September 2, 2026 | Supplement Industry Insights
Color has always influenced how consumers experience gummies, drink powders, capsules, and other supplement formats. It signals flavor, reinforces brand identity, and helps a product look consistent from one serving to the next.
Color has become an urgent compliance and product-development issue.
FDA’s revocation of FD&C Red No. 3 gives manufacturers of foods, including dietary supplements, until January 15, 2027, to comply. At the same time, regulatory activity, retailer requirements, and consumer preferences are accelerating interest in colors derived from fruits, vegetables, algae, spices, and other sources.
However, changing a product’s color system is rarely a one-for-one substitution. Different pigments respond differently to heat, light, oxygen, pH, minerals, active ingredients, packaging, and storage. In addition, the regulatory authorization for one color may not cover every supplement format.
For supplement brands, the transition requires a coordinated strategy that connects compliance, formulation, sourcing, testing, labeling, manufacturing, and inventory planning.
The regulatory clock is now running for supplement brands that use FD&C Red No. 3. Although FDA originally issued its revocation order in January 2025, objections created uncertainty about whether and when the order would take effect.
That uncertainty has ended.
On August 5, 2026, FDA denied the remaining objections and requests for a public hearing. The agency also removed the administrative stay affecting the revocation.
As a result, the authorization for Red No. 3 in foods, including dietary supplements, ends on January 15, 2027. Ingested drugs have a separate compliance date of January 18, 2028.
This distinction matters because dietary supplements are regulated as a category of food under the Federal Food, Drug, and Cosmetic Act. Therefore, supplement brands cannot rely on the later deadline for ingested drugs.
FDA states that products manufactured before the applicable effective date may remain in the market after that date. Nevertheless, companies need to coordinate raw-material purchasing, production dates, finished-goods inventory, and customer or retailer requirements carefully.
The agency revoked the authorization as a matter of law under the Delaney Clause. That provision prohibits FDA from authorizing a food or color additive found to induce cancer in humans or animals.
The decision involved studies in which high exposures to Red No. 3 produced cancer in male laboratory rats through a rat-specific hormonal mechanism. FDA has stated that this mechanism does not occur in humans, that typical human exposures are substantially lower, and that studies in humans and other animals did not demonstrate the same effect.
Therefore, the revocation should not be described as a new FDA finding that Red No. 3 causes cancer in humans. It is a legal action required by the Delaney Clause based on the animal findings.
This scientific and legal context is important for brands communicating with customers. Claims that overstate FDA’s conclusions could create unnecessary alarm or introduce credibility concerns.
For a supplement brand, compliance involves more than selecting a different red pigment. A complete reformulation project may require:
Color may also enter a product indirectly. A compounded flavor, fruit preparation, coating system, premix, or decorative inclusion can contain a certified color even when the color does not appear as a separately purchased raw material.
Consequently, a reliable audit must extend beyond the top-level formula. Brands should obtain complete composition and regulatory documentation from suppliers rather than relying solely on abbreviated commercial ingredient names.
Red No. 3 is the immediate legal deadline, but a narrowly focused replacement project could leave a brand exposed to another reformulation later.
Federal initiatives, state activity, retailer policies, and voluntary industry commitments continue to increase pressure on petroleum-based certified colors. Not all of those developments carry the same legal force, and brands should avoid assuming that every certified FD&C color is already prohibited. However, the direction of travel is clear enough to support a broader portfolio review.
A strategic audit can identify:
This approach allows a brand to separate immediate legal requirements from longer-term commercial risks.
Not every supplement relies on color to the same degree. A slight shade change in an opaque capsule may pass unnoticed. The same change in a cherry gummy or strawberry hydration powder can alter the consumer’s perception of flavor, freshness, and quality.
Visually driven products should therefore receive the highest priority.
Gummies combine several conditions that can make color reformulation difficult. The color system must tolerate heating, mixing, depositing, setting, drying, coating, packaging, and extended storage.
The formula’s pH also affects pigment behavior. Meanwhile, acids, minerals, botanical extracts, vitamins, flavors, and sweeteners can shift the final shade or accelerate fading.
A natural red color that performs well in a laboratory solution may behave differently in a finished gummy containing citric acid, vitamin C, zinc, botanical extracts, or reducing sugars. The gummy may leave production with the intended shade but become duller, browner, or less uniform during shelf life.
Appearance consistency is particularly important when gummies are visible through a clear or translucent bottle. Consumers may compare pieces within the package and interpret normal color variation as a quality defect.
Capsule products may face less consumer sensitivity to exact shade matching, but they still require application-specific regulatory review.
A color authorized for certain foods is not automatically authorized for capsule shells, coatings, or printing inks. For example, FDA currently permits spirulina extract in coating formulations applied to dietary supplement tablets and capsules, as well as in several other specifically listed food categories. Its authorization is not simply “foods generally.”
