Our California cannabis attorneys have been having inundated with packaging and labeling evaluation because every California cannabis licensing agency adopted its final guidelines in January 2019, and even just before that when the guidelines have been beneath consideration. 1 point that several California cannabis companies—and particularly cannabis businesses from other states who are stakeholders in California—often overlook or gloss more than are the specifications of the Secure Drinking Water and Toxic Enforcement Act of 1986 (or “Prop. 65”). It is been a even though because we’ve written about the precise specifications Prop. 65 for California cannabis goods, so we believed it finest to appear back at the Prop. 65 guidelines and see how they square with the final cannabis guidelines.
For some refresher, Prop. 65 is NOT a cannabis-precise law. It was passed extended just before the Medicinal and Adult-Use Cannabis Regulation and Security Act (or “MAUCRSA”) and applies broadly to all sorts of goods and other items in California. What’s significant for California cannabis businesses to know about Prop. 65 is that it calls for businesses to notify buyers about the presence of specific dangerous chemical compounds in cannabis goods.
Prop. 65 calls for the California Workplace of Environmental Well being Hazard Assessment (“OEHHA”), which is component of the California Environmental Protection agency, to publish a list of chemical compounds recognized to result in cancer, birth defects, or other varieties of reproductive harm. The OEHHA’s regulations give California corporations a roadmap for, amongst other items, how to supply notice to buyers if specific carcinogens or reproductive toxins are present in customer items (i.e., marijuana). In light of Prop. 65’s specifications, any cannabis licensee requirements to ask itself a quantity of significant inquiries:
Do Prop. 65’s Warning Needs Even Apply?
The initially query cannabis corporations have to have to ask themselves in a Prop. 65 evaluation is regardless of whether they’re topic to Prop. 65 at all. There are a brief list of exemptions that are applicable to California cannabis items:
- Companies with fewer than 10 workers and government agencies.
- Scenarios exactly where a company can demonstrate that “exposure poses no considerable threat assuming lifetime exposure at the level in query for substances recognized to the state to result in cancer, and that the exposure will have no observable impact assuming exposure at 1 thousand (1000) occasions the level in query for substances recognized to the state to result in reproductive toxicity, primarily based on proof and requirements of comparable scientific validity to the proof and requirements which kind the scientific basis for the listing of such chemical”. This is a mouthful, calls for demonstrable proof, and areas the burden on any defendant in a case to prove.
- According to the California Lawyer Basic, “[e]xposures to listed chemical compounds that take place naturally in foods” is also an exemption. There is a far more detailed discussion of this exemption in the regs.
Are Prop. 65-Sort Chemical substances Present?
When California cannabis businesses establish that Prop. 65 applies to them, they have to have to establish what precise chemical compounds are present in their cannabis goods. The Prop. 65 list now consists of far more than 1,000 chemical compounds. In 2009, marijuana smoke was added to the Prop. 65 list of chemical compounds recognized to result in cancer. Hence, all cannabis flower is topic to Prop. 65 warnings because all flower produces “ marijuana smoke.”
But Prop. 65 does not finish there. In most instances, other manufactured cannabis products—such as oils, vape cartridges, and even edibles—contain at least 1 chemical on OEHHA’s gigantic Prop. 65 list. Simply because of this, several (if not most) cannabis corporations in California will be topic to Prop. 65 warning specifications. And as noted beneath, none of the California cannabis agencies regulate or even clarify how to comply with Prop. 65.
How to Present Warnings?
This might be 1 of the far more difficult problems, and this is exactly where the cannabis regulations come in.
As any California cannabis licensee knows, the California Division of Public Well being (“CDPH”)—which regulates manufacturers—is the agency which has promulgated explicit packaging and labeling guidelines in its regulations. Even although these regulations apply to manufacturer licensees, the other two agencies explicitly incorporate them for packaging and labeling. The CDPH regulations do not explicitly call for Prop. 65 compliance, but the CDPH does have FAQs which note that Prop. 65 compliance might be essential. That stated, there are some fairly significant elements of the CDPH regulations to look at when considering about Prop. 65.
1st, the CDPH calls for that for any item, an informational panel and main panel be present and supply specific facts (the essential facts modifications from item to item). The CDPH is clear, on the other hand, that every label can include things like other facts. Usually, we see Prop. 65 warnings someplace on 1 of these two labels, although the CDPH does not especially call for it. The explanation is almost certainly since section 26501(d) of the OEHHA guidelines calls for that the warning be conspicuously displayed on a package in a way that a customer would be most likely to essentially study and comprehend it. That almost certainly will not occur if the label is tucked away into a corner on the bottom of the box.
Second, the CDPH has explicit specifications for multi-layered item packaging (CDPH guidelines 40403). The gist of these guidelines is that for items with separable layers of packaging, every layer have to include things like distinctive sorts of facts (the essential facts modifications primarily based on the item, but for some items all that have to be present is a compliant version of the CDPH’s universal symbol).
These regulations raise two significant inquiries: (1) Does a Prop. 65 warning have to have to be present on every layer of separable packaging? and (two) What does the Prop. 65 warning have to have to say?
The answer to the initially query is almost certainly “no.” In the OEHHA’s final statement of motives for its regulations, the OEHHA responded to a comment as follows: “These regulations do not call for a warning on each the container and the outer packaging, despite the fact that some corporations might pick out to supply each to assure that the typical customer receives a warning as essential by the Act.” Hence, a single warning is almost certainly fine, and our California cannabis attorneys normally see that on the outer layer of the packaging.
The answer to the second query is far more complicated, but there are a quantity of choices. OEHHA rule 25602(a) says that for customer items, a warning meets the secure-harbor if it is supplied through 1 of 4 procedures. 1 of these procedures is a “label” compliant with section 25603(a), and the other is an “on-product” warning that complies with section 26503(b). Label is defined as “a show of written, printed, or graphic material that is affixed to a item or its quick container or wrapper.” The term “on-product”, on the other hand, is not defined.
That stated, section 25603(a) offers a mechanism for supplying complete notice by working with the triangle, the word “WARNING”, and precise language that identifies the carcinogens and/or reproductive toxicants. It have to be on a label as notice above, which can be on the item or its quick wrapper. In this case, the label have to have 1 of the following 4 complete warnings which especially recognize the problematic chemical compounds.
On the other hand, section 25603(b) governs “on-product” warnings. On-item warnings are abbreviated warnings that call for only the Prop. 65 symbol, the word “WARNING”, and a brief-kind warning which does not have to have to recognize all chemical compounds. When the term “on product” is not defined, the OEHHA’s final statement of motives says in component:
For purposes of subsection 25603(b), the brief-kind warning might only be supplied on the item, which would include things like the quick container (box, packaging) or wrapper for the item, but would not include things like other varieties of “labeling” as defined in subsection 25600.1(j).
In other words, it seems that the brief-kind, on-item warning in section 25603(b) is fine on actual items or their packaging, but not on web-sites, placards, and so forth. In that case, the complete warnings from 25603(a) are most likely essential.
The guidelines also have precise specifications for the text size, the wording, the symbols that have to be utilised, and as noted above, the placement. These guidelines can be complicated for businesses to don’t forget, so it is crucial for California cannabis businesses to seek the advice of with seasoned regulatory counsel prior to generating packaging or labeling to assure that they comply with the CDPH regs and Prop. 65. That is since Prop. 65 is a complicated law and there can be several pitfalls—including litigation—for failure to adequately comply.