DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
MARIJUANA REGULATORY AGENCY
MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA PRODUCT
Filed with the secretary of state on
These rules take
effect immediately upon filing with the secretary of state unless adopted under
section 33, 44, or 45a(6)(9) of the administrative procedures act
of 1969, 1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under
these sections become effective 7 days after filing with the secretary of
state.
(By authority conferred on the executive director of the marijuana regulatory agency by section 206 of the medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206, sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No. 2019-2, MCL 333.27001)
R 420.401, R 420.402, and R 420.403
of the Michigan Administrative Code are amended, to the Michigan
Administrative Code as follows:
R 420.401 Definitions.
Rule 1. (1) As used in these rules:
(a) “Acts” refers to the medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to 333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967, when applicable.
(b) “Agency” means the marijuana regulatory agency.
(c) “Edible marihuana product” means any marihuana-infused product containing marihuana that is intended for human consumption in a manner other than inhalation. Edible marijuana product does not include marihuana-infused products that are intended for topical application.
(cd)
"Employee" means a person performing work or service for
compensation. “Employee” does not include individuals providing trade or
professional services who are not normally engaged in the operation of a
marihuana establishment.
(de) “Final packageform”
means the form a marihuana product is in when it is available for sale by a
marihuana sales location not including consumer packaging. For
marihuana products intended for inhalation, final form means the marihuana
concentrate in an e-cigarette or a vaping device.
(ef) “Inactive ingredients” means binding
materials, dyes, preservatives, flavoring agents, and any other ingredient that
is not derived from the plant Cannabis Ssativa L.
(f) “Marihuana business”
refers to a marihuana facility under the medical marihuana facilities licensing
act or a marihuana establishment under the Michigan regulation and taxation of
marihuana act, or both.
(g) “Marihuana establishment” means a location at
which a licensee is licensed to operate a marihuana grower, marihuana safety
compliance facility, marihuana processor, marihuana microbusiness, marihuana
retailer, marihuana secure transporter, marihuana designated consumption
establishment, or any other type of marihuana-related business licensed to
operate by the agency under the Michigan regulation and taxation of marihuana act.
(h) “Marihuana facility” means a location at which a
licensee is licensed to operate under the medical marihuana facilities
licensing act.
(ig) “Marihuana product” means marihuana or a
marihuana-infused product, or both, as those terms are defined in the acts
unless otherwise provided for in these rules.
(jh) “Marihuana sales location” refers to a
provisioning center under the medical marihuana facilities licensing act or a
marihuana retailer under the Michigan rRegulation and tTaxation
of mMarihuana aAct, or both.
(ki) “Marihuana tracking act” means the marihuana
tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(lj) “Medical marihuana facilities
licensing act” or “MMFLA” means the medical marihuana facilities licensing act,
2016 PA 281, MCL 333.27101 to 333.27801.
(nl) “Producer” refers to both a processor
under the medical marihuana facilities licensing act and a marihuana processor
under the Michigan rRegulation and tTaxation of mMarihuana
aAct.
(om) “Records of formulation” means the
documentation that includes at a minimum: the ingredients, recipe, processing
in order to be shelf stable, Certificates of Analysis for any ingredient used,
and description of the process in which all ingredients are combined to produce
a final package.
(pn) “These
rules” means the administrative rules promulgated by the agency under the
authority of the medical marihuana facilities licensing act, the marihuana
tracking act, the Michigan rRegulation and tTaxation
of mMarihuana aAct, and Executive Reorganization Order
No. 2019-2, MCL 333.27001.
(qo) “Tag” or “RFID tag” means the unique
identification number or Radio Frequency Identification (RFID) issued to a
licensee by the agency statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana product in the statewide monitoring system.
(2) Terms defined in the acts have the same meanings when used in these rules unless otherwise indicated.
R 420.402 Adoption by reference.
Rule 2. (1) The following codes, standards, or regulations of nationally recognized organizations or associations are adopted by reference in these rules:
(a) National fire protection association (NFPA) standard
1, 201821 edition, entitled “Fire Code,” is adopted by
reference as part of these rules. Copies of the adopted provisions are
available for inspection and distribution from the National Fire Protection
Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169,
telephone number 1-800-344-3555, for the price of $106.00114.50.
(b) The International Organization for Standardization
(ISO), ISO 22000 / ISO/TS 22002-1:2009, - fFood sSafety
bBundle, available for purchase at:
https://webstore.ansi.org/Standards/ISO/ISO22000TS22002FoodSafety, for the price of $275.00.
(c) International Organization for Standardization (ISO),
ISO/IEC 17025:2017, gGeneral rRequirements for the cCompetence
of tTesting and cCalibration lLaboratories,
available at:
https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2017, for the
price of $162.00.
(2) The standards adopted in subrule (1)(a) to (c) of this
rule are available for inspection and distribution at the agency, located at 2407
North Grand River Avenue, Lansing, Michigan MI, 48906. Copies of
these standards may be obtained from the agency at the cost indicated in subrule
(1)(a) to (c) of this rule, plus shipping and handling.
R 420.403 Requirements and restrictions on marihuana-infused products; edible marihuana product.
Rule 3. (1) A producer shall package and properly label marihuana-infused products before sale or transfer.
(2) Marihuana-infused products processed under these rules must be homogenous. The allowable variation for weight and THC and CBD concentrations between the actual results and the intended serving is to be + or – 15%. The agency shall publish guidelines for a producer to follow to verify the marihuana-infused product is homogeneous.
(3) A producer of
marihuana-infused products shall list and record the THC concentration and CBD
concentration of marihuana-infused products, as provided in R 420.305 and subrule
(4) R 420.404 of this rule, in the statewide
monitoring system and indicate the THC concentration and CBD concentration on
the label along with the tag identification as required under these rules.