Similarly, calcium carbonate may be used to color dietary supplement tablets and capsules, including coatings and printing inks. However, it is not authorized as a color for foods generally.
Brands should review the finished application, not simply the color’s source or reputation.
Powdered supplements create a two-stage color challenge. The dry powder must look acceptable in the package, and the prepared beverage must deliver the intended shade after mixing.
Color performance can change based on:
A color that looks concentrated and attractive in the dry blend may appear weak after dilution. Conversely, a high-intensity powder may produce an unexpectedly dark beverage.
Brands should also evaluate how consumers actually prepare the product. A hydration powder may be mixed into 12, 16, 20, or more ounces of water. The color should remain acceptable across the likely range rather than under one ideal laboratory condition.
Packaging is part of the color system. Light, oxygen, moisture, and temperature exposure continue after manufacturing, so the container can materially affect the product’s appearance at the end of shelf life.
Depending on the formula, developers may need to evaluate:
A clear bottle may strengthen shelf appeal on launch day but expose a light-sensitive pigment throughout distribution and consumer use. Therefore, a successful color transition may require a packaging change as well as a formula change.
Certified synthetic colors are often valued for their strength, reproducibility, and stability. Certification-exempt alternatives can provide attractive shades and support evolving brand preferences, but their behavior depends heavily on pigment chemistry.
Replacing Red No. 3 with “a natural red” is not a complete technical specification. Betalains, anthocyanins, carotenoids, carminic acid, and other pigments have different solubility profiles, shade characteristics, and environmental sensitivities.
In addition, “natural color” is not a single legal category under FDA regulations. The more precise federal distinction is between colors that require batch certification under 21 CFR Part 74 and those that are exempt from certification under 21 CFR Part 73.
Certification-exempt colors may come from plants, fruits, vegetables, algae, insects, minerals, synthetic production, or fermentation. Therefore, “exempt from certification” should not automatically be interpreted as plant-derived or natural.
pH can determine both the shade and stability of a pigment.
Anthocyanins found in materials such as black carrot, purple sweet potato, radish, grape, and other fruit or vegetable sources can change structure as pH changes. They generally produce stronger red shades in acidic conditions, while higher pH can shift the color toward purple or blue and may reduce stability.
This makes anthocyanins potentially useful in acidic gummies and beverages, but the complete formula must be tested. Even a modest pH shift can influence the initial shade and its development over time.
Beet-derived betalains behave differently. They can produce vivid red to reddish-purple shades, but heat, light, oxygen, water activity, and surrounding ingredients can affect their stability.
A broad scientific review of anthocyanins, betalains, carotenoids, and chlorophylls identified temperature, light, oxygen, moisture, pH, metal ions, enzymatic activity, and food-matrix composition as important stability variables.
Some certification-exempt pigments are more heat-sensitive than commonly used synthetic colors. That sensitivity becomes important during gummy cooking, hot filling, drying, agglomeration, coating, and other thermal processes.
The relevant question is not merely whether the color tolerates heat.
Adding a sensitive color later in the process may reduce heat exposure, but that change must remain compatible with mixing uniformity, sanitation, process controls, and commercial equipment.
Light and oxygen can promote oxidation and pigment degradation. As color intensity falls, a product may fade, become brown, or develop uneven coloration.
The degree of risk depends on the pigment, formula, packaging, headspace, and storage environment. Carotenoid colors such as beta-carotene and paprika-derived pigments can also be affected by oxidation, light, temperature, and moisture.
For this reason, an acceptable initial color does not establish an acceptable commercial product. Color measurements should continue through stability testing, ideally using defined instrumental values rather than visual observation alone.
Developers can track parameters such as:
L* for lightness
a* for the red-to-green axis
b* for the yellow-to-blue axis
Total color difference, often expressed as ΔE
Instrumental measurements help distinguish meaningful color change from normal variation and create clearer acceptance criteria for future production lots.
Supplement formulas contain compounds that are often absent from conventional food-color screening models.
Iron, copper, zinc, magnesium, botanical polyphenols, vitamin C, amino acids, acids, flavors, and sweeteners can all influence the final matrix. Some ingredients contribute their own strong colors. Others affect oxidation, ionic strength, pH, water activity, or pigment interactions.
Botanical extracts can create additional challenges because their native brown, green, red, or yellow tones vary by source and lot. A formulation may need greater color intensity simply to overcome the base color of the active blend.
As a result, color testing should take place in the complete formula using representative commercial raw materials. Testing a pigment only in water, syrup, or an unfinished gummy base cannot predict every interaction in the final product.
No. FDA requires color additives to be authorized for their intended uses unless the coloring effect falls within a separate legal exception.
