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cbd oil farm bill

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 2018 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 three to five years is a long time to wait for regulatory clarity, particularly given the significant public interest in hemp products, and CBD in particular. That is why, as I discuss in greater detail later in my testimony, the Agency is exploring options to reach a resolution more quickly and efficiently.

In December of 2018, the 2018 Farm Bill was signed into law. It removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) (no more than 0.3 percent THC on a dry weight basis), from the definition of marijuana in the Controlled Substances Act (CSA).

Listening to and Learning from Stakeholders

FDA has also received feedback from stakeholders interested in conducting research with cannabis and CBD. FDA is committed to doing what we can to facilitate and preserve incentives for clinical research. We are concerned that widespread availability of CBD in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.

In June 2018, FDA approved the drug Epidiolex 4 for treatment of seizures associated with two very rare and severe pediatric diseases. The approval of this medicine was a significant milestone for these patients and their families. The active ingredient in this drug is CBD. Based on both the approval of this drug, as well as previous substantial clinical investigations of 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 FD&C Act provisions that prohibit adding an active drug ingredient to foods or marketing an active drug ingredient as a dietary supplement contain an exception if the drug was marketed in foods or dietary supplements before the drug was approved and before it was subject to substantial clinical investigations. The Agency is not aware of any evidence that CBD was marketed in foods or dietary supplements prior to it being subject to substantial clinical investigation. Therefore, FDA has concluded this exception does not apply to CBD.

Testimony of Amy Abernethy, Md, Phd., Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health And Human Services
before the Senate Committee on Agriculture, Nutrition, and Forestry

The first priority of the CBD Policy Working Group has been to obtain and assess safety data for CBD, given the Agency’s public health mission. Although FDA has approved one drug, Epidiolex, that contains CBD, Epidiolex is approved for use in a limited population at a specific dose, was studied for safety and efficacy in rigorous randomized clinical trials, and is available only by a prescription from a licensed medical professional. When considering the use of CBD in non-drug products, such as conventional foods and dietary supplements, FDA must evaluate different factors than for a prescription drug product. CBD food and dietary supplement products would be directly available to a wide range of consumers, which could potentially include pregnant or nursing mothers, children, the elderly, those with chronic illnesses, and those taking medications that might interact with CBD. CBD products could also be given to a wide variety of animal species, some of which are used for food. These would also be available without discussions with a doctor or other medical professional. Given this, FDA must consider the potential safety implications of long-term use of CBD by different human and animal populations.

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 2018 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-2018 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. McConnell’s efforts, the hemp provisions would never had found their way into the legislation initially. 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.

Hemp farmers are treated like other farmers

John Hudak

Cannabidiol or CBD is made legal—under specific circumstances

Third, the law outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license or producing cannabis with more than 0.3 percent THC). The law details possible punishments for such violations, pathways for violators to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.

Mitch McConnell, cannabis champion?

There is one additional gray area of research moving forward. Under current law, any cannabis-based research conducted in the United States must use research-grade cannabis from the nation’s sole provider of the product: the Marijuana Program at the University of Mississippi School of Pharmacy’s National Center for Natural Products Research. That setup exists because of cannabis’s Schedule I status.[1] However, if hemp-derived CBD is no longer listed on the federal schedules, it will raise questions among medical and scientific researchers studying CBD products and their effects, as to whether they are required to get their products from Mississippi. 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 includes input and collaboration by many industry groups related to our food supply and production, including the American Farm Bureau Federation, the International Dairy Foods Association, the National Corn Growers Association, the Center for Rural Affairs, the Food Research and Action Center, and several more. SNAP (Supplemental Nutrition Assistance Program, formerly known as “food stamps”) is funded by and falls under the farm bill.

date back to the Great Depression era, with the first farm billing passing in 1933 as part of FDR’s New Deal. The original intention was to financially support farmers during an imbalance of supply and demand and to ensure an adequate food supply if famine or drought should occur.

The 2018 Farm Bill

President Trump signed the 2018 Farm Bill, which for the most part, continued funding and policies that were put into place in the 2014 Farm Bill, with one major exception: the federal legalization of industrial hemp, a crop that is expected to grow into a $20 billion industry by the year 2022.

Congress later passed a more permanent farm bill, known as the Agricultural Adjustment Act of 1938, with a stipulation to review and update the bill every five years. This was again updated in 2008 to what became known as the Food, Conservation, and Energy Act of 2008. There have been multiple revisions of this farm bill since 2008.

Have you heard about the U.S Farm Bill? You might be surprised to learn that when people and news sources refer to the “Farm Bill” they are often referring to the most recent legislation passed regarding a long-standing bill. The most recent Farm Bill (which passed in December of 2018) had a big impact on the cannabis industry, specifically CBD oil and products. Read on to learn more about this key piece of legislation.