Recently, on the Hoban Law Group blog, we covered five tips for product labeling. As mentioned, complying with various state-specific labeling requirements is essential for ensuring products follow all applicable labeling regulations governing the category of product being sold or distributed.
As we discussed, many states have established regulations that expressly govern how business should label hemp-derived products distributed or sold in the state. Importantly, most states that have passed hemp product labeling requirements mandate various label statements be included on the label, such as a QR code linked to a Certificate of Analysis, a THC disclosure statement, various health-related warnings (e.g., warnings concerning consumption and use by children, those who are pregnant/breastfeeding, etc.), among various other statements and disclaimers.
To paint a clearer picture of the types of labeling requirements implemented by various state regulators, we have included some examples of these statements below. As you will be able to see, creating a single, universally compliant label would likely be a difficult task, but you can certainly include the vast majority of state-required content if you so choose.
As you might suspect, several states require the label of hemp-derived products include a disclaimer concerning use or handling by children (e.g., “Keep out of the reach of children,” “Not intended for persons under the age of 18”), as well as disclaimers concerning THC content. However, certain states have been known to strictly enforce the language required for THC disclaimers (e.g., requiring reference be made to “including precursors” and spelling out “tetrahydrocannabinol” in some states, etc.).
Further, while many states have passed very similar product labeling requirements, several states have gone a bit further by proposing more extensive labeling requirements not adopted by their predecessors. For example, New York has proposed labeling regulations which mandate a variety of warnings and disclaimers be included on the label, some of which are brand new requirements not implemented by any other states. As of the date of this article, New York’s proposed regulations mandate the label of certain hemp-derived products include a statement indicating the product may contain THC, which can result in a failed drug test. Many states also require the label include potency and milligram statements regarding CBD and other cannabinoids, the milligrams of THC per serving and per container, and the milligrams per serving and per container of all other “marketed cannabinoids.”
Notably, several states require disclaimers concerning the lack of evaluation or analysis of the product by the U.S. Food and Drug Administration (FDA). New York’s proposed regulations require a statement indicating the product has not been evaluated by the FDA for safety or efficacy. This same statement was, ironically enough, required under Colorado’s regulations until roughly the same time New York proposed this labeling requirement, at which point Colorado eliminated the statement from its required label statements.
Importantly, most, if not all, of the FDA-related statements required under state regulations do not appear to satisfy the federally required disclaimer for dietary supplements marketed with structure/function claims (i.e., “These statements have not been evaluated . . . “). In fact, these disclaimers are often mistakenly used interchangeably as an attempt by hemp businesses to satisfy federal labeling regulations, but there are distinctions in the language required under state regulations versus federal regulations, such as indicating the “product” has not been evaluated by the FDA versus indicating the “statements” on the label have not been evaluated by the FDA.
Additionally, and similar to New York’s and Colorado’s previously required disclaimers, Minnesota’s regulations require a statement indicating the product “does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration.” Louisiana’s regulations mandate a statement that the “product has not been evaluated by the Food and Drug Administration and is not intended to diagnose, treat, cure or prevent any disease.” Moreover, some state require even more specific disclaimers concerning use of contaminants, statements expressing the product is “not medical marijuana,” and others concerning use by those who are pregnant or nursing.
Practically speaking, there are, of course, ways to combine or condense these disclaimers into fewer, but more “robust” statements as an attempt to satisfy several states’ labeling requirements at once, but crafting these disclaimers requires that close attention be paid to the terminology. Otherwise, the similarities between the state requirements (as well as similarities between state and federal requirements) may cause confusion as minor distinctions are typically less detectable.
To make things even more interesting, some states require that all hemp-derived products be labeled according to these state labeling regulations (e.g., making no distinction between orally ingestible products and topicals), whereas others exempt certain products types from the regulations (e.g., some states do not include “cosmetics” as part of the definition of the “hemp products” intended to be governed by the state labeling regulations).
Additionally, some states have included product-specific labeling requirements, such as including the requirement for disclaimers that apply only to certain categories of products, such as smokable hemp products. And if that’s not enough, as to smokable hemp products specifically, certain smokable hemp products may be permissible under state regulations (e.g., processed hemp oil products, such as vapes), and, thus, subject to these special labeling requirements, whereas other may be expressly prohibited (e.g., raw hemp flower products, such as hemp pre-rolls, hemp cigars, etc.).
Of course, creating a universally compliant label that adheres to all state labeling requirements may not be simple or practical, but there are a number of state-specific statements that are generally required in most states. Accordingly, there are some common “core statements” which are advisable to be included on all hemp-derived products, depending on the type of product, to help meet various state labeling requirements.
Navigate the complex evolving nexus of state-level labelling laws, policies, and regulations can be overwhelming. The Hoban Law Group team of attorneys have years of experience guiding businesses to help them meet all applicable labelling and registration regulations. Reach out to the Hoban Law Group today.