The source name alone does not establish authorization. For example, commercial colors described as black carrot, purple sweet potato, or radish may qualify under the vegetable-juice color listing if they meet its identity and processing requirements. However, a selectively extracted or highly fractionated pigment may not necessarily qualify as “vegetable juice.” 21 CFR §73.260
Grape-derived colors demonstrate why this distinction matters. FDA permits grape color extract for nonbeverage foods, while grape skin extract is authorized for specified beverage applications. A general commercial description such as “grape color” does not provide enough information to determine whether it is appropriate for a gummy, powder, or prepared drink.
Before using any replacement, brands should verify:
In February 2026, FDA announced a new enforcement approach for certain voluntary “no artificial colors” claims. The policy is intended to give manufacturers more flexibility when replacing certified FD&C colors with authorized, certification-exempt alternatives.
The change creates a potential labeling opportunity for supplement brands. However, it does not redefine every certification-exempt color as natural, authorize new color uses, or remove existing labeling requirements.
FDA stated that it intends to exercise enforcement discretion when a food intended for human consumption contains no colors listed in 21 CFR Part 74. Part 74 includes color additives that require FDA batch certification, such as FD&C Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3.
When a product contains no Part 74 colors, FDA does not currently intend to take enforcement action under the false-or-misleading provisions of the Federal Food, Drug, and Cosmetic Act solely because the company uses one of these voluntary claims:
“Made without artificial food colors” or “Made without artificial food coloring”
“No artificial color,” “No artificial colors,” or “No artificial coloring”
“No added artificial color,” “No added artificial colors,” or “No added artificial coloring”
The policy applies to foods intended for human consumption. Because dietary supplements are regulated as a category of food, the policy can be relevant to supplement labeling.
No. FDA’s action is an enforcement-discretion policy for certain voluntary claims. It does not establish a new statutory or regulatory definition of “natural color.”
Under FDA’s existing definition, “artificial color” broadly refers to a material that imparts color to a food, drug, cosmetic, or the human body. Historically, this definition did not distinguish between colors derived from natural sources and other color additives. That created a labeling challenge for companies replacing certified synthetic colors with authorized fruit-, vegetable-, spice-, algae-, or mineral-based alternatives.
The new policy addresses that challenge by focusing the specified claims on the absence of Part 74 certified colors. It does not mean that all Part 73 colors are botanically derived or interchangeable.
For example:
Therefore, brands should use precise language when describing an individual color’s source. A product may qualify for one of FDA’s specified “no artificial colors” claims without every color ingredient meeting a consumer’s assumed definition of “natural.”
No. Every color additive must still have a valid regulatory basis for its intended use.
A manufacturer must confirm that:
For example, a supplier may market a purple ingredient as a naturally sourced grape color. However, FDA treats grape color extract, grape skin extract, and qualifying fruit juice as different regulatory substances with different permitted uses. The phrase “grape color” alone does not establish whether it may be used in a gummy, powder, prepared beverage, or capsule coating.
Similarly, a blue spirulina color remains subject to the application categories listed in its regulation. FDA issued an order in February 2026 that would have expanded spirulina extract to foods generally, but timely objections delayed that expansion indefinitely. Brands must continue to rely on the narrower uses currently in effect.
Not necessarily. The claim should be reviewed against the complete finished-product formula and label.
Colors can enter a supplement through components such as:
If one of these components contains a Part 74 certified color, the product may not fall within FDA’s announced enforcement discretion. Therefore, the review should cover supplier subcomponents rather than only the ingredients shown on the master formula.
Brands should also consider whether another statement on the label changes the claim’s meaning. Images, product names, flavor statements, ingredient callouts, and “clean-label” positioning can collectively create a broader impression than the color claim alone.
For instance, “no artificial colors” is not equivalent to:
“All natural”
“100% natural”
“Made only with plant-based colors”
“Free from synthetic ingredients”
“Colored only with fruit and vegetable juice”
Each statement communicates something different and requires its own substantiation.
The appropriate ingredient declaration depends on the specific color.
Some certification-exempt colors can be declared by common or usual name or with an accepted collective term, subject to the applicable requirements. However, important exceptions exist.
Carmine and cochineal extract must be declared specifically as “carmine” or “cochineal extract.” A general declaration such as “color added” is not sufficient. This requirement helps consumers who may be sensitive to these ingredients identify their presence.
Grape skin extract must be declared by its common or usual name, “grape skin extract,” with “enocianina” optionally following in parentheses. Other color additives may also carry source or naming requirements under their individual listings.
Consequently, the formulation and labeling review should occur together. A technically successful replacement may affect the ingredient statement, front-panel claims, allergen or dietary-positioning expectations, and international versions of the label.
FDA’s list of certification-exempt color additives includes a broad range of possible shades. However, the legal authorization belongs to the specific color additive — not to a general pigment family or source description.
A developer selecting a red color cannot simply choose “anthocyanins” or “beet.” The supplier must identify the regulatory basis for the commercial ingredient, and the finished supplement must fit the permitted use.
