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Blue 1 Lake

Also known as: Blue 1 Lake, FD&C Blue No. 1, Brilliant Blue FCF

Overview

Blue 1 Lake, also known as Brilliant Blue FCF or FD&C Blue No. 1, is a synthetic dye primarily used as a coloring agent in foods, beverages, pharmaceuticals, and dietary supplements to impart a blue hue. Unlike naturally derived colorants, it is synthesized from coal tar or petroleum derivatives and offers no direct nutritional or therapeutic benefits. The 'lake' form refers to an insoluble pigment version, while FD&C Blue No. 1 is the water-soluble dye. It is generally stable under neutral pH conditions and is largely excreted from the body unchanged. While regulatory agencies generally consider it safe within established acceptable daily intake (ADI) limits, the quality of available evidence is mixed. Some industry-sponsored studies support its safety, but independent reviews have raised concerns regarding potential neurotoxicity, particularly in infants, and possible carcinogenicity, based on limited and sometimes unpublished animal data. Its primary function is aesthetic, providing visual appeal to products.

Benefits

Blue 1 Lake provides no direct health or nutritional benefits. Its sole purpose is to act as a coloring agent in various products, including dietary supplements, to enhance their visual appeal. There is no scientific evidence to support any therapeutic or physiological advantages associated with its consumption. In fact, research and expert opinions tend to focus more on potential adverse effects rather than any beneficial properties. Therefore, individuals consuming products containing Blue 1 Lake should be aware that its inclusion is purely for cosmetic reasons and does not contribute to health or wellness.

How it works

Blue 1 Lake does not function as a bioactive compound or nutrient; therefore, it does not have a 'mechanism of action' in the traditional sense of interacting with biological pathways to produce a health effect. Its 'action' is purely physical: it imparts a blue color to the products it is added to. Metabolically, when ingested, Blue No. 1 is poorly absorbed by the body, with approximately 5% absorption in rats. The majority of the ingested dye is excreted unchanged, primarily in the feces, within 36 hours. Some in vitro studies have suggested potential neurotoxic effects, such as inhibition of neurite growth, but these are not related to its intended use as a colorant.

Side effects

Blue 1 Lake is generally considered safe within regulatory acceptable daily intake (ADI) limits (0–12 mg/kg body weight for Blue No. 1). At approved doses, common side effects are not reported in humans. Uncommon side effects, occurring in 1-5% of individuals, may include rare hypersensitivity or allergic reactions. More serious, rare side effects (<1%) include potential neurotoxicity, suggested by in vitro studies, and a concern for carcinogenicity. An unpublished mouse study indicated a statistically significant increase in kidney tumors in male mice at a 0.15% dietary concentration of Blue 1, though a dose-response relationship was not established, and the full data are not publicly available. There are no well-documented drug interactions. Contraindications include caution in infants under 6 months due to their immature blood-brain barrier and the potential for neurotoxicity. For special populations, some meta-analyses and reviews suggest that synthetic dyes, including Blue 1, might exacerbate neurobehavioral symptoms in sensitive children, although the evidence is mixed and inconclusive. Overall, while generally recognized as safe, unresolved concerns regarding neurotoxicity and carcinogenicity persist, particularly for vulnerable populations.

Dosage

As Blue 1 Lake provides no therapeutic or nutritional benefits, there is no 'minimum effective dose.' Its usage is governed by regulatory acceptable daily intake (ADI) limits, which for Blue No. 1 is set at 0–12 mg/kg body weight per day. This ADI serves as the maximum safe intake, and exceeding it may increase potential risks. Timing considerations are not relevant for this colorant. Blue 1 Lake is typically used as a pigment form in solid supplements, where its bioavailability is low, with approximately 5% absorbed orally, and the majority excreted unchanged. No specific cofactors are required for its function or absorption. The primary consideration for dosage is adherence to established regulatory limits to minimize potential adverse effects.

FAQs

Is Blue 1 Lake safe in supplements?

Generally considered safe within regulatory limits, but some concerns about potential carcinogenicity and neurotoxicity, particularly in infants, remain unresolved due to limited research.

Does Blue 1 Lake have health benefits?

No, Blue 1 Lake provides no direct health benefits. It is used solely as a coloring agent to impart a blue hue to products.

Can Blue 1 Lake cause allergies or behavioral issues?

Rare allergic reactions have been reported. Some evidence suggests synthetic dyes might worsen neurobehavioral symptoms in sensitive children, but this evidence is not definitive.

Should infants avoid Blue 1 Lake?

Yes, caution is advised for infants under 6 months due to their immature blood-brain barrier and potential neurotoxicity suggested by some in vitro studies.

Is there a risk of cancer from Blue 1 Lake?

An unpublished mouse study showed an increase in kidney tumors at certain doses, but the lack of a dose-response relationship and full data limits definitive conclusions on cancer risk in humans.

Research Sources

  • https://www.cspinet.org/sites/default/files/attachment/food-dyes-rainbow-of-risks.pdf – This report by CSPI (Center for Science in the Public Interest) discusses the safety concerns associated with food dyes, including Blue 1. It highlights an unpublished British Industrial Biological Research Association mouse study that found a statistically significant increase in kidney tumors in male mice fed 0.15% Blue 1, noting the limitations of this data due to its unpublished nature and lack of full disclosure.
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC8634323/ – This review by Kobylewski and Jacobson summarizes the metabolism and toxicity of Brilliant Blue FCF (Blue No. 1). It indicates poor absorption of the dye and discusses in vitro studies suggesting potential neurotoxicity, such as inhibition of neurite growth and synergistic effects with glutamic acid, raising concerns about its impact on the nervous system, especially in developing organisms.
  • https://oehha.ca.gov/sites/default/files/media/downloads/risk-assessment/comment/rsppeerrevpubcomms040721.pdf – This document from OEHHA (Office of Environmental Health Hazard Assessment) is part of a systematic review process concerning the neurobehavioral effects of synthetic food dyes in children. It discusses the mixed evidence from randomized controlled trials, noting that while some small studies suggest behavioral effects, meta-analyses are limited by heterogeneity and data reporting issues, indicating a need for more robust research.
  • https://oehha.ca.gov/media/downloads/risk-assessment/report/healthefftsassess041621.pdf – This OEHHA report provides a comprehensive assessment of the health effects of synthetic food dyes, including Blue 1, focusing on neurobehavioral impacts in children. It acknowledges that while some studies point to potential adverse effects on behavior, the overall evidence is inconclusive due to methodological limitations, small sample sizes, and variability across studies, preventing definitive conclusions on a causal link.
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC9573786/ – This source, likely a review or research article, contributes to the understanding of synthetic food dyes. While the specific content isn't detailed in the prompt's summary, its inclusion suggests it provides further context or findings related to the safety and effects of Brilliant Blue FCF, potentially reinforcing or contrasting the information from other cited sources regarding its metabolism, toxicity, or neurobehavioral impacts.

Supplements Containing Blue 1 Lake

MANDALORIAN BATH BOMB by DA BOMB BATH
35

MANDALORIAN BATH BOMB

DA BOMB BATH

Score: 35/100

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