230-80-05 R.I. Code R. § 1.5

Current through April 23, 2024

Section 230-RICR-80-05-1.5 - Product Packaging and Labeling Requirements for Retail- Ready Medical Marijuana Products

1.5.1Authority and Applicability

A. These retail-ready medical marijuana product packaging and labeling requirements for compassion centers and licensed cultivators are promulgated pursuant to R.I. Gen. Laws §§ 21-28.6-12(f)(11) and 21-28.6-16(g).

B. Compassion centers and licensed cultivators shall have ninety (90) calendar days from the effective date of these regulations to comply with these requirements.

C. The compassion center is responsible for ensuring all medical marijuana products are retail-ready prior to sale to a qualifying patient, registered primary caregiver or authorized purchaser.

1.5.2General Packaging Requirements

A. All retail-ready medical marijuana products must be in compliant packaging upon entering the compassion center retail sale space.

B. In addition to any other requirements pursuant to § 1.5 of this Part, any package containing retail-ready medical marijuana product must:

1. Be opaque, of a neutral color, and light resistant;

a. Neutral colors include but are not limited to: black, white, gray, beige, brown, and tan. Neutral colors do not include primary and secondary colors (such as red, orange, yellow, green, blue, or purple) or any variant of primary or secondary colors.

2. Fully enclose the product;

3. Protect the product from contamination;

4. Not impart any toxic or deleterious substance to the medical marijuana product;

5. Be Child Resistant as defined in § 1.1 of this Part; and

6. Be able to be resealed in a Child Resistant manner unless the package contains a single-serving medical marijuana edible or ingestible pursuant to § 1.5.2(D) and (E) of this Part respectively.

C. Exit Package

1. Except for medical marijuana edibles and ingestibles, upon DBR approval, any other retail-ready medical marijuana product placed into a container that is not child-resistant shall be placed into a child-resistant Exit Package at the point of sale.

2. The Exit Package is not required to be labeled pursuant to § 1.5 of this Part if the package(s) within the Exit Package containing the retail-ready medical marijuana product comply with all labeling requirements pursuant to § 1.5 of this Part.

D. Additional Packaging Requirements for Retail-Ready Medical Marijuana Edibles

1. A single serving unit shall not exceed ten (10) milligrams ("mgs") of active THC.

2. A single serving unit, if sold individually, shall be placed into a child-resistant container that may or may not be resealable.

3. Multiple single serving units may be placed together into a single child resistant and resealable package, so long as the active THC per package does not exceed one hundred (100) mgs.

4. Multiple packages may be bundled and sold together so long as the:

a. Total amount of THC per serving unit does not exceed ten (10) mgs;

b. Total amount of THC per package does not exceed one hundred (100) mgs; and

c. Total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.

5. For Medical Marijuana Edibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.

6. For Medical Marijuana Edibles in liquid form containing multiple serving units, the container must have a resealing cap or closure which maintains child resistance compliance.

7. Medical Marijuana Edibles in liquid form containing multiple serving units must include a measuring device such as a measuring cap, cup or dropper with the package containing the medical marijuana product. Hash marks on the package do not qualify as a measuring device.

E. Additional Packaging Requirements for Medical Marijuana Ingestibles

1. A single serving unit, if sold individually, of a Medical Marijuana Ingestible must be placed into a child-resistant container that may or may not be resealable.

2. Multiple single serving units may be placed together into a single child resistant and resealable package.

3. Multiple packages may be bundled and sold together so long as the total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.

4. For Medical Marijuana Ingestibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.

5. For Medical Marijuana Ingestibles in liquid form with multiple serving units, the container must have a resealing cap or closure.

6. Medical Marijuana Ingestibles in liquid form with multiple serving units must include within the package:

a. A measuring device such as a measuring cap, cup or dropper that is capable of dispensing a ten (10) mg serving unit;

b. Hash marks on the package do not qualify as a measuring device.

F. Additional Packaging Requirements for Retail-Ready Medical Concentrates

1 Cartridges and any other devices, as determined by DBR, shall receive a consumer testing certificate which is subject to DBR review.

2. Electronic vaporization devices must have internal or external temperature controls to prevent combustion and have a heating element made of inert material.

