and Drug Administration (FDA) determines how Nutrition Facts labels should be displayed, what nutrients are included, how percent Daily Value (%DV) amounts should be calculated, as well as other guidelines for food product labeling. However, while companies are expected to display accurate nutrient content, there are a few ways that companies can determine how many calories, %DVs, and other nutrient values are contained in their food recipes. Typically, your options are:

Send product samples to a laboratory for nutrition analysis (which can be expensive).
Determine nutrients based on supplier spec sheets and build out recipe calculations in spreadsheets (which can be error-prone).
Or use a software that automates nutrition analysis and features built-in calculations and analysis based on regulatory guidelines (by far, the easiest option).

In this blog, we’ll take you through the latter option using �հ��ܲ��ٷɱ��’s comprehensive ingredient database and nutrition analysis calculations, which are baked right into Genesis Foods. Get your recipes ready, and let’s dive in.

Formulate Faster with a Trusted Nutritional Database

While Genesis Foods is the latest offering with an updated user interface, �հ��ܲ��ٷɱ��’s Genesis line has over 30 years of experience in nutrition analysis and labeling. It is thanks to this long-standing experience in the industry that Genesis has collected over 90,000 pre-populated nutrient and ingredient data from sources such as the USDA, FDA, customers, and other government and proprietary collections.

For formulators that want to test recipes, adjust ingredients, or compare nutritional value, the database can be a huge benefit to their process. And if a recipe needs a quick ingredient change – whether due to a change in who supplies the ingredient, or some other supply chain disruption – formulators can quickly update recipes and see accurate nutritional information in the system without having to wait on a lab test. However, where the real magic of Genesis Foods lies is in its code.

Simplify and Automate Regulatory-Compliant Calculations

Our team of regulatory and compliance experts work closely with our product development team to transcribe FDA regulations – such as accurate rounding rules, percent Daily Value (%DV) calculations, caloric content, nutrient unit conversions, and other calculations – all built directly into the software. (Genesis Foods can also be configured for Canada, Mexico, and European Union labeling and nutrition analysis regulations.) These built-in calculations ensure that R&D leaders can efficiently hand off their recipes to the Regulatory and Compliance team to create compliant Nutrition Facts labels, with a significant portion of the work being completed automatically.

The label created will also reflect the formatting requirements by the FDA, such as the appropriate font size, mandatory nutrient declarations, and more. The system also offers alerts for allergen declarations, which can aid compliance leaders when assessing their labels for accuracy, reducing the risk of a potential costly recall.

These built-in calculations and compliance checks are a game-changer for food manufacturers, eliminating the need for manual formulation or data entry.

Plus, when new regulations come out that might change calculation rules or update values, our regulatory team and engineers are quick to update the system before a compliance date arrives.

Streamline the Formulation and Development Processes Even More

In the competitive world of food formulation, companies are constantly looking for ways to streamline their product development process. Along with the built-in database and nutrition analysis calculations, Genesis Foods offers a host of tools to help simplify ingredient management and recipe development.

Add unique ingredients: If you’re unable to find the correct ingredient in the Genesis database, our system also lets you quickly add your own ingredients. All you need is your supplier spec sheet, and the system will walk you through the essential information needed for the ingredient to be appropriately added.
Find ingredients faster with Tags: By utilizing tags to categorize ingredients and recipes, companies can easily identify specific product attributes, allowing for faster searching and more efficient product formulation. With the Tags you can include information to further help you identify the ingredient when creating a recipe, such as tagging ingredients as “Kosher tested” or use naming conventions from within your organization (such as “GF” for gluten free).
Search and replace ingredients: Using the Search and Replace feature, manufacturers can easily swap ingredients across multiple recipes, saving time and effort. For instance, if an ingredient becomes too expensive or is no longer available, manufacturers can search for all the recipes that use that ingredient and replace it with a suitable alternative. Similarly, if an ingredient’s quality or flavor profile changes, manufacturers can quickly update their recipes with the new ingredient.

Access Accurate Nutrition Information and Label Calculations with Genesis Foods

While adding ingredients to a recipe and determining nutrients are only the first few steps in creating a compliant Nutrition Facts panel, they are essential. And with a database of nutrients and ingredients to choose from, Genesis Foods makes it easier than ever to manage recipes, analyze nutrients, and create accurate Nutrition Facts labels for food products.

