Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “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.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.
As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
FRIDAY, Aug. 9, 2019 (HealthDay News) — As the CBD craze sweeps the nation, some users may wonder whether the cannabis extract can make them fail a drug test. A preliminary study suggests the answer is “no” — at least if the CBD is pure.
She and her colleagues at the University of Utah Health Sciences Center in Salt Lake City spiked three batches of urine samples with CBD, CBN and two other cannabis compounds — cannabichromene and cannabigerol.
Licensed farmers can now grow the plant, as long as it contains less than 0.3% THC. The result? CBD is turning up in everything from oils and lotions to coffee and cookies.
CBN, meanwhile, is far less famous than its cousin, but it is used in products marketed as sleep aids.
The researchers tested each batch with two tests commonly used for THC screening. CBN reacted with one, while the other three compounds triggered no false-positives.
If you consume CBD oil or other CBD products, will you run the risk of ingesting THC?
First, CBD can be derived from hemp or from cannabis. If it’s from hemp, there can’t be any more than 0.3% THC in it, by law. That’s the CBD that you should be able to purchase in just about any US state because hemp is legal across the land. (Sorry, Idahoans, this doesn’t apply to you.) CBD that’s been extracted from marijuana, on the other hand, could have any amount of THC in it and is only available in states where medical and/or recreational cannabis is legal. In medical states, you’ll need to be a registered patient to participate.
So for these consumers, the question inevitably arises: Do CBD products contain THC?
The short answer is, yes, it’s possible to consume CBD products that have trace amounts of THC, but you may not notice. Understanding why, and how to avoid it, requires a basic knowledge of what CBD is, how it’s extracted, and how it works in your body. Get ready to read some labels.
While CBD isolate might in some ways function as a more potent or concentrated form of CBD, it may be less effective since isolate does not metabolize in your body alongside the other potentially important cannabinoids and terpenes. While some prefer the peace of mind of knowing there’s nothing but CBD in their oil, gummies, or tincture, there’s scientific evidence that consuming full-spectrum products, with all the goodies from the plant, delivers better results via the entourage effect.