18-691-1 Me. Code R. § 9

Current through 2023-3, January 18, 2023
Section 691-1-9 - Packaging and Labeling

All cannabis, cannabis concentrate and cannabis products received by a cannabis store from an authorized transfer, and offered for retail sale at a cannabis store must be packaged and labeled, including all required health and safety warnings, in accordance with the following section, in addition to any other provisions of this rule, 28-B MRS and any other applicable laws and rules.

A licensee may not label or package for sale adult use cannabis or an adult use cannabis product under this rule unless the cannabis or cannabis product has passed all mandatory testing required by this rule and the Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5.

9.1 - General Packaging and Labeling Requirements for Retail Sale
9.1.1General Packaging for Retail Sale Requirements. All cannabis or cannabis products must be packaged in containers that:
A. Are fully enclosable;
B. Are resealable;
C. Protect the packaged item from contamination; and D. Do not impart any toxic or deleterious substance to the packaged item.
9.1.2General Labeling for Retail Sale Requirements. In addition to any other requirements pursuant to this rule and 28-B MRS, all cannabis or cannabis product labels must comply with the following:
A. All required information must be printed directly on, or on a label or sticker affixed directly to, the marketing layer.
B. Labeling text on any marketing layer must be no smaller than size 6 font or 1/12 inch.
C. All information included in the labeling requirements, or any other provision of this rule, must be clearly written or printed and in the English language. In addition to the required English label, licensees may include an additional, accurate foreign language translation on the label that otherwise complies with this rule.
D. All information included in the labeling requirements, or any other provision of this rule, must be displayed on the marketing layer and must be unobstructed and conspicuous. A cannabis establishment licensee may affix multiple labels to the marketing layer, provided that none of the information required by this rule is obstructed.
E. The cannabis store that conducted the retail sale of the cannabis, cannabis concentrate or cannabis product must ensure that its license number is affixed to the marketing layer of the cannabis, cannabis concentrate or cannabis product, either on the label or on a separate sticker affixed to the item before placing the item in an exit package.
F. The label must include the full inventory tracking system-generated identification number of the final batch from which the testing sample for the mandatory testing of the contents of the cannabis or cannabis product was taken.
G. The label must include the following statement regarding mandatory test results: "Passed mandatory testing".
H. The label's statement of net contents must identify the net weight of the cannabis, cannabis concentrate or cannabis product prior to its placement in the container, using a standard of measure compatible with the tracking system.
I. The Department-approved universal symbol, as made available by the department, must appear on the front or most predominantly displayed area of the marketing layer and must be:
(1) No smaller than ½ inch by ½ inch;
(2) Placed on a white background and the interior of the icon must remain white;
(3) Maintained in the form provided to the licensee and may not be modified, recreated, stylized, stretched or otherwise distorted;
(4) Reproduced using the black and red color scheme published by the Department; and
(5) Displayed on a white or light-colored background.
J. The label must include, as a production date:
(1) For cannabis and cannabis products consisting in whole or in part of cannabis flower or cannabis trim, the date of the harvest batch; or
(2) For cannabis concentrate or cannabis products that were manufactured, the date on which the production batch was created.
K. Required information may be stated in a peel-back accordion style, expandable, extendable or layered label, so long as the label can be easily identified by a consumer as containing important information.
L. The label must state cannabinoid content, and, if applicable, gases, solvents and chemicals used in cannabis extraction. Statements regarding contaminants and use of solvents or absence thereof may not conflict with results reported in an approved cannabis testing facility's Certificate of Analysis.
M. In addition to any other warning statements required for specific categories of cannabis products, all cannabis and cannabis products must carry the following warning statement in no smaller than 6-point font: "There may be health risks associated with the use of this product. There may be additional health risks associated with the use of this product for women who are pregnant, breastfeeding, or planning on becoming pregnant. Do not drive a motor vehicle or operate heavy machinery while using this product."
9.1.3General Labeling Prohibitions. The label for retail sale of cannabis, cannabis concentrate or cannabis products may not:
A. Depict a human, animal or fruit or the word "candy" or "candies" on the label of any marketing layer, container holding cannabis, cannabis concentrate or cannabis product or intermediate packaging;
B. Display any content on a container, marketing layer or intermediate packaging making any claims regarding health or physical benefits to the consumer;
C. Cause a reasonable consumer confusion as to whether the cannabis, cannabis concentrate or cannabis product is a trademarked product;
D. Violate any state or federal trademark law or regulation;
E. Include any false or misleading statements;
F. Obscure identifying information or warning statements;
G. Reasonably appear to target or appeal to individuals under the age of 21, including but not limited to, cartoon characters or similar images; or
H. Report information regarding the quality or potency of the enclosed product, except as reported by a testing facility, unless the label clearly indicates that testing regarding the claim is not required or conducted by a testing facility.
9.2 - Packaging and Labeling of Trade Samples

