Illinois’s Cannabis Regulation and Tax Act places the labeling and packaging oversight for recreational cannabis products with the Illinois Department of Agriculture. In their recent emergency rules, the Department adopted regulations regarding labeling and packaging of recreational cannabis products in Illinois that mirrored the statutory requirements for packaging and labeling cannabis products and did not expand on those statutory requirements to any great degree. (You can find those requirements below).
The statutory requirements under the Cannabis Regulation and Tax Act as well as the regulatory requirements emplaced by the Illinois Department of Agriculture for cannabis businesses specifically mandate that in addition to the Cannabis Regulation and Tax Act’s stated requirements, packaging of cannabis products in Illinois also has to comply with the labeling requirements of the the Illinois Food, Drug and Cosmetic Act.
In reviewing products for sale in different dispensaries around Illinois and in helping prepare applications for the recent round of craft grower and infuser licensing, we noticed a dearth of applicant materials connecting or fully integrating and referencing some of the key points in the Illinois Food, Drug and Cosmetic Act’s labeling requirements that are not specifically reiterated in the Cannabis Regulation and Tax Act’s statutory provision. Cultivators, craft growers, and infusers would do well to familiarize themselves with these additional requirements to potentially avoid enforcement actions once the Department is able to start policing packaging and labeling and incorporates these additional requirements into its enforcement efforts.
This may be a tad troubling as the Illinois Food, Drug and Cosmetic Act contains multiple labeling sections for several commodities including food, drugs, cosmetics and… catfish… – each having distinct requirements. The Cannabis Act could have done a better job of specifying which sections require adherence. An Illinois cannabis lawyer looking press the issue might argue “just food” as the Food Handling Regulation Enforcement Act and the Sanitary Food Preparation Act and the Food Service Sanitation Code are also invoked by regulations concerning Illinois cannabis, but that argument is not certain of winning.
To that end, some, but not all of the major labeling issues they, and dispensaries, should be aware of under the Illinois Food, Drug and Cosmetic Act are:
The following acts are prohibited:
Sec. 3.9. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of or the doing of any other act with respect to a food, drug, device or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded.
Sec. 3.10. (1) Forging, counterfeiting, simulating or falsely representing or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under the provisions of this Act or the Federal Act.
(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.
(3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug.
Sec. 3.16. (1) Placing or causing to be placed upon any drug or device or container thereof, with intent to defraud, the trade name or other identifying mark, or imprint of another or any likeness of any of the foregoing; or (2) selling, dispensing, disposing of or causing to be sold, dispensed or disposed of or concealing or keeping in possession, control, or custody, with intent to sell, dispense or dispose of, any drug, device or any container thereof, with knowledge that the trade name or other identifying mark or imprint of another or any likeness of any of the foregoing has been placed thereon in a manner prohibited by clause (1) above; or (3) making, selling, disposing of; causing to be made, sold or disposed of; keeping in possession, control or custody; or concealing with intent to defraud any punch, die, plate, stone or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container labeling thereof so as to render such drug a counterfeit drug.
Sec. 11. A food is misbranded:
(a) If its labeling is false or misleading in any particular.
(c) If it is an imitation of another food other than honey, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.
(e) If in package form, unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count. However, under paragraph (2) of this subsection reasonable variations shall be permitted and exemptions as to small packages which shall be established by regulations prescribed by the Director.
(f) If any word, statement or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral and other dietary properties as the Director determines to be, and by regulations prescribes as necessary in order to fully inform purchasers as to its value for such uses.
(k) If it bears or contains any artificial flavoring, artificial coloring or chemical preservative, unless it bears labeling stating that fact. However, to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Director. This subsection and subsections (g) and (i) with respect to artificial coloring do not apply to butter, cheese or ice cream. This subsection with respect to chemical preservatives does not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.
Sec. 15. A drug or device is misbranded –
(a) If its labeling is false or misleading in any particular.
(d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote or sulphonmethane, (or any chemical derivative of such substance, which derivative, after investigation, has been found to be and is designated as habit forming, by regulations issued by the Director under this Act, or by regulations issued pursuant to Section 502(d) of the Federal Act) unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning–May be habit forming”
You may be at fault for what you omit as well as what you say:
Sec. 2.11. If an article is alleged to be misbranded because the labeling is misleading or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the labeling or advertisement fails to reveal material facts in the light of such representations or material facts with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.
In addition of to the cannabis labeling requirements of the Illinois Food, Drug, and Cosmetic Act, the statutory requirements for packaging and labeling cannabis products that craft growers, cultivators, and infusers packaging and labeling recreational cannabis products in Illinois are as follows:
Sec. 55-21. Cannabis product packaging and labeling.
(a) Each cannabis product produced for sale shall be registered with the Department of Agriculture on forms provided by the Department of Agriculture. Each product registration shall include a label and the required registration fee at the rate established by the Department of Agriculture for a comparable medical cannabis product, or as established by rule. The registration fee is for the name of the product offered for sale and one fee shall be sufficient for all package sizes.
(b) All harvested cannabis intended for distribution to a cannabis enterprise must be packaged in a sealed, labeled container.
(c) Any product containing cannabis shall be packaged in a sealed, odor-proof, and child-resistant cannabis container consistent with current standards, including the Consumer Product Safety Commission standards referenced by the Poison Prevention Act.
(d) All cannabis-infused products shall be individually wrapped or packaged at the original point of preparation. The packaging of the cannabis-infused product shall conform to the labeling requirements of the Illinois Food, Drug and Cosmetic Act, in addition to the other requirements set forth in this Section.
