Health Guidelines

At Balance8 Wellness, we are dedicated to transparency and providing accurate information. The benefits and claims of each ingredient used in BrainMatter® products are based on scientific research and studies. Below are the ingredients in BrainMatter Cognitive and BrainMatter Calm, along with references to studies supporting their benefits.

 

BrainMatter® Cognitive

1. Lion’s Mane Mushroom Extract (Hericium erinaceus)

  • Benefit: Supports cognitive function, memory, and mental clarity.
  • Research: A 2023 pilot study found that supplementation with Lion’s Mane improved cognitive function and mood in healthy young adults.
  • Source: PMC

2. Ginkgo Biloba

  • Benefit: Enhances circulation, focus, and memory.
  • Research: Ginkgo Biloba is a powerful antioxidant that supports circulation, cognitive function, and may reduce inflammation and anxiety.
  • Source: Healthline

3. Magnesium L-Threonate

  • Benefit: Promotes learning, memory, and mental clarity.
  • Research: Studies suggest that Magnesium L-Threonate can enhance learning abilities, working memory, and long-term memory.
  • Source: PubMed

4. L-Tyrosine

  • Benefit: Supports mental performance under stress.
  • Research: Research indicates that L-Tyrosine can improve cognitive performance, particularly in stressful situations.
  • Source: PMC

5. Omega-3 (Algal Oil)

  • Benefit: Supports brain health, cognitive function, and mood balance.
  • Research: Omega-3 fatty acids, especially DHA, are essential for brain function and have been linked to improved cognitive health.
  • Source: Healthline

6. BioPerine® (Black Pepper Extract)

  • Benefit: Enhances nutrient absorption and bioavailability.
  • Research: BioPerine® has been shown to increase the bioavailability of various nutrients, enhancing their effectiveness.
  • Source: Bioperine

7. Vitamin D3 (Cholecalciferol)

  • Benefit: Supports mood balance and cognitive function.
  • Research: Adequate levels of Vitamin D3 are associated with better cognitive function and mood regulation.
  • Source: PubMed

8. Vitamin B12 (Methylcobalamin)

  • Benefit: Supports energy levels and nervous system health.
  • Research: Vitamin B12 is crucial for neurological function and cognitive health.
  • Source: PubMed
 

BrainMatter® Calm

1. Reishi Mushroom Extract (Ganoderma lucidum)

  • Benefit: Supports stress relief, immune function, and restful sleep.
  • Research: Reishi mushroom has been traditionally used for its calming effects and immune support.
  • Source: PubMed

2. KSM-66® Ashwagandha

  • Benefit: Reduces stress, supports emotional balance, and enhances resilience.
  • Research: Clinical studies have demonstrated that KSM-66® Ashwagandha reduces stress and anxiety levels.
  • Source: KSM-66

3. Magnesium Bisglycinate

  • Benefit: Promotes muscle relaxation, better sleep, and stress management.
  • Research: Magnesium Bisglycinate is known for its high bioavailability and efficacy in improving sleep quality.
  • Source: Healthline

4. Montmorency Cherry Extract

  • Benefit: Supports restful sleep and recovery.
  • Research: Montmorency cherry is a natural source of melatonin, aiding in sleep regulation.
  • Source: PubMed

5. L-Theanine

  • Benefit: Promotes relaxation without drowsiness and supports focused calm.
  • Research: L-theanine has been shown to promote relaxation and reduce stress without causing drowsiness.
  • Source: PMC

6. Omega-3 (Algal Oil)

  • Benefit: Supports mood balance and stress management.
  • Research: Omega-3 fatty acids play a role in mood regulation and have been linked to reduced stress levels.
  • Source: Healthline

7. Vitamin B6 (Pyridoxal 5'-Phosphate)

  • Benefit: Supports mood regulation and energy production.
  • Research: Vitamin B6 is essential for neurotransmitter synthesis, influencing mood and cognitive function.
  • Source: MDPI

8. Vitamin D3 (Cholecalciferol)

  • Benefit: Promotes mood balance, immune health, and resilience.
  • Research: Vitamin D3 deficiency has been associated with mood disorders; adequate levels support overall mental health.
  • Source: PubMed
 

About  the FDA

The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of various products, including food, drugs, medical devices, and dietary supplements. The FDA sets and enforces regulations to maintain product quality and consumer safety.

The FDA's Role in the Supplement Industry

  1. Regulatory Classification: Dietary supplements are classified as a category of food, not drugs. This means supplements are intended to support health rather than diagnose, treat, cure, or prevent diseases.
  2. Manufacturing Standards: The FDA enforces Good Manufacturing Practices (GMPs) to ensure supplements are consistently produced and meet quality standards. These practices cover manufacturing, packaging, labelling, and storage.
  3. Pre-Market Requirements: Unlike pharmaceutical drugs, dietary supplements do not require FDA preapproval before being sold. Manufacturers are responsible for ensuring their products are safe and comply with regulations.
  4. Labelling and Claims: Supplement labels must be truthful and not misleading. The FDA monitors claims to ensure they do not suggest the product can diagnose, treat, cure, or prevent diseases, which would classify them as drugs.

By adhering to FDA regulations, we at Balance8 Wellness ensure that BrainMatter® products meet the highest standards for quality, transparency, and safety.