3. The total THC per package shall not exceed 500 mgs.

1.5.3General Labeling Requirements

A. Each package containing retail-ready medical marijuana products must be labeled with all required information pursuant to § 1.5 of this Part before being sold to a registered patient, registered primary caregiver or authorized purchaser.

B. Labeling text must be:

1. No smaller than size 6 font, unless otherwise specified.

2. In Times New Roman, Calibri, Arial, Helvetica or any other font determined by DBR to be easily read.

3. In black or white, unless otherwise specified.

4. Clearly written or printed in the English language.

a. In addition to the required English label, licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules.

C. All required information must be unobstructed and conspicuous. Multiple labels may be affixed to the package, provided that none of the information required is obstructed.

D. Required information may be stated in a peel-back accordion, expandable, or extendable style so long as the label can be easily identified by a consumer as containing important information.

E. All packages containing retail-ready medical marijuana products must be clearly labeled with the following information:

1. The business(es) or tradename(s) and license number(s) of the licensee(s) who produced the product;

2. The business or tradename and license number of the compassion center selling the product;

3. The unique identifier generated by the Medical Marijuana Program Tracking System;

4. Total THC and Total CBD as provided by a licensed cannabis testing laboratory;

a. Upon request, a compassion center must disclose the name of the licensed cannabis testing lab that conducted the tests and provide the results of all required tests for any medical marijuana or medical marijuana product.

5. A DBR-selected universal warning symbol must appear on the front or most predominantly displayed area of the package, no smaller than one (1) inch by one (1) inch;

a. Vape cartridges sold containing medical marijuana product must include the DBR-approved symbol in a manner that is clear and conspicuous;

6. If applicable, the recommended expiration date, or "use by" date;

7. Poison Control Contact Information "American Association of Poison Control Center (800) 222-1222 "; and

8. For smokable and vapable products, the net weight of the medical marijuana product prior to its placement in the package, using a standard of measure compatible with the tracking system.

F. Additional Labeling Requirements for Retail-Ready Medical Marijuana Infused Products:

1. Total contents of THC and CBD must be stated per serving unit in milligrams (mgs), and in font larger than size 6, bolded, underlined and in red, so as to stand from surrounding text to the consumer;

2. Total contents of THC and CBD must be stated per package, in milligrams (mgs), in font larger than size 6, bolded, underlined and in red, so as to stand out from surrounding text to the consumer;

3. The serving size; and

4. The number of servings per package.

G. The following information may be placed on an insert but must accompany each retail-ready medical marijuana product sold:

1. A complete list of all nonorganic pesticides, herbicides, and fertilizers that were used in the cultivation and production of the medical marijuana product;

2. For medical marijuana infused products, the net weight of the medical marijuana or medical marijuana product prior to its placement in a package, using a standard of measure compatible with the tracking system;

3. For medical marijuana products consisting in whole or in part of marijuana flower or marijuana trim, the date of the harvest batch;

4. For marijuana products including concentrates and marijuana infused products that were manufactured, the date on which the manufacturing batch was created;

5. For processed medical marijuana products, the processing technique or solvent(s) used to produce the product;

6. For processed medical marijuana products, a list of all chemicals, diluents, additives, ingredients and/or excipients used to produce the medical marijuana product or that were added to the medical marijuana product;

7. For medical marijuana infused products, a list of all ingredients used to manufacture the marijuana infused product, including identification 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;

8. For medical marijuana edibles and ingestibles, a nutritional fact panel in accordance with 21 C.F.R. Part 101, incorporated above at § 1.1.7(B) of this Part;

9. For medical marijuana topicals, a list of all ingredients in descending order of predominance by weight or volume as applicable; and

10. For medical marijuana topicals, the amount recommended for use at any one time.

1.5.4Imprinting of the Universal Symbol

A. As directed by DBR, unless deemed impracticable by DBR, each single standardized serving unit of a medical marijuana infused product shall be marked, stamped or otherwise imprinted with a DBR-selected universal symbol directly on at least one side of the medical marijuana infused product in a manner to cause the universal symbol to be distinguishable and easily recognizable. The universal symbol marking shall:

1. Be centered either horizontally or vertically on each standardized serving of marijuana; and

2. If only imprinted on one-side, the imprinted side must be the front or most predominantly displayed area of medical marijuana infused product; and

3. If centered horizontally on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving's width, but not less than ¼ inch by ¼ inch; or

4. If centered vertically on a serving, the height and width of the universal symbol shall be of a size that is at least twenty-five percent (25%) of the serving's height, but not less than ¼ inch by ¼ inch.