Along with all requirements pursuant to this rule and 28-B MRS, cannabis cultivation and cannabis products manufacturing establishments shall comply with the following minimum packaging and labeling requirements prior to authorized transfer of any trade sample to a licensed cannabis establishment.

A. Prior to authorized transfer, a trade sample must be placed in a container that is compliant with the packaging for retail sale requirements of this rule.
B. Prior to authorized transfer to a licensed cannabis establishment, every container containing a trade sample shall be affixed with a label that is compliant with the labeling for retail sale requirements of this rule.
C. Either the label affixed to the container or the marketing layer shall include the statement in a font that is bold: "Trade Sample. Not for Sale."
9.3 - Packaging and Labeling for Retail Sale of Inhaled Cannabis Products
9.3.1Retail Sale Packaging for Inhaled Cannabis Products. Prior to authorized transfer to a cannabis store, all inhaled cannabis products shall be packaged in accordance with the following:
A. The container must be fully enclosed on all sides, as follows:
(1) If container is soft sided, it must be four mil or greater in thickness; or
(2) If container has rigid sides, it must have a lid or enclosure that can be placed tightly and securely on the container.
(3) The container must be child-resistant or must be placed into child-resistant exit packaging by the cannabis store at time of sale.
(4) The container must be opaque or must be placed into opaque exit packaging by the cannabis store at time of sale.
B. The container must be tamper-evident:
(1) If the container is soft sided, the opening must be sealed by some means in a manner which would indicate if the container had been opened or tampered with. The tamper evident indicating feature of the opening must not be resealable, and once opened must remain clearly evident that the package has previously been opened; or
(2) If the container is rigid, the opening must contain a tamper evident seal, or the lid or enclosure must have an adhesive band or seal that once opened must remain clearly evident that the package has previously been opened.
C. The packaging must contain a marketing layer, on which required labeling information can be printed.
9.3.2Labeling for Retail Sale Requirements for Inhaled Cannabis Products. In addition to Section 9.1.2 any other provisions of this rule and 28-B MRS, all inhaled cannabis products must clearly display the following information on the marketing layer of the package for retail sale:
A. A statement, if applicable, that the packaging is not child-resistant;
B. The potency of inhaled cannabis products, expressed as:
(1) The actual potency results for total THC and total CBD reported by a testing facility on the certificate of analysis; or
(2) A range of percentages of total THC and total CBD that extends from the lowest percentage to the highest percentage for each cannabinoid listed that may be found in the inhaled cannabis product, so long as the lowest percentage and the highest percentage of total THC and total CBD do not differ by more than 20% of the lowest percentage stated; or
(3) The percentage total THC and total CBD and based on the results of analysis reported by a testing facility and as the average percentage total THC and total CBD found in the inhaled cannabis product, so long as the actual percentage totals of the inhaled cannabis product does not vary by more than 15% higher or 15% lower than the potency statement stated on the label;
(4) Except that if the testing facility reports that total CBD or total THC is "not detected" or "zero" ("0"), then the label may state "0" for those cannabinoids.
C. If applicable, a list of any solvent(s) used to produce any cannabis concentrate that was used in the manufacturing of the inhaled cannabis product;
D. If applicable, a list of all ingredients used to manufacture the inhaled cannabis product, including identification of the actual or potential presence of any major allergens contained in the cannabis concentrate in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010), specifically milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans; and
E. Net content, according to the following:
(1) For inhaled cannabis products, net contents shall be stated in grams, except that inhaled cannabis products containing less than one gram of net content may state the net contents in milligrams.
(2) Variance is allowed as follows:
(a) For inhaled cannabis products composed primarily of cannabis flower or trim, the actual net contents by weight may be as much as 0.1 grams less. or 0.5 grams greater than the statement of net content on the label;
(b) For inhaled cannabis products that are pre-rolled cannabis cigarettes, the actual net contents by weight may be as much as 5% less than or 15% greater than the statement of net content;
(c) For inhaled cannabis products composed primarily of cannabis extract, the actual net contents by weight may be as much as 5% less or 10% more than the statement of net content.
(3) Inhaled cannabis product labels may state the net contents in ounces in addition to stating the net contents in grams.
(4) In determining the weight of cannabis concentrate in a cannabis product, the weight of any other ingredients combined with cannabis or cannabis concentrate to prepare the cannabis products may not be included.
9.4 - Packaging and Labeling for Retail Sale of Edible Cannabis Products
9.4.1Retail Sale Packaging Requirements for Edible Cannabis Products. Prior to authorized transfer to a cannabis store, all edible cannabis products shall, unless otherwise specified, be packaged in child-resistant containers in accordance with 16 C.F.R. Part 1700 (2018) as follows:
A. For single-serving edible cannabis products:
(1) Single-serving edible cannabis products must be placed into a child-resistant container that may or may not be resealable.
(2) Single-serving edible cannabis products that are placed into a child-resistant container may be bundled into a larger marketing layer so long as the total amount of THC per marketing layer does not exceed 100 milligrams, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5.
B. For multiple-serving edible cannabis products:
(1) Every multiple-serving edible cannabis product must be placed into a child-resistant container that is resealable or made of plastic four mil or greater in thickness and heat sealed with no easy-open tab, dimple, corner or flap, as to make it difficult for a child to open.
(2) A multiple-serving edible cannabis product must not exceed 100 milligrams of total THC per multiple-serving container, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5.
(3) The packaging shall clearly indicate the size of a serving if the edible product is not in a form that indicates a serving.

