The current regulatory landscape
Cannabidiol’s (CBD) botanical origins can be sourced from both Cannabis sativa and Cannabis indica. However, hemp is legally defined as a Cannabis sativa plant containing no more than 0.3 percent Tetrahydrocannabinol, commonly referred to as THC or cannabis. THC is well known for its psychotropic side effects considered legal on a state-by-state basis for what is referred to as “medical” and “recreational” use. Until the legalization of the 2018 Farm Bill, there was no distinction in the federal jurisdiction between cannabis and hemp, treating both as schedule 1 substances. The 2018 Farm Bill established the US hemp policy, making hemp federally legal and distinct from its THC counterpart, cannabis.1 Since the recent change in legislation, CBD has gained international interest from the public and a variety of industries such as pharmaceuticals, health and wellness, cosmetics, and nutraceuticals.Paving the way for the future of hemp
As hemp legislation develops internationally, extraction of the hemp plant poses several challenges. A lack of pharmaceutical proficiency and industry-specific innovation when extracting CBD from hemp plant material can result in concentrating THC over the legal limit of 0.3% (w/w) or traces of solvents used in the process within the CBD hemp extract. Simply put, this means that appropriate diligence and careful selection of your CBD extractor and contract manufacturer is of dire importance to remain safe and legal. As a GMP-compliant provider of CBD, Vantage Hemp Co. ensures the purification and THC remediation of all extracts and finished products produced. Vantage verifies all products for potency internally via HPLC equipment and trained lab technicians and further confirms via third-party lab results. Darcie Moran, Vantage’s Quality Assurance Manager, quotes; “The only difference between hemp and cannabis is the concentration of THC that can only be determined by an analytical lab, therefore, a discrepancy in lab results could mean the difference of a successful CBD company or one that is illegal and may require a federal recall. At Vantage, we provide a trusted and legal resource for CBD companies. Our regulatory department is knowledgeable and stays current with the ever-changing hemp/CBD standards for international and state requirements. Laura Eder, our Director of Regulatory Affairs & Quality Assurance, is a prominent regulatory figure in the CBD space as a former consultant for the ACI and a member of several associations including EIHA, DIA, and RAPS. With Vantage, you not only get a quality product but reliability and repeatability for consistency to meet the growing market demands for CBD; and a partnership that will persevere through the ever-changing regulations.” 1https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd-explainer/Laura Eder
Laura Eder has more than 19 years of experience in the life-cycle management of pharmaceuticals and medical devices. She has had her Regulatory Affairs Certificate (RAC) since 2012. Through her time spent in the world of pharmaceuticals, she has developed a comprehensive knowledge and understanding of FDA regulations, as well as worldwide regulations. She has created an outstanding relationship with the FDA's Office of Prescription Drug Promotion (ODPD) for over 15 years submitting websites, commercials, and promotion materials without issue. Early in 2019, she transitioned into the CBD industry as the Regulatory Manager where she helped to guide the company through several significant regulatory milestones. Leading a team to complete ISO 9001:2015, as well as GMP 111 (dietary supplements) and 117 (food) certifications in record time. The audits with SGS were completed in just three months due to her leadership skills, experience and understanding of what would be needed for this industry. Following that Laura started her own consulting business for a short period before joining Vantage. Once she saw the opportunity at Vantage where she could use her pharmaceutical knowledge and experience in the CBD industry she knew it was the perfect relationship. Since being at Vantage Laura has again completed another successful audit. The annual surveillance audit this past February 2022 which was conducted by SGS at the pharmaceutical level and no findings was the final outcome. Laura is looking forward to moving the CBD industry forward ethically and legitimately with transparency to government agencies such as the FDA.
