PUBLIC COMMENTS SUMMARY
NACB Packaging and Labeling National Standards (Draft)
Last Updated: March 23, 2018
On January 23, 2018, the National Association of Cannabis Businesses published and requested comments on a draft of its Packaging and Labeling National Standards. On February 23, the public comment period closed.
During the comment period, the NACB received 114 comments from 25 commenters. A diverse group of businesses, individuals, and organizations provided input on the NACB’s Packaging and Labeling National Standards, including packaging experts, chemists from
testing laboratories, state regulators, the National Cannabis Industry Association (the cannabis industry’s largest trade association) and many other experienced professionals from inside and outside the cannabis industry. The NACB is grateful for these comments, which will enable the NACB to adopt a standard that advances its mission of advancing the cannabis industry by protecting public health and safety.
Transparency is a cornerstone of the NACB’s standards creation process. Accordingly, the NACB is publishing this summary of comments received on its draft Packaging and Labeling National Standards, which is organized subject matter. The NACB’s members will consider these comments and amend the Packaging and Labeling National Standards before voting on their adoption.
If you have any questions concerning the NACB’s National Standards or the process for their creation:
please visit https://www.nacb.com/national-standards or email the NACB at NationalStandards@NACB.com.
APPLICABILITY OF STANDARDS AND DEFINITIONS
The NACB received several comments regarding the scope and applicability of the Packaging and Labeling National Standards. Most or all of these comments will be resolved through the Definitions section of the NACB’s National Standards, which will be adopted by the NACB in the near future.Abide by and remain in compliance with all applicable local and state laws concerning cannabis;
Specifically, several commenters asked whether the Packaging and Labeling Standards would apply to hemp and other non-psychoactive products. Currently the Packaging and Labeling National Standards are not intended to apply to such products. Other commenters sought clarity in distinguishing actors – Cultivators, Processors, Retailers, and Establishments generally – and product types – Cannabis Flower and Trim, Cannabis Concentrates, and Cannabis Products. The Definitions section of the NACB’s National Standards, once adopted by the NACB, will answer these questions, making clear the precise applicability of each provision.
Warning Statements (Standard 2.11).
Regarding the warning about the delayed effect of edibles, one commenter suggested adopting Oregon’s approach, which the commenter says requires “a statement or pictogram of specific anticipated activation time” for each product.
Another commenter focused on the relationship between Standard 2.11 (Warning Statements) and Standard 2.16 (Health, Medical, and Disease Claims; Labeling), suggesting that we cross-reference each Standard in the other Standard and that we move Standard 2.11(b)(5)’s required warning to Standard 2.16.
Warning/Universal Symbol (Standard 2.10).
One commenter suggested narrowing the options for Cannabis Establishments in states with no required warning symbol. That commenter proposed picking a single symbol (perhaps Colorado’s “Universal Symbol”) for NACB Members from such states to use, standardizing the symbol of all Members from that state.
Along those lines, another commenter suggested a new symbol (a green cross) for all NACB Members to use, regardless of their state’s requirements. Such an approach would require some Members to have two symbols: the green cross and their state’s symbol.
Finally, a commenter noted that the citation to Oregon’s “Universal Symbol” should be O.A.R., not O.A.C.; this correction will be made.
Laboratory and Test Results.
One commenter suggested that labels state all tests performed on a product and the laboratory at which they were performed.
Another commenter suggested requiring labels to state the “identity of the active cannabis ingredients,” “the quantity of active cannabis in a serving,” “the portion or unit that makes up a serving,” and “the number of servings in the package.”
Both of these issues will be addressed as the NACB addresses standards related to laboratory testing.
Appeals to Children (Standard 2.13).
One commenter worried that prohibiting the depiction of any animal was overly strict and recommended Oregon’s approach, which prohibits only “cartoon animals, i.e., animals with exaggerated features or human-like characteristics.” That commenter also suggested removing the exemption that allows Cannabis Establishments to use the word “candy” (or “candies”) if it is part of the Establishment’s name. Third, that commenter suggested prohibiting depictions of cannabis consumption on labels.
Another commenter noted that the Washington State Liquor and Cannabis Board has proposed changes to its regulations regarding appeals to children, including a new definition of “cartoon,” which states that the term “cartoon” encompasses illustrations with “comically exaggerated features,” and attribution of human characteristics to animals or plants, and the attribution of unnatural abilities (e.g., superpowers).
False and Misleading Statements Prohibited (Standard 2.12).
