What Consumers Should Know About FDA Regulations on CBD Products


What Does the Food and Drug Administration (FDA) Regulate?

The FDA has a sprawling jurisdiction that regulates roughly 77 percent of the U.S. food supply, including more than 35,000 restaurants, tens of thousands of produce farms, and 270,000 facilities that manufacture products approved by the FDA. The regulator also supports more than 20,000 prescription drugs for marketing.

According to the FDA, CBD is a substance that affects bodily “structure” and “function,” which meets the definition of a drug. If a seller of any medication makes any kind of claim about what the drug will do, it has to go through the FDA drug process.

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What this means for consumers shopping for CBD products

Whether you are buying products for yourself, or even your pet, a CBD product cannot make claims about affecting the structure or the function of the body unless those claims have been proven to treat the issue it is claiming to remedy. This could be headaches, pain, and even anxiety.

This regulation is similar to dietary supplements that cannot make claims addressing known indications. For example, a dietary supplement can address anxiousness, but it cannot claim anything about treating anxiety altogether.

If a CBD reseller is attempting to comply with U.S. federal law, you won’t find any of these claims in their marketing or advertising, and you shouldn’t see any of it on the product label itself.

Many consumers assume their own risk by navigating and deciding on a product using anecdotal recommendations or isolated research studies. This kind of material is prevalent and readily available on the internet.

Until the FDA officially says that CBD is “generally regarded as safe” and conducts studies on CBD products, CBD sellers can’t know, for example, that CBD from a particular strain is especially useful for arthritis pain.

What Consumers Should Know About FDA Regulations on CBD Products 1

What if I see a claim on a CBD product label?

If you are shopping for a CBD product and come across a product that is making claims, it may be that the CBD product is mixed with another substance that has earned the blessing of the FDA.

For instance, if there is CBD in a bottle of a moisturizing lotion that claims to heal itchy, dry, cracking skin, it may be that the manufacturer is making these claims about the cream and not necessarily CBD itself. It is up to the consumer to consider the benefit of buying products with or without CBD.

Almost all CBD products must have a disclaimer using language originating directly from 21 Code of Federal Regulation, the FDA regulation that sets up the rules for food and drug labeling.


So what questions should I be asking?

1. How was the CBD extract manufactured?

The process is essential. Not all manufacturing processes are the same. Some CBD products are manufactured using the CO2 extraction machine, a process that has been used to decaffeinate coffee for more than 50 years. You may want to stay away from products that are manufactured using methods that don’t have a long history or maybe use non-food grade chemicals and solvents such as denatured ethanol for ethanol extraction.

2. Is the product labeled organic? If so, is it natural?

For a CBD product to indeed be considered organic, it has to be free of denaturants, residual chemicals, and other materials. Unless a product was made with food-grade ethanol, a CBD product could not be considered organic due to the denaturants the ethanol contains. So, if a product claims to be natural, and it was extracted using ethanol, it might be best to steer clear.

3. What about testing for residual solvents, pesticides, microbes, and heavy metals?

You are paying for this product, and you don’t want this junk in your CBD. To find out if the product you are considering has been tested, look for access to the Certificate of Analysis (COA). The COA is a document demonstrating that the product went through testing to ensure that your product is free of these unwanted materials. It should be easy to find. Many products have a Q.R. code on the packaging itself so you can easily find the COA.

4. Is any health claim made on the label attributed to something else contained in the bottle?

Ensure that this is the case. If there is something else contained in the product, how much of what you are buying is CBD? It may be true that the product contains CBD, but if the potency is extremely low, it may not be worth buying.


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