To learn more about Genesis Foods and how �հ��ܲ��ٷɱ��’s suite of solutions can help your company maintain consumer trust and loyalty through transparent, compliant solutions, today to schedule a custom demonstration of Genesis Foods.

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Trustwell Launches the Next Generation of Genesis Foods

Stephanie Ulrich — Tue, 02 May 2023 09:00:44 +0000

As we , Trustwell is excited to introduce a new iteration of its flagship product to food and beverage industry leaders. is a SaaS solution built on decades of industry expertise with a streamlined user interface that offers fast and intuitive product formulation while assisting users with regulatory compliance with built-in data checks and alerts.

“We’re thrilled to be launching the next generation of Genesis Foods. Our team has worked tirelessly to develop a product that meets the needs of food companies across the industry, from small food start-ups to large food manufacturers and corporate retailers,” said Stephen Bruce, CEO of Trustwell. “For businesses that are struggling with the complexity and time-consuming nature of food labeling and recipe management, Genesis Foods is a game-changer.”��

Now, while it may share the name with our previous version of Genesis Foods (the latest of which is version 11.13), this next generation of the product offers some distinct differences from its classical predecessor. Most notably, the dashboard provides a streamlined user interface with fast, intuitive formulation and data entry.

Faster Recipe Formulation, Accurate Calculations, and Intuitive Nutrition Analysis

Similarly to the Genesis Foods of before, the latest iteration includes access to our comprehensive database with over 90,000 ingredients and whole foods pre-populated with nutritional data. The nutrition database pulled into Genesis Foods��(formerly known as the ESHA Nutrition Database)��has been a staple in the industry for over 30 years, setting a gold-standard for nutritional analysis and recipe formulation in the food and beverage industry.

Genesis Food users can quickly create recipes, adjust formulas, and access comprehensive nutritional data within seconds from the software. And with built-in calculations based on FDA 2016 labeling regulations, R&D leaders can quickly transition from creating a recipe to populating a compliant Nutrition Facts label that considers FDA rounding rules, Percent Daily Values (%DVs), and other essential nutrient calculations. This means faster launches when developing new products, more accurate calculations when determining nutrient content, and an overall easier recipe formulation process for R&D leaders.

Simplifying Complex Label Regulations and Allergen Declarations

The regulations around Nutrition Facts labels can be complicated, and getting the nutrient calculations correct, as well as the necessary declarations, formatting, and more, can easily become overwhelming. Luckily, our updated Genesis Foods makes the entire process a lot simpler.

Our development team works closely with our regulatory team, so the regulations released by the FDA can be fully and accurately coded into the system. That way, when R&D leaders turn a recipe into a label, Genesis Foods will generate a regulatory-compliant Nutrition Facts label that accurately applies rounding rules and calculates the appropriate %DV for each nutrient to ensure FDA compliance. All the R&D leader needs to do is review the final product for compliance.

But it is not just the label that Genesis Foods provides. The system also has built-in guardrails to assist with allergen declarations and other essential elements. Specifically with allergies, undeclared allergens are one of the most common causes of food recalls in recent years. Our simple drag-and-drop allergen feature built into the system is essential for both accurate declarations and consumer safety. Users can add allergens to either the “Contains,” “May Contain,” or “Not Present” categories, and R&D leaders can review the final product for accurate declarations.

And when new regulatory changes happen, as they often do, our team is diligent to quickly update our system with the latest government guidance before a compliance date arrives.

Organize Recipes and Ingredients and Review Versions All in One Dashboard

Managing a recipe and ingredient database can get cumbersome if you have thousands of ingredients and hundreds of food products. Even if you only have a few recipes but manage them in spreadsheets, you likely struggle to organize and manage the data. Plus, when users change or update recipes, records of old recipes or versions can get lost, making it difficult to test or compare old versus new recipes and their nutrient profile.

