It is true that hemp policy in the United States has been radically changed by this new legislation. However, some misunderstandings remain as to what exactly this policy change does. The FDA has worked closely with our state, tribal, and local partners to help them regulate hemp products, including those containing CBD. A number of states, tribes, and local jurisdictions have passed various laws that decriminalize or authorize different types of cannabis compounds or products under state law. The FDA is also aware that products containing CBD have become available in these jurisdictions, as well as in jurisdictions that have not passed legislation to legalize cannabis. `(i) a reasonable date on which the hemp producer corrects the infringement negligently; and [1] Text – H.R.2 – 115th Congress (2017-2018): Agricultural Improvement Act of 2018, Congress.gov (2018), www.congress.gov/bill/115th-congress/house-bill/2/text (last visited on 26 December 2018). Many supporters applaud President McConnell for his administration of these hemp regulations in the Farm Bill and his leadership in the legislation as a whole. This assessment is correct. Without Mr. McConnell`s efforts, hemp regulations would never have found their place in the original legislation. And while his position as Speaker of the Senate gave him enormous institutional influence over legislation, he went further by appointing himself to the conference committee that would bring the House and Senate together to agree on a final version. The FDA recognizes that three to five years is a long time to wait for regulatory clarity, especially given the significant public interest in hemp and CBD products in particular.
For this reason, as I will say in more detail later in my testimony, the agency is looking at options to find a solution more quickly and efficiently. In April, the Senate invoked clause 14, skipped committees or debates, and put the bill directly on its calendar. [22] It`s only been seven months since the 2018 Farm Bill removed hemp, which contains low-THC derivatives of cannabis, such as CBD products, from the CSA`s definition of marijuana. I cannot stress enough the importance of this political change. Prior to the passage of the 2018 Farm Bill, the CSA did not distinguish between marijuana and hemp and all cannabis (with a few exceptions, e.g.. sterilized seeds and mature stems of the plant) was a List I substance and was therefore controlled by the Drug Enforcement Administration (DEA). Early interest in clinical research has focused on developing drugs that use THC instead of CBD. Recently, interest in CBD as a drug has increased, and as noted above, in 2018, the FDA approved Epidiolex, a drug used to treat two severe forms of childhood seizures. The 2018 Farm Bill explicitly retained FDA authorities for hemp products. Therefore, hemp products must meet all applicable FDA requirements and standards, just like any other FDA-regulated product. For example, existing FDA agencies apply to foods, dietary supplements, human and veterinary drugs, and cosmetics to hemp products to the extent that these hemp products fall into these categories.
These safeguards help ensure that Americans have access to safe and accurately labeled hemp products, and that patients can count on the effectiveness of these products in the case of drugs. The drug approval process offers significant benefits to prescribers and patients, including those who wish to prescribe or use hemp products for therapeutic purposes. Drug approvals are generally based on appropriate, well-controlled clinical trials that give prescribing physicians and patients confidence in the safety and efficacy of the drug for its intended use. In addition, approved drugs have uniform strength and consistent administration that support an appropriate dosage required to treat patients, especially in patients with complex and serious diseases such as epilepsy syndromes for which Epidiolex has been approved. In addition, patients using an approved prescription drug are under medical supervision to monitor for possible side effects of the drug. But for consumers who buy the types of CBD products that are spreading on the market, these protective factors are usually absent. The passage of the 2018 Farm Bill led to the misconception that all products made from or containing hemp, including those made with CBD, can now be legally sold in interstate trade. The result has been that shop windows and online retailers have flooded the market with these products, many of which have unfounded therapeutic claims.
The FDA has seen CBD in a variety of products, including foods, supplements, veterinary drugs, and cosmetics. As this new market emerges, we have seen significant interest from industry, consumers and Congress. However, amidst the enthusiasm and innovation, the FDA`s role remains the same: to protect and promote public health. In June 2018, the FDA approved the drug Epidiolex4 for the treatment of seizures associated with two very rare and serious pediatric diseases. The approval of this drug was an important milestone for these patients and their families. The active ingredient of this drug is CBD. Based on the approval of this drug and previous extensive clinical research on CBD, CBD cannot be marketed as a dietary supplement, and foods to which CBD has been added cannot be introduced into interstate commerce under the FD&C Act. The provisions of the FD&C Law, which prohibit the addition of an active substance to foods or the marketing of an active substance as a food supplement, provide an exception if the drug was marketed in foods or food supplements before the drug was authorized and before it was the subject of a thorough clinical investigation. The agency is not aware of any evidence that CBD was marketed in foods or supplements before undergoing a thorough clinical trial. Therefore, the FDA has concluded that this exemption does not apply to CBD. «(ii) the requirement for the hemp producer to report regularly to the Ministry of Agriculture or the tribal government on the hemp producer`s compliance with the state or tribal plan for a period of at least the next 2 calendar years.» (A) The Ministry of Agriculture or the tribal government shall immediately notify the hemp producer: «(i) a practice of retaining relevant information on the land on which hemp is produced in the state or territory of the Indian tribe, including a legal description of the land, for a period of at least 3 calendar years; We recognize that hemp growers, the food and supplement industry, the pharmaceutical industry, retailers, academic institutions, patients and consumers all want and need regulatory certainty in this area. The agency has also issued several statements since the passage of the 2018 Farm Bill to keep the public informed of the current regulatory landscape and our efforts to examine the relevance of potential new pathways for cannabis products.7 We also maintain a page with questions and answers on cannabis products to answer questions from the public and our stakeholders8.
We are committed to keeping the public informed about this evolving field. The 2018 Farm Bill significantly changed the regulation of hemp products, and the FDA is fully committed to the work ahead in this area. We are working and will continue to work, quickly and efficiently. We are aware of the great interest and potential of this crop for farmers in the United States. The FDA looks forward to keeping Congress and stakeholders informed of our work to bring eligible hemp products to market through existing regulatory pathways, as well as our efforts to determine whether additional regulatory frameworks are appropriate for products containing CBD. Our work on hemp products will continue to be based on our public health mission and commitment to sound, science-based policies. First, I want to thank my counterparts from the USDA and the EPA, who are also testifying today. The FDA has a close relationship with these agencies, and we work closely with them as the USDA and states implement hemp regulations in the 2018 Farm Bill. Since the 2018 Farm Bill removed hemp from the CSA definition of marijuana, this change could streamline the process for researchers to study certain cannabis derivatives that contain no more than 0.3% THC by dry weight, including cannabinoids such as CBD, which could lead to the development of new drugs from these substances.
In 2017, U.S. retail sales of products containing hemp, including food and beverages, personal care products, household products, and dietary supplements, reached $820 million. Based on current demand, forecasters predict that hemp and CBD will represent a $1 billion industry by 2020. This year`s adoption of the 2018 Farm Bill will certainly boost the production and sales of hemp and CBD. In late 2018, the FDA pursued three hemp seed-derived food products through the agency`s Generally Recognized as Safe (GRAS) process.1 Hemp seeds do not naturally contain cannabidiol (CBD) or THC, which are cannabinoid compounds found in other parts of the cannabis plant.