CBD/hemp extract products packaged and sold as dietary supplements are of course ubiquitous on the US market. According to the US Food and Drug Administration, though, that doesn’t mean they’re legal.
Not a legal dietary ingredient
FDA has ruled that the development of GW’s drug, Epidiolex, precludes the use of CBD as a supplement ingredient, as the pharmaceutical development process preceded the market entry of the supplement forms of the ingredient. The reverse case is allowed under federal law, as can be seen in the omega-3s market, where supplement and drug forms of the same base ingredient exist side by side.
Omega-3s had been on the market for decades before pharmaceutical companies started to work on developing ultra high concentration forms to sell via prescriptions.
GNC steers clear of CBD supplements
GNC, which is in the midst of Chapter 11 bankruptcy organization with Chinese company Harbin as the designated buyer, has declined to offer CBD except in products meant for topical use. Cosmetics regulations are less stringent than those for ingestibles when it comes to hemp derived products.
But along with other major retailers that have made the same decision because of legal liability grounds, GNC would like to get a piece of the burgeoning hemp/CBD market. According to Brightfield Group that market is expected to reach as much as $16.8 billion in 2025. These sales at the moment are going to smaller, less risk averse companies selling online and in a variety of channels including dispensaries, small, dedicated storefront outlets and even convenience stores and gas stations.
GNC: FDA needs to bring certainty
At the moment the facilities in which CBD/hemp extracts are being made are not being inspected by FDA because of the regulatory limbo these facilities find themsevles in. This seems to have contributed to a wide range of quality among CBD products on the market. In July 2020 FDA summarized the results of the CBD product testing it started to do in 2014 after the passage of the Farm Bill that first opened the door to this trade (the 2018 Farm Bill opened that door much wider). Up to that point in time FDA had tested almost 300 finished products and found that few of them met label claim when it came to CBD content and a number of them had undisclosed amounts of THC, the narcotic fraction of the Cannabis sativa plant.
GNC said in a statement issued by a spokesman that FDA has the authority to bring some certainty to the market.
“GNC’s legislative consultants met with OMB (the Office of Management and Budget) on September 22 and expressed GNC’s position that CBD be recognized by FDA as a legal dietary ingredient. Such products must be regulated in accordance with DSHEA, including good manufacturing practices, in order to ensure product quality,” GNC said.
“GNC is hopeful for such a change in the near future in order to replace the current situation where products deemed illegal by FDA continue to be sold without FDA enforcement and bring certainty to this area of the industry,” the company added.