Potential red and pink options include dehydrated beets, qualifying fruit or vegetable juice, grape-derived colors, and carmine or cochineal extract. These materials differ substantially in source, processing, permitted use, pH response, heat stability, and dietary-positioning implications.
Dehydrated Beets
FDA defines dehydrated beets as a dark red powder made by dehydrating sound, mature, edible beets. It may be used to color foods generally at levels consistent with good manufacturing practice. However, it cannot be used in a standardized food unless the applicable standard permits added color.
Dehydrated beet color contains betalain pigments. Although these pigments can produce attractive red to reddish-purple shades, developers must evaluate their response to heat, light, oxygen, water activity, and the finished formula.
Fruit & Vegetable Juice Colors
Fruit juice and vegetable juice may be used to color foods generally at levels consistent with good manufacturing practice. These listings can support colors made from sources such as black carrot, purple sweet potato, radish, and various fruits—provided the commercial ingredient meets the applicable regulatory identity.
Under FDA’s regulations, fruit or vegetable juice color must be prepared by expressing juice from mature, fresh, edible material or by water infusion of dried material. It may then be concentrated or dried.
A selectively extracted, highly purified, or differently processed pigment does not automatically qualify as fruit or vegetable juice. Therefore, brands should obtain a supplier’s regulatory rationale rather than inferring authorization from the source name.
Grape-Derived Colors
FDA recognizes more than one grape-derived color, and their uses are not interchangeable.
Grape color extract may be used in nonbeverage foods. FDA specifically defines it as an aqueous Concord-grape pigment solution, or a dehydrated, water-soluble powder made from that solution, prepared from precipitated lees generated during Concord grape-juice storage. It is not authorized for beverage applications.
Grape skin extract, also known as enocianina, is authorized for still and carbonated drinks and ades, beverage bases, and alcoholic beverages. Its authorization does not extend to gummies or other nonbeverage foods generally.
A third possibility is a grape-based fruit juice color that independently meets the identity and conditions of §73.250. Therefore, “grape color” is not a sufficient regulatory description.
Carmine & Cochineal Extract
Carmine and cochineal extract may be used to color foods generally at good-manufacturing-practice levels. They can provide strong red or pink shades and may offer useful stability in some applications.
However, both come from the cochineal insect. As a result, they may conflict with vegan, vegetarian, plant-based, kosher, halal, or consumer-preference requirements. Finished foods must also declare the specific common or usual name in the ingredient statement.
Yellow and orange options include annatto, beta-carotene, paprika, paprika oleoresin, turmeric, turmeric oleoresin, and saffron. Several are authorized for foods generally, but each has its own identity and specifications.
Annatto extract can provide yellow to orange shades. FDA permits it in foods generally at good-manufacturing-practice levels. The commercial ingredient must meet the prescribed identity and specifications, including applicable solvent-residue limits. Its labeling must indicate that the color comes from annatto seed.
Beta-carotene can provide yellow to orange coloration and may be used in foods generally. FDA’s listing covers beta-carotene made synthetically or obtained from natural sources, so supplier documentation is necessary before making a source-specific claim.
Paprika and paprika oleoresin can produce orange to red-orange shades. Both may be used in foods generally. However, paprika oleoresin must comply with FDA’s listed extraction methods and applicable residual-solvent limits.
Turmeric and turmeric oleoresin can provide yellow to yellow-orange shades. Although both are permitted for foods generally, developers should evaluate light stability, staining, flavor contribution, and interaction with the product matrix. Turmeric oleoresin must also comply with its extraction and residual-solvent requirements.
Saffron is also authorized for coloring foods generally. Nevertheless, its cost, flavor, identity-testing needs, and vulnerability to adulteration can limit its practicality as a mainstream supplement color.
Blue remains one of the more technically and regulatorily constrained shades.
Spirulina extract contains phycocyanins as its principal coloring components. Under the authorization currently in effect, it may be used in specified categories that include:
FDA’s February 2026 order would have expanded spirulina extract to human foods generally. However, the agency delayed that order indefinitely after receiving timely objections and a hearing request. The delay did not reverse FDA’s safety conclusion, but it means formulators must continue using the narrower existing authorization.
For supplement development, a gummy may potentially fit the listed confection category, while a powder may fit the beverage-mix or beverage-powder category. Nevertheless, the finished application and commercial ingredient should receive a product-specific regulatory review.
Spirulina’s blue pigment is also sensitive to processing conditions. Heat and acidic pH can destabilize phycocyanin, which can make some hot-processed or highly acidic systems difficult.
Caramel may be used to color foods generally and can produce shades ranging from light tan to dark brown. However, certification-exempt caramel color should not automatically be described as naturally sourced. FDA defines it according to the controlled heat treatment of specified food-grade carbohydrates, with permitted acids, alkalis, and salts
Calcium carbonate is a white powder that can create opacity. Its authorization is much narrower than “foods generally.” FDA permits it for:
Because Intermountain Nutrition does not manufacture tablets, its most directly relevant application is in capsule systems. A gummy application may need to fit the permitted candy category and should receive a finished-product review. Calcium carbonate is not broadly authorized as a white color for drink powders or other foods generally.
