The U.S. Food and Drug Administration (FDA) established its Human Foods Program Guidance Agenda for 2025 to improve food safety and transparency and support innovation. The two main priorities from the agenda focus on natural food color usage and New Dietary Ingredient Notifications (NDINs) updates, are key components of the FDA’s plan to promote nutritional product development and ensure that new food formulation and development efforts meet the highest standards of quality and safety. These initiatives encourage cleaner labels, better regulatory understanding, and safer product standards for both traditional and innovative food items.
Natural Food Colors, NDINs, and More on FDA’s 2025 Guidance Agenda
Introduction:
The U.S. Food and Drug Administration (FDA) established its Human Foods Program Guidance Agenda for 2025 to improve food safety and transparency and support innovation. The two main priorities from the agenda focus on natural food color usage and New Dietary Ingredient Notifications (NDINs) updates, are key components of the FDA’s plan to promote nutritional product development and ensure that new food formulation and development efforts meet the highest standards of quality and safety. These initiatives encourage cleaner labels, better regulatory understanding, and safer product standards for both traditional and innovative food items.
Natural colours and its sources:
Natural food colors derive from multiple origins which include plant-based ingredients and animal-derived substances and microbial and insect products. The extraction process of natural food colors produces red/pink from beets and yellow from turmeric and green from spinach and blue/purple from spirulina and red cabbage. The extraction process produces different forms of natural food colors which exist as liquids and powders and gels —that contribute to food product innovation while meeting the growing demand for clean-label formulations.
Sources of natural food colors
- Vegetables: Red/Pink: Beetroot, Orange: Carrot, Paprika, Yellow: Turmeric, Green: Spinach, Parsley, Alfalfa grass, Blue/Purple: Purple cabbage, purple carrots
- Fruits: Red/Pink: Raspberry, Pomegranate, Purple/Blue: Blueberry, Blackcurrant, Black grapes
- Spices: Brown: Cocoa, Cinnamon, Coffee, Yellow: Saffron, Turmeric, Orange: Paprika
- Algae and other sources: Blue/Green: Spirulina, Black: Activated Charcoal, Squid Ink
- Insects and animals: Red: Cochineal insects (for carminic acid)
This renewed focus aligns with FDA guidance 2025, where natural alternatives play a pivotal role in food color regulation and compliance with evolving safety standards.
New dietary ingredient notifications (NIDNs):
The FDA requires all dietary supplement ingredients known as NDI to have existed in the U.S. market before October 15th, 1994. The market introduces new synthetic nutrients and minerals which fall under this category.
The FDA needs notification when an NDI entered the U.S. market after October 15th 1994 and when it was absent from food supplies or underwent chemical modifications. The notification process requires companies to present evidence which demonstrates their NDI ingredients are safe for their intended usage. The submission process for notifications needs to start at least 75 days before the product enters interstate commerce. This requirement ensures safer nutritional product development and strengthens food formulation and development for supplements and functional products. [1]
FDA and New dietary ingredient notifications (NIDNs) connections:
- The Federal Food Drug and Cosmetic Act (FD&C Act) demands that manufacturers and distributors who want to market dietary supplements containing new dietary ingredients must submit these ingredients to the Food and Drug Administration (FDA) for review.[2]
- The notification process requires manufacturers and distributors to provide evidence which supports their determination that their dietary supplement with new ingredients will be safe when used as directed on the product labels. This ensures that food product development processes maintain compliance and transparency.
FDAs 2025 guidance Agenda:
The FDA guidance 2025 schedule highlights a progressive approach to food innovation and safety, particularly emphasizing:
The Food and Drug Administration Human Foods Program has established 2025 as the year to complete all priority topics from their agenda. The new topics include three items:[3]
- The FDA published Draft Guidance for Industry about establishing an Action Level for Opiate Alkaloids found in Poppy Seeds.
- The FDA published Draft Guidance for Industry to establish guidelines for using natural food colorings derived from fruit juice and vegetable juice in food products.
- The FDA published Guidance for Industry to explain how to submit New Dietary Ingredient notifications and handle related matters by providing information about NDI identity and safety.
NDIN vs. GRAS Pathways [4]
Feature | New Dietary Ingredient Notification (NDIN) | Generally Recognized As Safe (GRAS) |
Applies to | New dietary ingredients used in dietary supplements | Substances added to conventional foods |
Applicability Date | For dietary ingredients not marketed in the US before October 15, 1994 | Not applicable; GRAS status relies on history of safe use or scientific consensus |
Purpose | Notify FDA of the basis for concluding a new dietary ingredient is reasonably expected to be safe | Demonstrate a substance is safe for its intended use in conventional foods, exempting it from the food additive approval process |
FDA Review | Mandatory: NDIN must be submitted at least 75 days before marketing the supplement | Voluntary: Companies can self-affirm GRAS; optional notification to FDA |
Safety Standard | Must not present a “significant or unreasonable risk of illness or injury” | Must have “reasonable certainty of no harm” under intended use based on scientific evidence or history of safe use |
Information Privacy | NDIN is confidential for 90 days, then public (excluding trade secrets) | Safety data must be publicly available to qualify for GRAS through scientific consensus |
This distinction is essential for companies engaged in nutritional product development or food formulation and development, ensuring the right regulatory pathway for compliance.
