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United States' HHS Secretary Delivers Ultimatum on Artificial Food Dyes

By Julie Holt, Director, Global Advisory Services

U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. issued a bold ultimatum to some of the world’s largest food and beverage manufacturers earlier this month. Kennedy stated that companies have until the end of his term in 2029 to remove artificial food dyes from their products or face government intervention. The removal of these dyes is an urgent priority of the Trump administration and a pillar of the Make American Healthy Again (MAHA) platform. The directive is intended to create real and transformative change by removing what Kennedy claims are “the worst ingredients” out of food products. Artificial colorants have been used in processed foods for years, and their long-term safety has been debated. However, there is no conclusive scientific evidence that demonstrates they are harmful. Some of these dyes are petroleum-based.

Regulatory agencies such as the U.S. Food and Drug Administration and European Food Safety Authority (EFSA) have reviewed scientific studies and concluded that these food dyes do not pose significant health risks. However, not everyone agrees with this conclusion and the safety of these colorants remains controversial. Interestingly, a food dye may be deemed safe in one country but not in another, making it confusing to truly assess safety.

Secretary Kennedy’s firm federal stance on the removal of these colorant additives is supported by many lawmakers, and state pressures also exist in the form of additive bans. Many multi-national food companies are already preparing to respond by reformulating some of the products in their portfolios. Identifying and using natural food dye replacements will likely be a time intensive and costly proposition. Representatives from many large food manufacturers met with Secretary Kennedy and his team earlier this month, and the Secretary assured all that he is not pursuing punitive measures but “committed to working with the food industry” to achieve the goal of removing artificial food dyes.

Implications for Clients: How FoodChain ID Assists with Regulatory Change

The industry experts at FoodChain ID realize that reformulations are never easy. Our staff offer resourcing and consulting to ease the regulatory burden of the ingredient substitution process. Regulatory concerns related to reformulations include not only ingredient compliance, often for multiple markets, but the potential introduction of new allergens and label impacts. Our consultants have supported reformulation activities for multiple clients.

Julie Holt, Director, Global Advisory Services

Julie Holt is a subject matter expert in the areas of food and beverage, additives, and regulatory strategy. She has beverage industry expertise and currently provides consulting support across multiple beverage categories. Ms. Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, Julie supported several food and beverage clients including a Fortune 50 company. Julie has provided global regulatory knowledge covering more than 200 countries.

FoodChain ID experts in Regulatory and Scientific Consulting offer global guidance to meet the evolving demands of the food and beverage marketplace.

United States Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has directed the U.S. Food and Drug Administration (FDA) to explore rulemaking that would eliminate the existing pathway for companies to self-affirm that food ingredients are safe under specified conditions of use. The current process, called Self-Affirmed GRAS (generally recognized as safe) dates to 1997 and allows companies to do their own testing and convene an expert panel for a determination that their products are safe to enter the U.S. market. GRAS is a notification process rather than an approval process. The alternative pathway is for a company to submit their safety data directly to the FDA for review. Currently, the FDA evaluates approximately 75 GRAS notices per year. Notifications to FDA are publicly available via the FDA’s GRAS Notice Inventory.

A company is not required to notify FDA of its self-affirmed GRAS status, and there is no public database listing self-affirmed GRAS ingredients. This lack of tracking and transparency is a concern for critics of the self-GRAS program.

The idea behind eliminating the Self-Affirmed GRAS process is to introduce only food ingredients that are safe as part of the Make America Healthy Again (MAHA) platform. HHS will need to work with Congress to close this “loophole,” and there will be many issues to resolve. For example, would previously self-GRAS ingredients be grandfathered or would they undergo a full FDA GRAS evaluation? There is the potential to exempt some categories of ingredients and for FDA to triage those that are a priority for review. While some experts are concerned about the potential dismantling of a system that has worked for several decades, others see the change as an opportunity to improve food safety and transparency for consumers.

Julie Holt, Director, Global Advisory Services

By Kathy Van Zyl, Regulatory Consultant

Titanium dioxide is a versatile mineral that is used across a wide variety of consumer products, mainly as a pigment for lending whiteness and opacity. Its uses range from food and beverages to pharmaceuticals, cosmetics, industrial uses, paints and even solar paneling.

The use as a food additive is purely aesthetic, making foods more visually appealing for a whiter, brighter or more opaque appearance but without adding nutritional value. From milk, candy, baking ingredients, sauces, chewing gum and many processed foods, titanium dioxide is listed as E171, INS 171 or simply as an artificial colorant.

Health Concerns from Titanium Dioxide

Titanium dioxide (TiO₂) is produced mainly from naturally occurring minerals. The benefits used in food products are however not without controversies. Several lobby groups are calling for a ban on use in food due to the possibility of carcinogenicity in humans and animals, and damage to the immune system. It is also considered by some associations to irritate the mucous membranes, cause lung cancer in animals and even to be potentially genotoxic. The central element of the controversy surrounds the fact that TiO₂ contains nanoparticles that are generated during the manufacturing process. Alternatives as a whitener in foods also exist.