Luckily, our team understands how essential organization is to the R&D leaders’ workflow, which is why the next generation of Genesis Foods includes some essential features like:

Tags: Tags are customizable to your company’s needs, and you can use them to sort recipe or ingredient information. For example, you can use tags to sort gluten free items, Kosher-tested foods, foods in testing versus final version foods, or make a brand-new tag based on your company’s naming conventions. Tags let you get creative based on your company needs, so if you refer to categories as an acronym like “TN” for “Tree Nuts,” you can add this tag to ingredients or recipes for easier search.
Versioning and Approvals: To help companies track product changes or test the nutrient info and labels of various formulas, we have included a versioning and approvals process in the software. Once a change is approved, the system assigns a version number and captures the date and time the record was modified and locks it from being accidentally changed in the future. If the record is later updated, the system will prompt for another review and approval, and will save another version alongside the previous version. A new version will be created for every version approved, so you can easily view historic records.

But these fantastic features are just the beginning. A part of �հ��ܲ��ٷɱ��’s product plan with Genesis Foods is to create an agile system that can quickly adjust to changing government regulations and the needs of our customers. What we’ve covered is the beginning, and we are eager to release more features soon.

Streamline Your R&D Process with the Next Generations of Genesis Foods

If you have labels to create and recipes to formulate and organize, with our team to learn how our solution can simplify labeling and recipe creation for your organization. And to learn more about �հ��ܲ��ٷɱ��’s suite of SaaS solutions for the food and dietary supplement industry, today.

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The Benefits of Front of Package Labeling for Consumers and Manufacturers

Stephanie Ulrich — Thu, 27 Apr 2023 09:00:47 +0000

Consumers are accustomed to checking the Nutrition Facts panel on the back or side of a packaged food item for information about ingredients, allergens, and nutrition. In recent years, calls for food and allergen transparency and a greater focus on health have consumers paying even more attention to these labels and the ingredients listed on them. Recently, however, we’ve seen an increase in new regulations about what food and allergen labeling looks like and what information labels can (and can’t) include.

In some countries around the world, food manufacturers are required to publish front-of-package (FOP) labels to promote better consumer awareness and sway dietary choices. Usually, the regulations require a mandatory symbol, icon, or other visual cues on the front of food packaging that communicates healthy food choices and other critical ingredient information to consumers. But how do FOP labels help consumers and brands when the same information can be found on the Nutrition Facts panel? Let’s consider the various types of FOPs and their benefits.

FOP Labeling in North America

Neighboring countries like Mexico and Canada have both passed finalized regulations on the use of Front of Package (FOP) labeling, which is a major change for many food and beverage manufacturers.��Canada’s regulation went into effect in 2022 with a .��Mexico, on the other hand, is currently rolling out updated nutrition labeling regulations in three implementation phases.��

While the United States has yet to mandate FOP labeling on U.S. consumer goods, in January 2023, the FDA began to consider FOP regulations by issuing a and accepted public comments for 60 days following the publication of the notice. In the meantime, the U.S. allows voluntary FOP labeling options known as or Nutrition Keys.��

June 14, 2023 Update: The FDA released a on their intent to further research consumer responses to FOP labeling schemes. The study, titled “Quantitative Research on Front of Package Labeling on Packaged Foods,” is a follow up to the previous notice and studies that used focus groups to explore the benefits of FOP labeling. The procedural notice also opened a public comment period from June 15 – July 17, 2023.��

The was developed in 2011 to provide consumers with quick and easy-to-understand information about the nutritional content of packaged foods.

Under the program, food manufacturers can display calories, saturated fat, sodium, and sugar content to allow consumers to easily compare nutritional value across various products. While voluntary, many food manufacturers use the label on their products.��

FOP Labeling Benefits: Awareness, Transparency, and Healthy Habits

FOP labeling is gaining traction in different countries as a way to communicate food choices to consumers in an easy-to-understand manner. As researchers in these countries investigate the impact of FOP labeling, they have identified a few key benefits for consumers and food manufacturers.

Improved Consumer Awareness Through Standardization

Placing labels on the front of packages can help consumers quickly identify healthier food options. In Canada, for example, FOP labels will show a magnifying glass to help shoppers easily recognize products that are high in sodium, sugar, or saturated fats. Mexico and Chile similarly use octagonal warning signs, and the UK uses a voluntary (under certain conditions) to identify items with high, medium, or low amounts of specific nutrients.

FOP Examples Around the World

The new Canadian FOP label shows a black and white magnifying glass next to text that reads: High in / Eleve en | Sat fat / Gras sat. | (blank space for sugar if the product qualifies) | Sodium | Health Canada / Sante Canada.

English translation in the order above: excess calories, excess sugar, excess saturated fat, excess trans fat, and excess sodium.

An example of the UK "Traffic Light" FOP symbols used on food packaging.

The uniformity of the symbols used allows shoppers to instantly recognize healthier food options when browsing store shelves, regardless of store or brand. In turn, standardization helps build trust in new labeling faster and creates an easily learnable system for consumers.

Increased Nutrition Transparency

FOP labeling can provide consumers with clear and concise information about the nutritional content of food products. By displaying key information such as calories, saturated fat, sodium, and sugar content on the front of the package, FOP labeling allows consumers to quickly compare products and make informed decisions about what they eat.

Research studying the have found these tools can provide quick information on nutrients, a host of summary statistics on consumer behavior, and enable better food group categorization.

As food and allergen labeling regulations continue to evolve in the U.S., companies in the food industry will face increasing accountability for providing consumers with accurate and non-misleading information, even without mandated FOP labels. In addition, consumers are showing a growing preference for about their ingredients, nutrients, and company policies.

Encouraging Healthy Eating Habits

FOP labeling can promote healthier food choices by highlighting nutrient-dense foods and encouraging consumers to consider the nutritional quality of their food purchases.

Following the implementation of mandatory FOP labeling in Chile in 2016, researchers have discovered a in total sugars, saturated fats, and sodium in youth diets. Researchers believe FOP labeling, along with other mandatory changes implemented by the law, contributed to these dietary changes.

While more research is needed to understand the full and continued impact in Chile, Mexico and Canada have used these positive results to influence their FOP labeling laws. The U.S. may be next.

Considerations for Manufacturers Before Using FOP Labels

While there are a number of benefits to FOP labeling, there are also some impacts that food manufacturers will need to consider. While the U.S. has yet to implement mandatory FOP labeling, manufacturers should keep these considerations in mind in case future regulatory changes happen.

Limited Scope and Impact

FOP labeling may only provide a limited snapshot of a food product’s nutritional value. Many consumers already neglect to read the nutritional labels that are on the back or side of packaging and may now assume that it’s not necessary because they have a quick summary right on the front of their product. Consequently, shoppers may not understand the full nutritional complexity of the food but incorrectly believe they do.

Simply including FOP labeling may not be enough to effectively promote healthier food choices if consumers do not understand or use the labels. Consequently, regulatory agencies like the FDA or the companies themselves may be forced to spend money on marketing and educational campaigns. Even then, it’s not possible to know whether there will be widespread adoption of the labels or if they’ll be effective in the U.S. without trial (and perhaps error).

Increased Cost and Compliance Risks

Nothing is done for free, and FOP labeling is certainly the same. It can be costly for food manufacturers to design and implement new packaging across their product lines. It may also force companies to use more materials like cardboard, plastics, and ink if the packaging becomes larger. These costs may then be passed on to consumers in the form of higher store prices.

Additionally, companies will have to maintain compliance with any new regulations on FOP labeling in the U.S. As with any regulation change, companies can risk non-compliance if they don’t fully understand the regulation. And while the FDA often provides ample time to understand and implement changes, they are less forgiving of mistakes after the compliance date arrives. Companies that misuse FOP labels, mislabel products, or don’t follow compliance requirements could face an FDA Warning Letter or costly product recall.

Other Packaging Symbols

Manufacturers may notice other types of symbols or labels on the front of a product’s package that are different from FOP labels, but��have a similar intention to drive consumer awareness. Here are the difference between these various packaging claims:

FOP labeling is a standardized system that typically displays key nutrient information in a simple format for consumers to assess the nutritional value of products.
Nutrient content claims are statements about the amount of a specific nutrient in a food product. Some examples include “low-fat” or “a good source of vitamin C.” These claims are and can appear anywhere on the food or dietary supplement package.
Packaging claims are statements about the characteristics of a food product, such as the production method, ingredients, or health benefits. Some of these claims are regulated by the FDA, while others may be implemented by state groups or other organizations. Some examples include USDA Organic labels (regulated by the USDA), California Prop 65 labels (regulated by California code), and the term “healthy” (which will likely see qualification changes from the FDA soon).

