On Aug 12, the FDA formally rejected two New Dietary Ingredient (NDI) applications seeking to establish CBD as a lawful dietary supplement. Apparently, the fix was in from the start. The FDA never intended to approve the applications by Charlotte’s Web, a pioneer CBD brand, and Irwin Naturals, a legacy supplement company that has jumped into the CBD space.
Although millions of doses of CBD have been consumed in the United States, the FDA claims it has insufficient data to assess if there’s a dosage of CBD that’s safe for consumers. Irrespective of real or imagined safety concerns, it seems that the FDA was committed to delivering a predetermined thumbs-down verdict in keeping with the “exclusionary clause” of the 1994 Food Drug and Cosmetic Act, whereby supplements can’t contain pharmaceutical ingredients.
In effect, the FDA equated the CBD in the unregulated market (isolates as well as full-spectrum hemp extracts) with the cannabidiol in Epidiolex, the FDA-approved pharmaceutical CBD (mixed with ethanol and sucralose, the artificial sweetener) that’s used to treat pediatric epilepsy. Ironically, invoking the exclusionary clause implies recognition on the FDA’s part that the CBD sold as supplements could also be therapeutically beneficial – given that the same ingredient is found in pharmaceutical CBD.
Out of deference to Pharma, the FDA has refused to provide a regulatory framework for CBD supplements, which technically are not legal but remain on the shelves because of a lack of federal enforcement. So now it will be up to Congress to clarify CBD’s status and craft a better policy for producers and consumers.
All participants in the ValidCare study will receive free study product for the trial – either tinctures or soft gels. Those who complete the entire month-long study and provide a blood sample will also receive a $100 gift card. To learn more about volunteering and to submit a formal application to participate, contact ValidCare, the medical research company that is conducting this study. You will be required to use an app for 30 days to document your use of a hemp-derived CBD product, how it affects you, if you experience any side effects, and any other relevant feedback. After 30 days, you will be expected to provide a blood sample for liver test functioning at a nearby Quest diagnostic lab. (Please note that labs in NY, NJ, and RI have different regulations on drawing blood samples, so residents of these states will need to go to CT, MA, or PA to draw blood for a liver test.)
To recap, all volunteers who complete the 30-day trial will receive:
- A free supply of CBD tincture or gel caps for the duration of the study, and possibly longer
- Visa gift card ($100)
- An opportunity to advance our knowledge of the safety and efficacy of CBD.
For more information about this important study, contact ValidCare.
PHONE: (844) 825 – 4322