CBD and CBN are two of many chemicals found in cannabis plants. They differ from THC, the source of the marijuana “high.” CBD is present in marijuana but more abundant in hemp — cannabis plants that have little THC. CBN, meanwhile, is a THC derivative.
While the findings may be a relief to some CBD users, there is a big caveat: The researchers used pure CBD. In the real world, CBD products are largely unregulated and may contain other compounds due to processing.
A 2017 study found that about seven out of 10 CBD products did not contain the amount of cannabidiol stated on the label. And about one in five contained THC.
If you think CBD products are suddenly everywhere, you’re right: There has been an explosion since last year, when Congress lifted a decades-old ban on growing hemp.
CBN, meanwhile, is far less famous than its cousin, but it is used in products marketed as sleep aids.
A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
20. Does the FDA have concerns about administering a cannabis product to children?
A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.
Questions and Answers
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
1. What are cannabis and marijuana?
A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.
3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
Now that we’re all trekkin’ along the same trail, we can get to the heart of our topic.
Have confidence. There is significance to the 0.3% THC cap (though possibly not what you think it is). We swear it wasn’t just some rando person selecting a figure out of the blue. So, let’s see what’s behind this THC threshold….
CBD & The THC Threshold To Behold
So what’s got people in a tizzy? There are a few main areas of debate.
Detractors of the 0.3% THC maximum would argue that, just because this threshold amount has broad global acceptance, still doesn’t make it an effective measure. Ya just can’t force some things — especially if they aren’t grounded in scientific fact or economic practicality.
There are a couple of sources or influences: