Gardenia blue is a natural food colorant made from the fruit of the gardenia jasminoides plant. It is created from an enzymatic reaction and acts as a blue or dark purple colorant in foods, drinks, and cosmetics. The U.S. Food and Drug Administration (FDA) recently approved gardenia blue for food use in the U.S., and it is a safe, plant-based alternative to synthetic dyes. [1] Gardenia blue approval opens opportunities for food product development and food color product formulation in a variety of commercial application.
FDA Approves Gardenia Blue Color Additive for Food and Beverages (21 CFR Part 73.168)
Gardenia blue is a natural food colorant made from the fruit of the gardenia jasminoides plant. It is created from an enzymatic reaction and acts as a blue or dark purple colorant in foods, drinks, and cosmetics. The U.S. Food and Drug Administration (FDA) recently approved gardenia blue for food use in the U.S., and it is a safe, plant-based alternative to synthetic dyes. [1]
Gardenia blue approval opens opportunities for food product development and food color product formulation in a variety of commercial application.
Source: Colour is obtained from the fruit of the gardenia plant, which has also been used in traditional Asian medicine.
Production: Gardenia blue is produced via reaction between genipin (found in the gardenia fruit) and amino acids and generates a deep blue pigment.
Forms – Gardenia blue is available in both liquid and powered form
Uses: Gardenia blue can be used in various applications as a colorant, including: – desserts, candies, and baked goods – beverages that are teas and sports drinks – frozen foods and noodles – cosmetics
Safety and Approval: As a food color additive, the FDA has determined that Gardenia blue is safe for use. Gardenia blue is non-toxic and plant-based and is considered a natural substitute for chemical food coloring.
Gardenia Blue is widely used in nutritional product development, natural food color formulation and innovation, and food product formulation & innovation, providing both functional and aesthetic benefits.
List of Products that Gardenia Colour is Used:
Gardenia blue is used in several products, especially in food and beverage products. It appears in drinks, candy, yogurt and similar applications. It is also used in cosmetic products, pharmaceutical products, and as a natural dye for food. It is stable in food systems that are water-soluble and oil soluble.
Food and Beverages: sports drinks, flavored waters, fruit drinks, teas, sparkling drinks.
Candy: candies, gummies, jellies and icings.
Dairy products: Yogurt, flavored milk, and other dairy free products.
Desserts: Ice cream and other frozen desserts.
Bakery products: cakes, cookies, and specialty baked goods.
Snacks: cereals, coating on snacks.
Other applications Cosmetics: soaps, lotions, shampoos, bath bombs. Pharmaceuticals: as coloring agent for oral medications like pills and capsules to assist with identification.
With its stable blue color and plant-based origin, Gardenia Blue supports innovative food color product formulation and can enhance food product development for clean-label, visually appealing products.
Limit for the Gardenia usage in Food Application:
The amount of gardenia blue color to be used depends on the application, intensity, and regulations in your area. For food products, the use level ranged from 0.005% – 0.5%. Examples of uses in food: The amount of gardenia blue allowable in food is often legally defined by the Food and Drug Administration or local governmental agencies. The legal amounts correspond to “Good Manufacturing Practice”.
China: There are some regulatory documents that define the maximum application use in various food items. [2]
Instant rice and flour products: up to 0.5 g/kg.
Jams and candies: up to 0.3 g/kg.
Other foods: up to 0.2 g/kg.
International food additive companies: May suggest using data from around 0.005% to 0.01% as general use levels.
Research and Development and Testing: Toxicology and safety studies conducted in controlled laboratory systems usually studied much greater doses of gardenia blue to determine safety levels. As an example, one 2025 study conducted in informs rats of the “no-observed-adverse-effect level” (NOAEL), which indicated it was acceptable for rats to consume up to 5.0% of total diet. Note that these concentrations do not represent what is typically done in a consumer product application.
These properties make Gardenia Blue ideal for natural food color formulation and innovation in beverages, candies, desserts, and bakery products.
Product specification and intake value:
Products: Perfect solubility, natural, deodorized, and low odour. The top colour additive for geographic indication protection product in China. Gardenia blue dark blue in appearance. It is easily soluble in water, ethanol solution, propylene glycol solution, but insoluble in organic solvents. The shade colour is stable in a medium with a pH of 4 to 8. It has good heat stability and poor light stability. It has good dye ability in proteins than starch.
Daily intake: Gardenia blue can be used widely in instant rice and flour products, jams, fruit-flavored beverages, beverages of fruit and vegetable juice (pulp), candy, toppings, imitation wine. Instant rice & flour products maximum usage limit is 0.5g/kg, jam and candy is 0.3g/kg, and other food products is 0.2g/kg. [3]
Dietary restrictions: None
Nature application of Gardenia in food:
Function: A natural food colorant from safe, non-toxic for dinking and garment. It was prepared using bioengineering technology.
2: As a powder, it is dark blue in color and is soluble in water.
3: As for the cost of gardenia blue colorant in food, beverages and cosmetics, the cost is not high at 0.005-0.01%.