The toxicity and the use as a food additive is currently a matter of debate and conflicting decisions, with food agencies and authorities across the world having different stances, views and rules. This conflict leaves consumers confused and unsure about consumption of foods with TiO₂.

Global Regulatory Actions on Titanium Dioxide

The United States Food & Drug Administration (FDA) (2023), Health Canada, Food Standards Australia, New Zealand (FSANZ) and the Food Safety and Standards Authority of India, to name a few, found no safety concerns for the use of titanium dioxide as an additive at its intended level of use. Many states in the US have proposed bills to ban titanium dioxide but none have yet been passed. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2023) concluded that titanium dioxide (INS 171) did not pose significant effects to necessitate a ban.

The European Food Safety Authority (EFSA) deemed TiO₂ (E171) as not safe as a food or feed additive, due to concerns regarding genotoxicity (from 8 August 2022). Although oral ingestion of particles is low, they can accumulate in the body. The Saudi Food & Drug Authority issued a ban in 2022 and all the member countries of the Gulf Cooperation Council (GCC) followed suit, causing TiO₂ to be removed from the Additives Permitted for Use in Foodstuffs in 2023.

After the European Union classified TiO₂ as a carcinogen, category 2 by inhalation in Delegated Regulation (EU) 2020/217, several manufacturers took the matter to General Court, who annulled the Commission’s decision. The French Government and the Commission have both taken the matter on appeal. On February 12, 2025, the Advocate General issued a non-binding opinion that the European Court of Justice (ECJ) set aside the ruling. The matter will be heard by the ECJ in May or June 2025 and the outcome will be of tremendous interest for the future of TiO₂ as a food additive and many more of the current uses.

FoodChain ID’s subject matter experts can help your organization connect scientific research, ingredient benefits and regulatory policies in various markets. Contact us for guidance on regulatory parameters and market launch or expansion requirements for your food or supplement product.

Many retailers are introducing a new modern soda category of prebiotic sodas. The category features innovative brands such as OLIPOP, a soda that contains healthier ingredients and functional attributes geared towards gut health. The new prebiotic sodas tend to be lower in sugar and calories than their traditional soda counterparts and usually are free of artificial colors. Sugar-sweetened soda has long been a target for reformulation, and the new healthier prebiotic sodas strive to keep the fun of bubbly carbonated beverages while reducing sugar and adding functional ingredients such as botanicals and prebiotics for gut health.

Coca-Cola entered the prebiotic soda space earlier this month with the launch of its new product Simply Pop. Simply Pop contains 6 grams of prebiotic fiber for gut health along with Vitamin C and zinc to support immune function. It also contains 25 – 30% fruit juice, natural flavor and has no added sugar.

Many consumers, especially younger ones, are making a shift to healthier beverages with sugar reduction as a top concern. The carbonated soft drink category is projected to grow by close to 30% over the next three years, with the better-for-you subset growing as much as 75% during that time. As a larger global player, Coca-Cola’s new launch validates this category and may take prebiotic soda from niche to mainstream.

About the Author

Julie Holt is a subject matter expert in the areas of food and beverage, additives and regulatory strategy. Ms. Holt’s expertise includes the beverage industry, with current consulting support across multiple beverage categories.

Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, she supported several food and beverage clients including a Fortune 50 company. Holt has provided global regulatory knowledge covering more than 200 countries. Her consulting efforts have supported global regulatory needs, R&D projects, sustainability goals and innovation initiatives.

To maintain a competitive edge in today’s rapidly evolving food industry, companies must be able to quickly adapt to meet regulatory and consumer demands. Traditional methods of managing New Product Development (NPD) have become a barrier to innovation, leading to delays and errors.

This article explores six key benefits of embracing purpose-built tools like FoodChain ID’s Recipes & Specifications solution in food and beverage innovation to manage these complex requirements.

1. Enhanced Data Management

Data is the backbone of food product development, yet managing it can be a significant challenge. Traditional methods often involve manual entry, spreadsheets and scattered documentation, leading to errors, data silos and inefficiencies. Digital solutions offer a centralized platform where all data related to ingredients, nutritional content, allergens and more can be stored, accessed and analyzed in real-time.

With enhanced data management, you can ensure that every piece of information is accurate, up-to-date and easily retrievable. This not only reduces the risk of errors but also allows for more informed decision-making, ultimately leading to better product outcomes.

2. Streamlined Workflows

The complexity of food product development requires collaboration across various departments, including Research & Development (R&D), quality assurance, regulatory compliance and marketing. Managing these workflows manually can be time-consuming and prone to bottlenecks. Digital solutions streamline these processes by automating routine tasks, enabling seamless communication and providing visibility into every stage of development.

