The Amaranth Name Confusion: Grain vs. Dye
One of the primary sources of confusion surrounding the question, "Is amaranth FDA approved?" stems from the identical name used for two completely different substances. The nutritional amaranth grain (from the Amaranthus plant family) is a gluten-free pseudocereal with a rich history dating back thousands of years. In stark contrast, Amaranth (FD&C Red No. 2) was a synthetic, coal-tar derived azo dye used to color foods, drugs, and cosmetics. The dye was banned by the FDA in 1976 after animal studies raised suspicions about its safety as a potential carcinogen.
This ban did not affect the use of the nutrient-dense amaranth seed, oil, or leaves as food. As an ancient food source consumed for centuries, amaranth grain and leaves are considered generally recognized as safe (GRAS), and therefore do not require the same formal pre-market approval process as synthetic food additives. Manufacturers can, and often do, submit a GRAS notice to the FDA for confirmation, but the ingredient can be used in food products without formal FDA sign-off if it meets the GRAS criteria.
FDA's Regulatory Framework and Amaranth's Status
The FDA regulates food ingredients through a structured process that distinguishes between food additives and GRAS substances. Understanding this framework is key to understanding amaranth's status. A food additive requires pre-market approval through a rigorous petition process to ensure its safety. A GRAS substance, however, is exempt from this requirement because its safety has been established by qualified experts, often through a history of safe use or scientific procedures.
Amaranth grain falls under the GRAS category due to its long history as a food staple. Its use as a whole food ingredient does not necessitate a formal approval process. However, some manufacturers have sought and received confirmation of GRAS status for specific amaranth-derived ingredients, such as vegetable juice colorants from the plant's pigmented leaves. This shows that even within the broad category of amaranth, different applications may be subject to different regulatory considerations.
The Health and Safety of Amaranth Grain
Since the ban on the synthetic dye, the focus has shifted entirely to the health benefits and safety of the natural amaranth pseudocereal. Modern scientific review supports the safety of amaranth grain when consumed in typical food amounts. Studies have highlighted its impressive nutritional profile, high-quality protein, and status as a gluten-free option for those with celiac disease. While it is considered safe for general consumption, some natural compounds, like oxalates, are present in raw amaranth and can cause digestive issues, which is why proper preparation through cooking is recommended.
Amaranth's Potential as a Natural Colorant
The vibrant red and purple pigments found in some varieties of amaranth plants are attracting renewed attention from the food industry as a potential natural colorant. Unlike the banned synthetic dye, these natural pigments are derived directly from the plant. Extracts from amaranth leaves can be used as "vegetable juice" colorants, which are compliant with FDA guidelines and represent a safer, natural alternative to synthetic dyes. This development demonstrates how the industry is adapting to consumer demands for cleaner labels while navigating FDA regulations with safer, plant-based ingredients.
Comparison Table: Amaranth Grain vs. Amaranth Dye
| Feature | Amaranth Grain | Amaranth (FD&C Red No. 2) |
|---|---|---|
| Source | Seeds, leaves, and stems of the Amaranthus plant | Synthetic azo dye derived from petroleum or coal tar |
| Regulatory Status | Generally Recognized As Safe (GRAS) for food use | Banned by the FDA in 1976 as a suspected carcinogen |
| Application | Consumed as a whole food, flour, or oil in gluten-free products, cereals, and baked goods | Formerly used to impart a red color to foods, drugs, and cosmetics |
| Safety | Considered safe for consumption when properly prepared; contains some natural antinutrients that are reduced by cooking | Posed safety concerns due to links to carcinogenicity in animal studies, leading to its ban |
| Nutritional Profile | Rich in protein, fiber, minerals, and vitamins; a complete protein source | No nutritional value; purely a coloring agent |
Conclusion
The confusion surrounding the FDA status of amaranth is a classic case of mistaken identity. While the synthetic coal-tar dye, FD&C Red No. 2, was banned by the FDA in 1976 due to safety concerns, the nutritious and wholesome amaranth grain and leaves remain completely safe for consumption and are considered Generally Recognized As Safe. The regulatory framework correctly differentiates between these two distinct substances. As consumer interest in healthy, gluten-free pseudocereals grows, amaranth continues to flourish, with some of its natural derivatives even emerging as safe alternatives for food coloring, proving that the plant has moved far beyond the shadow of its namesake dye.
Frequently Asked Questions
Is amaranth grain safe to eat?
Yes, amaranth grain is considered safe to eat and is a nutrient-dense pseudocereal. It has a long history of human consumption and is a good source of protein, fiber, and minerals.
Is FD&C Red No. 2 the same as amaranth grain?
No, FD&C Red No. 2 was a synthetic, coal-tar derived red dye that is entirely different from the natural amaranth grain. The two are unrelated apart from sharing a name.
Why was amaranth dye banned by the FDA?
The FDA banned the synthetic dye, FD&C Red No. 2, in 1976 after studies indicated it might be carcinogenic. The ban was a precautionary measure based on concerns about its safety.
What is a GRAS substance?
GRAS stands for "Generally Recognized As Safe". A substance with GRAS status does not require formal FDA pre-market approval because its safety for its intended use has been established by qualified experts based on scientific evidence or common use in food prior to 1958.
How does the FDA regulate natural food ingredients like amaranth grain?
Natural food ingredients like amaranth grain are regulated under the GRAS framework and do not require pre-market approval. Manufacturers are responsible for ensuring the ingredient is safe, and can voluntarily notify the FDA of their GRAS conclusion.
Can amaranth be used as a food colorant today?
While the synthetic dye was banned, extracts from amaranth leaves can be used as natural "vegetable juice" colorants, which are compliant with FDA guidelines for natural food coloring.
Are amaranth supplements regulated by the FDA?
Dietary supplements containing amaranth are regulated by the FDA, but they do not require pre-market approval. Manufacturers are responsible for ensuring the product is safe and accurately labeled.
Keypoints
- Grain is not Dye: The synthetic dye banned by the FDA in 1976 (FD&C Red No. 2) is completely different from the edible amaranth grain.
- GRAS for Grain: Amaranth grain is safe for consumption and is classified as Generally Recognized As Safe (GRAS), exempting it from the more rigorous food additive approval process.
- Ban was for Dye: The FDA ban was specifically for the synthetic, coal-tar-derived color additive due to safety concerns, not the ancient pseudocereal.
- Natural Colorant Options: Natural colorants derived from amaranth leaves, such as "vegetable juice" extracts, are a separate category and can be used in food under FDA regulations.
- Safe When Prepared: While raw amaranth contains some natural antinutrients, proper preparation, such as cooking, makes it a safe and nutritious food choice for most people.
