Florida Releases Rules for THC-Infused Cannabis Edibles

UPDATE: August 31, 2020 - 8:00 PM EST

Edible cannabis products are finally set to enter the Florida's medical marijuana dispensaries! This is great news for patients who have long awaited marijuana infused treats to help alleviate ailments from chronic pain to chemotherapy-induced nausea.

The only catch? According to a report by the Miami Herald, "the edibles cannot have primary or bright colors in order to minimize attraction to children, must not resemble any commercially available candy and must be packaged appropriately"

Additionally, all companies that produce edibles will be required to apply for a food permit, which costs up to $650.

UPDATE: March 4, 2020 - 10:00 AM EST

In November of 2016, Florida voters approved a ballot initiative that legalized medicinal cannabis for debilitating conditions. It took the entire 2017 session and a week of special session to write an implementing bill, SB8A.

In July of 2017, MMTC Surterra had filed for a variance to allow them to produce and sell edibles. That variance request did not get a response.

March 3, 2020 - 10:00 PM EST

Nearly three years in the making, the State of Florida finally released the rules for cannabis edibles infused with THC. All MMTC's in the state will be held to these standards should they want to produce and sell medical cannabis in the form of edibles.

We're working on a full synopsis now and it will be ready in the next 24 hours. In the meantime you can access the rules directly on flrules.org.

A Missed Deadline for Issuing Edible Rules

The amendment language gave the Department of Health nine months to write the rules. Six months after that deadline, and one year after the legislature wrote the implementing bill, in March of 2018, the -rule writing process had yet to be begun, so the legislature threatened to cut funding to the DOH if they did not comply with the deadlines delineated in the ballot initiative and the implementing bill.

On March 28 of 2018, the beginning of the rulemaking development process for edibles was announced.

But it wasn’t until January of 2019 before the first public workshop was held, and the draft of the rules was submitted for approval in March of 2019. But the process stalled again at that point.  Changes were submitted for Definitions, Permits and Fees, Inspection and Reinspection, Permitting Requirements, and Guidelines for Imposing Administrative Penalties.

2 ½ Years Later; 24 Months Beyond Deadline

The final form of the rules was finally submitted to the Florida Administrative Code on March 3 of 2020, with an effective date of March 16. Finally, 2 ½ years after the initial deadline and 2 years after the process began, the Medical Cannabis Edibles rules finally posted in the Florida Administrative Code and a highly anticipated market is about to open.

During that time, several celebrated Edibles companies from across the country, like Wana, Incredibles, Binske, 1906 and others, set up licensing agreements with the existing MMTC’s in Florida, and now, they finally have the chance to produce and sell their products here.   5K-11.001 Documentation on flrules.org

Summary of Florida's Edible Rules, Identified as 5k-11.001- 5k-11.005

5k-11.001 lists the definitions critical to the rule. It defines Change of Ownership, the leading “Department” as the Florida Department of Agriculture and Consumer Services(FDACS), which is normally responsible for products that are meant to be part of the food chain in Florida, the definition of the main and defining ingredient, and MMTCs.

Defining "Edibles" and Marijuana Oil as an Ingredient

The two critical definitions are regarding Edibles, which are defined as “commercially produced food items made with Marijuana Oil, but no other form of marijuana, that are produced and dispensed by a Medical Marijuana Treatment Center.” But even more importantly, Marijuana oil is defined by two versions, “Marijuana Oil means oil derived from Low-THC Cannabis as defined in s. 381.986(1)(e), F.S(Medicinal cannabis, containing higher levels of THC)., or Marijuana as defined in s. 381.986(1)(f), F.S(low-THC cannabis, or CBD oil).

The latter is not the same as CBD oil from hemp, which was removed from Schedule 1 and deemed legal for interstate commerce and other use. This is CBD derived from Broad spectrum Cannabis, and only available from products produced by MMTC’s

Required Facility Permitting and Food Safety for Edibles Production

The second section, 5k-11-002, discusses the permits and fees. The overarching theme is that, “MMTCs producing or manufacturing Edibles are required to be permitted as food establishments and are subject to the requirements of ch. 500, F.S (The Florida Food Safety Act)., and this rule chapter”

It begins by noting that the MMTC must review and revise its business plan to include applying for a Food Permit and making changes to their facility, “for the purpose of evaluating whether proposed construction or remodeling plans conform to current requirements” for ch 500 F.S. Most importantly, prior to producing or manufacturing Edibles, an MMTC must obtain a food permit. This annual permit, which will cost $650 if purchased from Jan-July and $325 if purchased July-December is renewable for $650. It is also non-transferable or portable, so if the facility is moved, a new permit must be purchased.

