Compliance Mistakes in Marijuana Packaging

By Rachel Kane

It happened to me again recently. I was out on the town and ran across a newer dispensary. I popped inside to check it out. I purchased a bag of chocolate edibles that caught my eye. At home I opened them up, they were delicious. Great flavor, a tested product I knew I could trust, the only problem? It was not in a child resistant (CR) package, as required by state law. This unfortunately is not the first time I have come across products in regulated state markets that are not properly packaged.

Below is a list of the most common issues I’ve encountered with packaging compliance in the cannabis industry over the past six years:

1. Child Resistant Packaging: Single Use vs. Multi Pack

The main misunderstanding involves the different child resistant needs for single versus multi-serving products. I frequently see products, like my last purchase, packaged in mylar bags. It is a common misconception that any zipper mylar bag with a heat-sealed top meets CR requirements.

For flexible packaging, such as bags and stand-up pouches made from films, they must pass strength and puncture resistance tests to be considered CR. Many products not specifically designed to meet CR standards fail. Single use items such as cartridges, beverage mixes, transdermal patches, or a single serve edible have options like the AssurPouch® that only require a heat seal. However, when a product contains multiple servings, it must be sold in a re-closable CR package. Therefore, if your product has multiple servings then the flexible packaging must include a child resistant closure.

2. Not Keeping Up on State Labeling and Packaging Guidelines

Each State varies greatly when it comes to Cannabis Packaging and Labeling requirements. It can be a daunting task to keep on top of them. If your company has a chief compliance officer, make sure labeling accuracy is on their must-do list.

You can find online lists of state-by-state cannabis labeling requirements, but these are not always accurate and up to date with new and evolving markets; only your state regulatory site is trustworthy. It is a good habit to check back frequently or prior to any new packaging orders. If your state offers any sort of email subscription for updates, make sure to sign up. It’s in everyone’s interest to publicize new regulations, and states do so through email notification.

3. Mislabeling of Products

The mislabeling of products is common in many jurisdictions and negatively impacts the legal cannabis industry as a whole. The FDA recently signaled to Congress that a new regulatory pathway is needed, stating that the existing frameworks for foods and supplements are not appropriate for CBD products – and the agency has long prohibited THC edibles on the federal level, largely leaving all such governance to the states. Across the U.S. and Canada, cannabis manufacturers and dispensaries are facing recalls and lawsuits due to mislabeling of THC, such as:

• Minnesota: The state filed a lawsuit against several companies alleging that their edible cannabinoid products contained quantities of THC that surpassed state-allowed amounts.
• New York: A medical cannabis company recalled tens of thousands of units of cannabis after it switched to an unapproved method of labeling product potency without approval from state regulators.
• Oregon: A multistate cannabis operator paid $100,000 to settle a class-action lawsuit related to an ingredient mix-up resulting in drops containing THC being labeled only for CBD.
• California: Class action suits have been filed against multiple companies for inaccurate labels which state a higher THC content than actually in the product.
• Canada: Health Canada issued a public advisory on edible cannabis products containing more than the allowable limit of THC. Health Canada refers cases of illegal edible products to law enforcement for follow-up.

Whether a cannabis label errs on the side of more or less THC than is actually in the product, it is considered mislabeled and adulterated or fraudulent, with both being at issue.

• Mislabeling can be a particular issue for medical marijuana, for which precise amounts may be prescribed for particular conditions.
• Overrepresenting the amount of THC is defrauding and generally overcharging consumers who rightfully expect the THC content and “high” to be as expected by the labeled amount.
• Underrepresenting the amount of THC can cause issues for consumers who may intake more than they think they are based on the labeled content.
• Labeling a product as having a lower amount of THC can also mean the product actually surpasses the legal limit, causing further issues for both the provider and the consumer.

Similar issues are also found in CBD products. As discussed in an FDA presentation, a small sampling of retail CBD products showed extensive variability between CBD content and the product label claims. Several of the products contained no CBD at all, while others had significantly more than was labeled (up to 23 times the labeled amount). Additionally, one product contained only THC, some exceeded the 0.3% limit on THC, and a number had no label claim at all.

The FDA conclusion: “The public demand and potential abuses in this unique market sector warrant special attention to regulation of such products, in terms of label claim restrictions, cGMP enforcement and monitoring for potential adulterants.”

What is one to do if they run across a regulated product that is not meeting packaging and labeling requirements? As with my last problem purchase, I reached out to the owner and let them know of the mistake. I enjoyed their product, but I will not purchase it again until the packaging is corrected.

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