Titanium dioxide can also create white or opaque effects and remains federally authorized for foods generally at no more than 1% by weight of the food. However, it is synthetically prepared and does not belong in a table limited to naturally sourced alternatives. Brands should also consider international regulations, retailer policies, and market-positioning expectations before selecting it.
The following table summarizes common possibilities, but it does not replace a review of the specific commercial ingredient and finished application.
| Desired shade | Potential certification-exempt options | Important regulatory limitation |
|---|---|---|
| Red or pink | Dehydrated beets; compliant fruit or vegetable juice; grape color extract; carmine or cochineal extract | Grape color extract is limited to nonbeverage foods. Carmine and cochineal are insect-derived and require specific declaration. |
| Purple | Compliant fruit or vegetable juice; grape color extract; grape skin extract | Grape color extract is for nonbeverage foods. Grape skin extract is authorized for specified beverage uses. |
| Orange | Annatto extract; beta-carotene; paprika; paprika oleoresin | Each ingredient must meet its specific FDA identity. Beta-carotene may be synthetic or naturally sourced. |
| Yellow | Turmeric; turmeric oleoresin; saffron; beta-carotene; annatto | Review flavor contribution, staining, extraction method, residual solvents, light exposure, and shelf-life stability. |
| Blue | Spirulina extract | Current authorization is limited to specific categories. FDA’s broader 2026 authorization remains delayed. |
| Brown | Caramel | Permitted for foods generally, but certification-exempt does not necessarily mean plant-derived or naturally sourced. |
| White or opaque | Calcium carbonate | Authorized for specified applications, including dietary supplement tablets and capsules and certain candies—not foods generally. |
In February 2026, FDA issued an order authorizing a color called beetroot red. Despite the name, the color is not extracted directly from beets. It is produced through controlled fermentation using a genetically engineered strain of Saccharomyces cerevisiae that expresses genes involved in betanin synthesis.
The order would permit beetroot red in human foods generally at good-manufacturing-practice levels, with exceptions for infant formula, certain USDA-regulated products, and standardized foods that do not authorize added color.
However, FDA subsequently delayed the order’s effective date after receiving timely objections. FDA’s regulatory database describes beetroot red as permanently listed while also recording the delayed effective date. Until FDA completes the administrative process, supplement brands should confirm its current legal status before relying on it for commercial production.
A source name is only the beginning of the review. Two ingredients marketed with similar consumer-facing descriptions may rely on different raw materials, processing methods, carriers, pigment concentrations, and regulatory pathways.
Before approving a color for a dietary supplement, brands should obtain:
This verification prevents a common — and potentially costly — mistake: developing a technically successful color system before confirming that the ingredient is authorized for the intended supplement format.
The January 15, 2027 deadline requires brands to manage several overlapping workstreams. Regulatory review must align with formulation, testing, packaging, procurement, production, and inventory plans.
Brands that wait for a final commercial-scale trial may discover that the selected color fades, changes shade, or lacks sufficient supply. A staged process reduces that risk.
Begin by identifying every product that contains Red No. 3. The review should cover both active products and formulas scheduled for future production.
The audit should include:
Brands should obtain written confirmation from suppliers when a component’s full color composition is not visible from its commercial name.
The audit can also identify other Part 74 certified colors. Red No. 3 requires immediate action, while the broader information can support future portfolio planning.
Not every product should enter development at the same time. A prioritization matrix can help allocate R&D and production resources.
High-priority products may include those with:
A high-volume cherry gummy in a clear bottle may require earlier work than an opaque capsule with minimal consumer sensitivity to shade.
The project team should decide what the replacement must achieve.
Questions to resolve include:
An exact visual match to Red No. 3 may require a different pigment blend, higher use level, or more complex stabilization strategy. In some cases, adopting a new but attractive shade may produce a more durable and commercially realistic product.
Before investing in extensive trials, verify that each candidate color is authorized for the intended application.
The review should confirm:
This step is particularly important for spirulina extract, grape-derived colors, calcium carbonate, and other colors with application-specific restrictions.
A color that performs well technically but lacks authorization for the finished format cannot serve as a commercial solution.
Initial screening should use the complete formula with representative commercial raw materials. Water or simplified model systems can help compare pigments, but they cannot reveal every interaction.
Formulators should evaluate:
The team may need to adjust acids, flavors, carriers, opacifiers, antioxidants, or the point of color addition. However, each adjustment should preserve the product’s primary formulation and label objectives.
A bench sample does not reproduce every commercial process condition. Pilot work helps reveal how the color responds to actual equipment, mixing energy, hold times, temperatures, drying, and filling.
