Chapter 11-850 Revisions FAQ
What were the primary changes and what was the overall rationale for the revisions?
- Updates to chapter 329D and chapter 329 part IX, HRS, since 2015
- Wording change from “marijuana” to “cannabis”
- Allow change of individual licensee in event of death, retirement, incapacity; transfer of license is not allowed
- Enhanced product requirements for patient safety
- When dispensary section was established in 2015, the major focus was on public safety, hence requirements for security, tracking, preventing diversion
- Current revisions focus on the safety of cannabis and manufactured cannabis products for consumers (qualifying patients and qualifying out-of-state patients)
- Product Standards
- Good Manufacturing Practice
- Quality Control
- Edible cannabis product requirements
- The Legislature authorized the department to allow edible cannabis products in 2020
- Some existing product categories meet the statutory definition of edible cannabis products
- Edible cannabis products should meet the same safety requirements as non-cannabis consumable products
- Updated testing requirements
- Focus microbial testing on microorganisms of public health concern
- Align residual solvent requirements with solvents used by the industry
- Labeling requirements
- Ingredients and allergens
Edible products and Good Manufacturing Practices (GMPs)
Why so many new requirements for manufactured products and edible products?
These products are intended for humans to consume. The new requirements are the same as would be required for other consumer products (e.g., a brownie you buy from a bakery).
Do the new GMP standards need to be met before new edible products can be dispensed?
Do licensed dispensaries have to seek DOH certification of our GMP’s status prior to making new edibles?
No. Licensed dispensaries just need to follow everything that’s in the rules for GMPs.
Does edible production require a licensed kitchen?
No. Under the department’s food safety rules, cannabis is considered an adulterant and prohibited, so a cannabis facility would not be allowed to become a licensed kitchen. Also, the statutory definition of an edible cannabis product says that it’s not a food it’s not regulated as a food. However, the basic sanitation requirements from the food regulations, known as good manufacturing practices or GMPS, were inserted in the rules (subchapter 7). These are things that any food manufacturer would have to follow for any kind of food product. Any kind of product that a person is going to ingest or put onto their skin or inhale should be as safe as a similar commercial product that’s available that does not contain cannabis.
Edible products and time/temperature control for safety
Can I make an edible product that requires time and temperature control if I do a HACCP plan for review by food and safety?
No, edible cannabis products cannot require time/temperature control for safety.
Is a specific pH required for beverage products?
Beverages cannot require time/temperature control for safety. One way to meet this requirement is to have a certain combination of pH and water activity level and if met, a product assessment is not required. So, for certain beverages, pH will be the simplest to go to show that the product does not require time/temperature control for safety.
Lozenges or gummies may lose their form or melt in Hawaii’s weather. Are these products allowed? Are they allowed to be refrigerated?
Refrigeration may be used to preserve product texture but cannot be required for product safety.
Our licensed dispensary sells infused coconut oil and recommends keeping it refrigerated as coconut oil turns to liquid at room temperature. Are we no longer able to recommend this?
Refrigeration may be recommended to preserve product texture. The product cannot require refrigeration for safety.
Are brownies and cookies expected to stay good for a year to meet the time and temperature control requirement? We would put a use by date of a much shorter period on there.
No, there is no expectation that products have a one-year shelf life. Products can have a shorter “use by” date.
Safe Pulmonary Administration (SPA) devices and products
Will there be any changes regarding the addition of botanically delivered terpenes to safe pulmonary administration devices?
No. Safe pulmonary administration devices will remain restricted only to extracts that are derived from the cannabis plant. There is no allowance for any other additives.
Hemp and hemp products
Why is hemp processing not allowed in cannabis facilities?
- Hemp and medical cannabis production and products are regulated under separate programs and by separate statutes and rules
- Hemp/hemp products are not grown/manufactured under the same controlled environment as medical cannabis
- Inventory track and trace of hemp and cannabis within the same system would be challenging because they are essentially the same plant; distinction is essentially a legal one
Will cannabis licensees be allowed use or sell hemp products in dispensaries?
- Licensed dispensaries may sell hemp products that are Chapter 11-37, HAR, compliant, e.g., tablets, tinctures, lotions.
- Licensed dispensaries may incorporate CBD isolate and other cannabinoids that are naturally present (i.e., not synthesized or created through isomerization)—chapter 11-37 compliant hemp products—as an ingredient in manufactured products with the exception of safe pulmonary administration (SPA) cartridges, but must clearly state this in the ingredient list on product labels.
Cannabinoids created through isomerization
There are some beneficial cannabinoids that are made by converting CBD into other cannabinoids through isomerization. They are made this way because they are naturally present in such small quantities in flower that it would be very expensive to extract them individually. Why are these banned?
The department banned isomerized cannabinoids in manufactured cannabis products out of an abundance of caution over patient and product safety. Concerns have been raised nationally over the byproducts that are produced through the isomerization process. Several studies on delta-8 and other cannabinoids produced through isomerization have found potentially hazardous byproducts as well as unidentified chemicals in these products.
As more information becomes available on the safety of isomerized products and the conversion processes, this prohibition could change.
What about CBG and CBN and other cannabinoids that are non-psychoactive and are produced via converting CBD?
All cannabinoids that are produced by conversion or isomerization are prohibited regardless of their properties. There is an additional separate prohibition on other psychoactive ingredients such as caffeine.
Can we continue selling existing hemp CBN (isomerized) products until January 1, 2023?
No, the ban on isomerized cannabinoids became effective on February 24, 2022.
Why the changes to laboratory testing standards?
- Living plants will have microorganisms on them that are not necessarily a health hazard. The revised testing standards focus on microorganisms that pose a health risk for patients using the products.
- Allow non-plating techniques for microbial testing.
Why all the new pesticide testing requirements?
Pesticide testing is not a new requirement. The list of required analytes is being codified to clearly show what labs are required to test for.
Packaging and labeling
Why all the new packaging and labeling requirements?
- More clearly indicate what a dose is and help patients control their dosage
- More clearly indicate the cannabinoid content of the product
- Provide patients with information on product ingredients and additives, e.g., if external cannabinoids such as CBD have been added
- Alert patients to possible allergens
Are there any updates to marketing restrictions in these new rules?
No. This is a priority for the next round of rule revisions.
Future rule updates
What is the timeline on the next set of rule updates with the new marketing rules?
We do not have a specific timeline, but expect to begin working on the new rule revisions as soon as May 2022.