By streamlining workflows, your team can focus more on innovation and less on administrative tasks. This leads to faster project completion, reduced time-to-market and a more efficient use of resources.

3. Improved Decision Making

Making the right decisions at each stage of product development is crucial for success. However, traditional methods can leave decision-makers with incomplete or outdated information. Digital solutions provide real-time data and analytics, empowering you to make informed decisions based on accurate, comprehensive insights.

Whether you’re determining the nutritional profile of a new product, assessing the impact of a formulation change or creating a compliant food label, having access to the right data at the right time ensures that your decisions are aligned with business goals.

Business colleagues collaborating at a laptop in office.

4. Accelerated Market Readiness

In the competitive food industry, speed to market can be a critical differentiator. Digital solutions accelerate market readiness by reducing the time spent on manual data entry, approval processes and compliance checks. With automated workflows and real-time data, you can quickly identify and address any issues that might delay product launch.

Faster market readiness means you can seize opportunities, respond to consumer demands and outpace competitors, all while maintaining the high standards of quality and compliance that your brand is known for.

5. Enhanced Collaboration and Knowledge Sharing

Product development in the food industry is rarely a solo endeavor. It involves input from various stakeholders, including suppliers, manufacturers, regulatory bodies and even consumers. Digital solutions foster enhanced collaboration by providing a shared platform where all stakeholders have common visibility, can collaborate on key activities, and leverage historical knowledge and best practices.

This collaborative environment not only improves communication but also ensures that everyone is working from the same set of data and standards. The result is a more cohesive development process, fewer misunderstandings and improved stakeholder relations.

6. Assured Compliance & Quality

Compliance with regulatory standards and maintaining product quality are non-negotiable in the food industry. However, keeping up with ever-changing regulations and multiple markets can be daunting without the right tools. Digital solutions help you stay ahead by automating compliance checks and maintaining detailed records of the product throughout its lifecycle.

With assured compliance and quality, you can confidently bring products to market knowing that they meet all the necessary standards.

The food industry is at a pivotal moment, where the adoption of digital solutions is no longer just an option but a necessity for staying competitive. By leveraging tools like FoodChain ID’s Recipes & Specifications solution, you can transform your product development processes, making them more efficient, collaborative and aligned with market demands.

FoodChain ID’s Recipes & Specifications solution is an end-to-end tool built from the ground up to support food and beverage innovation and change management. This cloud-based platform supports supplier collaboration, digital specification management, advanced recipe development, compliant label generation, automated product data sheets and more.

Excess sodium consumption is associated with negative health effects such as cardiovascular disease, high blood pressure and stroke. The US FDA is seeking to reduce U.S. average sodium intake by 12 percent over time by encouraging voluntary reductions from food manufacturers and restaurants.

In August 2024, the United States (US) Federal Register published a notice announcing the availability of “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Packaged, Processed and Prepared Foods; Draft Guidance for Industry.” When finalized, the document will outline the US FDA’s current views on voluntary goals (Phase II) for sodium reduction in a variety of categories for products that are packaged, processed, and / or prepared. A 90-day comment period was provided.

Many from industry requested an extension of the comment period to allow more time for an adequate review of the guidance. Food companies stated that more time was needed to review the guidance against multiple product lines and brands. Another concern is that industry is already managing several other significant FDA initiatives, including the final ruling on “healthy” labeling.

The FDA has granted an additional two months for industry to respond to the draft guidance on reducing sodium content, with the new deadline for comments now January 13, 2025.

About the Author

In this e-book, we guide you through the latest regulatory developments in the U.S. and Canada affecting the food industry, provide comments from industry experts including members of the International Food Additives Council (IFAC) and the American Bakers Association (ABA) and outline how companies can remain compliant.

Click to read Regulatory Outlook: Key Updates in Food Labeling & Formulation

Discover how digital tools such as FoodChain ID’s Recipes & Specifications solution can help streamline reformulation, enhance traceability and automate compliance processes, ensuring that your company stays ahead of regulatory changes with minimal disruption. Whether you’re managing ingredient sourcing, product development or labeling requirements, this platform provides purpose-built tools and actionable insights to design for and maintain compliance in an increasingly complex regulatory environment.

By Sureyya Topaloglu, Regulatory Researcher and Regulatory Trends Consultant

For food and beverage product developers looking to streamline processes and manage recipes, specifications, suppliers and labels in one solution, Recipes & Specifications offers efficiency, collaboration and auditability.

