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The FDA and CBD: Understanding the stance of the FDA on CBD products

manila envelope with text saying FDA and CBD

Quick question… 

 

Do you, or someone you know, struggle with anxiety? What about pain or insomnia? 

 

Then chances are you’ve likely heard of the natural benefits of CBD. 

 

Now, we could cite studies all day long about how CBD contains therapeutic properties that researchers suggest might help both people and animals. 

 

In fact, in the last several years, CBD has gained a ton of attention for these reasons, and now many scientists, renowned doctors, and veterinarians agree that CBD really does hold a lot of medicinal value. But where does the Food and Drug Administration (FDA) stand with CBD? 

 

Does the FDA agree with the results of these studies? And what is the future of the FDA and CBD? 

 

Let’s find out, but first… 

What is CBD?

 

Now we understand this isn’t a groundbreaking question. In fact, you may already know what CBD is. 

 

But we’re looking at how the FDA defines CBD.

 

According to the FDA, CBD and Delta 9 THC are two of the most prominent compounds found in the cannabis plant. And because of this, the FDA states that: 

 

Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”).” 

 

They also mention that because marijuana contains a high ratio of Delta 9 THC, the cannabinoid responsible for getting its users “high”, marijuana has a high potential for abuse which places it as a Schedule I Controlled Substance. 

 

Hemp, on the other hand, is not considered a controlled substance and it’s what most CBD products are derived from. 

 

Still, the FDA treats all products containing cannabis-derived compounds the same, regardless of whether the compounds are classified as hemp even under the 2018 Farm Bill. 

 

This raises the question…. 

Is CBD legal? 

 

In 2018, the Agriculture Improvement Act, otherwise known as the 2018 Farm Bill, defined hemp as the following: 

 

The plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” 

 

For these reasons, hemp and all of its derivatives, are considered federally legal, as long as the product contains no more than 0.3% Delta 9 THC. 

 

So if hemp is considered legal under federal law… 

Is CBD FDA approved? 

 

Not in the way you would think. 

 

To date, there is only one FDA approved CBD product called Epidiolex. 

 

Now, Epidiolex is an oral medication designed to treat rare forms of epilepsy, like Lennox-Gastaut and Dravet syndrome and Tuberous sclerosis complex. 

 

But aside from Epidiolex, no other CBD products are FDA-approved, and that includes the hemp-derived CBD products you see sold online and in your local CBD shops. 

 

So… 

Why aren’t CBD products FDA approved?

 

The main issue the FDA has with the hemp-derived CBD industry is how hemp companies advertise their CBD products. 

 

As it turns out, many hemp companies falsely market their CBD products as a therapeutic substance that can treat diseases. And that’s a big no-no. 

 

According to the FDA:

 

 Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.”

 

That said, the FDA continues to monitor the CBD marketplace, thus only taking action when needed.

 

Which brings us to our next point…

How the FDA cracks down on CBD brands 

 

The FDA is well aware that some hemp companies advertise their CBD products for medical use, in which case they’ve taken it upon themselves to test the chemical content of several cannabinoid-based products. 

 

And the results were shocking… 

 

As it turns out, many of those products did not contain the amount of CBD listed on the label. In fact, some of the products didn’t contain any CBD at all. 

 

That’s pretty scary! 

 

For those reasons, the FDA has issued warning letters to several companies to stop advertising their products for medical use. Furthermore, they’ve emphasized that those same companies must accurately label their products when it comes to their CBD content. 

 

That said, there have been many shady CBD brands that have been demoted from online search results and even shut down completely. 

 

Now, the FDA isn’t necessarily going around, shutting down CBD brands and online suppliers. Instead, they work to put a stop to any brand that advertises that their CBD products can either cure, treat, diagnose, mitigate, or prevent any disease or health condition. 

 

So what does this mean for the future of CBD? 

FDA and CBD: Where they stand together

 

It’s hard to believe that it’s been several years since the 2018 Farm Bill legalized the cultivation, production, and formulation of hemp and CBD. Yet, the CBD industry is still not regulated by the FDA, even as a dietary supplement. 

 

But that hasn’t stopped CBD products from proliferating across the US. 

