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Once Congress legalized hemp-based cannabidiol (CBD) products in the farm bill in 2018 – the FDA has found increased pressure to regulate both the CBD dietary supplement market and the medical drug market.
The entire CBD supply chain saw the passing of the farm bill as a major opportunity for hemp farmers, distributors and manufacturers.
But, there is some uncertainty around the legalities. “Nobody knows if it’s legal or not or what to do,” said Jessica Wasserman, an attorney at Greenspoon Marder, which represents CBD companies. “FDA can’t just ignore it or regulate it out of existence.”
Cannabinoid (CBD) is derived from marijuana plants. The process of manufacturing CBD oil removes the THC which is the ingredient that induces the ‘high’.
CBD is much more mainstream than you might think. Unlike medical marijuana which is sold in dispensaries, CBD is available to purchase online, in coffee shops, and even at convenience stores. Not to mention the shelves at stores like GNC and Vitamin Shoppe are starting to fill with many CBD product lines.
Cowen research group have identified through market research that the CBD market could surpass $16 billion by 2025.
Rite Aid and CVS recently rolled out CBD infused wellness and beauty products in a patch, spray and cream form.
“It literally resembles a gold rush. People are looking at this ingredient as a medical miracle,” said Marc Scheineson, an attorney at Alston & Bird and a former associate FDA commissioner.
Epidiolex was the first FDB approved CBD based drug for the treatment of epilepsy.
Under the current FDA agency rules, any CBD product must be considered a drug and thus subjected to stringent approval.
Today, adding CBD to foods or dietary supplements in interstate commerce are both illegal.
The FDA is feeling pressure to create regulations in an exponentially growing market.
Rep. Chellie Pingree (D-Maine), along with 11 other House members, sent a bipartisan letter to former FDA Commissioner Scott Gottlieb on the issue in February.
“I realize this is complicated, but I just want to emphasize the need for some sense of urgency around it, the timing of this,” Pingree said. “So many of our states have legalized hemp, have growers growing … CBD is being sold in a lot of places, and it’s created an enormous amount of confusion. … The role of the FDA confuses everyone, I think.”
CBD presents a unique challenge as it has never been a part of our food supply.
Some States such as Florida, Ohio, Maine and the city of New York have enforced their own rules and banned CBD infused foods.
The FDA still holds the position that CBD is illegal but has made it clear it doesn’t have any regulatory or enforcement resources to pursue these products.
The FDA’s current solution is to pursue the placement and messages of how CBD is being marketed. They are looking for misleading claims on the medical benefits of CBD.
On May 31, 2019, the FDA will host a public meeting on broad CBD regulation. Many believe that regulation of the amount of CBD in certain products could be a streamlined solution. This way, if a manufacturer exceeds the approved limit would require a more strict approval process.
Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing
Date:May 31, 2019Time:May 31, 2019
– Location:White Oak Campus: The Great Room
The Great Room
10903 New Hampshire Ave
Bldg 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
Registration: click here to register
Source Article The Hill