(e) Each cannabis product shall be labeled before sale and each label shall be securely affixed to the package and shall state in legible English and any languages required by the Department of Agriculture:
(1) the name and post office box of the registered cultivation center or craft grower where the item was manufactured;
(2) the common or usual name of the item and the registered name of the cannabis product that was registered with the Department of Agriculture under subsection (a);
(3) a unique serial number that will match the product with a cultivation center or craft grower batch and lot number to facilitate any warnings or recalls the Department of Agriculture, cultivation center, or craft grower deems appropriate;
(4) the date of final testing and packaging, if sampled, and the identification of the independent testing laboratory;
(5) the date of harvest and “use by” date;
(6) the quantity (in ounces or grams) of cannabis contained in the product;
(7) a pass/fail rating based on the laboratory’s
microbiological, mycotoxins, and pesticide and solvent residue analyses, if sampled;
(8) content list.
(A) A list of the following, including the minimum and maximum percentage content by weight for subdivisions (e)(8)(A)(i) through (iv):
(i) delta-9-tetrahydrocannabinol (THC);
(ii) tetrahydrocannabinolic acid (THCA);
(iii) cannabidiol (CBD);
(iv) cannabidiolic acid (CBDA); and
(v) all other ingredients of the item, including any colors, artificial flavors, and preservatives, listed in descending order by predominance of weight shown with common or usual names.
(B) The acceptable tolerances for the minimum percentage printed on the label for any of subdivisions (e)(8)(A)(i) through (iv) shall not be below 85% or above 115% of the labeled amount.
(f) Packaging must not contain information that:
(1) is false or misleading;
(2) promotes excessive consumption;
(3) depicts a person under 21 years of age consuming cannabis;
(4) includes the image of a cannabis leaf;
(5) includes any image designed or likely to appeal to minors, including cartoons, toys, animals, or children, or any other likeness to images, characters, or phrases that are popularly used to advertise to children, or any packaging or labeling that bears reasonable resemblance to any product available for consumption as a commercially available candy, or that promotes consumption of cannabis;
(6) contains any seal, flag, crest, coat of arms, or other insignia likely to mislead the purchaser to believe that the product has been endorsed, made, or used by the State of Illinois or any of its representatives except where authorized by this Act.
(g) Cannabis products produced by concentrating or extracting ingredients from the cannabis plant shall contain the following information, where applicable:
(1) If solvents were used to create the concentrate or extract, a statement that discloses the type of extraction method, including any solvents or gases used to create the concentrate or extract; and
(2) Any other chemicals or compounds used to produce or were added to the concentrate or extract.
(h) All cannabis products must contain warning statements established for purchasers, of a size that is legible and readily visible to a consumer inspecting a package, which may not be covered or obscured in any way. The Department of Public Health shall define and update appropriate health warnings for packages including specific labeling or warning requirements for specific cannabis products.
(i) Unless modified by rule to strengthen or respond to new evidence and science, the following warnings shall apply to all cannabis products unless modified by rule: “This product contains cannabis and is intended for use by adults 21 and over. Its use can impair cognition and may be habit forming. This product should not be used by pregnant or breastfeeding women. It is unlawful to sell or provide this item to any individual, and it may not be transported outside the State of Illinois. It is illegal to operate a motor vehicle while under the influence of cannabis. Possession or use of this product may carry significant legal penalties in some jurisdictions and under federal law.”.
(j) Warnings for each of the following product types must be present on labels when offered for sale to a purchaser:
(1) Cannabis that may be smoked must contain a statement that “Smoking is hazardous to your health.”.
(2) Cannabis-infused products (other than those intended for topical application) must contain a statement “CAUTION: This product contains cannabis, and intoxication following use may be delayed 2 or more hours. This product was produced in a facility that cultivates cannabis, and that may also process common food allergens.”.
(3) Cannabis-infused products intended for topical application must contain a statement “DO NOT EAT” in bold, capital letters.
(k) Each cannabis-infused product intended for consumption must be individually packaged, must include the total milligram content of THC and CBD, and may not include more than a total of 100 milligrams of THC per package. A package may contain multiple servings of 10 milligrams of THC, indicated by scoring, wrapping, or by other indicators designating individual serving sizes. The Department of Agriculture may change the total amount of THC allowed for each package, or the total amount of THC allowed for each serving size, by rule.
(l) No individual other than the purchaser may alter or destroy any labeling affixed to the primary packaging of cannabis or cannabis-infused products.
(m) For each commercial weighing and measuring device used at a facility, the cultivation center or craft grower must:
(1) Ensure that the commercial device is licensed under the Weights and Measures Act and the associated administrative rules (8 Ill. Adm. Code 600);
(2) Maintain documentation of the licensure of the commercial device; and
(3) Provide a copy of the license of the commercial device to the Department of Agriculture for review upon request.
(n) It is the responsibility of the Department to ensure that packaging and labeling requirements, including product warnings, are enforced at all times for products provided to purchasers. Product registration requirements and container requirements may be modified by rule by the Department of Agriculture.
(o) Labeling, including warning labels, may be modified by rule by the Department of Agriculture.
The post Remember, the Illinois statutes and regulations regarding cannabis packaging and labeling include the labeling requirements of Illinois’s Food, Drug, and Cosmetic Act, not just the Cannabis Act’s requirements. appeared first on Libation Law Blog.