by Griffen Thorne, Attorney at Harris Bricken
Because the Food and Drug Administration (FDA) says that CBD-infused foods and dietary supplements cannot be lawfully sold or marketed in the United States, we’re left with a patchwork of often inconsistent state laws. One of the areas where there can be the biggest differences is in CBD product labels. Complying with CBD label requirements in each state of sale is a grueling – though necessary – task.
We’ve said for a long time that CBD companies need to deeply understand label laws in every state of sale. Because these laws are all over the place, companies usually opt to follow the most stringent rules, such as those imposed by Indiana, Texas, and Utah. Today, I want to cover the top six requirements for CBD product labels that tend to flow across all of these most stringent states.
CBD label requirement 1: the FDA’s general labeling requirements
All states that allow CBD products require that CBD product labels comply with Food, Drug and Cosmetic Act (FDCA) label requirements. The FDCA requires product labels to contain four basic elements:
An identity statement (as the name implies, this indicates what the product is);
A net weight statement;
A list of all ingredients, which in many states, must clearly identify hemp and CBD. This requirement makes it difficult for companies that are steering clear from using the term “CBD” in an attempt to mitigate the risk of enforcement action (generally a bad idea that you can read about here); and
The name and address of the manufacturer, packer, or distributor along with their street address.
Even though the FDA says that many CBD products cannot be sold, these requirements still exist by virtue of state law incorporating the FDCA.
CBD label requirement 2: FDA warning statement
States like Colorado require that the following statement appear on CBD product labels: “FDA has not evaluated this product for safety or efficacy.”
CBD label requirement 3: no medical or health claims
The FDA hates medical and health claims on CBD products. These are virtually the only things it spends enforcement resources combatting. Health claims don’t need to be explicit things like “this will cure COVID-19.” Even the simple implication (and we mean this as broadly as possible) that a CBD product could treat or cure a disease or sickness could upset the agency. This is one of the most common problems we see with CBD product labels. It is not fun to be looking down the barrel with the FDA on the other side. A good CBD attorney can help mitigate these issues and flag problematic health claims early on.
CBD label requirement 4: scannable bar code or QR code
More and more states require labels to have a scannable bar code, QR code link, or web address linked to a document containing information, pertaining to:
the batch identification number;
the product name;
the batch date;
the expiration date, which in some states like Indiana, must be not more than two (2) years from the date of manufacture;
the batch size;
the total quantity produced;
the ingredients used; and
certificate of analysis.
Unlike the prior requirements, this isn’t something that the FDCA covers. Instead, the purpose of the QR code is to ensure that people know what they buy is actually CBD and not something else.
CBD label requirement 5: cannabinoid content
Many states now require CBD labels to identify cannabinoid concentration per serving and/or package. This is also not an FDCA requirement and serves a similar purpose to the QR code. The goal here is for people to know how much they are consuming.
CBD label requirement 6: Prop. 65
California requires products that contain reproductive toxicants or carcinogens to have certain label warnings. The law is known as Prop. 65. The state determines which chemicals fall under this umbrella. And of course, THC is a listed compound with no bare minimum level. In other words, if there is any THC in a product, even trace amounts, Prop. 65 requires warning labels. So even manufacturers out of state need to be aware of Prop. 65’s requirements so that they don’t run afoul of the law. Prop. 65 authorizes private plaintiffs to sue and we’ve seen enough of these cases to know they are no fun to deal with.
Re-published with the permission of Harris Bricken and The Canna Law Blog
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