A commenter suggested listing examples of or criteria for false and misleading statements, including unsubstantiated medical claims, misrepresentations of clinical results, and graphics that mislead consumers about the safety or medical efficacy of a product. In general, the commenter considered the current Standard too vague.
Product Identification (Standard 2.09).
One commenter emphasized that “nearly all processors create products using the same process from different or multiple cannabis batches,” arguing in favor of allowing Processors to use multiple batches of Cannabis when making Cannabis Products.
Contact Information (Standard 2.22).
One commenter argued that contact information other than a phone number would be just as effective in allowing consumers to contact the producer of the product.
Ingredient List (Standard 2.14).
One commenter wondered whether Standard 2.14 applied to Cannabis Concentrates in addition to Cannabis Products. Another commenter suggested adding “including all non-active ingredients such as sugar and salt” to the end of the Standard, clarifying the scope of the requirement.
Applicability of Non-Cannabis Food Laws.
Two commenters recommended requiring Edible Cannabis Products to include food information that the USDA requires for non-cannabis retail food products, such as calorie counts and other nutrition facts. One commenter suggested the Standard explicitly require compliance with all applicable state and local food laws, specifically mentioning states’ cottage food laws.
Allergen Warnings (Standard 2.15).
A commenter suggested requiring labels to note whether the product was “made in a facility that processes peanuts, tree nuts, soy and sesame seeds, etc.,” even if the product itself does not contain these ingredients.
Health, Medical, and Disease Claims; Labeling (Standard 2.16).
One commenter commended us for Standard 2.16; another commenter said that the distinction between permissible and impermissible claims was confusing; still another said that Standard 2.16 was a clear violation of the federal Food, Drug, and Cosmetic Act because such claims must be approved by the FDA.
The skeptical commenter argued that the “substantiation” language in Standard 2.16(b)(3)(A) was inadequate. That commenter said that the criteria for what constitutes substantiation should be clearer, perhaps requiring that the research be published in academic journals, backed by studies using prescribed methodology, or the like.
Label Inserts; Accompanying Materials.
Three commenters were concerned that many products would not have enough label space to accommodate the information required on them.
Of these, one commenter advocated allowing “miniature printed informational inserts” as an alternative to requiring all information on the product label itself. The commenter pointed out that such inserts allowed for additional languages, too. Another commenter recommended this same solution, but only for products with labels that are too small to contain all required information.
The third commenter pointed out that the Washington State Liquor and Cannabis Board has proposed regulations allowing for certain information to be passed along to the consumer via QR codes or URLs to websites with the pertinent information.
Text Size (Standard 2.21).
Concerned that “clear and legible to consumers” was too subjective, one commenter recommended setting a lower and upper bound for text size: “no smaller than XX and no larger than XX.”
One commenter suggested requirements to ensure that labels remain legible and affixed to the container throughout the life of the product.
Packaging Layers (Standard 2.08).
Two commenters argued that the Standards do not clearly distinguish between internal layers, intermediate layers, outermost layers, exit packages, and shipping containers. This is an important distinction for labeling purposes, as not all layers are required to be labeled.
Two commenters suggested that the NACB consider and address the environmental impact of the Packaging and Labeling National Standards. Both argued against specifically requiring plastic for containers.
One of the commenters argued that resealable packaging is especially material-intensive and is unnecessary for multi-serving products other than edibles. The other commenter suggested encouraging or even requiring the use of recycled materials in containers.
Package Thickness (Standard 2.02).
Four commenters argued that Standard 2.02(b)(2) & (3)’s requirement that plastic be “at least four millimeters thick” should instead require that the plastic be “at least four mils thick” (i.e., one-thousandth of an inch thick), which is in line with several state requirements; this was a drafting error that the NACB will correct.
Two commenters suggested requiring that packaging be tamper-evident, as is required of alcohol packaging. One commenter would require either the container itself or exit packaging to be tamper-resistant.
Unit Dose Packaging.
One commenter suggested that the Standards require “unit dose packaging” (e.g., blister or pouch packaging) for each dose and argued for a high standard for testing such packaging.
Child-Resistant Packaging (Standard 2.02).
Three commenters addressed various aspects of Child-Resistant Packaging. The first argued that only edible product packages be required to be opaque, since “consumers may wish to inspect extracts and concentrates for color and consistency.” That commenter also argued that if a package has been certified by the Consumer Products Safety Commission (CPSC), it should be acceptable under these Standards. Finally, that commenter suggested reconsidering the “metal cap” specification in Standard 2.02(b)(3), since most plastic packages do not use metal caps.
The second commenter suggested amending Standard 2.02(b)(2) to read “tamper-resistant” instead of “heat-sealed,” since a heat seal “may not work for temperature-sensitive formulas and perishables.”