For gummies, pilot evaluation may include:
For powders, pilot work may address:
Pilot results should guide the commercial formula and process instructions.
The replacement should be evaluated throughout the intended shelf life. Accelerated testing can identify likely failure modes, but it may not always predict pigment behavior under normal conditions.
The stability plan should consider:
Color can be tracked visually and instrumentally. Establishing L*, a*, b*, and ΔE criteria helps determine whether observed changes remain within an acceptable range.
Importantly, a protective measure should not preserve color while compromising potency, texture, flavor, dissolution, or another critical quality attribute.
If light, oxygen, or moisture drives fading, packaging may provide a more effective solution than increasing the color level.
Potential changes include:
At the same time, the label review should address:
Existing packaging inventory can affect the implementation schedule. Even when the Supplement Facts panel remains unchanged, a new color may require an ingredient-statement update.
The transition plan should account for:
FDA states that products manufactured before January 15, 2027, may remain in the market after the effective date. However, brands must maintain records that establish when the product was manufactured. Retailers or commercial partners may also impose earlier deadlines.
The cutover should therefore use explicit dates for final Red No. 3 purchasing, last compliant production, first revised production, packaging implementation, and customer notification.
The immediate objective is Red No. 3 compliance. The broader opportunity is to establish a more durable color-development system.
Brands can use the project to create:
This foundation can make future product development faster and reduce the risk of repeated reactive reformulation. It also helps teams distinguish between regulatory requirements, retailer expectations, consumer preferences, and technical feasibility.
The Red No. 3 deadline creates an immediate compliance obligation. However, brands can use the project to build a stronger color-development system across the entire product portfolio.
A durable strategy should connect regulatory authorization, supplier qualification, formulation science, manufacturing performance, packaging, and consumer expectations. That foundation can reduce the time and cost required for future launches or reformulations.
Red No. 3 is the certified color with a confirmed federal compliance deadline. Other FD&C colors remain federally authorized for their permitted uses unless FDA takes additional action.
Nevertheless, several forces are encouraging a broader review:
These influences do not carry equal legal weight. A federal prohibition, state requirement, retailer policy, and voluntary consumer preference are different types of constraints.
Brands should document which requirements apply to each product and market. This prevents a commercial preference from being mistaken for a legal mandate—or a binding legal deadline from being treated as optional.
A reusable color platform is a prequalified system designed for a specific supplement format, shade family, and range of processing conditions.
Instead of beginning every product with a new color search, a manufacturer may develop platforms such as:
Each platform can include approved suppliers, target use ranges, processing instructions, stability boundaries, packaging recommendations, and regulatory documentation.
The final formula still requires application-specific review. However, a validated starting point can reduce early-stage uncertainty.
Consumers expect color and flavor to tell the same story. A bright red product may signal cherry, strawberry, watermelon, or fruit punch. Purple may suggest grape, blackberry, elderberry, or mixed berry.
A reformulation that changes the color without considering flavor expectations can create a sensory mismatch. Even when the flavor formula remains unchanged, consumers may perceive it differently because color influences anticipation.
Color and flavor development should therefore address:
If an exact shade match requires excessive cost or creates instability, the brand may be better served by changing the visual direction. A softer botanical shade can still look intentional when it aligns with the flavor, source story, and overall design.
No. The transition creates an opportunity to ask whether added color contributes enough value to justify its cost and complexity.
Some products depend on color for flavor recognition, brand differentiation, or consumer enjoyment. In other products, a lighter or uncolored appearance may be acceptable.
A reduced-color strategy may offer several advantages:
However, removing color can expose the native appearance of botanical extracts, minerals, vitamins, and flavors. That base color may vary between lots or become less attractive over time.
The decision should therefore follow product testing rather than an assumption that “no added color” is always simpler.
Visual descriptions such as “bright red” or “berry purple” leave too much room for interpretation. Lighting, surroundings, packaging, and individual perception can change how a sample appears.
Instrumental color measurement provides a more repeatable standard. Brands may define:
For powders, specifications may cover both the dry product and the prepared beverage. For gummies, measurements may need to account for surface coatings, translucency, thickness, and background.
A numerical standard should not replace visual approval entirely. Instead, it gives quality teams a consistent tool for evaluating whether variation remains within the brand’s acceptable range.
The January 15, 2027 deadline leaves limited time for supplier qualification, reformulation, pilot work, stability evaluation, packaging updates, customer approval, and production scheduling.
Starting early gives brands more room to compare alternatives and make deliberate decisions. It also reduces the risk of accepting a higher-cost or less stable color because the preferred solution cannot be qualified before the cutover.
A well-planned project can do more than remove Red No. 3. It can create stronger color systems, better supplier controls, and a clearer development process for future products.
Color influences product identity, sensory expectations, manufacturing performance, and shelf-life appearance. Changing it requires both regulatory precision and practical formulation experience.