Invest in Tools to Help with FOP Labeling

Ultimately, FOP labeling can be a useful tool for promoting healthier food choices and increasing transparency in the food industry, keeping consumers safe and protecting brands and companies from a non-compliance headache. It’s important, however, that governments or health agencies carefully regulate FOP labeling to prevent misleading labeling practices and ensure that consumers have access to accurate and comprehensive nutritional information. And soon, the U.S. could see regulation changes around FOP labeling requirements.

Whatever type of labeling your food or beverage products require, a solution like �հ��ܲ��ٷɱ��’s Genesis Foods Formulation & Labeling Software can help companies ensure product transparency and regulatory compliance. If you are interested in learning more, today.

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Demystifying Nutrition Facts Labeling: How to Navigate Different Package Sizes

Stephanie Ulrich — Wed, 19 Apr 2023 09:00:49 +0000

In the United States, you can find a variety of Nutrition Facts labels on food packaging. The Food and Drug Administration (FDA) (and in some cases, the US Department of Agriculture) creates and maintains guidelines for how companies must display Nutrition Facts labels, what nutrients are required, and how nutritional information should appear on a label.

However, food packaging isn’t “one size fits all,” which means the standard Nutrition Facts label doesn’t always fit the packaging appropriately. And in some cases, the food inside the packaging may require additional ingredients or contain multiple servings. So, to help food manufacturers label their food and beverage products appropriately, the FDA has several labeling formats that adjust the size and shape of the Nutrition Facts panel to fit various packages and servings. In this blog, we’ll cover the formats and what is required for each.

Note for Genesis Foods users, keep an eye out for our tutorial links in each section for each label format!

Single Serving Label Formats

Food or beverages that are packaged in a single serving should use the standard label for most packaged items. However, if the package is too small for the standard label, food companies can also use tabular or linear labels. Whichever label you use, the values should be based on the entire contents of the package.

Standard Vertical Label

The most common, standard label format for food packaging is the vertical Nutrition Facts label (as shown below). This format is recommended as the primary format by the FDA unless packages have less than 40 square inches of vertical space or multiple servings. We cover the essential elements for standard label compliance on our blog: How to Create a Compliant Nutrition Facts Label.

Note for Genesis Foods users, you can learn how to view and select these formats in our Nutrition Facts FAQ webinar, at about the 26 minute mark.

Tabular or Horizontal Nutrition Facts Label

For food packaging that offers less than 3 inches of vertical space, or less than 40 square inches of total surface area (), the FDA recommends using the tabular or horizontal format. This type of label can be found on packaged items that have more horizontal space than vertical space.

Notice, much of the formatting required for the standard, vertical label carries over to the horizontal version. Font sizes, serving information, calories in bold, nutrient set, and the footnote are all consistent between the vertical and tabular option.

Linear Nutrition Facts Label

If food packaging cannot accommodate either the standard vertical label or the horizontal label (less than 40 square inches of total surface area), then the linear format is allowed. This style is often seen on smaller individually packaged items but should contain most of the same information as a standard label. However, the linear label does allow some omissions, including the footnote, and some abbreviations are allowed.

Again, certain values are bolded to draw attention to them (serving size, calories, fat, cholesterol, sodium, and total carbohydrates), and the font size for calories is as large as “Nutrition Facts” at the top. The dimensions of the border can be adjusted to fit the size and shape of small packages.

��(Note: If your food product only has a single ingredient, check out our blog post about how to create a single ingredient Nutrition Facts label.)

Aggregate Labels for Different Varieties or Flavors

If a food or beverage product comes in different flavors or varieties, the nutrition information must be listed for each. For example, a large box of cereal contains 3 different bagged varieties inside: cornflakes, all bran, and banana nut flavors. Each option has different calorie counts, ingredients, and nutrients, so the Nutrition Facts label on the outside of the box will need to account for each variety using an aggregate label.

