With so much variation in rules and regulations, compliance can be tricky. More systems are being put in place to help manage the cannabis industry. Those systems focus on the cultivation, sale, and use of cannabis products.
There are some packaging and labelling rules for recreational and medicinal cannabis products. People who grow, distribute, and sell cannabis must follow those rules. Otherwise, they can risk getting in trouble.
Regulations for all products are not easy to understand. There are different federal agencies overseeing THC products and CBD products.
The Food and Drug Administration is in charge of CBD and CBD-related products.
Each state has its own set of rules about growing, distributing, and selling cannabis. There are some standard packaging regulations in place everywhere cannabis is legal. Distributors have to follow those packaging guidelines before dispensaries sell their products.
Every product requires child-resistant exit packaging. That means a child cannot easily open the package on their own. Packaging must reseal if the products are not meant for single use.
The cannabis product must have a child-resistant exit package. The product must be resealable if it is not intended for single use.
Solid cannabis-infused edible containers must include an identifier stating the product contains cannabis. The package identifier should also mention the existence of THC in each product. If a product contains THC, the label must include a state-mandated THC warning symbol.
There are specific packaging guidelines for cannabis-derived products sold in the United States. The idea is to keep these products from falling into the wrong hands. Companies get in trouble for not following the rules.
Most cannabis products require packaging that is difficult for a child under the age of five to open. The ideal solution is plastic packaging that is at least four mils thick. It can't have pull tabs at the opening either.
Packages must also be heat-sealed or liquid products sealed with a metal crown or cork.
The seal must be intact and noticeable if it breaks.
It’s not just to prevent children from opening the packages. It must still accommodate adults who may have difficulty accessing the product. To be considered child-resistant, containers must also be opaque, so the product is out of sight when it’s sealed.
If your product requires child-resistant packaging, it also must include certification from the manufacturer that each container or exit package meets the standards. That certification must include a batch or lot number to be in compliance.
If child-resistant packaging is not necessary, get a certification from the manufacturer. That document should verify that the packaging contains FDA-approved materials.
Tamper-Evident Packaging Requirements
In addition to child-resistance, cannabis products must be placed in tamper-evident packaging, as well. This feature ensures the retailer and the customer that no one has tampered with the product at any point from cultivation to the shelf.
Cannabis products must have one or more ways to indicate whether someone has attempted to access the product. If the products are tampered with, the packaging should be broken to alert you that something is wrong.
These tamper-evident seals include transparent film around the exterior or a foil or paper pouch inside that must be cut or torn in order to access the product.
For liquids, the caps or lids must include a sealed band that is visibly obvious whether it has been broken. If a tape seal is used, it must be unique enough not to be adhered to the product again without being noticeable.
Ingredient List and Compound Concentration
The rules and guidelines surrounding recreational cannabis and medical cannabis can vary slightly. Still, both products require many of the same label features.
Every cannabis concentrate or edible must include the entire ingredient list on its outer label. The manufacturer or distributor will list those ingredients in descending order based on each item’s weight. A list of active compounds must also be included on the label, along with the specific concentration of each one.
For example, each product package that contains one serving size of cannabis edible must list the amount of THC for that one item. Products packaged for several servings must list the THC concentration included in the entire container and the amount per serving.
You’ve likely seen warning statements on all types of products. Those warnings are typically required, especially for products not intended for children. For cannabis and cannabis-related products, several warnings must be included before they are sold.
The first warning must state that consuming the product could lead to potential health risks. Another warning is about the potential risks of the product to pregnant and breastfeeding women.
Each product must include a warning label that mentions cannabis and cannabis products have the potential to impair your ability to drive. They must also include the phrase, “keep out of reach of children.”
Finally, somewhere on the package or label must be a statement that the Food and Drug Administration has not approved the intended psychological or physiological effects of cannabis.
For edible products, an additional message must be included stating the effects may not be felt for up to two hours. That goes for any edible product aside from tinctures.
Any solid cannabis edibles must be separated and packaged in single-serving sizes or separated into serving sizes and individually wrapped inside another package. If the product contains multiple servings, the inner packaging must also be labeled with the same warnings as the exterior package.
The only difference between these products’ internal packages is that they do not have to be opaque or child-resistant. That only applies to the outer packaging that houses the individual items.
What to Avoid With Packaging and Labelling
Being in compliance doesn’t just mean doing all of the right things. It also means avoiding doing other things that are not allowed. Several things are prohibited in cannabis packaging and labelling, and disregarding these rules can lead to products being pulled from the market.