(4) Marihuana-infused products
that are part of a product recall issued in the statewide monitoring system,
or by the agency or other state agency, if applicable, are subject to all
of the following requirements:
(a) Must be immediately pulled from production by the producer of the marihuana-infused product.
(b) Must be immediately removed from the sales area of a marihuana sales location.
(c) Must not be sold or transferred.
(5) Marihuana-infused products must be stored and secured as prescribed under these rules.
(6) All non-marihuana inactive ingredients must be clearly listed on the product label. Inactive ingredients must be approved by the FDA for the intended use, and the concentration must be less than the maximum concentration listed in the FDA Inactive Ingredient database for the intended use.
(7) A producer shall label all marihuana-infused product with all of the following:
(a) The name of the marihuana-infused product that includes a product modifier such as “marijuana product,” “THC product,” or “cannabis product” using the same or larger font than the product name.
(b) The ingredients, including excipients and diluents, of the marihuana-infused product, in descending order of predominance by weight.
(c) The net weight or net volume of the product.
(d) For an edible marihuana product, the marihuana
processor shall comply with subdivisions (a) to (c) of this subrule and all of
the both of the following must be included:
(i) Allergen labeling as specified by the Food and Drug Administration (FDA), Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), 21 USC 343.
(e) The date the marihuana product was produced.
(8) A producer of edible marihuana product shall comply
with all the following to ensure safe preparation:
(a) Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventative Controls for Human Food, 21 CFR part 117. Any
potentially hazardous ingredients used to process shelf-stable edible marihuana
products must be stored at 40 degrees Fahrenheit, 4.4 degrees Celsius, or
below.
(b) Current Good Manufacturing Practice in
Manufacturing, Packaging, or Holding Human Food, 21 CFR part 110. A marihuana
business shall ensure that any handling of marihuana product is compliant.
(cb) Keep formulation records for all marihuana
products. Maintain and adhere to records of formulation and make them
available to the agency upon request. These records at a minimum must
include the recipe, any additional processing documentation that
demonstrates the product in order to be shelf stable, and test
results for any all ingredients used.
(dc) Provide annual employee training for
all employees on safe food handling and demonstrate an employee’s completion of
this training by providing proof of food handler certification that includes
documentation of employee food handler training, including, but not limited to,
allergens and proper sanitation and safe food handling techniques. Any course
taken pursuant to this rule must be conducted for not less than 2 hours and
cover all of the following subjects:
(i) Causes of foodborne illness, highly susceptible populations, and worker illness.
(ii) Personal hygiene and food handling practices.
(iii) Approved sources of food.
(iv) Potentially hazardous foods and food temperatures.
(v) Sanitization and chemical use.
(vi) Emergency procedures, including, but not limited to, fire, flood, and sewer backup.
(ed) Have an employee on site during the
production of edible marijuana products who is certified as a Food
Protection Manager.
(fe) To ensure compliance with the safe
preparation standards under this subrule, comply with 1 or more of the
following:
(i) The FDA food safety modernization act, 21 USC
2201 to 2252. Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventative Controls for Human Food, 21 CFR part 117.
(ii) The International Organization for Standardization (ISO), ISO 22000/ISO/TS 22002-1 adopted by reference pursuant to R 420.402.
(gf) If requested as provided in
this subdivision, provide to the agency documentation to verify certifications
and compliance with these rules. The agency may request in writing
documentation to verify certifications and compliance with these rules.
(9) A producer of edible marihuana product shall comply
with all the followingmay not:
(a) Edible marihuana product packages shall not
be in Produce an edible marihuana product in a shape or with a
labeled in a manner that would appeal to minors aged 17 years or
younger. Edible marihuana products shall not be associated with or
have cartoons, caricatures, toys, designs, shapes, labels, or packaging that
would appeal to minors.
(b) Produce an edible marihuana product that is associated with or has cartoons, caricatures, toys, designs, shapes, labels, or packaging that would appeal to minors.
(bc) Package Eedible
marihuana products shall not be in a package that can be easily
confused with a commercially sold candy available food product.
The use of the word candy or candies on the packaging or labeling is
prohibited. Edible marihuana products shall not be in the distinct shape of
a human, animal, or fruit, or a shape that bears the likeness or contains
characteristics of a realistic or fictional human, animal, or fruit, including
artistic, caricature, or cartoon renderings. Edible marihuana products that
are geometric shapes and simply fruit flavored are permissible.
(d) Produce edible marihuana products in the distinct shape of a human, animal, or fruit, or a shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings. Edible marihuana products that are geometric shapes and fruit flavored are permissible.
(c10) An edible marihuana product must be in
opaque, child-resistant packages or containers that meet the effectiveness
specifications outlined in 16 CFR 1700.15. An edible marihuana product
containing more than one 1 serving must be in a resealable package
or container that meets the effectiveness specifications outlined in 16 CFR
1700.15.
(a) A product expiration date, upon which the edible marihuana product is no longer fit for consumption and after which it must be destroyed. Once a label with an expiration date has been affixed to an edible marihuana product, a licensee shall not alter that expiration date or affix a new label with a later expiration date. The expiration date must consider all the following:
(i) The quality and characteristics of the edible marihuana product.
(ii) The packaging of the edible marihuana product.
(iii) The customary conditions encountered by the edible marihuana product from product to sale.
(b) Any other information requested by the agency that is not inconsistent with the acts and these rules.
(11) As used in this rule, the term “edible marihuana
product” means any marihuana-infused product containing marihuana that is
intended for human consumption in a manner other than smoke inhalation.
(12) This rule does not affect the application of any applicable local, state, or federal laws or regulations.