According to the rules, “An MMTC may produce or manufacture Edibles in more than one physical location. An MMTC must complete the application requirements and receive an individual food permit for each physical location, by address, in which Edibles are produced or manufactured.”

The application must include a description and inspection of the facility and a list of all products that will be produced there. Any product change must be reported and approved prior to production.

Labelling requirements and advertising limitations, noted in the statutes, were absent from this batch of rules, but it was noted that, “The permit or permit number shall not be used on any label or in any advertisement of Edibles. Permits shall be conspicuously displayed at the locations for which they were issued”

The third section discusses inspections and inspections, noting that anytime a reinspection is necessary to ensure compliance, a fee of $135 is required to cover the cost.

Section 5K-11.004 Notes THREE Important Permitting Requirements:

(1) Edibles may not be manufactured, distributed, or sold under the Cottage Food Operations Law in s. 500.80, F.S (Cottage Food operations refer to home-made edible goods).

(2) Food used to create Edibles shall be as defined in s. 500.03(1)(n), F.S, which are:

1. Articles used for food or drink for human consumption.

2. Chewing gum.

3. Articles used for components of any such article.

4. Articles for which health claims are made, which claims are approved by the Secretary of the United States Department of Health and Human Services and which claims are made in accordance with s. 343(r) of the federal act, and which are not considered drugs solely because their labels or labeling contain health claims; and

5. Dietary supplements as defined in 21 U.S.C. s. 321(ff)(1) and (2).

(3) Marijuana Oil shall not be considered an unapproved food additive as defined in s. 500.03(1)(o), F.S., if used in the production and manufacture of Edibles by a licensed MMTC

Punishable Offenses and Penalties Pertaining to Edibles in Florida

The fifth and final section details punishable offenses and their subsequent penalties, including aggravating (negative) and mitigating (positive) circumstances that would increase or decrease those penalties.

The penalties vary according to the situation, and per the newly released rules, “The Department will enforce compliance with ch. 500, F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, stop-use order,  release order, notice of non-compliance, permit suspension or revocation, or an immediate final order for violations of ch. 500, F.S., and this rule chapter.”

Aggravating Factors Include:

1. The violation caused, or has the potential to cause, harm to the public and the degree or extent of such harm.

2. The violation endangered the public safety or welfare.

3. Previous violations for the same or a similar offense that resulted in enforcement action

Mitigating Factors Include:

1. Any documented efforts by the violator at rehabilitation.

2. Whether intentional actions of another party prevented the violator from complying with the applicable laws or rules.

3. Acts of God or nature that impaired the ability of the violator to comply with ch. 500, F.S., or this rule chapter.

4. The violation has a low risk of, or did not result in, harm to the public health, safety, or welfare.

5. The disciplinary history of the violator.

6.    The violator expeditiously took affirmative or corrective action after it received written notification of the violation to rectify any financial damage or harm to the public.

7.    If a repeat violation, whether three years has passed since the prior violation.

The rules then go in depth into the various tiers of major and minor violations.

Major violations emphasize the possibility of public harm, such as adulteration of product or mislabeling.

For instance, “The presence of a pathogenic Escherichia Coli, Salmonella Enterica, or Listeria Monocytogenes found in the environment of a Food Establishment in a location where contamination of food is likely to occur from the presence of the organism(s). In case of such violation, a stop-use order(s) shall be issued and shall not be released by the Department until the Food Establishment has cleaned and/or repaired the affected areas and all test results following  environmental sampling  are observed by the Department and reported as “negative”  from an ISO (International Organization of Standardization) 17025 based accredited laboratory certified to conduct testing for the microorganism of concern. Any and all cleaning, repairs, environmental sampling and testing shall be at the expense of the facility.”

Tier II major violations include the intentional introduction of adulterated or misbranded products into commerce.

Minor violations include a wide variety of issues that do not immediately impact the health of the public, or “where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

What Florida Should Expect Next for Edibles

These rules are not all-inclusive. Issues like potency requirements and labelling rules will be covered elsewhere, including statutes 381.986 and 500.03.

It's taken a long time, but we are finally on our way to have Edibles sales in Florida, and this highly anticipated addition to the medical cannabis program rules will mean an economic boon to the MMTC’s but it will also give a variety of products that seniors have been awaiting, as preferable to smoking, and Floridian patients have been patiently expecting.

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