by Charlotte Peyton, Independent Consultant, EAS Consulting Group
The new U.S. Domestic Hemp Program will approve cultivation plans issued by states and Indian Tribes and can approve plans submitted by producers that live in a state or Tribe where plans are not already submitted and where hemp production is not forbidden. According to the USDA website, 28 states and Puerto Rico and U.S. Virgin Islands have had their hemp plans approved by the USDA, 11 states have plans under review, 5 states have obtained a license from USDA, 5 are electing to continue under the 2014 Hemp Pilot Program, Colorado is resubmitting their plan, Alaska is drafting their plan, and Idaho is awaiting state legislation. What is surprising is that some of the biggest hemp growing states, such as Montana (44,910 acres), Colorado (20,330 acres) and Kentucky (18,910 acres) do not yet have their plans approved by the USDA. Montana is choosing to operate under the 2014 Hemp Pilot Program, Colorado is resubmitting their plan to USDA and Kentucky’s plan is still under review.
While there has been a rush to plant hemp by farmers eager to cultivate a high-priced crop with enormous demand, there has not been the same rush to set up extraction facilities. This is a critical step for the manufacture of cannabidiol (CBD) raw material. Hemp must be dried properly before extraction or it will rot so cultivating a plant that is susceptible to rot without an assigned material manufacturer (extractor) is risky. The impact of the differences between hemp and typical crop cultivation for farmers and the lack of extraction companies has been disastrous for some farmers. Hemp must be monitored for THC levels as the crop grows because any hemp harvested with an amount of THC over 0.3% must be destroyed. This is completely different from soy or cotton cultivation. And when the cost of clones to plant in a large field is included, the potential loss increases dramatically.
Then there are the Food and Drug Administration (FDA) hemp/CBD product issues. While there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” There is speculation that dietary supplement FDA rules are imminent but until the FDA makes those rules public, sales of finished product is still illegal.
In a Consumer Update statement revised on November 25, 2019 the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.” Numerous warning letters have been issued by FDA to CBD manufacturers for disease claims about their products. Whether sold as dietary supplements, conventional foods, cosmetics, animal food, so of the violative disease claims include pain relief, anti-inflammatory, diabetes, acne, anxiety, depression, and cancer. For example, one Warning Letter issued by FDA on November 22, 2019, cites 45 diseases. FDA has stated that CBD in products sold as dietary supplements does not meet the definition of a dietary ingredient in the Federal Food, Drug, and Cosmetic Act (321(ff)(B)(i)(ii)). This provision clarifies that a dietary ingredient cannot be a substance that has been approved as an active ingredient in a drug. FDA has approved CBD as an active pharmaceutical ingredient in the drug Epidiolex. Although the FDA is only taking enforcement action on companies making products that contain disease claims, once the disease claim is made the FDA will cite other regulatory enforcement issues. Companies not making disease claims have not been targeted for enforcement yet. Several states, including New York and Oregon, are following the FDA’s lead by banning some products containing CBD, mostly infused food.
In addition to these challenges, there have been a series of class-action lawsuits filed against hemp/CBD manufacturers. These are based on the fact that the FDA has stated hemp and CBD is illegal in food and dietary supplements. The lawsuits claim the plaintiffs suffered economic loss because the products were not dietary supplements according to the FDA. The 11th Circuit Court of Appeals is allowing the consumer injury requirement necessary to sustain a complaint to be satisfied by the allegation that an FDA product is “illegal.” This ruling may open the floodgates for more class-action lawsuits.
All testing of hemp must be performed by a laboratory with a Drug Enforcement Agency (DEA) license. This is because hemp that does not meet the less than 0.3% tetrahydrocannabinol (THC) does not fall under the industrial hemp definition and is still under the jurisdiction of the DEA. A list of U.S.-based licensed laboratories is available on the DEA website and also on the USDA website. Pesticide screening is one of the tests dictated for hemp in the US Domestic Hemp Program. Ten pesticides have been approved for use on hemp by the Environmental Protection Agency (EPA). The latter is a notable step since the EPA could not do this before the removal of hemp from The Controlled Substances Act. Nine of the allowed pesticides are biopesticides and one is a conventional pesticide.
Then there is the matter of CBD as either a full-spectrum oil vs. an isolate. Unlike marijuana flower which is a very popular product, hemp flower is very rarely sold at the retail level. Full-spectrum oil is extracted from the plant, and depending on the solvent used, produces an oil with the same, or close to the same, naturally occurring chemicals from the plant. The oil, therefore, includes all the cannabinoids present along with any terpenes, lipids, or other compounds present in the plant. Full-spectrum oil is a botanical extract and is a dark thick oil. Isolate is produced by separating the constituents of the full spectrum oil by molecular weights or boiling points to have very pure chemicals in the 95%+ purity range. CBD isolate is a white crystalline substance and bears the greatest resemblance to synthetic raw material and at its purest form cannot be distinguished as coming from a plant in the dirt or a synthesized chemical. Full-spectrum oil bears the greatest resemblance to a botanical dietary supplement. It remains to be seen what the FDA will allow in the future.
I believe in this industry and I am rooting for the pioneers who have taken all the risk thus far, but am concerned about the lack of understanding over FDA’s authority particularly as this industry aims to transition to a regulated future. Most don’t understand FDA’s purview or don’t think it applies to them or their products. When that day comes, bringing the hemp industry into compliance with federal regulations will be challenging.
Hemp pioneers deserve to benefit from their labor and the risk they have taken. For those hemp product companies that do not think compliance is worth the effort or cost, there are many FDA compliant human food, animal food, dietary supplement, pharmaceutical, or cosmetic companies that are waiting to take your business…
Charlotte Peyton supports EAS Consulting Group hemp, CBD and hemp clients as well as that of dietary supplement and pharmaceuticals. As an independent consultant she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD. www.easconsultinggroup.com