On this episode of Healthy Happenings, Dr. Holly Lucille speaks with legal expert Justin Prochnow about what the passing of the 2018 Farm Bill means for CBD and the Hemp industry. They discuss the importance of the passing of the Farm Bill for the CBD industry and why it is longer recognized as a Class I substance is so important. This classification change greatly affects other ancillary issues like payment processing, banking, and transporting across state lines. The one thing the Farm Bill did not do is control how the FDA regulates CBD however. Essentially, because of this the Farm Bill does not assure that CBD is legal in all 50 states.

Justin explains that while CBD is a botanical and not very different from other botanicals, the FDA’s position is a very technical provision of the Food Drug and Cosmetic Act that says if the ingredient is the subject of an IND (investigational new drug), then you cannot turn around and use it in a food, beverage and supplement product if it wasn’t first used in a food, beverage and supplement before the IND. The FDA has indicated this with some other ingredients like piracetam where it was investigated as new drug first so it then was not allowed to go into food and beverage. The FDA says that there is no evidence that people were using CBD in food and supplement prior to when GW Pharma investigated it as their main argument.

A common question that comes up is what is the difference between CBD isolate, full-spectrum hemp and/or broad-spectrum hemp. These names boil down to wordsmithing and marketing based on where the product is being sold. Isolate is typically when the majority if not all of it is CBD. In a standard Cannabis Sativa plant, the naturally occurring amount of CBD is about 5% where some industrial hemps can reach slightly higher levels. Companies that promote a full spectrum hemp extract may also be mostly CBD, but they are saying all of the other components like terpenes and CBN are in the formulation as well. This marketing is just sometimes used to stay under the radar of the FDA.

Holly asks Justin what he thinks are the biggest risks of people selling CBD then. He thinks that the FDA is not necessarily the biggest risk and actually the individual state departments are because they can issue a policy saying no CBD in food and beverage like California did for example. This has been seen in states like Texas and Maine as well. In New York recently the Department of Health has been making restaurants pull products with CBD in them off of the shelf citing the FDA’s policy. States red-tagging retailers is proving challenging until the FDA clarifies their position.

For state to state transport, the Farm Bill really helped address this because it’s no longer a Schedule I controlled substance. Some shipments however are being confiscated in transport and tested for the .3% or less of THC content. So for companies selling CBD, they are really starting to make sure that their source product is below that .3% threshold. Justin also shares that we will see CBD in more clinical studies because it was restricted as a Class I substance before the Farm Bill, generally big pharma just had the funds to run studies on it. These issues are the biggest concerns currently as we are experiencing changes in the CBD industry and we look forward to more guidance from Justin as it changes even more in the future.

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Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration, the Federal Trade Commission and other regulatory agencies. This includes the review of product labels, labeling, advertising, websites and other marketing materials. Justin assists companies with responding to governmental and regulatory actions, including FDA inspections and warning letters, FTC Civil Investigative Demands, and ASRC and NAD cases. He prepares and reviews business documents for industry members, including consulting, manufacturing, supply and distribution agreements. Justin and his team also defend industry companies from both governmental agencies and civil litigators in litigation ranging from breach of contract cases to the growing number of class actions alleging false and misleading advertising.

Dr. Holly Lucille, ND, RN serves as the President of California Association of Naturopathic Physicians. Dr. Lucille works at the Los Angeles Free Clinic providing health education, promotion and prevention. Dr. Lucille serves as a Naturopathic physician, an expert on women’s health issues. In her private practice, Healing from Within Healthcare in Los Angeles, California, she specializes in Women’s Wellness. She has extensive education in various modalities, including homeopathy, clinical nutrition, botanical medicine, body and energy work and mind body and lifestyle counseling. She serves as a Member of the Scientific Advisory Board of PhytoPharmica Inc. She serves as a Member of Scientific Advisory Board at EuroPharma, Inc. She serves as a Member of Medical Advisory Board at Integrative Therapeutics, Inc. She served as Member of the Scientific Advisory Board of Enzymatic Therapy, Inc. She serves as Member of Naturopathic Scientific Advisory Committee at Kamedis Bio Herbal Skincare. She is the recipient of the 2004 Southwest College of Naturopathic Medicine Legacy Award recognizing her incredible service and contributions to the naturopathic medical community. She is a Registered Nurse. Dr. Lucille has Doctorate from the Southwest College of Naturopathic Medicine where she received the ‘Daphne Blayden’ award for her ‘Commitment to Naturopathic Medicine.

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