DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
MARIJUANA REGULATORY AGENCY  
MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA PRODUCT  
Filed with the secretary of state on March 7, 2022  
These rules take effect immediately upon filing with the secretary of state unless adopted under  
section 33, 44, or 45a(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, 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.  
(d) "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.  
(e) “Final form” 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.  
(f) “Inactive ingredients” means binding materials, dyes, preservatives, flavoring agents, and  
any other ingredient that is not derived from the plant Cannabis sativa L.  
(g) “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.  
(h) “Marihuana sales location” refers to a provisioning center under the medical marihuana  
facilities licensing act or a marihuana retailer under the Michigan Regulation and Taxation of  
Marihuana Act, or both.  
(i) “Marihuana tracking act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901  
to 333.27904.  
November 8, 2021  
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(j) “Medical marihuana facilities licensing act” or “MMFLA” means the medical marihuana  
facilities licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.  
(k) “Michigan Regulation and Taxation of Marihuana Act” or “MRTMA” means the Michigan  
Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.  
(l) “Producer” refers to both a processor under the medical marihuana facilities licensing act  
and a marihuana processor under the Michigan Regulation and Taxation of Marihuana Act.  
(m) “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.  
(n) “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 Regulation and Taxation of Marihuana Act, and Executive Reorganization Order No.  
2019-2, MCL 333.27001.  
(o) “Tag” or “RFID tag” means the unique identification number or Radio Frequency  
Identification (RFID) issued to a licensee by the 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, 2021 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 $114.50.  
(b) The International Organization for Standardization (ISO), ISO 22000 / ISO/TS 22002-  
1:2009, Food Safety Bundle, available for purchase at:  
(c) International Organization for Standardization (ISO), ISO/IEC 17025:2017, General  
Requirements for the Competence of Testing and Calibration Laboratories, available at:  
$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,  
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.  
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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 R 420.404, 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 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, 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.  
(ii) If any health or nutritional claim is made, appropriate labeling as specified by the federal  
regulations regarding Food Labeling, 21 CFR part 101.  
(e) The date the marihuana product was produced.  
(8) A producer of edible marihuana product shall comply with all the following:  
(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) 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 to be shelf stable, and test results for all ingredients  
used.  
(c) 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,  
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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.  
(d) Have an employee on site during the production of edible marijuana products who is  
certified as a Food Protection Manager.  
(e) To ensure compliance with the safe preparation standards under this subrule, comply with 1  
or more of the following:  
(i) 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.  
(f) 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 may not:  
(a) Produce an edible marihuana product in a shape or with a label that would appeal to minors  
aged 17 years or younger.  
(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.  
(c) Package edible marihuana products in a package that can be easily confused with a  
commercially available food product. The use of the word candy or candies on the packaging or  
labeling is prohibited.  
(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.  
(10) 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 1 serving must be in a resealable package or container that meets the  
effectiveness specifications outlined in 16 CFR 1700.15.  
(11) A producer shall not produce an edible marihuana product that requires time and  
temperature control for safety. The agency may publish validation guidance for shelf stable  
edible marihuana product. The agency may request to review the validation study for a shelf  
stable edible marihuana product. The end product must be a shelf stable edible marihuana  
product and state the following information:  
(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.  
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(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.  
(12) This rule does not affect the application of any applicable local, state, or federal laws or  
regulations.  
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