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What are the CBD Label Requirements for the FDA?

CBD Hemp Infused Oil Tincture Bottle

The federal Food and Drug Administration (FDA) has come to recognize the potential benefits of therapies and other consumer products derived from the cannabis component cannabidiol (CBD). Over the last few years, the FDA has legalized hemp-derived CBD for industrial use, and those products are now treated as agricultural commodities. CBD products have exploded into the market in the health and wellbeing industry, and CBD product growth is expected to skyrocket for the foreseeable future. With legalization, however, comes regulation. It’s important to follow all local, state, and federal rules when producing any CBD products to avoid unnecessary liability. Read on for a discussion of the CBD label requirements under federal law, and call a seasoned cannabis business attorney for help setting up or managing a California cannabis enterprise.

The Basics of CBD Labeling

The specific requirements under FDA rules can be challenging to identify or describe; there are, in fact, many things left vague or undefined. There are useful general guidelines to follow, however, that apply to all products regulated by the FDA. These general guidelines and how they apply to CBD products include:

  • Product Identity. The identity dictates what the CBD product is for or what it does. For example, does the product serve as a topical oil or a dietary supplement?
  • Ingredients. All ingredients used to make the product must be listed on an information panel on the outer packaging.
  • Brand Name. The brand name will likely be the most prominent feature of the label, dictating the name under which the CBD products are marketed.
  • Warning/Caution Statement. The label should include warnings about potential side effects and known dangers. It’s wise to include standard warnings for children and pregnant women, as well as known concerns regarding interactions with other medications or medical conditions. It’s also helpful to give instructions on proper use and storage of the product (e.g., that the product should be stored in a cool, dry place).
  • Responsibility Statement. The product label should include the name and address of the product manufacturer as well as information about product development such as testing. It’s wise to include a phone number as well, in order to facilitate consumer communication.
  • Net Quantity of Contents. The label must state the actual amount of the product contained within the packaging, not including the packaging itself. The product must also state the amount of active CBD per serving, measured by volume for liquids or weights for solids. The net quantity must appear on the outside container as well as on an informational panel on an inner container.
  • Disclosure of Material Facts. Your label should include facts that a reasonable person would want to know about the product before trying or buying, such as the expiration date, the manufacturing date, and other specifics such as whether it’s meant for nighttime use only.
  • Nutrition. If the product is a food product, it should include information about the nutritional content.
  • Disclaimers. If you are making any statements about the efficacy of your product for any purpose not approved by the FDA, make sure to include the appropriate disclaimer. The FDA has not approved CBD for treatment of anxiety, pain relief, or other purposes, for example. If you claim your product serves these purposes, make sure your product label includes a disclaimer that such statements have not been evaluated or approved by the FDA.

Consequences of Mislabeling CBD Products

Failing to properly label a product can lead to a number of consequences. If you fail to disclose a known side effect, for example, you could open your company up to liability for an injured consumer. If your label is not deemed accurate, you could be hit with a claim for deceptive advertising or marketing. An inadequately labeled product can also get pulled from the shelf. To avoid unnecessary fines or liability, make sure your label is thorough, accurate, and truthful.

Reach out to a Knowledgeable California Cannabis Business Lawyer for Help With Your Marijuana Business

If you are interested in setting up a cannabis business or are dealing with regulatory, tax, licensing, or other legal issues with your hemp, CBD, or cannabis business in Los Angeles or Southern California, call McReynolds Vardanyan, LLP, in Glendale at 818-855-2115. Our California cannabis business lawyers will work with you to get your budding business off the ground efficiently, effectively, and legally.

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