Without regulatory oversight at the federal level, the cannabis industry in the United States has developed through a patchwork of regulations that differ in every state. This has resulted in cannabis industry practices being developed without adequate consideration or protection for public health and safety.

Cannabis legalization at the state level began formally in the United States in 2012, with California establishing a cannabis program for medical use even earlier. Since 2012, nineteen (19) states plus Washington DC have all legalized cannabis for adults over 21 years of age. Thirty-eight (38) states have legalized cannabis for medical use.1 There have been hundreds of legislative bill proposals floated in Congress since. Yet, despite all of this action, little progress at the federal level has been made to date, with the exception of the 2018 Farm Bill. Further, the illicit market continues to grow including in many legalized states. This project neither supports nor opposes legalization. Instead, it seeks to provide a framework that prioritizes public health and safety, should Federal legalization be pursued.

In 2021 alone, despite being in the midst of a global public health pandemic, 43 different cannabis and cannabis-related bills were introduced in Congress.2 However, it is critical to point out that each piece of legislation dealt with separate and specific aspects of the industry, such as banking, de-scheduling, rescheduling, decriminalization, social justice and equity, veterans’ access, minority- and women-owned small businesses, hemp, and Cannabidiol (CBD). None of these bills offered a comprehensive framework that addressed the needs of the cannabis industry as a whole.

Data from the OTC & Pharmaceuticals in the U.S. 2021 special of Statista’s Global Consumer Survey3 shows that 43 percent of Americans have tried cannabis or one of its derivative products like CBD for medical purposes. According to the survey, three in 10 adults consider cannabis/CBD a good alternative to traditional medical products, while 24 percent prefer it over chemical medications. More recent data, collected in a nationwide survey commissioned by SICPA US and conducted by Harris polled Americans to learn whether there is support for the federal government to set standards for cannabis products at the national level. An overwhelming 84 percent of Americans and 84 percent of cannabis users alike are on board with setting federal standards for product safety and quality for U.S. cannabis products.4

Federal involvement and oversight are imperative to the safety of all Americans. The lack of movement at the federal level not only threatens our safety, but also threatens the potential future of the US as a major player in the global cannabis economy.




3 Statista

4 SICPA US June 2022




It is not uncommon for the decades-old stigma related to cannabis, also known by the slang term, marijuana, to obscure a straightforward path for the regulation of cannabis at the federal level. Nor, is it abnormal for cannabis to be pigeonholed into a specific category, such as alcohol or tobacco. However, it is important to remember that many agricultural products, such as corn, have multiple uses—and regulatory pathways—and cannabis is no different. Federal cannabis regulation and legalization would require comprehensive legislation, specific to each regulatory pathway and the regulatory bodies appropriate for each type of use. Further, each specific pathway will require its own set of regulatory adoptions.

In September 2021, the Cannabis Administration and Opportunity Act (CAOA), 5a proposal for the federal legalization of cannabis, was published by congressional Democrats in an effort to collect feedback. This proposed legislation received the most attention of any of the proposed bills. Although only presented in draft form, the measure has shaken up the industry and seemingly stalled movement in Congress. AFDO & FOCUS submitted a formal response, in which we identified critically important public health and safety related concerns that must be considered, as well as the multiple regulatory pathways which will be needed.

What is needed is a simple architecture for cannabis legalization and regulation that addresses all uses of cannabis, including Therapeutic/Psychotropic, Consumer Packaged Goods (CPG)/Food & Beverage, Industrial, and Pharmaceutical. Should legalization be pursued, the entire cannabinoid space must be pragmatically addressed and include extensive educational campaigns. Any acceptable regulatory framework for cannabis in the US must first prioritize the health and safety of all Americans.

Given the staggering amount of unsafe, intoxicating cannabis products flooding the shelves of stores across the country, 6AFDO and FOCUS took immediate action to launch a federal regulatory framework to help resolve this concerning situation.

In early May 2022, the two organizations hosted an initial strategic-development meeting to bring together a small Workgroup to plan the project. The vision for the meeting was to see beyond today, and work together to determine how and what is required to build a comprehensive federal regulatory framework for cannabis in the United States that addresses, product safety, quality, and consistency while balancing economic, equity, and oversite objectives. Before work could begin determining an ideal system would entail, Workgroup Members first had to come to consensus on a number of intrinsic topics, such as: identifying and prioritizing all stakeholder groups and determining the goals of regulation. The work required an open mind, and the Workgroup rose to the challenge.


5 CAOA Draft Bill 2021

6 FDA Delta 8 Announcement

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