Containers should not include any false or misleading statements, regardless of the nature of those statements. Products should also never appear to mimic mainstream imagery geared toward advertising to anyone under 21. Avoid symbols, pictures, and graphics that resemble media, characters, or popular culture events explicitly designed for children or teens. Also, avoid using any cartoon character, action figure, or images such as balloons on any cannabis product package. Your product packaging and labelling cannot use the word “candy” or resemble any candy product in any way.
There are things you can't do on packaging. Labels can't have false or misleading claims. Although many people say they benefit from these products, there is still quite a bit of research and regulatory approval needed to verify those claims. You also want to make sure there is no information included on the label that claims to diagnose, treat, or prevent any type of disease. You also want to avoid associating your product with any kind of health condition, in addition to not making claims about treating any disease.
Labels and marketing materials for products should never have any medical, health, or disease-related claims. Many people say they get benefits from these products. There is still quite a bit of research and regulatory approval needed to verify those claims. That is why claims that a product can diagnose, treat, or prevent any type of disease are prohibited.
Product labels should never appear to replicate current brand medications or prescription drugs of any kind. They should also not claim to match those medications in functionality or use. On that same note, make sure your label does not include medical symbols, such as the Rx symbol or medical association logos.
Retailers can choose to place items in exit packages once purchased, although that is not required. If exit packaging is used, it must follow the same guidelines regarding medical claims, health statements, and warnings.
Labels on CBD Products
The rules surrounding CBD products are still quite vague in some respects. This makes it challenging for some cultivators to find and adhere to compliance guidelines.
The blanket rule for CBD products is that they must contain 0.3% THC or less. The Food and Drug Administration now regulates any CBD product that fits that requirement through the Federal Food Drug & Cosmetic Act. Even under that control, CBD products are not precisely regulated because federal officials have been slow to get involved in the rule-making process.
There are few federal rules, so most labelling and packaging decisions are left up to the manufacturers, distributors, and retailers. They can get guidance from the states in which they operate. Most reputable companies that sell, market, and distribute CBD products follow similar labelling set within the industry.
To make sure you’re getting one of those reputable products, you’d want to look for several key pieces of information on the package and the product label. On the outside label, most companies include the amount of CBD concentration per serving, along with any other ingredients that may be included. The package may also list the net weight, suggested use, and a batch code that includes that manufacture date. These products should also include information about whether it’s a full-spectrum, broad-spectrum, or isolate product and what that means as far as purity.
It is becoming more common for companies to include health and medical claims on their products. Still, without regulation, those claims are unfounded. You may also notice buzz words, such as “organic” or “natural,” which don’t mean much and have not been verified.
The FDA has not made any official decision on what benefits these products may offer. They stop short of categorizing CBD products as supplements.
Rules for Medicinal Cannabis Packaging
Rules surrounding medicinal cannabis are more straightforward because they have been legal long enough to create a few streamlined systems. Laws still regularly change, and it can be tough to stay in line with emerging regulations.
Use a sealed container with a visible medical label before distributing any cannabis harvested for medicinal purposes.
Cannabis-infused medical products like edibles must be individually wrapped or packaged where they are made. The labels must meet the criteria of the Food, Drug, and Cosmetic Act.
Medical-grade cannabis products must include a list of ingredients, including any colors or preservatives included, as well as a list of the cannabis compounds and their concentration levels. In addition to the ingredient list, these products must also include any possible allergens in the product.
These products also must denote the total THC and CBD content in milligrams, which cannot be higher than 100 mg of active THC compounds.
They must also include a warning that the product contains cannabis and include a statement about where it was manufactured. When dealing with products made specifically for medical sales, the products must also have a message saying the product is intended only to be used by authorized patients.
Federal guidelines are not in place, but many states do have policies about cannabis packaging.
That will improve nationally as more states legalize cannabis for recreational and medicinal purposes.
Regardless of where you’re buying or selling your products, you need to adhere to these basic packaging guidelines to prevent distributor, retailer, and customer problems.
Individual states are often left to draft and enforce rules and regulations for most cannabis products. If you stay informed, you can prevent problems throughout the supply chain.
The Food and Drug Administration is gathering information to help create standardized rules for the industry.
Only time will tell when that all comes together, and new requirements are issued nationwide for the cannabis industry.