Rest Easy - NYS DOH Relaxes and Refines Packaging and Labeling Regs
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Packaging and Labeling in New York’s Cannabinoid Hemp Market
The latest revision of the regulations includes substantial changes to the packaging and labeling requirements detailed in the first iteration of such rules issued by DOH in October of 2020. Generally speaking, the updated regulations allow for more flexibility and further clarify specific packaging and labeling requirements. In an industry where violations can mean hefty fines, license suspension or revocation, such refinement is a crucial piece of ensuring the implementation of such requirements is practicable and successful by regulated entities.
Notably, products that fall under the definition of a cosmetic are exempted from such requirements and are rather governed pursuant to the Food, Drug, and Cosmetic Act. For cannabinoid hemp products made for human consumption, however, the requirements have been somewhat relaxed and refined. One of the most notable relaxations is the removal of the requirement that all detectable cannabinoids existing above 0.05% in a product must be listed on a label. Such requirement has been modified so that processors are only required to list “marketed cannabinoids,” including THC and CBD, on the product label. To conform with the added ban on Delta-8 THC and Delta-10 THC (discussed in detail earlier in this Tap Root Series) in cannabinoid hemp products, the concentrations of such substances, if applicable, must be included on the label.
Further relaxing such requirements is the clarification that required warnings may be combined into a single statement on the label to save space. Additionally, product packaging or labeling must now only include the country or countries of origin of the sourced hemp rather than the state(s) of origin.
New York’s updated regulations also clarified what constitutes attractiveness to youth, specifying that “no cannabinoid hemp product packaging shall imitate a candy label or use cartoons or other images popularly used to advertise to children or otherwise be marketed to anyone under 18 years of age, or for inhalable cannabinoid hemp products and flower product, to anyone under 21 years of age.”
When it comes to packaging specifically, the updated regulations clearly state that food and beverage products must be “individually packaged” per serving, or otherwise “premeasured, separated, or delineated. In lieu of such separation, the product must include a measuring device, such as a “cap, cup, or dropper.”
Other State Requirements
For comparison, let’s look at what some other states require when it comes to packaging and labeling. States generally have their own rules when it comes to the packaging and labeling of cannabinoid hemp products manufactured for human consumption. However, such requirements tend to share some commonalities across state lines pertaining to product identity, net quantity of contents, name and place of business, ingredient declaration, warning or caution statements, and disclosure of material facts.
Colorado, with one of the biggest hemp markets in the country, explicates packaging and labeling requirements for CBD and hemp-derived products in regulations, such requirements include but are not limited to statements concerning, product identity, net weight, ingredient disclosure, as well as company name and address.
On Mar. 21, 2018, Gov. Holcomb signed SB 52 into law, which allows distribution and retail sail of “low-THC hemp extract,” defined as a product “(1) derived from Cannabis sativa L. that meets the definition of industrial hemp; (2) that contains not more than 0.3% delta-9-THC (including precursors); and (3) that contains no other controlled substances.” Information required on the label includes, a scannable bar code or QR code linked to a document that contains various product information, the batch number, the internet address of a web site to obtain batch information, the expiration date, the number of milligrams of low THC hemp extract, the manufacturer, the fact that the product contains not more than three - tenths percent (0.3%) total delta-9 THC by weight.
Similar to New York’s concern with product appeal to youth, the state’s guidelines for packaging and labeling of hemp products specially state that hemp products “cannot be packaged in a manner that is attractive to minors.” As with all CBD/hemp-derived products that wish to conform to FDA guidelines, product packaging cannot contain “untruthful or misleading statements” particularly when it comes to structure or function claims. The guidelines also specify information panel requirements, as well as those pertaining to product identity, net weight, font size and requirements concerning certain mandated information, among other provisions.
Moving Forward: The Comment Period and Beyond
DOH is encouraging those currently operating in NY’s cannabinoid hemp market to review and become familiar with the updated proposed regulations, the comment period for which runs through July 17, 2021. While it is possible that further changes may be made to these draft regulations as a result of the new comment period, processors should become familiar with the new packaging and labeling requirements, as they may require processors to add certain items such as warning labels and product information. As the updated draft regulations included revisions to account for industry stakeholder concerns expressed in the original public comment period, we expect some minor changes may be made, but overall anticipate that the final regulations will look similar.