B. Unless determined by DBR to be impractical, the following categories of marijuana infused product are considered to be per se practicable to mark with the universal symbol:

1. Chocolate;

2. Soft confections;

3. Hard confections or lozenges;

4. Consolidated baked goods (e.g. cookie, brownie, cupcake, granola bar); and

5. Pressed pills and capsules.

1.5.5 Prohibitions

A. Medical marijuana products shall not:

1. Be in the shape of a human, animal, fruit, cartoon character, or any other shape that is especially attractive to children as determined by DBR;

2. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana;

3. Be in the shape of a marijuana plant or leaf; and

4. Cause a reasonable consumer confusion as to whether the medical marijuana product is a trademarked product.

B. All logos or graphics are prohibited unless prior to use are approved by DBR.

1. The logo or graphic submitted to DBR for approval:

a. Must not be larger than the required universal symbol;

b. Can be colored; and c. Must only be used for the purpose of identifying the compassion center selling and/or the cultivator(s) producing the product.

2. The logo or graphic submitted to DBR for approval must not:

a. Reasonably appear to target individuals under the age of twenty-one (21), including but not limited to, the use of animal characters, toys, cartoon characters or similar images.

b. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana.

c. Include images of children or minors.

d. Include images of a marijuana plant, marijuana leaf or marijuana product or any person using or consuming the product.

e. Include words, a design or brand that resembles a product that is commonly associated with children or minors or marketed to children or minors.

f. Include symbols or celebrities that are commonly used to market products to minors.

g. Include the word or make any reference to "candy" or "candies".

h. Include any false or misleading statements, including any statements regarding health or physical benefits to the consumer.

i. Include any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any reasonably prudent person to believe that the product has been endorsed or manufactured by the State of Rhode Island or any agency or municipality thereof.

j. Cause a reasonable consumer confusion as to whether the medical marijuana or medical marijuana product is a trademarked product.

k. Violate any state or federal trademark law or regulation.

1.5.6Warnings

A. Warnings on all retail-ready medical marijuana products must:

1. Be in the English language;

2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;

3. Be in text no smaller than size 8 font and bolded;

4. Not be covered or obscured; and

5. Be displayed in a bright yellow box as to stand out from other labeling requirements, unless otherwise stated.

B. The following warnings must be displayed on all medical marijuana products, when applicable;

1. "Warning: For Medical use ONLY. This product contains marijuana. Store in a securely locked cabinet away from children."

2. "Warning: It is unlawful to transport this product outside of Rhode Island."

3. "Warning: For medical use by a registered patient only. Not for resale."

4. For medical marijuana products intended to be smoked or vaporized:

a. "Warning: Smoking and Vaping is hazardous to your health."

b. "Warning; Vaping can expose you to toxic chemicals that may lead to death".

5. For all medical marijuana infused products, it must state in slightly larger or bolded font as to stand out from surrounding text, with priority placement,

a. "Effects of this product may be delayed by 3 or more hours."

6. For all topical products, it must state:

a. "For Topical Application - Do Not Eat or Smoke."

C. In addition to the warnings above, rotating warnings must accompany all retail-ready medical marijuana products at the point of sale.

D. Rotating warnings shall:

1. Be in the English language;

2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;

3. Be in text no smaller than size 10 font and bolded; and

4. Not cover or obscure any required information pursuant to § 1.5 of this Part.

5. Accompany all retail-ready medical marijuana products at the point of sale based on a rotating schedule as determined by DBR.

E. The rotating warnings are:

1. "Warning: Marijuana has intoxicating effects and may be habit forming and addictive."

2. "Warning: Do not operate a vehicle or machinery under the influence of marijuana."

3. "Warning: Marijuana should not be used by women that are pregnant or breastfeeding."

4. "Warning: Early and frequent cannabis use has been associated with the onset of psychosis."

F. Compassion Centers shall post any additional warnings at the point of sale as determined by DBR.

230 R.I. Code R. § 230-RICR-80-05-1.5

Amended effective 3/25/2020