A single-serving tincture may contain no more than 10 milligrams of THC, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5, and must be placed into a child-resistant container that may or may not be resealable.

D. Single-serving cannabis drinks that do not contain more than 10 milligrams of THC, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5, may be packaged in:
(1) A child-resistant container;
(2) An aluminum or metal can with a stay tab mechanism opening; or
(3) A bottle with a metal crown cork style bottle cap.
E. Multiple-serving cannabis drinks that contain more than 10 milligrams of THC but no more than 100 milligrams of THC, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5, must:
(1) Be packaged in a child-resistant container compliant with 16 C.F.R. Part 1700 (2018) that has a resealing cap or closure; and
(2) Include a measuring device such as a measuring cap or dropper with the package containing the cannabis-infused liquid edible product; hash marks on the bottle or package do not qualify as a measuring device.
F. Cannabis drinks packaged according to this section may be bundled into a larger marketing layer so long as the total amount of THC per marketing layer does not exceed 100 milligrams, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5.
G. The container must be tamper-evident or must be placed into tamper-evident exit packaging by the cannabis store at time of sale.
H. The container must be opaque or must be placed into opaque exit packaging by the cannabis store at time of sale.
9.4.2Labeling for Retail Sale Requirements for Edible Cannabis Products. In addition to Section 9.1.2, any other provisions of this rule and 28-B MRS, ch. 1, all edible cannabis products must clearly display the following information on the marketing layer of the package for retail sale:
A. Total contents of THC and CBD, stated in milligrams and for edible cannabis products containing at least 5 milligrams of THC, not more than 10% less or 10% greater than the actual THC and CBD content, and for edible cannabis products containing less than 5 milligrams of THC, not more than 20% less or 20% greater than the actual THC and CBD content, including:
(1) The total contents of THC and CBD per serving unit; and
(2) If the label is on the marketing layer of a package containing more than one serving unit, the total contents of THC and CBD contained within the entire package;
B. The serving size, which may contain no more than 10 milligrams of THC, except as permitted in Section 3.8.6 and 18-691 CMR, ch. 5;
C. The number of servings per container or marketing layer;
D. Total net weight of the edible cannabis product separate from the package and label;
E. A statement in font no smaller than 6 point: "This product contains cannabis. Keep away from children.";
F. If applicable, a list of all ingredients used to manufacture the edible cannabis product, including identification of the actual or potential presence of any major allergens contained in the product in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010), specifically milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans;
G. A nutritional fact panel in accordance with 21 C.F.R. Part 101 (2018);
H. A statement in font no smaller than 6 point: "Effects of this product may not be felt for up to 4 hours."; and
I. If applicable, a statement that the packaging is not tamper-evident.
9.5 - Packaging and Labeling for Retail Sale of Topical Cannabis Products
