Phytocannabinoid Supplement Manufacturing Do's & Don'ts for Brand Owners
CBD is a hot ticket, no question about it. Not wanting to be left behind, it’s no surprise that many supplement companies now want to include one or more CBD supplements as part of their product line. When doing so, however there are some vital “Do” and “Don’t” considerations that should be understood. This article will provide some guidance in that regard.
CBD's Current Status as a Dietary Supplement
First of all, do go into the CBD world with both of your eyes wide open.
With passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”), many people are under the false impression that CBD supplements can be lawfully marketed. Unfortunately, that is not correct.
Former FDA commissioner, Scott Gottlieb, issued a press release on December 20, 2018 which made the FDA’s position clear. In the release he said, “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.”
Gottlieb’s stated reason for taking this position was that 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.
Given this position, you might think that the FDA would be going after all of the CBD products, taking them all off the market—but that has not happened. In fact, the only time they’ve gone after a product is if the brand was making egregious claims (e.g. “treats cancer”)—which is the same approach they’ve always adhered to.
If you look at the wording of Gottlieb’s statement it is revealing, indicating that “added CBD” could not be introduced into a food or dietary supplement. This may suggest that CBD isolate cannot be part of a dietary supplement.
But, what about a plant, such as hemp, that contains naturally-occurring phytocannabinoids, among which is CBD? After all, many plants, besides hemp, contain phytocannabinoids. These include, but are not limited to:
- Black pepper
- Echinacea spp., Curcuma spp. (turmeric)
- Glycyrrhiza (licorice)
- Theobroma cacao (from which chocolate is derived)
- Camellia sinensis (green and black tea)
- Brassica spp. (e.g. broccoli, cabbage, etc.)
- Apiaceae family (e.g. carrot, parsley)
- Helichrysum spp. (the sunflower family of plants)
- Amorpha spp. (the pea family of plants)
These plants are clearly lawful to sell in dietary supplements and/or as foods, despite the fact that they all contain naturally occurring phytocannabinoids. Along these same lines, some legal experts have taken the position that products containing naturally occurring phytocannabinoids from plant sources such as hemp are not a problem. On the other hand, CBD isolates are a clear violation of the FDA’s position. So, don’t use CBD isolate in your dietary supplements.
Verification of Phytocannabinoid Content
Don’t just buy any hemp extract to include in your product. Do make sure that the material you use has been thoroughly tested for 1) its CBD content and, 2) its THC content.
Remember, THC is the psychoactive compound in marijuana, and is present in significantly smaller amounts in hemp as well. To avoid serious legal issues, you must be certain you’re your hemp extract provides less than 0.3% THC—and even less is even better.
So how do you make sure of this? Ask your manufacturer for a Certificate of Analysis or similar official document showing the THC content of the extract. If you want to make doubly sure of the THC content, you can even have the material tested at a third-party analytical lab. By the same token, you should also get documentation from the manufacturer that the hemp material contains the promised amount of CBD.
Claims About Your CBD Dietary Supplement
With many CBD brands making a broad array of health and disease related claims about their products, you may be tempted to do the same. But don’t make claims about your CBD product that are illegal and/or that you can’t substantiate. It is staggering how many disease claims are currently being made about CBD—including the two big no-no’s, cancer and Alzheimer’s. Such egregious claims have a very high risk of regulatory/legal action by the FDA and FTC.
Conversely, do make structure/function claims about CBD that you can substantiate. The Dietary Supplement Health and Education act of 1994 (DSHEA) allows such structure/function claims to be made while prohibiting disease related claims. In general, this includes claims about sleep, stress and temporary pain and inflammation—although you should consult with your regulatory expert before finalizing claims for CBD products.
Potency of Your CBD Supplement
There are a range of possible potencies you can chose for your CBD product. Given how costly CBD-rich hemp extract is, however, you need to carefully consider your options. A smaller amount of CBD (5 or 10 mg/serving) will cost less, but then you can’t rely on the potency to support many of the more meaningful CBD claims. In this case, do include relevant doses of other nutraceuticals in your CBD products to substantiate claims. For example, if you’re selling CBD for its sleep-promoting benefits, then you’ll need to include melatonin, valerian or some other evidence-based nutraceutical. Of course you may choose to do that anyway for a more complete formula even if you have sufficient CBD.
So what amount of CBD has been shown to provide benefits all on its own? For sleep and stress, 25 mg has been shown to be effective. For pain, doses exceeding 100 mg have been used. That doesn’t mean that less CBD would be ineffective, but it does mean that we don’t have documented evidence to that effect.
While there may be other issues to consider, those previously discussed here are some of the major do’s and don’ts associated with the development of your own CBD products.
For more information on how the experienced team at NutraScience Labs can help you manufacture your own line of high-quality dietary supplements, give us a call at 855-492-7388 or send us your request to receive a free nutraceutical manufacturing quote.