Cannabis Patient Care - March/April 2021

Cannabis Patient Care - March/April 2021

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SPONSORED CONTENT THE ENTOURAGE EFFECT: CANNABINOIDS + TERPENES + FLAVONOIDS In 2016, after taking an interest in cannabis and CBD for its effect on the mind, mood, sleep, and digestion, Jason Mitchell, N.D., founded HempFusion. HF Labs, a division of HempFusion, is a line of CBD+ products designed for licensed practitioners—from primary care physicians and chiropractors to naturopaths, nutritionists, osteopaths, and more. "Practitioners and independent pharmacists are faced with a high demand from patients but with little clinical data available to understand application contraindication and drug adverse interactions," said Nancy Angelini, director practitioner division at HempFusion, Inc. "So, the biggest struggle for CBD in the licensed professional channel is practitioners are looking for companies who meet FDA compliance and are working to have a body of data about CBD, from safety to application and clinical use." HP Labs believes in the intelligence of all cannabinoids, so its broad-spectrum products not only feature the famed CBD, they also feature other cannabinoids, terpenes, flavonoids, fatty acids, and phospholipids and less than 0.017 of THC. "We don't want an isolate of CBD," Angelini said. "We want as many of the cannabinoids as possible in the final extraction." Plus, HP Labs has a host of certifications, including USDA organic and EU certified organic, self-affirmed GRAS, as well as a national drug code (NDC) for the HempFusion topicals and NOAEL (no observed adverse effect level). "We are exquisitely aware of the importance of meeting FDA regulatory compliance for both our raw materials and finished products," Angelini said. "Our quality assurance certificates are available through our website by lot number, and we use a proprietary blend of DNA- verified industrial hemp that is unique to us." Grown in the same region of Poland for more than 400 years, the DNA-verified hemp plants it uses are sourced from a microclimate that only grows these genetic strains of hemp plants, meaning there are no competitive strains in the region. "Our products feature a proprietary panoramic hemp extract from the heirloom strains Fidora, Futura 74, Seneca, Bialobrzeski, and Wojko," Angelini said. "When we combine these strains together, we get the array of cannabinoids we're looking for—CBD, CBG, CBN, CBC, etc.—and good amounts of flavonoids that are excellent co-factors in the final product." Additionally, HP Labs' extraction process uses supercritical CO2 extraction using time of flight mass spectrometry (TOFMS) in order to standardize the end product, so there is minimal deviation from lot to lot. To validate its CBD blends, HP Labs participated in the Valid Care human safety study and a company-backed pilot study in 2020. To test for liver toxicity, eight different CBD brands, including HP Labs, participated in a human safety study in which CBD was administered among 839 consumers. More specifically, HP Labs' flagship 20 mg CBD product was distributed to over 125 participants. Although the data has yet to be published, the preliminary results are positive. In the 2020 pilot study, conducted with Inflammatory Markers Laboratory, 19 subjects supplemented HF Labs' 20 mg CBD capsules twice daily. After three days, 14 of the 19 subjects experienced a 16% reduction in thromboxane A2, an inflammatory enzyme. HP Labs is also participating in two CBD clinical trials, set to start in 2021, one on cardiovascular markers and the other on its effect on post-infection malaise. HP Labs will continue to substantiate its products through science, transparency, and uncompromising adherence to regulatory standards. In a nutshell, "Radical transparency is woven into our company DNA," founder Dr. Mitchell said. "We radically disclose farming, extraction, manufacturing, testing and validation methods in order to create a solid bond of trust with practitioners." For more information, visit Cannabiome.com.

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