FDA Reader
Simplifying Food Regulation

FDA Reader

FDA Reader: Simplifying Food Regulation

How to Legally Sell CBD-Infused Foods

 
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Contrary to popular belief, Cannabidiol (CBD) does not exist in a legal gray zone. In fact, the regulations surrounding cannabis and CBD are clear, and for food producers looking to get into the market, there’s good news: There may be a legal route for selling CBD infused foods, supplements, and cosmetics, even if recreational cannabis use is not legal in your state.

Here are some guidelines about how to stay between the lines when it comes to selling CBD food products:

Verify Your CBD Ingredients

The 2018 Farm Bill legalized hemp as an agricultural commodity. This means it’s legal to possess, grow, sell, and transport hemp throughout the country, just like corn or sugar. And if you’ve been paying attention, there are a lot of user-vetted CBD products on the market.

Here’s the catch — the CBD has to have a THC content of <0.3% and be hemp derived. Most importantly, it’s your responsibility as a food manufacturer to make sure your hemp- is compliant.

Tip #1: Only use CBD which is hemp-derived and with a THC content of below 0.3%. If you are sourcing CBD to include in a food product, it’s important that you work with reputable suppliers so that you can ensure your CBD ingredients are indeed legal. If your CBD ingredient exceeds the THC threshold then the ingredient will be classified as a Schedule 1 substance and your business could face serious legal repercussions. You may wish to request a certificate of analysis from your CBD supplier or consider sending out a sample of the product to a lab yourself.


Avoid FDA Oversight

At this point, the FDA has been very clear that CBD is not a legal ingredient in foods and dietary supplements. However, FDA jurisdiction doesn’t cover all foods, so it’s possible to avoid FDA jurisdiction and legally sell CBD food products. Here’s how you can avoid falling under FDA Jurisdiction (Or check out our comprehensive guide to FDA Jurisdiction)

Tip #2 Sell CBD at your food service establishment. The FDA doesn’t regulate foodservice businesses — for example, food trucks, restaurants, and other places where food is served to customers for immediate consumption. These businesses are typically regulated by local health departments, most of which don’t explicitly disallow CBD as a food ingredient (see below). This is potentially good news for a cafe owner seeking to add CBD products to their menu. However, it doesn’t mean that a food manufacturer can avoid FDA jurisdiction merely by selling to food service establishments.

Another major factor which would trigger FDA jurisdiction is interstate commerce. This means that if you sell your product to a buyer which resides in a different state, then the FDA has jurisdiction over your food business.

Tip #3: Sell In-State. Limit the sales of your product to the state where you’re producing the product. This doesn’t mean “no ecommerce” but it does mean limiting your ecommerce to in-state buyers. Whether your customers are wholesale buyers or retail consumers, make sure they’re in-state.

Tip #4: Source In-State. If your product contains ingredients or packaging that was sourced from out of state, then your product has technically already entered interstate commerce, even before you assembled it. This gives a near-total breadth to the’s FDA jurisdictional claim since few items are 100% composed of ingredients sourced in-state. However, the FDA is unlikely to assert this broad of a jurisdictional claim. Bottom line: source your ingredients in state

Tip #5: Avoid making claims about the health benefits of CBD. So far, the FDA has only gone after CBD products which make claims about the health benefits of CBD. Avoid making any claims on your product label, marketing materials, or even your website — about the healing powers of CBD. Even if the claim is delicately worded “CBD may treat…”, it can still cause problems. Here are some examples of problematic health claims that the FDA has struck down:

“Cannabidiol may treat depression”

“CBD may be used to avoid or reduce withdrawal symptoms.”

“Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling."

“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”


Understand and Follow The Local/State Laws

Even if you are able to strategically avoid FDA oversight, food production and sales will still be regulated by the local or state government.

Tip #6: Confirm your local or state jurisdiction has no specific regulation against CBD in food. Most jurisdictions have not specifically regulated against CBD as a food ingredient. However, if you are producing a CBD food product, it’s best to confirm this yourself before you receive an inspection from local health agencies. If CBD is an unlawful ingredient in your jurisdiction, then the health authorities may have the power to recall or quarantine your products. Here’s how you can figure out whether CBD is allowed for use in food.

  • Search online for the health code which governs food processing and see if CBD is among ingredients which are explicitly banned. Often the state regulates food processing and the city/local government regulates restaurants and each agency will have their own health code.

  • Confirm that your state/local health dept. doesn’t automatically operate under the FDA regulations. Some states, in order to avoid the hassle of writing and maintaining their own health regulations, merely adopt the FDA regulations as their own. You can find this out by searching online for the state/local health code. If your region adopts the FDA code, then this will be stated prominently at the beginning of the code (and it’ll be a short health code)

  • Call the health dept yourself and ask whether CBD is banned in food. This should be a last resort because, even if there’s no law to support it, the health dept will say that CBD is disallowed— this is because they want to avoid the hassle of dealing with this type of complexity Most CBD food businesses would rather quietly permit and operate their business and handle issues with the health dept if and when they appear organically.’’

Tip #7: Follow Industry-Standard Practices. If you producing and selling a CBD-infused product, you probably face more scrutiny than food products with less controversial ingredient compositions. Demonstrate your commitment to food safety and manufacturing standards by following the general health-code rules that apply to your product. If you’re creating a food product, this means operating in a suitable facility, following industry labeling standards, and following the local health dept regulation.

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