Legalization

Schumer presses FDA to regulate budding CBD industry

WASHINGTON — Senate Minority Leader Charles E. Schumer pushed the U.S. Food and Drug Administration Wednesday to “immediately” issue regulations on the use and sale of popular hemp-based cannabidiol products, a flourishing new industry in upstate New York.

Thanks to a state pilot program and passage of the 2018 Farm Bill, hundreds of New York farmers grow hemp, a cannabis plant strain with low-levels of the psychoactive component of marijuana. Many hemp farmers and processors produce cannabidiol (CBD) oils, tinctures, pills, foods and beverages. The hemp industry saw sales of CBD products — which some people claim have mental and physical health benefits — surpass $200 million nationally in 2018.

But consumers, farmers and producers are operating in a hazy landscape as they wait for the FDA to clear up questions about how CBD can be safely and legally consumed. Other than one prescription drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products for use in food or drugs or as dietary supplements. Still, many of the products are readily available on retail shelves in New York.

Schumer, a New York Democrat, believes the absence of clear federal guidelines is holding back the CBD and hemp industry in the state and exposing CBD users to potential health risks.

“The lack of regulatory clarity is creating a real fog for farmers, producers and manufacturers,” Schumer said. “CBD is not explicitly illegal, but there are no guidelines as to where you can use it and where you can’t.”

Schumer urged the FDA to expedite its evaluation of CBD and issue regulations soon. The 68-year-old does not use CBD himself, but has a “close relative” who does, he said.

Schumer blamed delays in completing health studies and issuing regulations on inadequate staffing at the FDA. Ten months have passed since the Farm Bill was signed, and the FDA should “get it done,” Schumer said. Democratic Sens. Ron Wyden and Jeff Merkley of Oregon have issued similar calls.

The FDA has been working to answer health questions about CBD and determine how to govern the marketing and sale of it for months. The agency has held public hearings and solicited stakeholder comments on CBD. It has issued warnings to companies making unsubstantiated claims about health benefits of CBD.

“FDA’s working quickly to further clarify our regulatory approach for products with cannabis/cannabis-derivatives like CBD while using all available resources to monitor the marketplace (and) protect public health by taking action as needed against companies,” said Amy Abernethy, FDA acting chief information officer, on Twitter Tuesday. “We plan to provide an update on our progress in this area in the near future.”

The FDA did not answer questions about whether its staffing was insufficient to quickly accomplish CBD regulation. The agency is also responding to similar criticism about the pace of regulation in response to another new product, e-cigarettes and vaping products.

Schumer predicted the regulations would be “lenient and simple,” but stressed they are important.

“Upstate New York will particularly benefit more than just about any other region in the country,” he said.

State action

As the wait for federal regulation continues, New York state has pursued its own legislation and regulations governing use and sales of CBD products.

CBD and hemp does not make people high, like cannabis-products with high levels of tetrahydrocannabinol.

New York City health officials and the state Department of Agriculture and Markets have made a clear distinction between the legality of supplements and topical applications infused with CBD and food and beverage products. Any food and beverage products with CBD that are still available for sale in New York must qualify as supplements, or they’re being sold illegally. Enforcement of that policy has not begun yet, as the state works to educate businesses on the rules.

Legislation approved overwhelmingly by state lawmakers in June would legalize CBD-infused beverages, but the measure has not yet been acted on by Gov. Andrew M. Cuomo.

“We encourage and support the growth of this emerging industry, investing resources and creating guidelines to ensure industrial hemp and CBD products can be manufactured through our Industrial Hemp Agricultural Research Pilot Program while keeping public health and safety in mind,” Jola Szubielski, a spokesperson for the state Department of Agriculture and Markets, said Wednesday.

In the current landscape, New York farmers are uncertain whether growing hemp with the intention of turning it into CBD will permit them to process it and sell it in the coming months and years, said Steve Ammerman, manager of public affairs for the New York Farm Bureau.

“Basic scientific and health standards are really imperative to the growth of the CBD market because right now, we don’t know what those safety thresholds are,” Ammerman said. “We don’t have the research that determines what is a safe level of CBD for people to ingest. … That’s really tying the hands of the CBD industry right now.”

A budding NY industry

But interest in hemp has exploded and production of it is occurring in 56 of 62 New York state counties, Schumer said.

Since the state launched its Industrial Hemp Agricultural Research Pilot Program, it has authorized the growth of hemp on more than 20,000 acres around the state.

The state has issued permits to 459 farmers to grow hemp and 376 of those farmers told the state they are growing hemp to produce CBD, according to a state Department of Agriculture and Markets list published two weeks ago.

The state has also authorized 96 businesses to process hemp, including 58 permits for processing CBD. In addition, there are 18 companies growing and processing their own hemp, the list shows. Two thirds of those companies are processing hemp into CBD.

Some of the farmers and processors are getting into agriculture for the first time, Ammerman said, while others are diversifying their existing farms to supplement income from dairy, fruit or vegetable production. He predicted more people would join the industry after the passage of federal regulation.

“Regulations are needed to a certain degree to allow the market to grow in a consistent way [where] everyone knows the rules of the game,” said Ammerman.

New York state is accepting applications from interested hemp farmers and processors for the 2020 season, the Department of Agriculture and Markets said.