Intermountain Nutrition works with scale-minded supplement brands to develop and manufacture gummies, powders, capsules, stick packs, pouches, and tubs. Our teams can help evaluate color alternatives, support pilot work, assess manufacturability, and prepare revised products for commercial scale.
Food uses of FD&C Red No. 3 — including dietary supplements — must cease by January 15, 2027. Ingested drugs have a separate compliance date of January 18, 2028.
FDA removed the administrative stay affecting the food-use revocation on August 5, 2026.
FDA states that a product manufactured before the applicable effective date may still appear in the market after that date. Therefore, a supplement made before January 15, 2027, may remain in distribution even if it contains Red No. 3.
Brands should maintain records that clearly establish the manufacturing date. They should also check retailer, distributor, state, and customer requirements, which may impose earlier transition dates.
FDA revoked Red No. 3 under the Delaney Clause, which prohibits authorization of a food or color additive found to induce cancer in humans or animals.
The action was based on findings in male laboratory rats exposed to high levels of Red No. 3. FDA states that the rat-specific hormonal mechanism does not occur in humans, typical human exposures are substantially lower, and available evidence does not show that Red No. 3 causes cancer in humans. Therefore, the revocation should be described as a legal action under the Delaney Clause—not a new finding that ordinary Red No. 3 consumption causes cancer in people.
Gummies and flavored powders face some of the greatest technical risk because consumers associate their appearance with flavor, freshness, potency, and product quality.
Other potentially affected components include:
The audit should extend beyond colors purchased as separate raw materials. Red No. 3 may be present within a compounded flavor, premix, or other supplier-provided component.
Yes. A color derived from a fruit, vegetable, spice, algae, mineral, insect, or fermentation process is not automatically permitted in food.
FDA must authorize a color additive for its intended use unless a specific legal exception applies. The applicable regulation may define the ingredient’s identity, manufacturing method, purity specifications, permitted applications, use level, and labeling requirements.
The most accurate regulatory distinction is between colors subject to FDA batch certification under 21 CFR Part 74 and colors exempt from batch certification under 21 CFR Part 73. “Natural color” is a common industry term, but it is not a single FDA regulatory category.
No. Certification-exempt colors include materials from several types of sources and manufacturing processes.
For example:
Brands should verify the origin and production method before making plant-based, naturally sourced, vegan, or similar claims.
FDA stated in February 2026 that it intends to exercise enforcement discretion for certain voluntary claims when a food contains no color additives listed in 21 CFR Part 74.
The specified claims include:
“Made without artificial food colors”
“No artificial color”
“No added artificial colors”
The policy does not authorize a new color additive or a new use. It also does not permit misleading claims. Brands must review the complete formula, including flavors, premixes, coatings, shells, and inks, before determining whether a finished supplement contains a Part 74 certified color.
Not automatically. A color sold with a fruit or vegetable source name must meet the identity and conditions of an applicable FDA color-additive listing.
FDA permits qualifying fruit juice and vegetable juice to color foods generally at levels consistent with good manufacturing practice. However, the listings specify how those ingredients are prepared. A highly purified, selectively extracted, or differently processed pigment may not necessarily qualify as fruit or vegetable juice.
Brands should request the supplier’s regulatory rationale for the exact commercial ingredient.
It depends on the specific grape-derived color.
Grape color extract is authorized for nonbeverage foods. It may be relevant to a gummy but is not authorized for a drink application.
Grape skin extract, or enocianina, is authorized for still and carbonated drinks and ades, beverage bases, and alcoholic beverages. It is not a general-use color for gummies.
A qualifying grape-based fruit juice color may follow a separate regulatory pathway under §73.250. Therefore, the commercial description “grape color” is not specific enough to determine permitted use.
Spirulina extract is currently authorized for specified applications. Those categories include confections, beverage mixes and powders, nonalcoholic beverages, and coating formulations applied to dietary supplement tablets and capsules.
A gummy supplement may potentially fit the confection category, while a drink powder may fit the beverage-mix or beverage-powder category. However, the finished application and ingredient should receive product-specific regulatory review.
FDA issued an order in February 2026 that would have expanded spirulina extract to human foods generally. Timely objections delayed that expansion indefinitely, so the narrower existing authorization remains relevant.
Brands should proceed cautiously.
FDA issued a final order in February 2026 authorizing a fermentation-produced color called beetroot red for human foods generally, subject to several exceptions. Despite its name, the additive is not extracted directly from beets. It is produced using an engineered yeast strain that expresses genes involved in betanin synthesis.
However, FDA subsequently delayed the order’s effective date after receiving timely objections. Brands should confirm its current regulatory status before relying on beetroot red for a commercial supplement.
They can be more sensitive to formulation and processing conditions, but performance varies by pigment and application.
Important variables include:
Anthocyanins, betalains, carotenoids, and phycocyanins do not behave identically. A color should be evaluated in the complete formula and under representative manufacturing, packaging, and shelf-life conditions.
