Mich. Admin. Code R. 420.403 - Requirements and restrictions on marihuana-infused products; edible marihuana product

Current through Register Vol. 21-17, October 1, 2021

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 Rule 420.305 and subrule (4) 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.
(b) The ingredients 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 following:
(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.
(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.
(c) Keep formulation records for all marihuana products. These records at a minimum must include the recipe, any additional processing in order to be shelf stable, and test results for any ingredients used.
(d) Provide annual employee training for all employees on safe food handling and demonstrate an employees 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.
(e) Have an employee who is certified as a Food Protection Manager.
(f) 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.
(ii) The International Organization for Standardization (ISO), ISO 22000/ISO/TS 22002-1 adopted by reference pursuant to R 420.402.
(g) 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 following:
(a) Edible marihuana product packages shall not be in a shape or 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) Edible marihuana products shall not be easily confused with commercially sold candy. 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.
(c) 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 serving must be in a resealable package or container that meets the effectiveness specifications outlined in 16 CFR 1700.15.
(10) 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 marihuana product is no longer fit for consumption. Once a label with an expiration date has been affixed to a marihuana product, a licensee shall not alter that expiration date or affix a new label with a later expiration date.
(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.

Notes

Mich. Admin. Code R. 420.403
2020 MR 12, Eff. June 22, 2020

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