CBD and THC in Dietary Supplements
Can THC or CBD products be sold as dietary supplements?
No. Based on readily available proof, FDA has actually concluded that THC and also CBD products are omitted from the dietary supplement meaning under area 201(ff)( 3 )(B) of the FD&C Act [21 U.S.C. § 321(ff)( 3 )(B)].
Under that arrangement, if a substance (such as THC or CBD) is an energetic ingredient in a medicine item that has been approved under area 505 of the FD&C Act [21 U.S.C. § 355], or has actually been authorized for investigation as a new medicine for which considerable scientific investigations have actually been instituted and also for which the existence of such examinations has been made public, then items having that compound are excluded from the meaning of a dietary supplement. The FDA takes into consideration a compound to be “licensed for examination as a brand-new medicine” if it is the subject of an Investigational New Drug application (IND) that has entered into impact.
Here’s the confusion about CBD and THC
Dietary supplements, unless they have health claims associated with them, are not under the regulatory control of the FDA. So many would assume that CBD and THC would fall under that category. Then came the Farm Bill, which legalized hemp-derived CBD products that contain less than 0.3% THC. So it would be assumed that foods containing this would also be exempt from the FDA regulatory body, as it pertained to the CBD contents.
And that’s a logical conclusion.
Enter … the government.
The Farm Bill and the FDA Stance on CBD and Dietary Supplements Explained
There’s a little piece of exclusions in the FDA rulings about dietary supplements that products that have been studied, extensively, as a condition for approval as a therapeutic substance, a drug essentially, cannot then be included in foods without FDA approval. (Cannabis and CBD have been studied, and approved as a medical treatment for epilepsy as the drug Epidolex).
So even though hemp-derived CBD is available over the counter now, and is considered legal, you can’t sell it commercially in food, according to the FDA.
I know, there are a wealth of products that are controlled substances, and have been studied and used as drugs that are in foods, alcohol and caffeine come to mind, not to mention, well, vitamins.
There’s an exception to the rule if the products were used in food before the clinical studies and products were approved.
Ahhhh, ok, so that makes sense … NO, it doesn’t.
- Cannabis has been added to food for years before it was legal. Key point. Before it was legal.
- But then, cocaine was used in foods before it was studied, too.
In a nutshell, the government just punted the decision and will deal with it later. In the mean time they’re just not going to deal with it unless forced to, so they won’t crack down on the products that contain CBD unless they make health claims based on it’s inclusion.
If you’re selling food with CBD in it, don’t claim that that means it has health benefits. Also, only sell products that use hemp-derived CBD with less than 0.3% THC, because that’s the only one that is considered legal. Otherwise, make sure you get your prescriptions from a licensed dispensary, and if your state requires it, you have a prescription for it.
And stay tuned, there’s a lot riding on this. The hemp industry is huge, and is an agricultural concern and focus, which is big business in this country. So for the FDA to claim control over an industry that spans building, clothing, fabric … that’s a bit nebulous, so it won’t likely maintain it’s control for a long while.
- FDA: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
- FDA: FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
Looking for Something?
Pardon the mess as we are just preparing to launch over the next few weeks and months as your source for THC, CBD etc.
Sign-up for early updates,
releases, & promotions.