Label Content SOP for Michigan Operators

My lawyer and I put together this checklist for our designers and co-pack QC team. I figured it would be useful for anyone else making legal moves in Michigan.

Cheers!

Packaging Requirements for both MMFLA and MRTMA

MARIHUANA PRODUCT:

A marihuana product includes both marihuna and marihuana-infused products. Before a marihuana product is sold or transferred to a marijhuana sales location the container, bag or product holding the marihuana product must be sealed and labeled with all of the following information:

  • The name and the state license number of the producer, including business or trade name, and tag and source number as assigned by the statewide monitoring system.
  • The name and the marihuana license number of the licensee that packaged the product, including business or trade name, if different from the producer of the marihuana product.
  • The name and the marihuana license number of the licensee that packaged the product, including business or trade name, if different from the producer of the marihuana product.
  • The unique identification number for the package or the harvest, if applicable.
  • Date of harvest, if applicable.
  • Name of strain, if applicable.
  • Net weight in United States customary and metric units.
  • Concentration of Tetrahydrocannabinol (THC) and cannabidiol (CBD) as reported by the laboratory after potency testing along with a statement that the actual value may vary from the reported value by 10%.
  • Activation time expressed in words or through a pictogram.
  • Name of the laboratory that performed any test, and any test analysis date.
  • The universal symbol for marihuana product published on the agency’s website.
  • A warning that states all the following:
  • “It is illegal to drive a motor vehicle while under the influence of marihuana.”
  • “National Poison Control Center 1-800-222-1222.”
  • For products being sold by a licensee under the medical marihuana facilities licensing act that exceed the maximum THC levels allowed for products sold under MRTMA, “For use by registered qualifying patients only. Keep out of reach of children.”
  • For all other products being sold by a licensee “For use by individuals 21 years of age or older or registered qualifying patients only. Keep out of reach of children.”

MARIHUANA INFUSED PRODUCT:

  • The name of the marihuana-infused product.
  • The Ingredients of the marihuana-infused product, in descending order of predominance by weight.
  • The net weight OR net volume of the product.

If marihuana-infused product is an edible marihuana product:

  • Allergen labeling as specified by the Food and Drug Administration (FDA).
  • If any health or nutritional claim is made, appropriate labeling as specified by federal regulations regarding Food Labeling.
  • Product package shall not be in a shape or labeled in a way that would appeal to minors aged 17 years or younger. Example: cartoons, caricatures, toys etc.
  • Product shall not be easily confused with commercially sold candy.
  • The use of the word “candy” or ‘candies” is prohibited.
  • Edible marihuana products shall not be in the distinct shape of a human, animal or fruit shapes. Shape must not bear a likeness or contain characteristics of a realistic or fictional human, animal or fruit.
  • Opaque packages or containers.
  • Child-resistant packages or containers meeting the requirements of 16 CFR 1700.15.
  • If more than one serving, it must be in a resealable package or container that meets the effectiveness of 16 CFR 1700.15
  • Edible products must not require time and temperature control for safety.
  • A product expiration date.

MEDICAL ONLY PRODUCTS:

All marihuana sold through provisioning centers must include on the exterior of the marihuana packaging the following warning printed in clearly legible type and surrounded by a continuous heavy line:

WARNING: USE BY PREGNANT OR BREASTFEEDING WOMEN, OR BY WOMEN PLANNING TO BECOME PREGNANT, MAY RESULT IN FETAL INJURY, PRETERM BIRTH, LOW BIRTH WEIGHT, OR DEVELOPMENTAL PROBLEMS FOR THE CHILD.

ALLERGEN LABELING REQUIREMENTS:

The label of a food that contains an ingredient that is a major allergen must declare the presence of the major food allergen.

Major Food Allergens:

  • Milk
  • Eggs
  • Fish
  • Crustacean Shellfish
  • Tree Nuts
  • Peanuts
  • Wheat
  • Soybeans

The ingredient list must contain the major allergen in the list of ingredients or have the word “CONTAINS” followed by a list of the major allergens used in deriving the ingredients. For example if whey is an ingredient milk is derived from whey and must be listed in the ingredient list or immediately following the ingredient list must be the word “CONTAINS” followed by the word “Milk”.

HEALTH OR NUTRITIONAL CLAIM LABELING

AVOID MAKING ANY HEALTH OR NUTRITIONAL CLAIM

REGULATIONS ARE COMPLEX AND CAN BE DISCUSSED IF NEEDED

CHILD-RESISTANT PACKAGING

  • Child-resistant effectiveness of not less than 85 percent without a demonstration and not less than 80 percent after a demonstration of the proper means of opening such special packaging. In the case of unit packaging, child-resistant effectiveness of not less than 80 percent.
  • The packaging must also continue to function with the effectiveness specifications of this section for the number of openings and closings customary for its size and contents.
  • How to test effectiveness of child-resistant packaging is contained in 16 CFR 1700.20.
15 Likes

Fantastic write up! These guidelines hold true for almost all consumer packaged good across the country. This should be a good guide for almost anyone doing thier own labeling Im house :pray:

Mind if I copy pasta parts into a wiki at some point for wikijane.com?

6 Likes

Of course! Spread the love! And thanks for the kind words.

5 Likes

Awesome post! Thanks for sharing!

Now it’s been over a year; I’m curious if you have updated anything in your SOP?

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The state has gone heavy into the restriction of cartoons and such. They’ve also included the requirement of a modifier, i.e. ‘Thc-infused’ ‘cannabis-infused’ etc

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…and that’s a GOOD thing, right?

3 Likes