WEBSITE UNDER CONSTRUCTION. WE SHOULD BE OPERATIONAL BY THE END OF JANUARY
There is a widespread belief in the hemp/cbd business that the passage of the 2018 Farm Bill last December made hemp CBD legal and opened the doors for all manner of CBD products and interstate commerce in those products. That isn't quite true. CBD is still a Schedule 1 narcotic and the hemp industry is still operating under the very limited terms of the 2014 Farm Bill which allowed for "small scale pilot programs under state and USDA monitoring to study market interest in hemp derived products". The 2018 Farm Bill creates an exception for CBD produced from hemp but only if grown under the State and USDA regulations yet to be issued under the terms of that bill. It is unlikely those regulations will be in place until some time in 2019. And then there is the FDA. The CBD that is "excepted" from the narcotics list will now be regulated by the FDA (Food and Drug Administration) instead of the DEA. The FDA is responsible for basically anything that goes into your body. The FDA is currently taking the position that CBD can not be added to anything that is ingested. No edibles or tinctures. And they feel that making such products is a crime. Finally, though the 2018 Bill says hemp can be transported interstate, it doesn't really explain how local police can easily differentiate between a truck load of hemp and one of marijuana. Which is a big problem.
The Farm Bill does not make CBD legal and unregulated. CBD is still a "Schedule 1 Narcotic" but the Farm Bill makes a limited exception for CBD produced ONLY under the terms of the new Farm Bill, from hemp grown under the regulations to be issued by the USDA under the Farm Bill. Each state will have to come up with a regulatory plan for controlling hemp production and that plan must be approved by the USDA. If a state doesn't create its own regulatory scheme, the USDA will provide general regulations for growing and processing hemp. But until all those regulations are adopted by the states and the USDA, no hemp or CBD is being produced under the new Farm Bill so it is controlled by whatever programs were developed under the previous Farm Bill which provided for limited hemp production to test marketing of hemp products. (When we consider the large acreages of hemp being grown across the country and the huge CBD processing plants which have been built, and the large number of CBD retail products on offer online as well as in many stores, it is pretty obvious that we have stretched the intent of the 2014 "pilot program" law far past what Congress had in mind).
Only hemp and hemp derived products (CBD) produced under the yet to be issued regulations will be allowed to be transported and sold in the US. There does not appear to be any provision for importing hemp grown outside the US because it would not be regulated by the USDA. There is a possibility of trade agreements with other countries that would permit imports of hemp CBD but that is probably some years in the future. Obviously there are CBD products (mostly isolate) being imported now under an interpretation of the 2014 Farm Bill but even that sometimes meets inconsistent treatment by Customs. US Customs has no policy allowing hemp and is likely to seize any shipments they find since it is simply illegal cannabis until proven otherwise.
There are reports of large quantities of hemp biomass being imported to the US from Jamaica, Uruguay, and Columbia as well as from Europe and China. The Ministry of Agriculture in Jamaica reports they have no hemp program but are studying the new US Farm Bill with the idea of developing a cultivation program for export to the US sometime in the future. Uruguay does have a large cannabis program including hemp but have exported a limited amount of hemp only to Switzerland which shares their 1% THC limit on hemp. Uruguay in interested in hemp exports and is also considering how this might be done in the future. Columbia has so far not responded to enquiries about their hemp production, if any. Most hemp grown in these countries, and in Canada, is for seed and fiber using plants with low CBD content. So far, there does not appear to be much if any reality to reports of imported hemp biomass.
WHAT THE FDA SAYS:
So if CBD is produced from USDA regulated cultivation under the 2018 Farm Bill (sometime in the future when there are such regulations), instead of the DEA regulating it as criminal issue, the FDA will have responsibility for any products containing CBD. The FDA made this real clear in a statement issued by the Director, the day following signing of the 2018 Farm Bill (see citation and full statement below).
Basically, the FDA is responsible for determining if a product is first "safe" so it can be used in food, medicine or cosmetics, and second, if the product actually does what is claimed for it (when some health benefit is claimed). They have decided that hemp seed oil and protein is safe and so can be added to food. They have also approved the drug "Epidiolex" for treatment of seizure disorder (which uses CBD sourced from marijuana in the UK). And since they now consider CBD a "prescription drug", under the FD&C Act, they can not allow it to be used in any food product (including tinctures). They do allow that if a manufacturer will do clinical trials to show the safety and effectiveness of CBD in other products, the FDA might approve such use. But until then, any use of any cannabinoids, including CBD is "illegal". No mention in this statement about CBD in cosmetics, topical ointments or pet supplements. As a direct result of this policy statement from the FDA, New York, California and other states have issued bans on CBD in edibles and that is likely to expand to most states in the near future. But even without State bans, CBD in edibles is federally illegal and making, advertising and selling CBD edible products is strictly illegal. Simply putting the standard disclaimer that the product or ad has not been evaluated or approved by the FDA is no defense. It would appear very unlikely that a hemp business can get bank financing or product liability insurance on CBD edibles until this situation changes.
INTERSTATE SHIPMENT OF HEMP:
The 2018 Farm Bill does provide that States and Tribes may not interfer with interstate shipment of hemp. However, as the January 24 seizure and arrests of the driver (charged with a felony) of a hemp carrying truck in Idaho shows, there is a big issue for local police trying to determine if a shipment of cannabis plant material is illegal marijuana or "maybe legal" hemp. This was a shipment of hemp biomass from a farm in Oregon to a processor, Big Sky Scientific, in Colorado. So far the court in the Idaho case has ruled that the Farm Bill does not apply because the crop was not grown under the 2018 Farm Bill since no USDA regulations have been issued yet. And in any case, the driver has to prove that the product is legal hemp. How to do that? At least one court has suggested that having the origin state certify that the material is legal hemp may suffice. However, unless the truck is locked with a "seal", there remains a question of if the material being carried is the batch the origin State certified. And the only way to be sure would be very extensive and expensive testing of that batch. So this process is not really clear at this point.
December 20, 2018
Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.
Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.
We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD). This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act. To help members of the public understand how the FDA’s requirements apply to these products, the FDA has maintained a webpage with answers to frequently asked questions, which we intend to update moving forward to address questions regarding the Agriculture Improvement Act and regulation of these products generally.
In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We’ll also continue to closely scrutinize products that could pose risks to consumers. Where we believe consumers are being put at risk, the FDA will warn consumers and take enforcement actions.
In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.
We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.
These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.
In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.
It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe(GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.
Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.
We’ll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.
At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Hemp biomass stored in Colorado
The primary source of cannabinoids, including cannabidiol or CBD, is the bloom or "bud" of the cannabis plant, also called the "calyx".
Typically the leaves and stems are separated from the calyx, which is dried. That part is then ground or milled to a coarse powder and the CBD oil is extracted using a variety of techniques.
Like many annual plants, cannabis will turn a variety of bright colors in the fall as it ripens for harvest.
We started with a cannabis farm on this beautiful site on the Okanogan River.
New products are coming soon!