Five Essential Tips For Labeling Hemp Products

This article was originally published on Hoban Law Group, and appears here with permission.

If you manufacture, distribute, or sell hemp products in the U.S., you must ensure your products comply with all applicable federal and state labeling regulations. These requirements are mandated by various laws and regulations and can be challenging to navigate. These include federal labeling regulations enforced by the U.S. Food and Drug Administration (FDA), state regulations enforced by applicable state regulatory agencies (like the Colorado Department of Public Health and Environment), organic labeling regulations enforced by the United States Department of Agriculture (USDA), and more.

While complying with a large volume of regulations can be overwhelming for any business, historically, hemp businesses have especially been challenged with regulatory uncertainty and a general lack of affirmative guidance provided by the FDA.

To help sort through these various federal and state requirements, we’ve provided five essential tips for labeling hemp products. As you might suspect, these tips are not intended to be an exhaustive list, but rather provide a helpful starting point to ensure your labels are compliant with all applicable laws and regulations.

1. Ensure Label Complies with Federal Labeling Regulations

First, ensure your product label adheres to federal labeling regulations governing the type of product you are manufacturing, distributing, or selling. While not all categories of products are expressly governed by federal regulations, most products fall into an established category of consumer product, such as “dietary supplements,” “conventional “foods,” “beverages,” or “cosmetics.”

As an example, products positioned as “dietary supplements” must always contain the following statements on the label under applicable federal labeling regulations:

(1) Statement of Identity;
(2) Net Quantity of Contents Statement;
(3) Nutrition Information (in form of “Supplement Facts” panel);
(4) Ingredient list (often referred to as “Other Ingredients” if any dietary ingredients are identified in the
Supplement Facts panel); and
(5) Name and Place of Business of the Manufacturer, Distributor or Packer

Of course, the information required under federal regulations depends on the kind of product being sold. For example, “cosmetics” (i.e., topically applied products meeting the federal definition of “cosmetic”) do not require “nutrition information” as the federal labeling regulations governing cosmetics do not include the same requirements as those governing conventional foods, beverages, or dietary supplements.

Additionally, the regulations governing conventional foods and beverages vary significantly from the regulations governing dietary supplements. For example, the “statement of identity” required for a conventional food or beverage is different from the statement required under dietary supplement regulations. Further, the format and information required as part of the nutrition information varies depending on whether the product is marketed as a food, beverage, or dietary supplement (e.g., Nutrition Facts panel v. Supplement Facts panel, etc.). The title of the panel is not the only difference; the required information in the panel varies greatly, as well.

Accordingly, ensuring the product meets the applicable regulations for the category in which the product falls is imperative to ensuring compliance with applicable federal labeling regulations.

2. Ensure No “Drug” Claims are Present in the Labeling

This requirement can be classified as part of the task in complying with federal labeling regulations, but both federal and state regulations typically prohibit the “labeling” of the product (i.e., virtually any printed material distributed to consumers in connection with the sale of the product, such as the product website, company social media accounts, testimonials, etc.) from including any improper “drug” claims.

Importantly, a claim does not have to mention a specific disease to be considered a “drug” claim under the law. For example, a statement may not mention a disease, but may refer to identifiable characteristic signs or symptoms of a disease such that the intended use of the product to treat or prevent the disease may be inferred (e.g., certain claims related to inflammation, sleep, etc.). Including improper drug claims in the labeling of non-drug products can expose your company to liability from the FDA/FTC to consumer actions brought under state consumer protections statutes, class action lawsuits, etc.

Similar to the federal labeling statements required to be place on labels, the types of “claims” permitted under applicable regulations will generally depend on the category of product being distributed or sold. While, generally speaking, products positioned as topically applied cosmetics cannot include any claims indicating the product affects the “structure or function of the human body,” products positioned as dietary supplements may be able to include certain “structure/function” claims not in violation of federal labeling regulations.

Whether a “structure/function” claim is permissible depends on whether the business marketing the product with the claim(s) complies with applicable regulations, such as ensuring the claim is not an implied “disease” claim, including the required disclaimer on the label, ensuring the claim is adequately “substantiated” per federal law, etc.

3. If Applicable, Ensure the Label Complies with State-Specific Labeling Requirements

While the FDA has not explicitly directed how businesses must label hemp-derived products at this time, many states have established state-level regulations that expressly govern how these products may distributed or sold.

For instance, most states that have passed hemp product labeling requirements mandate various label statements that must 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/use by children, those who are pregnant/breastfeeding, etc.), among various other statements and warnings.

Although creating a universally compliant label that adheres to all state labeling requirements may not be simple or practical, there are a number of state-specific statements that are generally required in most states which have implemented labeling regulations, such as QR codes, THC disclosures, cannabinoid potency statements, expiration dating, FDA-related warnings, etc.

A number of states have passed similar labeling statements, but New York is one of the most recent states to propose labeling requirements specifically applicable to hemp-derived products (which are called “cannabinoid hemp products” under New York’s regulations). Notably, the currently proposed regulations in New York appear to go further than several other states, such as requiring the label to include a disclaimer that the product contains THC, which could result in a failed drug test.

Accordingly, ensuring the product meets federal labeling regulations is important, but state regulations must also be met if the product is sold to consumers in certain states, such as Indiana, New York, Ohio, Florida, among several others.

4. Ensure the Validity and Compliance of All Other Product Claims

Of course, all other claims on the label must generally comply with the applicable laws and regulations governing the type of claim. For example, the USDA generally regulates all “organic” claims, including organic claims about hemp-derived products. As such, all organic claims must adhere to the USDA NOP regulations (e.g., “100% organic,” “organic,” “made with organic ingredients,” etc.).

Additionally, all other claims must adhere to applicable regulations governing that claim, such as nutrient-content claims (e.g., claims characterizing the level of a nutrient in a product, such as “healthy,” “sugar-free,” etc.), gluten-free claims, non-GMO claims, natural claims, FDA-facility related claims, etc.

5. If Applicable, Obtain State Retail Registration, Permit or License

While not technically a “labeling” requirement, several states have now passed regulations that expressly require some type of state registration, permit, license, etc., to legally sell hemp-derived products in the state. Not surprisingly, each state regulates the distribution and/or retail sale of hemp-derived products a little differently, so the elements triggering the need for the registration or license, as well as the practical process for obtaining such registration or license, varies significantly depending on the state. For example, some states require a registration for only certain categories of hemp-derived products, such as orally ingested foods/dietary supplements versus topically applied cosmetics (e.g., New York, Florida, etc.).

Additionally, while each state’s process is similar, some states have implemented more stringent regulations than others. For example, Louisiana has created a system whereby the Louisiana Department of Health must essentially “approve” all hemp derived product labels prior to sale, which process also typically results in Louisiana regulators reviewing the business website, social media, etc., to ensure the content adheres to Louisiana law prior to issuing the registration.

Several state requirements have only recently become effective. For example, the permit/retail registration application in Iowa became available in March of 2021 and for New York in January of 2021. Accordingly, products sold in any state that requires a retail registration, license or permit must adhere to the applicable state regulations, which typically includes products sold via brick-and-mortar physical locations as well as e-commerce sales only.

For any business that distributes or sells hemp-derived products in the U.S., the challenge of complying with a variety of federal and state product labeling regulations is monumental. The Hoban Law Group team of attorneys have years of experience guiding businesses to help them meet all applicable labeling and registration regulations. Reach out to the Hoban Law Group today so we can help your business navigate the complex evolving nexus of hemp law, policies, and regulations.