Mich. Admin. Code R. 420.403

Current through Vol. 24-19, November 1, 2024

Section 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 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, 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.

(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.

Mich. Admin. Code R. 420.403

2020 AACS; 2022 MR 5, Eff. 3/7/2022