Introduction: The Shifting Landscape of Flavor

As we approach 2025, the world of flavors is evolving with a blend of cultural diversity, scientific advancements and a renewed focus on sustainability. Interest in global flavors remains strong, with consumers enthusiastically trying new flavors that connect them to distant cultures and innovative culinary ideas. This trend goes beyond dining out; people are recreating bold flavors from restaurants in their own kitchens, experimenting with natural and synthetic ingredients alike. The interplay of taste and smell is transforming our understanding of flavor, while rising concerns for food safety and eco-friendly sourcing guide these developments.

Global Flavor Exploration: Bold and Unexpected Combinations

The current flavor landscape is defined by adventurous global tastes and distinct culinary influences. Sour and spicy flavors, such as tamarind, calamansi, and gochujang, take center stage, bringing tang complexity to dishes. Korean, Thai, and Filipino ingredients are making waves, blending spicy, sweet, and umami flavors in innovative ways. Fusion flavors are popular as well, creatively pairing traditional tastes with new cultural elements. These creative combinations reflect a demand for culinary exploration and authenticity, allowing consumers to experience the world on their plates.

Innovations in Flavor Production: Sustainable Bioengineered Enzymes

A significant trend in flavor innovation is the use of bioengineered enzymes to create sustainable natural flavors. In May 2024, A team from Tokyo University developed a genetically modified enzyme that efficiently converts ferulic acid from plants into vanillin, the primary compound in vanilla flavoring. This process is eco-friendly, producing vanillin at high yields without additional catalysts. Such advancements offer scalable solutions to meet the high demand for natural vanilla and reduce reliance on traditional vanilla production, which is often constrained by climate and limited crop yields.

Prioritizing Safety: Regulatory Measures for Flavor Ingredients

As flavor innovation progresses, food safety is paramount. The EU has recently moved to phase out eight smoke flavorings, following the European Food Safety Authority’s (EFSA) findings on genotoxicity risks. These smoke flavorings, once popular as alternatives to traditional smoking methods, will be gradually banned, especially in processed foods like soups and sauces. This regulatory action reflects a broader trend of strengthening health standards to ensure that both traditional and synthetic flavors meet rigorous safety criteria, aligning with the global emphasis on safe and high-quality food.

Conclusion: The Future of Flavors

In 2024, the world of flavors is vibrant, diverse, and driven by a balance of cultural curiosity and scientific innovation. From sour global flavors to cutting-edge bioengineering in natural ingredients, the push for unique, sustainable, and safe tastes is transforming how we experience food. With nostalgic flavors, thoughtful fusions, and strict safety regulations guiding the way, current flavor trends reflected a unique blend of authenticity and novelty, promising an exciting future for culinary exploration and creativity.

Traditional compliance methods, such as manual checks and fragmented data systems, are increasingly insufficient due to their time-consuming and error-prone nature. This whitepaper explores how FoodChain ID’s Recipes & Specifications solution integrated with our Compliance Analysis platform is transforming regulatory compliance for food manufacturers.

Streamline New Product Development and enhance regulatory compliance with FoodChain ID’s Recipes & Specifications solution. Click here to learn more.

Benefits of Recipes & Specifications Solution with Integrated Compliance Analysis:

Increased Market Reach: Streamlines identification of compliant markets, facilitating faster market entry.
Enhanced Innovation: Allows manufacturers to ensure compliance as their recipes change, knowing their products meet regulatory standards.
Operational Efficiency: Automated compliance checks reduce the need for manual interventions, optimizing workforce productivity.

Want to learn more? Schedule a meeting with our experts.

Part of FoodChain ID’s ‘It Begins with You’ Webinar Series

Accurate food labeling is crucial for consumer safety, particularly when it comes to allergens and other important considerations. This webinar will provide an overview of the critical aspects of labeling for food safety, including allergen declarations, ingredient lists, other key safety considerations and compliance with regulatory requirements.

We discuss best practices for creating clear and effective food labels, address common labeling challenges and explore strategies to ensure your labels meet both regulatory standards and consumer expectations. View our webinar on demand to enhance your understanding of the role of labeling in food safety and protect your consumers with precise, informative product labels.

Want to learn more about food labeling? View our e-book, “Beyond the Label: Six Key Components for Successful Food Labeling.”

FoodChain ID Services and Solutions for the Food Industry

Regulatory Library: Global regulatory reference database providing instant access to current and historical regulations
Regulatory Assessment: Global regulatory reference tool that analyzes products or bills of materials for quick identification of compliance across 220+ countries
Regulatory Trends: Global regulatory and compliance search engine providing market intelligence on enforced regulations, drafts, proposals, scientific & trade journals and more
Ingredient Risk Identification by HorizonScan™: A daily supply chain monitoring system of ingredient and supplier threats for biological, chemical and physical hazards
Recipes & Specifications Solution: A comprehensive solution for managing specifications, suppliers, recipes and labels, purpose-built for the food industry
Expertise as a Service: Leverage our renowned global expertise to address challenges and achieve objectives across the industry