In an aggregate label, the information for each item is listed in separate columns, as shown below.

Note for Genesis Foods users, watch our Aggregate Label tutorial to learn how to create this format in Genesis.

Combination Foods and Multi-Serving Labels

Sometimes packaged food requires additional ingredients before being eaten or includes multiple servings in a single package. In these cases, food packaging can use a dual column format.

Note for Genesis Foods users, to learn how to adjust panel sizes for your packaging inside the Genesis program, watch our tutorial on Dual Column Nutrition Facts and alternative labeling formats.

Dual Column Format for Multiple Forms of a Food

The Dual Column Label is used when food requires further preparation or is commonly prepared with another food, such as dry cake mixes or cereal with 2% milk. One column lists information for the product as packaged and one column for the product as prepared or as commonly eaten. In the example of cereal, the first column lists the cereal as packed while the second column lists cereal with milk (written above the calories amount).

Dual Column for Multiple Serving Sizes

A Dual Column Label is also required when a package contains 200 to 300 percent of the Reference Amounts Customarily Consumed (RACC). A dual column is optional when the package contains more than 150 percent to less than 200 percent of the RACC. The dual column label will show Nutrition Facts for one serving as well as the entire package.

Label Your Products with Confidence

Navigating FDA labeling guidelines can get complicated, and failing to follow guidelines can lead to an FDA Warning Letter and even a costly product recall. However, you can take the guesswork out of your labeling compliance needs with a software that provides the government guardrails to streamline label creation. Easily resize, reformat, or adjust your label’s appearance and access a comprehensive database of nutrients with Genesis Foods Formulation and Labeling Software from Trustwell.

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Supplier Management Best Practices and Tips in the Modern Food Era

Stephanie Ulrich — Wed, 29 Mar 2023 17:12:50 +0000

Strong supplier management practices are critical to any organization, and are the key to ensuring successful production, that regulatory compliance is met, and that good relationships with partners across the supply chain are established. For food and supplement manufacturers in particular, strong supplier management is perhaps even more crucial to daily operations, enabling them to better identify and mitigate potential risks related to allergens, contaminants, and other food hazards.

In the Food and Drug Administration (FDA)’s , which prioritizes new business models, technology-enabled solutions, and a culture of greater food safety, what does managing suppliers look like? Here are five for managing suppliers in our current modern food era:

1. Establish Clear Criteria for Supplier Selection

Food manufacturers should develop a clear set of criteria that suppliers must meet to be considered for your business. Consider qualifications such as quality standards, pricing, delivery schedules, certifications, and a supplier’s ability to meet regulatory compliance. These criteria should be reviewed regularly and updated as necessary. Your suppliers are an extension of your business, so select collaborative partners that align with your organization’s values and goals, too.

2. Conduct Regular Supplier Assessments

Regularly assess your suppliers to ensure they are meeting your quality and safety standards. You will also want to routinely check to make sure they have the necessary certifications and are following protocols and processes to meet regulatory compliance. These assessments may involve on-site audits, product testing, and reviewing related to the supplier’s quality management system.

3. Foster Communication and Collaboration with Suppliers

It is always best practice to establish open lines of communication with your suppliers so they understand your expectations and requirements. Setting up those channels can help you quickly address any issues that may arise, such as sharing updated information on product specifications, production schedules and delays, and other quality control measures. Fostering a culture of effective communication and collaboration with your suppliers will also ensure that everyone is on the same page and prepared to take appropriate action if and when a food quality issue occurs.

4. Invest in Technology

Leverage a technology solution to help monitor supplier performance and regularly identify any trends or issues that may impact your business. This can involve tracking metrics such as on-time delivery, product quality, or a supplier’s ability to accurately and quickly complete compliance documentation. A also provides a centralized location for you to manage supplier documentation, conduct those assessments that we mentioned earlier, and have access to performance data exactly when you need it.

5. Develop a Contingency Plan

Develop a contingency plan to address supplier disruptions. There is value in identifying alternative suppliers, sourcing alternative ingredients or materials, or pursuing alternative production processes if something goes awry. The pandemic forced many manufacturers to reconsider their contingency plans – and in some cases, completely establish new ones – when they realized they did not have the backup resources necessary to continue with business as usual. So, it is always best to have a “plan B,” or even a “plan C,” in place in case unexpected circumstances arise.

