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CBD consumer safety warnings are mounting as cannabis-derived products flood shelves across New York.
Several public-health alerts have emphasized CBD, or cannabidiol, is being improperly, and possibly illegally, marketed as a cure-all for everything from cancer to canine anxiety.
The crackdown on questionable CBD sales comes as federal regulators consider imposing stricter rules to improve oversight and quality controls.
One U.S. Food and Drug Administration, or FDA, warning letter recently targeted health-related claims by Curaleaf, a company selling CBD products in New York and other states.
“Selling unapproved products with unsubstantiated therapeutic claims, such as claims that CBD products can treat serious diseases and conditions, can put patients and consumers at risk by leading them to put off important medical care,” said Acting FDA Commissioner Ned Sharpless, referring to the July 22 warning to Curaleaf.
“Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” he added.
An industry exploding
Despite the FDA scrutiny, the CBD industry is booming, particularly across the Southern Tier of New York.
In many ways, the CBD gold rush stemmed from Congress passing the federal Farm Bill last year, which made some cannabis plants legal and loosened restrictions on the use of CBD hemp products that contain less than .3% THC, the psychoactive element.
Further, the bill removed the low-THC hemp, used to extract CBD, from the schedule 1 category that includes marijuana and other drugs such as cocaine and heroin.
Since then, the newly legal low-THC products have flowed largely unchecked by federal regulators, prompting major investments by farmers, cannabis companies and other businesses scrambling to cash-in on the fledgling industry.
After getting the FDA warning, Curaleaf ended its CBD hemp blog and removed the related marketing claims, vowing to comply with federal rules for future sales.
It also noted many of the offending CBD lotions, oils and pet products, such as bacon-flavored drops, had already been discontinued.
“Our industry needs, wants and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace,” said Joseph Lusardi, CEO of Curaleaf.
The Curaleaf warning joined similar alerts in the past, underscoring an increasingly urgent push by regulators to address complaints about bogus CBD products, as well as legal confusion surrounding them.
The FDA is expected to report findings of a CBD policy review in the fall, suggesting new rules could be issued in time for the hemp harvest in New York.
“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders,” FDA Principal Deputy Commissioner Dr. Amy Abernethy said last month.
“The step-wise, science-based approach we’re taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence,” she added.
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What’s the FDA reviewing
So far, federal regulators have only approved medical grade CBD for treating severe epilepsy, handling other CBD products similar to nutritional supplements.
One aspect of the FDA review is focused on potential health risks of using CBD.
During its approval of the seizure disorder drug, Epidiolex, the FDA reported finding the potential for liver injury connected to using CBD regularly over a long period of time.
“These are serious risks that can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how these risks might be managed when CBD is used far more widely, without medical supervision and not in accordance with FDA-approved labeling,” the agency noted.
Further, the FDA is reviewing safety issues tied to using a variety of CBD consumer products like lotions and oils simultaneously and regularly, as well as the potential effects for different ages of people and species of animals.
Meanwhile, online shoppers currently have plenty of CBD choices through retailers like Amazon. Pharmacy giants like CVS in March also started selling CBD products in select states, despite uncertainty about the potency and quality of some products sold through the existing marketplace.
More than 70% of CBD extracts sold online, for instance, were mislabeled regarding potency, according to a Penn Medicine study in 2017.
But the era of lax CBD oversight appears to be nearing an end.
In addition to the expected federal reforms, state lawmakers and regulators in New York are also poised to overhaul the CBD industry.
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What’s New York’s law
Gov. Andrew Cuomo and Alphonso David, counsel, discuss a bill lawmakers approved that would regulate the hemp-extract industry in New York; June 21, 2019. Jon Campbell, email@example.com
In New York, legislators in June passed a bill to reform the permitting process for hemp growers and clarify rules for the burgeoning CBD market in the state.
Gov. Andrew Cuomo has yet to commit to signing the bill into law, citing his ongoing review of the issue.
The reform push comes amid confusion about existing federal and state laws regulating
CBD products sold in New York, according to Marco Pedone, owner of EVIO New York, which is affiliated with a cannabis-testing conglomerate with laboratories in several states.
“It is such a Wild West climate not only for the CBD but as to the general understanding and regulation in New York state,” he said.
The bill would ensure proper labeling for all hemp products sold in the state and initially require background checks for anyone looking to grow or sell hemp and hemp-containing products.
Stringent testing would also be performed on products containing hemp extract to ensure accurate levels of the compound are in each product, USA TODAY Network reported.
Elisa Gwilliam, founder of the Hudson Valley Healing Center in the Town of Poughkeepsie arranges CBD products from Hudson Valley CBD offered for sale at the healing center on May 16, 2019. (Photo: Patrick Oehler/Poughkeepsie Journal)
EVIO New York is planning to open a cannabis testing lab in Orange County this fall, Pedone said, adding it’s investing more than $1 million in the business.
EVIO is expecting to provide a variety of testing for hemp and CBD products. It is also pending approval to add testing for medical marijuana, which is much more tightly regulated by New York state law, he said.
While medical marijuana products must be tested in-state under New York law, the low-THC hemp products can be tested across the country.
“There is no reason a New York operation should take a sample from a product in New York and send a sample to a lab in California,” Pedone said.
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What about CBD food and drinks?
Adam Roesnthall of Iron Heart Canning adjusts the mobile canner during a production run of Recess at Drink More Good’s production facility in Hopewell Junction on January 31, 2019. Recess, which is produced under contract by Drink More Good is a CBD-infused beverage. (Photo: Patrick Oehler/Poughkeepsie Journal)
Some of the high-stakes debate over CBD rules has involved food and beverages infused with CBD.
After the federal farm bill passed, businesses scrambled to launch soft-drinks, coffees and edibles containing the low-THC hemp CBD.
But the FDA in December clarified that it is unlawful to add CBD to food or drink, prompting New York City health officials to ban them last month.
The fines for food service establishments and retailers offering CBD in food or drinks, including packaged food products, are set to begin in October in New York City.
Similarly, the state Department of Agriculture and Markets, which regulates hemp, has been notifying companies that CBD food or drinks are not allowed anywhere in the state.
One was Beak & Skiff Apple Orchards in Lafayette, just outside Syracuse, which last month started marketing its CBD-infused cold brew to be sold at its farm store and Wegmans grocery stores, according to The Post-Standard.
But the CBD cold brew has since been removed from commerce after regulators directed the company to pull it, according to state officials.
Beak & Skiff referred questions about the issue to Allan Gandleman, president of the New York Cannabis Growers and Processors Association.
Several companies have destroyed hundreds of thousands of dollars in CBD-infused beverage inventory since state regulators this year started removing the products from shelves, he said.
The new hemp bill in New York, however, would allow for CBD-infused food and beverages, a potential turning point for cannabis growers and processors.
“For New York farmers, beverages will be a huge economic boom creating anywhere from $5 million to $20 million in farm sales to processors who will be making CBD beverages,” Gandleman said.