 

Nevertheless, the FDA may continue to drag their feet in recognizing hemp-derived CBD as a dietary supplement. So it may take Congress to pave the way, just as it did for the passing of the 2018 Farm Bill. 

 

This brings us to February of 2021, when Congress tried to step in and introduce legislation to approve CBD as a dietary supplement. 

 

In fact, this congressional bill will make hemp and CBD subject to the very same regulations and requirements as all other dietary supplements, such as being accurately produced and labeled using Good Manufacturing Practices (GMP). 

 

Keep in mind that there are hemp brands that have already made these steps on their own and with their own money, which defines them as reputable CBD brands. We believe these are the only brands consumers should purchase from. 

 

But the more the FDA refuses to recognize and regulate CBD, the more we’ll continue to see shady hemp companies and unsafe CBD products. 

 

Which brings us to our final point… 

The FDA and topical CBD

 

It seems that the FDA doesn’t necessarily have issues with topical CBD products like creams, lotions, salves, and rubs. 

 

However, they do have issues if those CBD products are marketed to treat or cure disease and skin conditions. 

 

This may explain why you see topical CBD products and CBD beauty products in big chain stores like Walgreens, CVS, and even Whole Foods. 

 

That said, the FDA defines cosmetics like this: 

 

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

 

And to be frank, there’s a lot of leniency from the FDA when it comes to cosmetic ingredients. This is why the guidelines for these products aren’t nearly as strict as dietary supplements or products. 

 

So for these reasons alone, consumers need to be on guard regarding the ingredients, formulation, testing, and label accuracy of their CBD bath bombs, creams, and lotions. 

 

Which brings us to final thoughts… 

How to identify a reputable CBD brand

 

Since the FDA refuses to regulate the CBD market, it’s up to individual CBD brands to take it upon themselves and self-regulate. 

 

This simply means going by certain standards such as utilizing high-quality hemp, using safe and effective extraction methods, formulating their products with real and safe ingredients, having their products third-party tested, and accurately labeling their CBD products before they hit the market. 

 

If you come across a CBD brand that doesn’t follow each and every one of those steps, we encourage you to steer clear. 

 

In the end, yes, the FDA can definitely help weed out potentially harmful CBD brands, and make way for existing CBD companies to flourish more than they are now. It can also open other doors for the CBD industry. 

 

But if you know what to look for in a CBD brand and product, you can rest assured that you’ll have a safe and effective product to rely on until we see a drastic change in the hemp industry. 

 

Until then, we encourage you to do your research and to only purchase CBD products from reputable brands. 


That said, if you have any questions or concerns, feel free to reach out to our Alki team. We’d love to hear from you.

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Ingredient Information

Sodium Bicarbonate & Citric Acid: Otherwise known as baking soda and Vitamin C. These two ingredients combined create the “fizzy” effect of a bath bomb.

Epsom Salt: Epsom salt baths can help soften rough or dry skin and can exfoliate dead skin cells. It also aids in reducing soreness & pain.

Corn Starch: Corn starch manages the fizzing reaction of the ingredients; so if you drop your bath bomb in the water, it will not “explode”!

Sunflower Oil: Sunflower oil is a non-comedogenic carrier oil which is highly absorbent. In short: sunflower oil won’t clog your pores. Additionally, it is non-irritating for most people and can be used on all skin types.

Water: What scientists refer to as H20.

Organic Hemp-Derived Cannabidiol (CBD): CBD is a naturally occurring & non-intoxicating cannabinoid (chemical compound) found in both hemp and cannabis plants.

Aromatherapy Oils: Aromatherapy is simply the combination of essential oils for therapeutic benefit. When inhaled, the molecules in essential oils work their way from the olfactory nerves directly to the brain and can positively impact the amygdala, which is the emotional center of the brain.

Sodium Lauryl Sulfoacetate (SLSA): SLSa is derived from coconut and palm oils. SLSa is safe and skin-friendly.

Mica Powder: The biggest benefit of mica is its ability to create a natural shimmery finish, since it can be milled to a fine powder. It is naturally produced and safe to use on almost all skin types.