Why legalize hemp

One of the FDA-approved drug therapies is Epidiolex, an oral CBD solution that is indicated for the treatment of seizures associated with two rare and severe forms of childhood-onset epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex is the first FDA-approved drug that contains a substance derived from marijuana.

As part of its new drug application, GW Pharmaceuticals submitted three randomized, double-blind, placebo-con-trolled trials as well as nonclinical and clinical studies to demonstrate the low potential for abuse posed by CBD. Apart from product claims, FDA has asserted that CBD products are excluded from the dietary supplement definition because of the clinical investigations of drugs containing CBD, such as Epidiolex.

Under the FDCA, if a substance is authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, then any product containing that substance falls outside the definition of a dietary supplement. Importantly, FDA recently announced that it is considering whether to pass a regulation that would permit the use of a pharmaceutical ingredient in a food or dietary supplement.

Such a move would require that the ingredient satisfy other requirements of the FDCA, including those required for food additives or new dietary ingredients, which could pose a challenge for certain hemp-derived ingredients.

In the meantime, FDA is distinguishing hemp ingredients that do not contain, or contain de minimis levels of, CBD when used in foods. Congress continues to press FDA to facilitate access to products containing hemp-derived ingredients, particularly CBD used in foods and dietary supplements.

Fill out the form below to receive emails highlighting our upcoming programs, early registration savings, and engagement opportunities for the food and drug law community. Please enable JavaScript in your browser to complete this form. An unapproved new drug cannot be distributed or sold in interstate commerce. FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA.

Often such products are sold online and are therefore available throughout the country. 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 also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases. Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved.

At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.

The Center for Drug Evaluation and Research CDER is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug IND and drug approval process see Question FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition.

The agency has, however, approved one cannabis-derived and three cannabis-related drug products see Question 2. FDA relies on applicants and scientific investigators to conduct research. The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition.

The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so.

It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

Has the agency received any adverse event reports associated with cannabis use for medical conditions? The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions.

The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products.

General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA.

Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

Is it legal for me to sell CBD products? It depends, among other things, on the intended use of the product and how it is labeled and marketed. We are aware that state and local authorities are fielding numerous questions about the legality of CBD.

FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application IND that has gone into effect.

There is an exception to section ff 3 B if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

To date, no such regulation has been issued for any substance. Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products.

For example, manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" i. Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices CGMPs and labeling. Is it legal, in interstate commerce, to sell a food including any animal food or feed to which THC or CBD has been added?

Therefore, FDA must consider questions related to good manufacturing practices for CBD products and potential labeling that might be appropriate for these products to address any potential risks to consumers.

FDA has made it a priority to address these questions, and we are working diligently to make progress. However, FDA will only consider creating legal pathways for CBD to be marketed as a dietary supplement or in a food if the Agency is confident that it can develop a framework that addresses safety concerns. Another issue that FDA plans to consider is whether allowing CBD to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds.

Less research into the promise of cannabis-derived compounds and fewer drug approvals in this area would be a significant loss for American patients. The goal of the public hearing was to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

The hearing was attended in person by more than people, with over 2, more viewing it on line, and included presentations from more than speakers, representing a broad and diverse array of stakeholders, including patients, consumers, and their advocacy groups; health care providers; academia; manufacturers, retailers and distributors; agricultural coalitions; and state, tribal, and local government representatives. The public hearing raised many issues, including the need for more and better data regarding the benefits and risks of CBD, concerns related to manufacturing, adulteration, and unlawfully marketed products, and even as simple as the need for consistent terminology related to cannabis products.

We opened a public docket to collect comments as part of the public hearing, and it just closed on July 16, We received 4, comments submitted to the docket, which we have been reviewing. As this issue progresses, we are committed to being transparent with the public about our path forward and providing information that is based on sound science and data. We recognize that hemp producers, the food and supplements industry, the pharmaceutical industry, retailers, academic institutions, patients, and consumers all want and need regulatory certainty in this area.

The Agency has also put out several statements since the passage of the Farm Bill to keep the public informed about the current regulatory landscape and our efforts to consider the appropriateness of potential new pathways for cannabis products 7.

We also maintain a Questions and Answers page on cannabis products to help address questions from the public and our stakeholders 8. We are committed to keep the public updated on this evolving area. FDA recognizes that our approach to regulating hemp products must occur in close collaboration with our Federal, state, tribal, and local regulatory partners.

FDA has strong relationships with these agencies, and we are working closely with them as USDA and states implement the hemp provisions in the Farm Bill. FDA and EPA remain in communication on this issue and plan to further discuss together moving forward. FDA has been working closely with our state, tribal, and local partners to assist them in navigating the regulation of hemp products, including those that contain CBD. A number of states, tribes, and local jurisdiction have enacted various laws that decriminalize or allow different types of cannabis compounds or products under state law.

FDA is also aware that products that contain CBD have become available in these jurisdictions, as well as in jurisdictions that have not enacted any cannabis legalization-related legislation. There is one additional gray area of research moving forward. This will likely require additional guidance from FDA the Food and Drug Administration who oversees drug trials , DEA the Drug Enforcement Administration who mandates that research-grade cannabis be sourced from Mississippi , and NIDA National Institute on Drug Abuse who administers the contract to cultivate research-grade cannabis to help ensure researchers do not inadvertently operate out of compliance.

The Farm Bill has no effect on state-legal cannabis programs. Over the past 22 years, 33 states have legalized cannabis for medical purposes, and over the past six years, 10 states have legalized cannabis for adult use.

Every one of those programs is illegal under federal law, with no exceptions, and the Farm Bill does nothing to change that. That said, many in the advocacy community hope that the reforms to hemp policy under the Farm Bill serve as a first step toward broader cannabis reform. Although I would argue that a soon-to-be-sworn-in Democratic House majority alongside a president with a record of pro-cannabis reform rhetoric is the more likely foundation for broader cannabis reform.

Even CBD products produced by state-legal, medical, or adult-use cannabis programs are illegal products under federal law, both within states and across state lines. This legal reality is an important distinction for consumer protection.

There are numerous myths about the legality of CBD products and their availability. Under the Farm Bill, there will be more broadly available, legal, CBD products; however, this does not mean that all CBD products are legal moving forward. Knowing your producer and whether they are legal and legitimate will be an important part of consumer research in a post Farm Bill world.

Many advocates applaud Leader McConnell for his stewardship of these hemp provisions into the Farm Bill and his leadership on the legislation overall.

That assessment is accurate. Without Mr. And although his position as Senate leader gave him tremendous institutional influence over the legislation, he went a step further by appointing himself to the conference committee that would bring the House and Senate together to agree on a final version. McConnell understood much about this issue.