Saturday, June 6, 2020
Why could CBD be labeled as a dietary supplement?
Seasoned CBD users know a lot about CBD legislation and regulations. As per the food, drug, and cosmetics act (FDCA), CBD is a drug but not a dietary supplement. Consequently, selling and marketing of CBD products as nutritional supplements are unlawful.
A particular exclusion clause in the FDCA’s definition for the dietary supplement is the reason behind this rationale. It states, “any article that is approved by FDA as a drug cannot be sold as a dietary supplement”. Epidiolex is a CBD based drug approved by the FDA, and the approval came well before CBD-infused dietary supplements hit the market.
Many stakeholders in the industry put forth a different perspective stating that CBD could be labeled as a dietary supplement. They claim that they market and sell products that contain full-spectrum and broad-spectrum hemp extracts, which is not the same as CBD isolates.
The debates remind us of the court verdict on the status of lovastatin, which is a compound present in red yeast rice. Red yeast was a health product that was in use from thousands of years. The FDA approved the isolated compound (lovastatin) as a drug for treating cholesterol. Consequently, the FDA challenged the use of lovastatin in a dietary supplement.
The court held that the lovastatin utilized in the nutritional product was from a single strain red yeast rice grown under lab conditions. The court added, “the product maker purposely chose and carried out a technique to deliver explicit levels of lovastatin that are distinct than those typically present in red yeast rice.
There are more than hundred distinct cannabinoids plus terpenes present in the hemp plant, and CBD is one of them. Hemp is processed using organic and synthetic extraction methods. Individually, the cannabinoids can be isolated using various extraction methods.
Epidiolex doesn’t contain any cannabinoids other than CBD. Also, it doesn’t contain THC or terpenes that are available in the full-spectrum CBD extracts. Likewise, broad-spectrum CBD extract is another variant that includes several cannabinoids other than CBD.
The similarities of the Pharmanex case and the CBD dietary supplements can’t be overlooked. It may seem that the argument is reliable, but the reality could be different. However, none of the CBD manufacturers filed a legal case with the said argument to oppose the FDA’s stance on CBD infused dietary supplements. Notably, the FDA stated that it may consider the facts against the exclusion clause that prevent the sale and marketing of full-spectrum and broad-spectrum products.
The 2016 draft guidance from FDA says that the FDA secretary has the authority to overrule a particular clause in drug exclusion rule, and the same can be done by issuing a regulation.
A recent congress bill (H.R.5587) would remove the barriers on the sale and marketing of hemp CBD as a dietary supplement across states. Likewise, it seems the lawmakers are not particularly happy about the agency’s stance on CBD, and they would support the regulation of CBD as a dietary supplement.
All we can do is to wait for the FDA’s response in this matter. Nevertheless, it is prudent that the stakeholders in the CBD industry would put forth the similarities of lovastatin case and CBD products as a legal theory to counter any unfavorable actions from the FDA.