New Dietary Ingredient (NDI) notifications
The FDA released clarifying materials and a draft guidance about NDI Master Files instead of granting approval in 2025.
- Educational resources: The FDA published educational videos together with a fact sheet on June 11, 2025, to assist manufacturers in preventing submission errors that result in delayed NDIN processing. The resources provide detailed instructions about submitting a complete notification on time.
- Master files: The FDA released a draft guidance about NDI Master Files in April 2024 which explained how manufacturers can submit confidential information about their NDI products to the agency. The master file submission process becomes more efficient because manufacturers can authorize different clients to use their master file content for their NDIN submissions.
- Broader guidance agenda: The FDA plans to publish a draft document about New Dietary Ingredient Notifications and Related Issues: Identity and Safety Information About the NDI as part of their 2025 guidance schedule.
These actions reinforce FDA’s role in facilitating safe and transparent food product innovation.
Natural color additives
The FDA has established multiple initiatives to support natural food color usage while it works to eliminate synthetic dyes from the market.
The FDA granted approval for three new food colors which derive from natural sources during May 2025.
- The blue color from Galdieria Extract Blue originates from red algae and can be used in beverages and yogurts and candies.
- The Butterfly Pea Flower Extract provides different blue and purple and green shades which work well for tea products and coated nuts and yogurt applications.
- The white mineral-based colorant Calcium Phosphate serves as a food coloring agent for candy coatings and processed meat products.
- The FDA and government have launched a plan to eliminate petroleum-based synthetic dyes from American food products, withdrawing approval for Orange B and Citrus Red No. 2, and requesting manufacturers to remove eight more synthetic dyes by 2026. The FDA plans to publish a draft document on natural food colors.
Simultaneously, the FDA began phasing out petroleum-based synthetic dyes like Orange B and Citrus Red No. 2, accelerating the shift toward sustainable food product development using natural ingredients.
Conclusion:
The 2025 FDA Guidance demonstrates the agency’s ongoing commitment towards food innovation, food safety, clean-label formulations, and consumer transparency. The prioritization of natural food colors and New Dietary Ingredient Notifications (NDINs) demonstrates the FDA’s advancement of food product innovation, safe consumption innovations, and food product transparency in product development, product formulation, and nutrition.
At Food Research Lab, we do more than develop food products, we take a complete approach that encompasses:
- Regulatory & compliance support, from FDA, EFSA dossier preparation, and submission.
- Ingredient research and sourcing, for GRAS status, purity, and global regulatory limits/review.
- Safety and efficacy studies for evidence-based validation of functional, nutraceutical, and health claims.
- Comprehensive formulation development, from concept to lab-scale and commercialization.
This science-based-regulatory-driven model provides assurance that every new ingredient, formulation, or product claim is fully scientifically validated and compliant with relevant regulatory requirements — enabling brands to advocate and market the safe consumption of good, nutritious foods that build trust with consumers and earn regulatory approval.
The evolving regulatory landscape highlights a new era where transparent, clean-label, and scientifically substantiated formulations provide a competitive advantage in the global food and supplement industries. For detailed guidance on navigating regulatory submissions, safety-efficacy validation, and compliant product development, connect with Food Research Lab — your trusted partner in advancing safe, innovative, and regulation-ready foods and nutraceuticals.
Reference:
- R (n.d.). U.S. FDA New Dietary Ingredient (NDI) Notification. Retrieved October 31, 2025, from https://en.reach24h.com/service/food/us-fda-new-dietary-ingredient-ndi-notification.reach24h
- S. Food and Drug Administration. (2025, June 10). New Dietary Ingredient (NDI) Notification Process. Retrieved October 31, 2025, from https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process.fda
- Food Safety News. (2025, July). New FDA guidance in the works for 2025. Retrieved October 31, 2025, from https://www.foodsafetynews.com/2025/07/new-fda-guidance-in-the-works-for-2025/
- GRAS Experts. (n.d.). What are the differences between GRAS and NDIN? Retrieved October 31, 2025, from https://grasexperts.com/insights/gras/understanding-the-differences-between-gras-and-ndin-a-guide-to-regulatory-compliance/
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