9.5.1Retail Sale Packaging for Topical Cannabis Products. Prior to authorized transfer to a cannabis store, all topical cannabis products shall be packaged in a child-resistant container in accordance with the following:
A. Salves, creams, lotions and balms shall be packaged in a child-resistant container that has a resealing cap or closure compliant with 16 C.F.R. 1700 (2018).
B. Transdermal patches shall be packaged in a plastic four mil or greater in thickness and be heat sealed with no easy-open tab, dimple, corner or flap, as to make it difficult for a child to open.
C. The packing must be tamper-evident or must be placed into tamper-evident exit packaging by the cannabis store at time of sale.
D. The container must be opaque or must be placed into opaque exit packaging by the cannabis store at time of sale.
9.5.2Labeling for Retail Sale of Topical Cannabis Products. In addition to Section 9.1.2, any other provisions of this rule and 28-B MRS, ch. 1, all topical cannabis products must clearly display the following information on the marketing layer of the package for retail sale:
A. A potency statement for topical cannabis products stating the total content of THC and CBD in milligrams in the container, and for transdermal products the total content of THC and CBD in milligrams contained in each transdermal product;
B. A list of all ingredients in descending order of predominance by weight or volume as applicable;
C. The amount recommended for use at any one time;
D. The following warning statement: "For Topical Application - Do Not Eat or Smoke."; and
E. If applicable, a statement that the packaging is not tamper-evident.
9.6 - Packaging and Labeling for Retail Sale of Cannabis Seeds
9.6.1Retail Sale Packaging for Cannabis Seeds. Prior to authorized transfer to a cannabis store, or for nursery cultivation facilities, prior to authorized transfer to consumer, all cannabis seeds shall be packaged in accordance with this section. Packaging for cannabis seeds for sale to consumers shall:
A. Keep all cannabis seeds dry;
B. Prevent germination of the seeds in the packaging;
C. Not impart any deleterious substances into the cannabis seeds; and
D. Be exempt from the requirements that packaging be child resistant, tamper evident and opaque.
9.6.2Labeling for Retail Sale of Cannabis Seeds. There is no mandatory testing required for cannabis seeds, therefore labels affixed to individual retail packages of cannabis seeds shall not contain information regarding test results, including without limitation cannabinoid content, potency or the absence or presence of contaminants. All cannabis seeds must clearly display the following information on the marketing layer of the package for retail sale:
A. The inventory tracking system package number for the package of cannabis seeds sold by the cannabis store or nursery cultivation facility licensee;
B. The license number of the cultivation facility where the cannabis seeds were propagated;
C. The license number of the cannabis store or nursery cultivation facility (if different from the cultivation facility that produced the seeds) that is offering the individual retail package for sale to consumers;
D. The net weight or the number of individual seeds in the package, a licensee may include either or both values on the label; and E. The following statement: "For cultivation only by consumers 21 years of age or older."

