Colorado’s New Hemp Regulations: Safe Harbor Registrants

Since I will be in Denver, Colorado in April 2024 to speak at NOCO Hemp (1) in Estes Park, I thought it would be fitting to go back to my roots and write about the recent changes in regulations in my home state of Colorado. Hopefully I’ll get to see you all there!

Colorado tends to be on the leading edge of creating regulatory content for the cannabis industry, both cannabis and hemp. Impressively, state voters approved cannabis legalization in 2000, then again with retail legalization in 2012. Even the state’s hemp regulatory oversight was implemented well before other states’. In a big new move for Colorado, towards the end of 2023, the state approved a new set of hemp regulations that includes tighter restrictions over hemp derived cannabinoids, which were met with both pushback and acceptance from the industry. Here are a few big changes with the much-anticipated new regulations.

Colorado’s New Hemp Regulations

Colorado Department of Public Health and Environment (CDPHE) and stakeholders helped guide several scheduled meetings in creating new hemp regulations. The state’s Board of Health adopted the new hemp regulations in November of 2023, which specify regulatory oversight for the hemp industry. Previously, the hemp regulations were combined with the state’s wholesale food regulations. Now, the hemp requirements are completely separated from the traditional wholesale food manufacturing regulations.

The newly created hemp regulations include regulatory expectations with hemp manufacturing requirements, testing, labeling, etc., which were clearly detailed in the previous set of regulations. One of the most controversial aspects of the newly adopted regulations is the distinction between and allowance of both hemp derived non-intoxicating cannabinoids and hemp derived intoxicating cannabinoids.

Specifically, the updated regulations detail how intoxicating and non-intoxicating cannabinoids can be produced in the same facility. Non-intoxicating cannabinoids include full spectrum with tetrahydrocannabinol (THC) restrictions, broad spectrum, cannabidiol (CBD), tetrahydrocannabivarin (THCV), cannabichromene (CBC), cannabigerol (CBG), cannabinol (CBN), and more. Intoxicating cannabinoids include Delta 7-THC, Delta 8-THC, Delta 9-THC, Delta 10-THC, and their isomers, etc. CDPHE is allowing the production and handling of intoxicating cannabinoids, and these businesses now fall under the names “safe harbor product” and “safe harbor manufacturers.”

Safe Harbor Registrants

Many states do not have a regulatory framework for intoxicating cannabinoids derived from hemp. These states either do not allow these types of cannabinoids or do not actively regulate them. In CDPHE’s new regulations, if the licensee manufactures or handles safe harbor products, the regulations have clear expectations for the industry to follow, but are far different from the traditional non-intoxicating hemp product expectations.

CDPHE allows the production, handling, packaging, holding, and distribution of safe harbor hemp products. Some industry leaders see this as a huge win, while others see this as dampening the industry’s progress. At the end of the day, safe harbor products are allowed but come with unique state requirements—and we mean unique!

These expectations include the need for an annual current Good Manufacturing Practice (cGMP) audit, strict product export requirements, and allowance of handling non-intoxicating cannabinoids under the same roof as safe harbor products, but this is only allowed under strict limitations.

Safe Harbor Registrants—Third Party cGMP Audit Requirement

Safe harbor registrants must demonstrate compliance with the Food and Drug Administration’s (FDA) cGMP for food or dietary supplements before registering or within 12 months after the previous registration with supporting documentation. The safe harbor registrant must obtain a cGMP audit from a department-approved third-party accredited auditing company, and every year after. This creates an issue because not many accredited third-party certification companies will step inside of a hemp facility. While there’s a small handful of accredited third-party auditing companies, the industry may struggle when finding and scheduling with an approved company.

Many safe harbor registrants and soon-to-be registrants will benefit from a pre-audit to help identify areas of improvement before paying for the official audit required by CDPHE. Allay Consulting is well practiced with accredited third-party cGMP audits and their standards. Even if a safe harbor company is not interested in becoming cGMP certified, we can help get your facility prepared prior to the state’s required audit!

Safe Harbor Registrants—Intoxicating Cannabinoid Export Allowances

CDPHE allows safe harbor registrants to handle intoxicating cannabinoids derived from hemp, but registrants are not permitted to sell these products within the state of Colorado. However, these companies are allowed to export intoxicating cannabinoids to other states. Read and re-read: safe harbor hemp products are not permitted to be sold or distributed in Colorado. You read that right.

According to the Registration Requirements of the Colorado Hemp Products and Safe Harbor Hemp Products Regulations (2): “The safe harbor hemp product manufacturer or storage facility does not export a safe harbor hemp product to a state where the safe harbor hemp product is prohibited by state law.”

If a safe harbor registrant wants to export their product outside of Colorado’s borders, the accepting state must allow these types of products. These exported products must also contain additional labeling. Safe harbor product manufacturers must abide by recordkeeping conditions that include purchasing of product, where the product was exported to, accepting state details, concentration limitations, and labeling requirements from the receiving state.

Safe Harbor Registrants—Intoxicating and Non-Intoxicating Products Under the Same Manufacturing Facility

Colorado does allow a single facility to have both the wholesale food manufacturing license and a safe harbor registration, but expect restrictions. CDPHE offers three options when safe harbor products are also handled in a facility with non-safe harbor product handling. These options are focused on limiting cross contamination and adulteration between the product types.

1. Option 1: Complete physical separation of these products
2. Option 2: Create a process validation demonstrating no cross contamination between products
3. Option 3: Create a process validation demonstrating no cross contamination between products that differ from option 2

The industry needs to be careful when handling both product types under the same facility, all in the effort to reduce adulteration of non-safe harbor products. The state will allow companies to use the same equipment for safe harbor products and non-intoxicating cannabinoids but require a process validation (options 2 and 3). If option 2 or option 3 are selected, CDPHE must review and approve the company’s process validation. This process validation plan may include detailing the production line, equipment, cleaning/sanitizing methods, testing, packaging, recordkeeping, change management, etc.

When it comes to other states, this could be a trend for intoxicating cannabinoids. Other states are starting to adopt similar regulations to Colorado’s. We will just have to wait and see how things will change in each state, and keep in mind that things are changing on a federal level as well. We are still waiting for regulations to be approved and enforced. As always, I recommend getting ahead of the game when it comes to becoming compliant with federal regulations. They may be coming sooner than you think.

Contact Allay Consulting to learn more about CDPHE’s updated hemp regulations and prepare for your upcoming cGMP audit.

Need additional support with the state’s newly released regulations? Navigating through CDPHE’s updated hemp regulations and preparing for a comprehensive third-party cGMP audit may be challenging for any company, but we are here to support the industry. Based out of Colorado, Allay Consulting is here to best guide you through the cGMP audit requirements and state compliance.

References

1. https://www.nocohempexpo.com/schedule/
2. https://drive.google.com/file/d/1NAlvsECyJO8npS4BtAMbt-sKKBF52XJe/view

About the Author

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com.