Even when following the above best practices, there may be external factors that would require manufacturers to adjust suppliers, like:

Allergen Regulation Changes: Food allergen regulations may change due to new scientific research, evolving consumer preferences, or updates in government regulations. These changes may require manufacturers to adjust their ingredient lists, update labeling, and switch up manufacturing processes to avoid potential allergen cross-contact, ensure the safety of their products, and meet compliance with regulatory requirements. If a supplier is unable to provide sufficient documentation on allergen control measures or cannot guarantee the safety of their products, manufacturers may need to find an alternative supplier who can, in fact, meet those standards.
Supply Chain Disruptions: Supply chain disruptions can be caused by a range of factors such as natural disasters, transportation issues, economic instability, or labor shortages, among others. When these disruptions occur, manufacturers may face challenges in obtaining the necessary raw materials, components, or finished goods from their existing suppliers and may need to adjust suppliers to ensure the continuity of their business operations and maintain product quality standards. This may involve evaluating alternative sources of supply or working with new suppliers to develop new products or processes. Manufacturers may also need to adjust their specifications or requirements to accommodate the new supplier’s capabilities and still maintain production schedules and meet customer demand.
Economic Volatility: Economic volatility, like an inflation or recession, can cause manufacturers to change their suppliers for a variety of reasons. When inflation occurs, the cost of raw materials, labor, and other inputs can increase, which can lead to higher production costs for manufacturers. As a result, manufacturers may need to adjust their suppliers to . This may involve finding new suppliers who can provide the same inputs at a lower cost, negotiating with existing suppliers for better pricing, or seeking out alternative materials or products that are more cost-effective. However, manufacturers must ensure that any changes in suppliers do not compromise the quality or safety of their products, which could result in a costly food product recall.

Trustwell Can Help

Managing suppliers involves a range of practices and strategies to ensure the safety, quality, and consistency of the ingredients and products used in the food manufacturing process – particularly with evolving regulatory requirements and an increasingly . It is important for food and supplement manufacturers to stay informed of the latest regulations, conduct regular supplier assessments and audits, and invest in the right platforms to help streamline their supplier management efforts.

In the current era, strong supplier management practices are key to ensuring compliance and, ultimately, keeping the consumer safe. For food and supplement manufacturers looking for additional tools and resources to help navigate regulatory compliance and ensure consumer safety – from accurate labeling and formulation when suppliers change, to more visibility into supplier documentation – at Trustwell today.

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How to Accurately Label Allergens On Dietary Supplement Facts Panels

Stephanie Ulrich — Wed, 15 Mar 2023 08:30:34 +0000

There are some distinct differences between labels for food products, which use Nutrition Facts panels, and labeling for dietary supplements that use Supplement Facts panels. But are there differences when it comes to labeling allergens? Yes and no.

Labeling regulations put in place by the U.S. Food and Drug Administration (FDA), are intended to keep consumers safe and help them make informed decisions about the products they choose to consume. Whether it is a box of cereal or a bottle of Vitamin C supplements, accurate product labeling is essential to protect the consumer, ensure compliance, and help prevent a costly product recall due to an undeclared allergen.

Allergen Labeling Regulations for Dietary Supplements

Both dietary supplements and food products are required to declare the presence of major allergens on a product’s ingredient list, near the Nutrition or Supplement Facts label, as outlined in the (FALCPA) of 2004 and the of 2021. As of 2023, there are nine major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

There are a couple FDA-approved ways that supplement manufacturers can notify customers of potential allergens: using a parenthetical in the Supplement Facts panel, using a “Other ingredients” statement when listing ingredients, and following ingredient lists with a “Contains” statement. Here are examples of what that might look like:

On the Supplement Facts panel: protein (as whey) (milk)

Other Ingredients: whey (milk), coconut …

Contains: Milk, coconut

The “Contains” statement should follow directly after the list of ingredients near the Supplement Facts label and be the same font size as the rest of the ingredients. For dietary supplements that don’t include an ingredient list, the “Contains” statement should be adjacent or immediately after the Supplement Facts label.