A licensee may include additional information regarding the contents of the individual retail packages of cannabis seeds, provided that such information does not conflict with this rule. A licensee may provide to consumers information on the limitations of home cultivation of cannabis for person use contained in 28-B MRS §1502.

9.7 - Packaging and Labeling of Samples Collected by a Licensee
9.7.1Self-Samplers and Sample Collectors Must Contact Cannabis Testing Facility. Any licensee collecting samples for mandatory testing in accordance with 28-B MRS, subchapter 6, and Section 7.2 of this rule must contact the cannabis testing facility that will conduct the mandatory testing and comply with the cannabis testing facility's specific recommendations regarding, without limitation:
A. Required sample collection tools and equipment based upon sample matrix type and mandatory tests required;
B. Required sample collection containers based upon sample matrix type and mandatory tests required;
C. Required sample transportation conditions based upon sample matrix and mandatory tests required;
D. A plan for sample receipt which includes any limitations on days or times when samples will be accepted by the cannabis testing facility; and
E. Any additional quality measures required by the cannabis testing facility to ensure sample integrity and prevent contamination of the licensee's samples or the samples of other licensees.

All cannabis testing facility recommendations regarding sample collection will be recorded for every sampling event in the licensee's sample collection records in accordance with Section 3.11 of this rule. Cannabis testing facility recommendations must align with the Department's Best Practice Guide as applicable.

9.7.2Self-Samplers and Sample Collectors Must Use Sample Collection Containers Required by Cannabis Testing Facility. A licensee collecting samples for mandatory testing must collect samples in accordance with the Department's sample collection SOP and deposit the required sample increments in the sample collection containers required by the cannabis testing facility analyzing the samples. When all required sample increments are collected, the person collecting the samples must:
A. Affix a tamper evident seal to each sample container and must initial the seal. The seal must be initialed by another individual identification cardholder witnessing the sealing of the sample containers;
B. Ensure that the universal symbol is on every sample collection container, no smaller than ½ of an inch by ½ of an inch;
C. Ensure that each sample collection container has the following notice: "FOR TESTING PURPOSES ONLY"; and
D. Ensure that each sample collection container is accompanied by the appropriate label generated by the inventory tracking system required by the Department.
9.67.3Self-Samplers, Sample Collectors and Cannabis Testing Facilities Must Comply with All Sample Collection Recordkeeping Requirements and Use the Department-required Sample Collection SOP and Best Practices Guide. A licensee must conduct all sample collection in accordance with the Department's sample collection SOP and Best Practices Guide and must submit to the cannabis testing facility all information required by the cannabis testing facility's quality system for each batch of cannabis or cannabis product sampled for mandatory testing. A licensee conducting sample collection for mandatory testing must comply with the sample collection recordkeeping requirements of this rule.
9.8 - Packaging and Labeling for Storage by a Cannabis Establishment
9.8.1Storage Prior to Testing. Following samples being taken from a batch of cannabis, a licensee must:
A. Store the batch in one or more sealed containers enclosed on all sides, so as to prevent the cannabis or cannabis product from being tampered with or transferred or sold prior to test results being reported.
B. Affix to the container(s) in which the cannabis is stored a label including the following information:
(1) The batch number; and
(2) In bold, capital letters, no smaller than 12-point font, "PRODUCT NOT TESTED"; and
C. Report the transfer of the sample into the tracking system and the batch number being sampled.
9.8.2Storage of Cannabis Not Labeled for Retail Sale. All cannabis or cannabis products stored on the licensed premise must be secured in a limited access area and tracked consistent with the inventory tracking rules.
9.8.3Health and Safety Standards for Storage. Storage of cannabis and cannabis products shall be under conditions that will protect products against physical, chemical and microbial contamination, as well as against deterioration of any container.

18-691 C.M.R. ch. 1, § 9