By Vaidik Trivedi
Contract Pharmacal Corporation, a Hauppauge-based dietary producer, joined five other Long Island producers of hemp-based supplements in early March.
The 400-employee company’s hemp based supplement, called ‘Uleva,’ is CPC’s attempt to penetrate the fast-growing market of hemp-based products currently occupied by CBD Oils of Long Island, Piping Rock and Nature Plus, all companies native to Long Island.
“President Trump’s 2018 Farm Bill allowed farmers to only grow hemp for non-pharmacological use,” Dr. David Gortler, a professor of pharmacology at The Yale School Of Medicine and a former FDA official, who is an expert in drug safety and FDA regulatory affairs, said.
This makes CBD legal, however, the use and regulations to govern the industry, have been put on hold till further investigations on the substance is carried out.
“It is illegal, according to FDA law, to place CBD or THC into interstate commerce, or market CBD or THC products into food or dietary supplements, regardless of whether the substances are hemp-derived or synthetically produced,” Dr. Gortler, said.
In the wake of the Farm Bill 2018, pharma companies like Contract Pharmacal Corp, are producing more hemp based dietary supplements since the FDA removed hemp from the controlled substance list, placing Cannabidiol (CBD) in the Investigative New Drug (IND) category.
Despite restricting the use of CBD in dietary supplements, the FDA hasn’t been strict in enforcing its regulations.
“Regulations to govern CBD products exist, but the FDA hasn’t been strict with enforcing it,” Evelyn Cadman, Principal Consultant of FDA Compliance Simplified, said. “The FDA is working on regulating CBD slowly since no health hazards have been recorded with its use so far.”
“They deliver a list of reliefs such as reducing pain and alleviating stress to the consumer,” Robert Fronza, Owner of St. James Nutritions, said.
Apart from alleviating physical pain, hemp based products have seen a risen demand due to their organic qualities.
“The sudden rise may be due to multiple causes, including the demand for safe and natural pain and stress relief that is not addictive, the lack of affordable health care, and an interest in being proactive about one’s health through the use of foods and natural products,” Blake Ebersole, President at NaturPro Scientific, said.
Many consumers are also turning to hemp based products because they believe that it is healthier than the usual chemicals that are used in the mainstream dietary supplements.
“I am trying to stay away from all the chemicals that we are growing up with,” Lusie Coteses, 60, a CBD supplement user, said. “I am trying to go all natural.”
According to Fronza, the sales of CBD products have significantly increased in the past three years, comprising of almost 25 percent of his daily sales.
Pharma companies like Contract Pharmacal Corp. and Piping Rock, jumped at the opportunity to diversify into the hemp market.
“Over the years, it has been very demanding,” Colleen Simon, Piping Rock Factory Outlet Manager and Certified Nutritionist, said. “We are selling a lot more of it [CBD and hemp based dietary supplements]and people are becoming aware of its uses and what it’s good for.”
The FDA, however, clearly states that the use of CBD in food or dietary supplements is prohibited, yet pharma companies use it as an active ingredient in dietary supplement products.
Hemp based CBD dietary supplements that advertise eliminating ailments, have yet another roadblock to face.
“By law, dietary supplements cannot be advertised as therapeutic drugs,” Cadman added. “The FDA might issue a warning letter to the companies that violate this rule.”
In February, Sen. Ron Wyden (D-OR) and Sen. Jeff Merkley (D-OR) wrote a letter to Scott Gottlieb, FDA Commissioner, to update the regulations governing CBD products.
But, since the news of Gottlieb’s resignation, who wanted to work a way through for CBD to remain in the food and dietary industry, it has left the future of hemp based dietary products in the market, in an unclear position.