Supplement Allergen FAQ

While identification of allergens may seem obvious – either the product has them or it doesn’t – there are a couple unique situations that supplement manufacturers may find themselves in. Here are some common questions we came across while researching this topic.

What if Your Supplement Uses Ingredients from Roots, Leaves, Stems, or Other Plant Parts From a Major Allergen?

While the term “major food allergen” refers to milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, sesame, and any proteins derived from these allergens, there are exceptions. For example, the FDA states that there are allergen exemptions for highly refined oil derived from a major food allergen.

In addition, many supplements use other ingredients derived from plants that are the source of the major allergens but are plant parts that don’t contain the allergen proteins. This can cause confusion when it comes to allergen labeling, and the to supplement manufacturers:

“Roots, leaves, stems, bark, or other parts that are distinct from the tree nut portion of the plant are not major food allergens. For example, if a dietary supplement is derived from the leaves of the Ginkgo biloba L. plant, not the Ginkgo nut, and no other ingredients containing proteins derived from the Ginkgo nut or any other major food allergen were used to make the dietary supplement, the food allergen labeling requirements would not apply to the dietary supplement labeling.”

How do You Label Source Ingredients if Sourcing From an Allergen?

In the , the FDA also emphasizes accurately labeling source ingredients if they are derived from a major allergen. For example, sodium caseinate derived from milk, should be labeled with the proper contains statement, including milk as a parenthetical. That looks like:

On the Supplement Facts panel: protein (as sodium caseinate) (milk)

Other Ingredients: sodium caseinate (milk)

Contains: Milk

The same rules apply to excipient, filler, binder, flavor, and other ingredients that derive from allergens.

What if Your Supplement is Manufactured in a Facility That Manufacturers an Allergen?

For some supplement manufacturers, depending on where your product is sourced and processed, you may also need to worry about allergen cross-contact. Cross contact can occur when an allergen is unintentionally introduced into another food product or supplement through the manufacturing, sourcing, or cooking process.

For example, a manufacturing plant may make a peanut-based protein powder, then later make a ginger root supplement; accidentally contaminating the ginger root with residue from peanuts manufactured on the same line. In these cases, manufacturers can include precautionary allergen labeling on their product, stating “may contain (allergen)” or “produced in a facility with (allergen).”

However, it’s important to note the FDA does not want manufacturers using precautionary allergen labeling in place of through good manufacturing practices (GMPs). This is mandated under the (also known as the CGMP &PC rule), which requires manufacturers to implement practices, safety procedures, and sanitary processes to minimize the risk of spreading allergens and other food hazards. If the FDA does find a company to have inaccurate nutritional claims, undeclared allergens, or manufacturing shortfalls, they could issue a or declare a recall.

Can You Label Your Supplement as “Allergen Free”?

Currently, the FDA does not set testing thresholds for allergens, but there are a few extra steps you should take if you wish to label your supplements as either “contains no [allergen]” or “[Allergen] free.”

The best way to ensure your products are allergen free is by having samples pass allergen lab tests. Currently, you can get either a Polymerase Chain Reaction (PCR) test or an Enzyme-Linked Immunosorbent Assay (ELISA) test, which will show the presence of an allergen in the parts per million (ppm). If your results clearly show no allergens are present (and you’re sure cross-contact isn’t a potential issue at your manufacturing facility), you can safely claim your items are allergen free. However, the FDA may test that claim using their labs if they perform an FDA audit or inspection.

Ensuring Accurate Labeling for Supplements

While the allergen labeling rules for food products and supplements share many similarities, companies must be aware of the specifics to ensure their consumers are safe and can make a well-informed decision during their purchasing journey.

This is also why it’s so important to have accurately labeled Supplement Fact panels. Luckily, there are solutions that can provide the government guardrails you need to ensure your labels are FDA compliant, including automated allergen labeling when inputting ingredients. Our powerful ��app�� Supplements Formulation & Labeling Software has these sorts of features built-in so consumers can fully understand what is in your dietary supplement product. Contact our team��at today to learn more about our labeling solutions.

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