Two federal agencies fired a double-barreled warning shot across the hemp industry’s bow recently when delta-8 THC was called out as a potentially harmful substance by federal health regulators.
Additionally, the acting head of the Food and Drug Administration said this month the agency was in a “stalemate position” with regards to approving CBD for use in food and dietary supplements. This dampened hopes the agency would approve a regulatory path for CBD to be adopted by large food, beverage and supplement companies, creating demand for U.S. cannabinoid hemp growers.
The Centers for Disease Control and Prevention issued an emergency notice Sept. 14 reporting that delta-8 products were leading to hundreds of poison control center calls, many requiring hospitalization.
In a parallel notice released the same day, the Food and Drug Administration warned that Delta-8 THC products have not been FDA-approved and “may be marketed in ways that put the public health at risk.”
The coordinated effort by two federal health agencies gives more firepower to states to push forward with bans or heavy regulation of delta-8 THC. Already at least 17 states have banned sales of delta-8, and Michigan and California have passed laws to put prohibition into effect.
The CDC notice warned health departments that U.S. poison control centers had logged almost 700 calls related to adverse effects of delta-8, almost 20% of them resulting in hospitalization. Almost 40% of poison-control calls were for juvenile patients, the agency said.
The FDA notice remarked that solvents and coloring agents used to make delta-8 products could remain as impurities that are toxic to consumers. Additionally, products could contain contaminants such as heavy metals or pesticides, health officials said.
“Regulators, law enforcement and many in the hemp industry are concerned about proliferation of these products,” Jonathan Miller, a D.C.-based attorney for the Hemp Roundtable, told The News Station. “A loophole in the law is being used to sell intoxicating products that have potential health hazards to consumers.”
Hemp Roundtable and other hemp organizations have called for Congress to break the logjam with legislation to “Regulate CBD Now.” The organizations draw the line at intoxicating versions of cannabis extracts, which they say should be regulated under state cannabis laws.
A hemp-derived intoxicating cannabinoid sometimes called “diet weed” or “weed lite,” delta-8 has sprung up as a cottage industry in the hemp world. In a home laboratory, CBD can be treated with solvents to isolate delta-8 isotopes. The compound is then added to vapes, gummies, chocolates and even sprayed on non-THC hemp flower.
Having watched the price of non-intoxicating CBD collapse, many in the U.S. hemp industry have tried to salvage their investments in leftover crops and expensive extraction equipment by making and selling delta-8, and other minor cannabinoid products such as delta-10 THC and THC-0, especially in states where marijuana is illegal.
The delta-8 phenomenon has historical echoes of 100 years ago during the U.S. Prohibition era of “Bathtub Gin,” where amateurs cooked up homemade spirits, mixing grain alcohol with additives, water and flavorings to make a quick buck.
The dangers of unregulated delta-8 also could bring back a similar public health crisis to the 2019 deadly vaping EVALI lung disease outbreak, caused by illegal THC vapes adulterated with petroleum filler oil.
But some hemp groups such as the Hemp Industries Association have argued that delta-8 is a legal product under the 2018 Farm Bill, which permits THC under .3% by dry weight.
The official statements this month from two federal health agencies may put an end to the delta-8 gold rush, Miller said.
“From what I understand, if made under proper controls and good manufacturing processes, delta-8 can bring health benefits like delta-9 can,” said Miller. “But when it’s not regulated, consumers are taking an enormous risk to their health,” he added.
Another blow to the U.S. hemp industry came this month when Janet Woodcock, the acting FDA commissioner, told Natural Products Insider on Sept. 9 the agency’s hands were tied to regulate CBD for use in food, beverages and cosmetics because CBD (in medical dosages) was already approved as an ingredient in the anti-seizure drug Epidiolex, so it must be excluded from the definition of a dietary supplement.
“In my reading, the law is fairly clear about this, and so it puts us in a stalemate position,” Woodcock told attendees at the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference. “We also need additional data on the safety of lower doses and how that might be controlled, say, in the supplement market. How could you manage exposure of consumers?”
This is why Congress must jump in and act to regulate CBD, Hemp Roundtable’s Miller said.
“It’s not enough for the FDA to send out a warning. It’s time to actually start regulating these products,” Miller said.