The good news is that hemp is no longer considered a controlled substance and can now be freely grown and harvested in the U.S. without fear of breaking Federal laws, because of the Farm Bill.
Along with the de-scheduling of hemp, the USDA was given one year to implement new regulations regarding hemp production in the United States.
This is exciting news and definitely moving the needle in the right direction, but it does not mean that the flood gates have suddenly open to freely sell CBD supplements.
The FDA still mandates what goes into dietary supplements and over-the-counter products, and their stance remains the same: CBD is not considered a dietary supplement, and definitely not OTC-compliant.
Below is a Q&A taken directly from fda.gov on January 10, 2019:
“Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively.”
This means that as of right now, selling CBD as a dietary supplement is still Federally restricted, with the only exception being if the compound is used in an FDA-approved drug such as Epidiolex, a drug manufactured by GW Pharmaceuticals, specifically for children with severe forms of epilepsy.
Under the FD&C act, once an active ingredient is used in an FDA-approved drug, it’s illegal to introduce those ingredients into the food supply or dietary supplements (see below quote taken from fda.gov):
“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”
The FDA is still researching CBD and other hemp-derived cannabinoids, and they may change their views at some point, but for now it’s safe to say that selling CBD itself as supplement is still a big no-no.
So what does this mean?
Let me clarify something here: while the FDA is extremely critical when it comes to labeling and marketing supplements, they aren’t as strong-armed on the supplements themselves, as long as they’re manufactured properly. The biggest issue they have is when a company makes medical claims (i.e. “this supplement will cure cancer and reverse dementia!!”). They are right to be overly concerned with that, otherwise anyone could create a supplement, market it as a cure-all, and then make millions by taking advantage of sick people.
Because of this, the supplement industry is extremely limited with what they can legally say to the public concerning the benefits of their products. Even if there’s clinical studies on the herbs or ingredients contained in a supplement, you still cannot make those claims when addressing the manufactured end product.
This presents a challenge in communicating to customers, which is why I’ve always encouraged anyone shopping for natural alternatives to do their own research on all ingredients contained within supplements. I have personally learned much more about supplement ingredients by doing my own research instead of looking for claims from product manufacturers.
It is important for consumers to do their own research
Once you start researching, you may find out there are some discrepancies in the laws, and even some large contradictions.
One big example of this is myrcene, a plant terpene and natural constituent of many foods such as hops, carrots, pomegranates, and more notably, mangoes. Mangoes are rich with naturally-occurring myrcene.
Myrcene is listed on the Prop-65 list in California as a chemical that causes cancer. That means that if you added myrcene to a supplement, you would legally have to put a Prop-65 warning on the labels, warning consumers of this danger.
However, if you were to extract the oils from a mango, which would obviously include high levels of naturally-occurring myrcene, and listed it on the supplement as “mango extract,” there would no longer be a requirement to put the Prop-65 warning on your product.
In a parallel argument, this is why supplement companies can sell a product that is made with hemp oil and label it as such without violating Federal law. Hemp oil has over 500 unique compounds in it, with CBD only being one of them. Much like myrcene is naturally-present in mangoes, CBD is a natural constituent of hemp oil, but since CBD is used as an ingredient in an FDA-approved drug, and it could also be sourced from marijuana, you cannot legally call it out on the label of a dietary supplement.
Be Trū Wellness maintains compliance
Be Trū Wellness’ products are labelled compliant with FDA guidelines because we do not list CBD on our packaging and we only use clean hemp oil derived from Federally legal sources. We have 0% THC and we are 3rd party tested for heavy metals and microbes.
Our BODY topical products are OTC-compliant because of our menthol and lidocaine, NOT our hemp oil, which is why hemp oil must legally be listed as an “Inactive Ingredient” on the label. This is not because we feel our hemp oil is ineffective, but because it’s an FDA requirement that we must follow if we are to remain OTC-compliant.
We take pride in doing as much research as possible to create the cleanest products that are in accordance with Federal law, and we will continue to update our ingredients and products as often as needed to ensure compliance on all avenues.
I hope this helps clear up any questions you may have about the Farm Bill related to hemp and CBD products. As always, please feel free to contact me directly with any questions or concerns you may have!
Julie Wilson-Gordon President,
Be Trū Wellness