It may, but the financial impact depends on more than the price of the replacement pigment.
Brands should evaluate:
A more expensive but concentrated and stable color may deliver a lower cost in use than a less expensive material that requires a higher dose or protective packaging.
Yes. A successful bench sample does not demonstrate that the color will remain acceptable through manufacturing and shelf life.
Testing should evaluate the finished formula in its intended packaging. Depending on the product, the protocol may include heat, light, oxygen, humidity, pH drift, open-container use, and realistic storage conditions.
Brands should monitor color alongside other critical attributes, including potency, flavor, odor, texture, dissolution, water activity, and microbiological quality.
Sometimes. A reduced-color or no-added-color approach may lower ingredient cost and simplify sourcing.
However, removing color can expose the native appearance of vitamins, minerals, botanical extracts, and flavors. That background color may be brown, green, yellow, gray, or variable between lots.
The uncolored product should still be evaluated for appearance, stability, flavor expectations, packaging compatibility, and consumer acceptance.
Immediately. The January 15, 2027 deadline leaves limited time for auditing, supplier qualification, formulation, pilot batches, stability work, label updates, packaging changes, commercial validation, and inventory cutover.
High-volume gummies, colored powders, complex botanical formulas, and products in clear packaging should receive early attention. Starting now also gives brands more flexibility to compare suppliers instead of accepting the only option available close to the deadline.
U.S. Food and Drug Administration. (n.d.-a). FD&C Red No. 3.
U.S. Food and Drug Administration. (n.d.-b). Final rules and final orders: Color additive petition 3C0323—FD&C Red No. 3.
U.S. Food and Drug Administration. (2025, January 15). FDA to revoke authorization for the use of Red No. 3 in food and ingested drugs.
U.S. Food and Drug Administration. (n.d.-a). Summary of color additives for use in the United States in foods, drugs, cosmetics, and medical devices.
U.S. Food and Drug Administration. (2026, February 5). Letter to the food industry on “no artificial colors” labeling claims.
Cochineal extract; carmine, 21 C.F.R. § 73.100 (2026).
Dehydrated beets (beet powder), 21 C.F.R. § 73.40 (2026).
Fruit juice, 21 C.F.R. § 73.250 (2026).
Grape color extract, 21 C.F.R. § 73.169 (2026).
Grape skin extract (enocianina), 21 C.F.R. § 73.170 (2026).
U.S. Food and Drug Administration. (n.d.-a). Beetroot red: Regulatory status of color additives.
Vegetable juice, 21 C.F.R. § 73.260 (2026).
Annatto extract, 21 C.F.R. § 73.30 (2026).
Beta-carotene, 21 C.F.R. § 73.95 (2026).
Paprika, 21 C.F.R. § 73.340 (2026).
Paprika oleoresin, 21 C.F.R. § 73.345 (2026).
Saffron, 21 C.F.R. § 73.500 (2026).
Turmeric, 21 C.F.R. § 73.600 (2026).
Turmeric oleoresin, 21 C.F.R. § 73.615 (2026).
Food and Drug Administration. (2026, March 24). Listing of color additive exempt from certification; spirulina extract; delay of effective date. Federal Register, 91, 13966–13967.
Spirulina extract, 21 C.F.R. § 73.530 (2026).
Calcium carbonate, 21 C.F.R. § 73.70 (2026).
Caramel, 21 C.F.R. § 73.85 (2026).
Titanium dioxide, 21 C.F.R. § 73.575 (2026).
Wijesekara, T., & Xu, B. (2024). A critical review on the stability of natural food pigments and stabilization techniques. Food Research International, 179, 114011
https://intermountainnutrition.com/wp-content/uploads/2026/09/andrographis.jpg 1200 1200 Larisa Graham https://intermountainnutrition.com/wp-content/uploads/2026/01/IMN-gradient-logo-NEW.png Larisa Graham2026-09-14 09:00:002026-09-14 12:53:59Andrographis for Immune Support https://intermountainnutrition.com/wp-content/uploads/2026/09/stock-formula-elderberry-gummy-07.jpg 1200 1200 Larisa Graham https://intermountainnutrition.com/wp-content/uploads/2026/01/IMN-gradient-logo-NEW.png Larisa Graham2026-09-13 05:27:342026-09-13 06:53:38STOCK FORMULA: Elderberry Gummies for Immune Support https://intermountainnutrition.com/wp-content/uploads/2026/09/propolis-for-immunity-support-17.jpg 1200 1200 Larisa Graham https://intermountainnutrition.com/wp-content/uploads/2026/01/IMN-gradient-logo-NEW.png Larisa Graham2026-09-11 09:00:002026-09-08 04:53:15Inside the Hive: How Propolis Supports Seasonal Wellness
STOCK FORMULA: Berry Biome