The third commenter stated that many child-resistant packages are Chinese-made and are not tested for compliance with the Poison Prevention Packaging Act regulations (16 CFR Part 1700).
Packaging of Solid Edible Products (Standard 2.06).
One commenter argued that Standard 2.06(a) should allow for multiple-serving edible products such as powders to be sold in a single child-resistant container, rather than requiring such products to be divided into single-serving internal child-resistant packaging. Such products would contain a measuring scoop to enable consumers to measure out single servings.
Another commenter suggested that Standard 2.06 reiterate Standard 2.02(c)’s requirement that multiple-serving packages retain their child-resistant effectiveness for multiple openings.
Another commenter pointed to the Washington State Liquor and Cannabis Board has proposed regulations that are more flexible on edible product packaging than the state’s 6 current regulations, including clarifying that individual doses in a multi package unit, such as lozenges, need not be separately wrapped.
Packaging of Liquid Edible Products (Standard 2.06(f)). One commenter wondered whether the Standards should provide for verification that any measuring device in a liquid edible product is accurate.
Another commenter stated that the usual measuring mechanism for liquid edible products is not the cap itself but an “overcap” that is “banded over the child-resistant closure.” In addition to this, the commenter argued that the Standards should allow for measuring caps that are manufactured separate from the liquid edible package but are attached to the package at the point of sale. That commenter also questioned whether and how the current version of Standard 2.06(f) applied to tinctures.
We also received a comment arguing that hash marks on a container (which are not a sufficient measuring device under this Standard) are equivalent to the “demarcated and stamped” approach accepted for multiple-serving solid edible products. The commenter argued for consistency.
One commenter proposed an additional Standard mandating that containers “not be reactive, additive, or absorptive” so as to alter the product. The containers should also protect the product from foreseeable external factors that might be deleterious to the product. Finally, the commenter suggested requiring the containers to be clean and, where appropriate, “sterilized and processed.”
Exit Packages (Standard 2.07).
One commenter argued that most or all of the information required for container labels also be required for exit packages. Another commenter agreed with the substance of the Standards but argued that Standard 2.07 should be clearer that it requires child-resistant exit packages if the product’s container is not child-resistant. Currently the Standards cross-reference to state laws with respect to this requirement.
Reuse of Containers and Exit Packages.
One commenter suggested that the Standards consider whether to allow for the reuse of containers and exit packages. If so, the commenter suggested prescribing measures to prevent product contamination arising from reuse.
Exemption for Elderly and Handicapped Persons (Standard 2.02(d)).
One commenter questioned what oversight NACB would have over state exceptions to the childresistant package requirement for elderly and handicapped persons. The commenter worried about abuse.
Health, Medical, and Disease Claims; Retailers (Standard 2.17).
One commenter suggested outright prohibiting employees of Retailers (budtenders) from discussing patients’ medical diagnoses and treatments, even if they’re still permitted to discuss the limited, general effects described by Standard 2.16(b).
Another commenter felt that Standard 2.17(b)(2)’s requirement that a budtender notify the consumer that effects of cannabis vary by person is overly strict, as most consumers are already aware of this.
Certificate of Conformance; Child-Resistant Packaging (Standard 2.03).
One commenter argued that requiring certificates of conformance to be included in each shipment was overkill; maintaining one copy of the certification per packaging model should be sufficient. That commenter also suggested requiring that the containers or exit packages be certified as child-resistant “in accordance with 16 CFR 1700 by an ASTM-certified third-party testing agency.”
Another commenter suggested requiring a copy of the certificate “in the files of the shipping containers.”
Standard Operating Procedures.
One commenter suggested either (i) requiring Cannabis Establishments to document their standard operating procedures for avoiding product, package, and label mix-ups or (ii) prescribing such procedures in the Standards.
Another commenter proposed adopting Standards similar to the FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 CFR 111).
Two commenters mentioned recordkeeping. One suggested requiring transportation manifests; the other suggested record-retention requirements. Both ideas have merit, but arguably belong in another set of Standards.
Repackaging and Relabeling for Flower and Trim (Standard 2.04).
One commenter asked whether repackaging and relabeling for Cannabis Flower and Trim would be allowed and, if so, whether and how the Standards should regulate this.
Two commenters asked about the Standard Serving, which was intentionally left undefined in these Standards. One commenter emphasized that the Standard Serving must be defined and noted that maximum or standard serving sizes vary across states.
The other commenter asked whether the Standard Serving should vary “based on the age, gender, or other characteristics of the end user.”