1. Product Description

• Product Name: CBD Coffee Drops with Piperine (Natura-Clarity)
• Description: CBD Coffee Drops combining the neuroprotective effects of CBD with the neurostimulation properties of coffee oil, enhanced by piperine for maximum bioavailability. Specifically formulated to support mental clarity, focus, and optimal brain function.
• Intended Use: Oral care; designed for sublingual application.
• Physical Form: Liquid, in a 10 ml dark-colored glass bottle with a dosing pipette.
• Packaging: Glass bottle approved by Commission Regulation (EU) no. 10/2011, equipped with a dosing pipette.

2. Product Claims

• Natura-Clarity Series:
  • Provides neuroprotection, mental clarity, and sustained focus through the synergy of CBD, caffeine, and piperine.
  • Scientifically formulated with a synergistic blend of CBD and caffeine to promote a calm alertness, improved focus, and reduced jitteriness often associated with caffeine alone.
  • Innovative blend crafted to support cognitive health by balancing neurostimulation and calming effects.
• Supporting Scientific Evidence:
  • Studies suggest that CBD offers potential neuroprotective benefits through its interaction with the endocannabinoid system, while coffee oil, rich in caffeine, enhances alertness and mental clarity. Piperine further optimizes the bioavailability of these ingredients.

3. Product Safety Report (CPSR)

Part A: Safety Information

• Quantitative and Qualitative Composition:
  • INCI Ingredients:
    • Cannabidiol (CBD) derived from extract or tincture or resin of cannabis
    • Coffea Arabica Seed Oil
    • Piper Nigrum Seed Oil
    • Helianthus Annuus Seed Oil
  • CBD Concentration: 7% CBD concentration (700 mg per 10 ml).
• Physical/Chemical Characteristics and Stability:
  • Store at 15°C to 25°C in a dry, dark, and cool environment.
  • Shelf life: Up to 3 years unopened; use within 12 months after opening.
• Microbiological Quality:
  • Complies with microbiological quality standards for oils.
  • Heavy metal check performed under DIN EN 13657:2003-01 standards.
• Exposure to the Cosmetic Product:
  • Recommended dosage: Start with one drop to assess tolerance and gradually increase if needed.

Part B: Safety Assessment

• Prepared by: Charalambos Georgiou, Chemical Engineer

Safety Assessment for Natura-Clarity CBD Coffee Drops with Piperine

This product contains CBD, cold-pressed coffee oil, and piperine, formulated under stringent quality and safety protocols. Based on available data, it is considered safe with adherence to recommended dosages. The coffee oil is processed in an ISO 22000 and HACCP certified facility. These drops are designed to improve mental clarity and provide balanced energy.

Although CBD is generally well-tolerated, users may experience side effects such as dry mouth, nausea, or drowsiness when exceeding recommended doses. CBD may interact with liver enzymes, potentially affecting medication metabolism.

Manufacturing Process and Quality Control

The CBD and piperine extracts are produced using cold ethanol extraction in a c-GMP compliant facility. Carrier oils and coffee oil are ISO 22000 and ISO 9001 certified. Access to the laboratory is restricted, and all equipment is sterilized before use. Storage is in a humidity- and sunlight-free environment.

Safety Profile and Precautions

CBD does not produce lethal effects and has a favorable safety profile. Users should be aware of potential side effects, including dry mouth and gastrointestinal discomfort, and consult a healthcare provider when combining with medications, especially if sensitive to caffeine. The content of caffeine in the final product is low (below 30mg per bottle).

Conclusion

The Natura-Clarity CBD Coffee Drops with Piperine are produced under stringent quality and regulatory standards, suitable for general use. Users should adhere to usage guidelines and consult a healthcare provider if on other medications or sensitive to caffeine.

References

• Cornelis, M. C., Erlund, I., Michelotti, G. A., Herder, C., Westerhuis, J. A., & Tuomilehto, J. (2018). Metabolomic response to coffee consumption: application to a three-stage clinical trial. Journal of Internal Medicine, 283(6), 544-557. doi:10.1111/joim.12758
• Costenla, A. R., Cunha, R. A., & De Mendonça, A. (2010). Caffeine, adenosine receptors, and synaptic plasticity. Journal of Alzheimer’s Disease, 20(s1), S25-S34. doi:10.3233/JAD-2010-1371
• Liou, G. I., Auchampach, J. A., Hillard, C. J., Zhu, G., Yousufzai, B., Mian, S., & Khalifa, Y. (2008). Mediation of cannabidiol anti-inflammation in the retina by equilibrative nucleoside transporter and A2A adenosine receptor. Investigative Ophthalmology & Visual Science, 49(12), 5526-5531. doi:10.1167/iovs.07-1575
• Salvi, K. (2022, April 12). CBD with caffeine: What’s the benefit? Highline Wellness. Retrieved from highlinewellness.com
• Ross, M. (2024). 5 health benefits of CBD coffee. Dr. Michele Ross. Retrieved from drmicheleross.com