The 2018 US Farm Bill, officially known as the Agriculture Improvement Act of 2018, ushered in a new era for the hemp and hemp-derived cannabinoid industry. By removing hemp from the Schedule I controlled substance list and reclassifying it, the bill laid the foundation for significant growth within the industry. However, the situation has been far from straightforward, with regulatory confusion ensuing, particularly concerning the role of the Food and Drug Administration (FDA) in regulating Cannabinoid and CBD products.

2018 Farm Bill: Key Changes and Impact

De-scheduling of Hemp

The 2018 Farm Bill defined hemp as the plant Cannabis sativa L. and any part of the plant with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent by dry weight. This significant change in definition separated hemp from other cannabis plants and removed it from the Schedule I controlled substances list, thereby legalizing its cultivation and sale at a federal level.

Boom in the Industry

The de-scheduling of hemp led to a surge in hemp cultivation and the production of hemp-derived products, including CBD. Entrepreneurs, farmers, and investors all saw the potential for growth and profit, making hemp one of the most sought-after agricultural commodities.

Hemp-derived Cannabinoids

The bill’s impact extended beyond hemp itself, affecting hemp-derived cannabinoids such as CBD. With the federal legalization of hemp, hemp-derived CBD products became legally accessible to consumers, further propelling the CBD industry.

Continued Confusion: The FDA’s Role

Lack of Regulations

The FDA has been slow to establish clear guidelines and regulations for the production, labeling, and marketing of CBD and other cannabinoid products. This neglect has put manufacturers in a unique position, where they must maintain quality and safety without specific federal guidelines.

A Legal Gray Area

Without FDA regulations, the industry operates in a legal gray area, creating confusion among producers and consumers alike. Some states have filled the regulatory void, instituting their own rules for CBD products, but this piecemeal approach has led to inconsistencies across the country.

THC Compounds: Delta-9 and Delta-8, Regulations and Implications

Delta-9 THC: Allowed in Light Amounts

The 2018 Farm Bill’s definition of hemp includes provisions for delta-9 THC concentrations to not exceed 0.3 percent by dry weight. While this threshold is relatively low, it can still produce intoxicating effects, particularly in certain products. For example, a 5-gram gummy with 0.3 percent delta-9 THC equates to 15 milligrams of THC, an amount that can be intoxicating for some consumers.

This has raised concerns over products that adhere to federal regulations but may still have unforeseen impacts on consumers, leading to calls for better education and potential adjustments to regulation.

Delta-8 THC: A New Controversy

Delta-8 THC, a lesser-known isomer of delta-9 THC, has seen a surge in popularity and accessibility due to the ambiguity in current regulations. Though it is typically present in small amounts in the cannabis plant, it can also be synthesized from CBD, a process not explicitly regulated under the 2018 Farm Bill.

Availability and Quality Concerns

Delta-8 THC is currently sold in various forms at gas stations, smoke shops, and online platforms. The widespread availability and low regulation have led to issues with quality control. Poor quality products, potentially contaminated with harmful substances or mislabeled with inaccurate THC concentrations, can pose serious health risks to consumers.

The Impact of Poor Regulation

The lack of oversight in the production and sale of delta-8 THC products is a vivid example of the broader challenges facing the hemp and cannabinoid industry. It highlights the urgent need for clear guidelines and regulations that not only align with federal law but also prioritize consumer safety and product integrity.

A Call for Clarity

Both delta-9 and delta-8 THC illustrate the complex landscape of hemp-derived cannabinoids and the unexpected consequences that can arise from broad legislation without nuanced regulation. As the industry and consumers grapple with these challenges, there is a growing consensus that more detailed oversight is needed.

The anticipated 2023 Farm Bill, along with potential interim actions by federal and state regulators, offers an opportunity to address these issues. It may provide the much-needed clarity, guidance, and safeguards that can balance innovation and accessibility with consumer protection and public health. The continued growth and success of the hemp and cannabinoid industry will likely hinge on achieving this delicate balance.

The Future: 2023 Farm Bill

With a new Farm Bill expected in 2023, the hemp and cannabinoid industry is bracing for potential changes. Stakeholders are hopeful for clarity and structure, particularly in areas neglected by the 2018 bill. The new legislation could include:

1. Clear FDA Guidelines: The 2023 bill may address the FDA’s regulatory role, providing explicit guidelines for manufacturers and reinforcing consumer trust.
2. Adjustments to THC Threshold: There may be discussions around adjusting the 0.3 percent THC threshold that defines hemp, influencing the types and varieties of hemp that can be grown.
3. Focus on Sustainability: Environmental sustainability and responsible farming practices could become more prominent in the 2023 bill, aligning with broader national and global sustainability goals.

Conclusion

The 2018 Farm Bill was a milestone in the hemp and cannabinoid industry, opening doors but also creating confusion. The continued ambiguity surrounding regulations, especially from the FDA, has led to a complex and sometimes uncertain environment for manufacturers. As the industry looks to the future and the anticipated 2023 Farm Bill, there are hopes for clarification, increased regulatory guidance, and continued growth in this dynamic sector. The new legislation will undoubtedly shape the industry’s trajectory, potentially resolving existing challenges and fostering innovation and expansion.