New Congressional CBD Bill Introduced to Give Policy Clarity for CBD Products

Congress has introduced the bi-partisan CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.” The bill is sponsored by U.S. Representatives Rice (NY-04), Griffith (VA-09), Craig (MN-02), and Crenshaw (TX-02).

According to the bill’s press release: 

“While the 2018 Farm Bill removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, it did not make changes to existing Food and Drug Administration (FDA) law or regulatory policies governing its use in FDA-regulated products. Since then, the market for CBD products has exploded, and CBD is ubiquitously available to consumers in oils, cosmetics, supplements, and foods, and it is even marketed in products for pets. The discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated – and considered illegal – by FDA. 

The bipartisan CBD Product Safety and Standardization Act would allow FDA to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure accountability. It also charges the agency with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use. This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling, and claims, and it will bring safety and clarity to the market.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

New Lanton Law Webinar on December 4th with the American College of Apothecaries (ACA)

We have a new webinar on December 4, 2019 via the American College of Apothecaries (ACA) on CBD.

Cannabidiol (CBD) products are flooding the market at an alarming rate. Many consumer stakeholders are excited about this new product line, while providers such as pharmacies, natural health food stores, and other retailers are casting a watchful eye; torn between developing market strategies to meet demand while also watching for state and federal regulatory oversight. This webinar will discuss the various aspects of CBD regulations and market trends to give stakeholders a better understanding of the CBD environment for patient and market opportunities.

Register at: https://ce.ppsinc.org/index.cfm?pg=semwebCatalog&panel=showLive&seminarid=10631

Cannabidiol Made Simple

This article appeared in Specialty Pharmacy Times.

Cannabidiol (CBD) has certainly drawn significant attention over the past few months. Marked by the recent passage of the Farm Bill and the FDA’s hearing on CBD at the end of May, the curiosity about and demand for the products have never been stronger. Unfortunately, misinformation on the effects of CBD remains rampant, including details on whether combining CBD with food affects the body’s absorption and conflicting reports on the various differences in state regulation.

This article examines the basis of CBD use in health care along with the recent major regulatory discussions surrounding this emerging trend.

Market Trends
Market projections for CBD have varied widely. A study by cannabis investigators BDS Analytics and Arcview Market Research projected the collective market for CBD sales to exceed $20 billion in the United States by 2024. The study also showed that US retail sales of CBD consumer products in 2018 were between an estimated $600 million and $2 billion. The investigators estimated that CBD products could generate approximately $16 billion in retail sales by 2025.1

What Is CBD?
According to the FDA, “Cannabis is a plant of the Cannabaceae family and contains more than 80 biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class ‘Marihuana’ (commonly referred to as ‘marijuana’) [21 U.S.C. 802(16)].”

The FDA classifies marijuana as a schedule I drug under the CSA because of a high potential for abuse, largely attributable to the psychoactive effects of THC and a lack of agreement on acceptable medical use in the United States.2

CBD Regulation
The passage of the 2018 Farm Bill, also known as the Agriculture Improvement Act of 2018, reauthorized many expenditures from the Agricultural Act of 2014. Enacted on December 20, 2018, the law deemed hemp a legal substance and set the THC threshold of CBD products to 0.3% on a dry weight basis.2

Most important, the law maintains the FDA’s authority to regulate cannabis and its derivatives, as any product claiming therapeutic benefits derived from CBD requires FDA approval for its intended use before going to market. The Farm Bill stated that significant shared state–federal regulatory power over hemp cultivation and production will be instated. State departments of agriculture must consult with their governors and chief law enforcement officers to devise a regulatory plan to submit to the secretary of the US Department of Agriculture (USDA) for approval. Hemp cultivators in states that opt not to devise a program will need to apply for licenses and comply with a federally run program constructed by the USDA.

Before the passage of the Farm Bill, CBD took a major step forward with the FDA approval of Epidiolex. On June 25, 2018, the oral solution was approved for the treatment of seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years and older. This was the first FDA-approved drug containing a purified substance derived from marijuana. It was also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.3

What is happening in state legislatures? Thirty-four states, the District of Columbia, Guam, Puerto Rico, and the US Virgin Islands have approved comprehensive medical marijuana programs, and 12 states allow the use of products containing low THC and high CBD for medical reasons in limited situations or as a legal defense, according to the National Conference of State Legislatures. Furthermore, as of June 5, 2019, 13 states and territories have approved the adult use of cannabis.4

On May 31, 2019, the FDA held a public hearing to gather information from industry stakeholders on the use of CBD in cosmetics, dietary supplements, and food. The FDA made no new regulatory announcements, as the agency recognized that further discussion is needed before it can determine the appropriate regulatory pathway for these products. This point was emphasized by former FDA Commissioner Scott Gottlieb, MD, who outlined the need for a high-level internal agency to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. He also emphasized the need to find answers to frequently asked questions to help the public understand how the FDA’s requirements apply to these products, as well as next steps for the FDA.

What Is Next for CBD?
Pharmacy professionals should monitor statements from the FDA in the immediate future to see how it intends to regulate CBD. Further, they can glean regulatory insight by examining warning letters, such as the 3 recent warnings the agency sent to companies making unsubstantiated claims regarding the ability of their products to limit, treat, or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious conditions without sufficient evidence and legally required FDA approval.

The USDA’s Agricultural Marketing Service (AMS) is another place to look for clues to CBD oversight. Earlier this year, the AMS issued a notice to trade over hemp production and cultivation. Cannabis-based stocks such as GW Pharmaceuticals, OrganiGram, Tilray, and the Canopy Growth Corporation could offer further insights into how the FDA will regulate this industry.

However, my closing advice for retailers looking to enter this market is to learn how your hemp products are created, processed, and tested for contaminants, because no uniform standard exists. Lastly, I would advocate for the use of counsel to ensure that the products you wish to sell comply with current FDA regulations and to help you understand the different state regulatory requirements surrounding CBD.

References

1. U.S. CBD market anticipated to reach $20 billion in sales by 2024 [news release]. Boulder, CO: BDS Analytics; May 9, 2019. bdsanalytics.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024. Accessed June 8, 2019.

2. FDA regulation of cannabis and cannabis-derived products: questions and answers. FDA website. fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers. Updated April 2, 2019. Accessed June 8, 2019.

3. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy [news release]. Silver Springs, MD: FDA. www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms. Accessed June 8, 2019.

4. State medical marijuana laws. National Conference of State Legislatures website. ncsl.org/research/health/state-medical-marijuana-laws.aspx. Published June 5, 2019. Accessed June 8, 2019.