4: A Blue powder, almost tasteless and odorless, is water soluble in hydrous ethanol and aqueous Propylene Glycol; bright blue, there is no change of color tone at pH 3 ~ 8 range. Heat stabilized; 60 min at 120°C will not fade. Moisture absorption is very low, and light resistance is very poor. This product has strong staining capability of protein. The absorption (at 590nm) is 0.5 (1000 times diluted aqueous solution).
Applications: As a food supplement and natural pigment, it is used widely in the food industry. Can be used in fruit flavored beverages, mixed wine, jams, and candy, pickled vegetables and fried nuts and seeds, convenient rice and noodle products, food products fillings, condiments (other than salt), fruit and vegetable juices and beverages, protein drinks, and solid drinks dry cooked and puffed foods baked and cold foods.[4]
Products Parameters: [5]
Product Name: Gardenia Blue Shelf Life: 12 months
Parameter | Limit | Result |
Sensory Item | ||
Color | Blue to deep purple blue | Complied |
Flavor | Slightly peculiar aromatic odor | Complied |
Appearance | Powder | Complied |
Impurity | No visible impurity | Complied |
Solubility | Water-soluble | Complied |
Physicochemical Item | ||
Color Value E% 1cm 600nm | ≥155 | 156.77 |
Loss on drying | ≤7% | 3.76% |
Arsenic (As) | ≤2.0 mg/kg | Undetected |
Lead (Pb) | ≤3 mg/kg | Undetected |
Conclusion | Qualified | |
Storage | Sealed and store in cool, dark, and dry place |
FDA Study about Gardenia Blue Colour Additive
- The S. Food and Drug Administration (FDA) has authorized gardenia (genipin) blue for use as a color additive in food products, making it the fourth natural-source color approved in the past few months.
- The July 14, 2025, approval allows the color for use in:
- Sports drinks
- Flavored or enhanced non-carbonated water
- Fruit drinks and ades
- Ready-to-drink teas
- Hard candy
- Soft candy
(Usage consistent with good manufacturing practice)
- Gardenia blue is derived from the fruit found in gardenia, a flowering evergreen.
- The FDA approval followed the Gardenia Blue Interest Group’s (GBIG) petition and was granted based on section 721 of the Federal Food, Drug, and Cosmetic Act, which requires all color additives to be reviewed and approved by the FDA before use in food.
- The FDA evaluation process considers:
- Estimated human dietary exposure
- Toxicological evidence
- Relevant literature
to support the determination of “reasonable certainty of no harm.”
- The gardenia blue approval follows the agency authorization in May 2025 of three other naturally derived food colors:
- Guide extract blue (from Galdieria sulphuraria, a type of red algae)
- Calcium phosphate (a white powder)
- Butterfly pea flower extract (producing bright blue, purple, and green hues)
- These approvals correspond to an initiative from the Department of Health and Human Services (HHS) to reduce synthetic, petroleum-based color additives in the U.S. food supply.
- In April 2025, HHS Secretary Robert F. Kennedy, Jr., outlined actions aimed at phasing out such additives, stating:
“Every single day, children are exposed to synthetic chemicals in their food, that have no place in their diet and are threatening to their health.”
- Kennedy emphasized:
“The FDA’s approval of gardenia blue shows we are putting our kids first. Thank you, Dr. Marty Makary, for your courageous leadership on this issue. We are cutting through the influence of the industry and taking action to Make America Healthy Again.” [6]
FDA Approval of Gardenia Blue
Aspect | Details |
Approval Date | July 14, 2025 |
Regulatory Status | Exempt from certification under 21 CFR Part 73 |
Source | Derived from Gardenia jasminoides fruit using genipin |
Uses | Sports drinks, flavored waters, fruit drinks, teas, hard and soft candies |
Allowed Food Categories | Sports drinks, non-carbonated flavored water, fruit drinks, teas, candies |
Regulations & Guidelines | Good manufacturing practices (GMP); safety evaluation includes toxicology and exposure |
Supporting Initiatives | Supports HHS efforts to phase out synthetic dyes, especially FD&C Red No. 3 [7] |
The FDA’s approval supports efforts to phase out synthetic dyes, particularly FD&C Red No. 3, advancing nutritional product development and food product formulation & innovation in safe, plant-based colorants.
Conclusion:
The FDA approval of Gardenia Blue marks a key step toward safer, natural food colorants. Derived from Gardenia jasminoides fruit using genipin, it is now authorized for use in various foods and beverages like sports drinks, flavored waters, fruit drinks, teas, and candies, under strict safety and manufacturing guidelines. This approval supports efforts to phase out synthetic dyes, especially FD&C Red No. 3, enhancing public health by reducing exposure to harmful chemicals. Consumers can trust Gardenia Blue as a stable, plant-based colorant. Leverage our global expertise in natural food color formulation and innovation to bring your safe, plant-based concepts to market with confidence. Visit Food Research Lab to learn more or get started on your next food product formulation & innovation project.
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