CBD Provider NuLeaf Naturals Appears Before FDA in Support of Industry Regulation and Standards
On May 31, NuLeaf Naturals representative Crystal Guess was one of 140 individuals to testify in a groundbreaking public meeting called by the Food and Drug Administration (FDA). In light of the 2018 Farm Bill, which federally legalized the hemp crop and its derivatives, the FDA held an open forum in an effort to gain more information about the safety, efficacy, and research surrounding cannabidiol (CBD). In the interest of public safety, the FDA intends to create industry standards around the manufacturing, packaging, dosing, and marketing of products containing CBD.
In this first-of-its-kind all-day public meeting, the FDA heard testimony on CBD-related topics from a broad range of representatives including academia, growers, consumers, health professionals, manufacturers, patients, public safety, retailers, distributors, and more. According to the Brightfield Group, the CBD industry has the potential to build to $22 billion by the year 2020. But without consistent regulatory standards throughout the U.S., this puts consumers at risk from fly-by-night producers of new CBD products.
During the FDA public meeting, Guess used one such example to illustrate the need for FDA regulation. She suggested some manufacturers may be advertising their product as “full spectrum CBD,” whereas this could be an entirely false claim. According to the company’s website, the full spectrum CBD oil manufactured by NuLeaf Naturals contains high concentrations of CBD as well as other beneficial cannabinoids such as CBC, CBG, CBDA, and CBDV. Additionally, NuLeaf Naturals’ products are lab-verified upon extraction, then tested again by a third-party lab to confirm CBD levels, and to ensure the absence of pesticides, herbicides, mold, fungi, heavy metals, and mycotoxins. This additional testing expense is incurred by NuLeaf Naturals because of the company’s commitment to delivering the highest quality product. In other words, testing for contaminants in CBD is not currently required by the FDA, which can create substantial risks for consumers.
Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services also spoke at the FDA meeting and said, “Without the FDA’s guidance and leadership, individual states may carve out their own regulatory exceptions for CBD. We urge the FDA to resolve the statutory issues and properly establish a legal pathway for CBD products to enter the market place.”
FDA principal deputy commissioner Dr. Amy Abernethy summarized the key points from Friday’s public meeting, including a need to “further clarify the regulatory framework to reduce confusion in the market,” to conduct and gather additional scientific research and data on CBD usage on humans and animals, to create labeling standards, safety thresholds for dosing, and quality standards that include lab testing and data analyses.
The FDA regulators have opened a public docket in conjunction with last week’s public meeting. Until July 2, any member of the general public can comment. The FDA is specifically looking for detailed information related to health and safety risks, product quality and manufacturing, and the marketing and distribution of CBD products and additives. Comments can be posted on the official docket here: https://www.regulations.gov/document?D=FDA-2019-N-1482-0001
About NuLeaf Naturals
Founded in 2014 by a group of health-conscious plant medicine aficionados, NuLeaf Naturals is one of America’s top pioneering hemp companies. The company vision is to continue to create cannabinoid wellness products that promote a healthy body and mind and to help people and their loved ones live a happier, healthier life. NuLeaf Naturals CBD oil contains all the synergistic cannabinoids, terpenes, essential oils, and other beneficial phytonutrients of the original plant. The brand is committed to providing the highest quality products in their most pure and simple form.