In a significant regulatory shift, the U.S. Food and Drug Administration (FDA) has recently moved to restrict the use of FD&C Red No. 3 in food products. This decision has sparked conversations about the safety of color additives and how regulations differ across industries. FD&C Red No. 3, also known as erythrosine, has been the subject of scrutiny for decades due to its potential health risks. Notably, this dye was banned in cosmetics over 30 years ago, yet it remained approved for use in foods until now. Let’s delve into the background of these restrictions and compare the regulatory frameworks for food and cosmetic color additives, while also examining other FD&C dyes that follow similar patterns.
The FDA banned the use of FD&C Red No. 3 in cosmetics in 1990. This decision was based on studies conducted in the 1980s that linked the dye to an increased risk of thyroid tumors in laboratory animals. Specifically, erythrosine was found to disrupt thyroid function in high doses, raising concerns about its safety in products applied directly to the skin. Since cosmetics often come into prolonged contact with the body, the FDA took a precautionary approach and prohibited its use in external applications.
This ban highlighted the FDA’s stricter stance on cosmetic safety compared to food products. In cosmetics, particularly those applied externally, there is a higher risk of prolonged exposure and absorption through the skin. The FDA’s decision to remove FD&C Red No. 3 from the list of approved cosmetic additives was part of its mandate to protect public health from potentially harmful substances.
Despite its ban in cosmetics, FD&C Red No. 3 continued to be used in food products, such as candies, baked goods, and beverages. The reasoning behind this was rooted in differences in exposure routes. When ingested, the dye undergoes metabolic processing that may reduce its potential to cause harm, particularly at the low levels typically used in food. However, recent studies and advocacy efforts have reignited concerns about the additive’s safety, particularly for vulnerable populations like children, who consume more brightly colored foods.
The FDA’s recent decision to restrict FD&C Red No. 3 in foods reflects growing evidence and public pressure to align food safety regulations with modern scientific understanding. However, the U.S. has long lagged behind other nations when it comes to regulating food dyes. Countries in the European Union have banned or restricted many synthetic dyes, including FD&C Red No. 3, opting instead for natural alternatives. This delay in the U.S. has left consumers exposed to potentially harmful substances for decades longer than necessary, raising serious questions about the adequacy of U.S. food safety standards.
FD&C Red No. 3 isn’t the only dye subject to different regulations across food and cosmetics. Several other FD&C dyes highlight the contrasts in safety assessments and approval processes between the two industries. Below are examples:
FD&C Blue No. 1 (Brilliant Blue FCF):
Food: Approved for widespread use in foods and beverages.
Cosmetics: Approved but restricted to externally applied cosmetics. Products that come into contact with mucous membranes, such as lipsticks, are prohibited from using it.
FD&C Yellow No. 5 (Tartrazine):
Food: Approved with labeling requirements due to potential allergic reactions, particularly in individuals sensitive to aspirin.
Cosmetics: Permitted only in external applications; use in eye-area cosmetics is not allowed.
FD&C Red No. 40 (Allura Red AC):
Food: Approved as a general-purpose color additive.
Cosmetics: Permitted only in externally applied cosmetics, with similar restrictions for products used on mucous membranes.
Citrus Red No. 2:
Food: Approved for use in coloring the skins of oranges (but not the flesh).
Cosmetics: Completely banned due to toxicity concerns.
FD&C Green No. 3 (Fast Green FCF):
Food: Approved for general use in foods like frozen desserts and beverages.
Cosmetics: Approved only for external application, with strict restrictions to avoid use near sensitive areas like the eyes.
FD&C Yellow No. 6 (Sunset Yellow FCF):
Food: Widely used in baked goods, cereals, and snacks.
Cosmetics: Limited to external applications due to concerns about potential allergic reactions and mild toxicity in prolonged exposure.
The differences in regulations stem from the distinct ways in which these products interact with the body. For food additives, the primary concern is ingestion and the ability of the digestive system to process and eliminate chemicals. In cosmetics, the focus is on topical absorption and prolonged exposure, which can have different health implications. The skin acts as a barrier but can still absorb small amounts of chemicals, especially in products designed for long-term use, such as moisturizers or makeup.
Additionally, the cosmetic industry’s regulations are more cautious for products that come into contact with sensitive areas like the eyes or mucous membranes. This explains why certain dyes approved for general food use are prohibited in eye-area cosmetics or lipsticks. In contrast, the U.S. food industry has been criticized for its comparatively lenient stance, often allowing dyes that other nations have banned outright. The reliance on synthetic dyes in foods appears to prioritize cost and aesthetics over consumer health.
The recent restriction of FD&C Red No. 3 in foods reflects a growing trend toward harmonizing safety standards across industries. As public awareness of food and cosmetic additives grows, there is increasing pressure on regulatory bodies to ensure consistency and transparency in their decisions. Having a experienced and reputable quality control team goes a long way. However, the U.S. remains far behind many European nations, where stricter regulations have led to widespread bans on synthetic dyes and the adoption of safer, natural alternatives.
While FD&C Red No. 3 may no longer color your favorite candies, its removal marks a victory for consumer safety and a step toward more unified regulations. It also serves as a reminder that the journey toward safer products is an ongoing process, requiring vigilance, research, and advocacy to protect public health across all sectors. The U.S. must do more to catch up with global standards and prioritize the well-being of its citizens over the interests of industry.
