CBD (cannabidiol), one of many cannabinoids derived from the plant Cannabis sativa L. (cannabis) has gained great popularity among consumers in recent years. Given the seemingly exponential growth of all categories of consumer products (e.g., foods, beverages, cosmetics, personal care products, dietary supplements, etc.) containing, or claiming to contain, CBD on store shelves, confusion around the legality and safety of these products on the part of consumers and producers alike is understandable.
The confusion is made worse because, although legal in some states, cannabis remains federally illegal. At the same time, the decades-long federal prohibition on hemp production1 was recently lifted. During this dynamic phase of government oversight, businesses and consumers depend on the producers of hemp-derived CBD to deliver quality and safety. Transparency and pharmaceutical-grade quality are the standard operating procedure for Vantage Hemp Co., making it one of the few hemp-derived CBD producers to be pre-emptively prepared for the coming regulatory enforcement.
CBD in Consumer Products
While the 2018 Farm Bill succeeded in federally legitimizing the cultivation of hemp by removing it from DEA oversight, under the FFDCA (Federal Food, Drug and Cosmetic Act) and the PHSA (Public Health Service Act), FDA maintains authority over hemp-derived CBD. Put simply, this means that the hemp-derived CBD found widely marketed and sold as an ingredient in food or beverages, cosmetics, personal care products, and dietary supplements is under FDA jurisdiction and subject to FDA regulation.1 In addition, part of the evidence package that the FDA can use to evaluate the safety, efficacy, and provenance of a drug is the Drug Master File (DMF).2
The continued ambiguity around the legality of hemp-derived CBD in consumer products has led to confusion for producers and consumers alike. Inconsistent rules – or no rules at all – in individual states have created problems for producers and endangered public health. Indeed, since 2019, Congress has been requesting that the FDA clarify its position regarding hemp-derived products, and thus establish some legal surety for producers and consumers across the country.
New in 2022
The 2022 omnibus spending bill signed by President Biden in March has tasked the FDA with setting CBD enforcement policies within 90 days of the package’s adoption – these policies would be in effect pending the establishment of “a process for stakeholders to notify the FDA of use of CBD in products that include safety studies for intended use per product and makes a determination about such product,” under language inserted by the Senate appropriations committee.3
The FDA is authorized to run clinical trials on foods, drugs, dietary supplements, food additives, and cosmetics, but the agency has failed to invest in CBD research. Through this 2022 bill, President Biden has clarified that the FDA must establish safety and efficacy data for CBD through internal and external research and clinical trials.
The Vantage Advantage
DMFs submitted to the FDA can be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs and ingredients.4
Vantage is one of the select few producers to be submitting DMFs for all its hemp-derived CBD ingredient formats to the FDA, thus establishing itself as a transparent partner to both clients and regulatory bodies. Vantage’s engagement of the FDA through the submission of DMFs is exactly the type of collaboration that the President and Senate expect from industry leaders. In addition, through its submissions, Vantage has made clear its confidence in the robustness and reproducibility of its processes and procedures, providing the solid foundation pharmaceutical clients need when applying for FDA approval of their drug product(s).
“We have worked extremely hard to be the first CBD company to finalize equipment qualifications, process validations, and start our stability program for Zones II and IVB in both accelerated and real-time. With Vantage being the first company to file a DMF for Distillate, we plan on paving the path for CBD and FDA recognition. DMFs for Isolate and Full Spectrum Oil submissions will follow soon after. I anticipate my long-lasting relationship with the FDA to continue to grow positively and help to open the dialogue on CBD,” said Laura Eder, Director of Regulatory Affairs and Quality Assurance at Vantage.
Partnering with Vantage in the development of hemp-derived CBD for all types of products, especially pharmaceuticals, ensures legal protection and communication consistency throughout the approval process meeting the high level of compliance, quality and reproducibility required by all global regulatory bodies.
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.