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New York marijuana: What to know about CBD craze, FDA crackdown on cannabis-based drugs

this article originally was published via USATODAYnetwork and, original post located here all credit given to David Robinson of Rockland/Westchester Journal News

Federal authorities seem poised to tighten restrictions on CBD-brand cannabis products already being sold throughout the state just as New York's recreational marijuana push is rebooting.

CBD, or cannabidiol, is typically sold as cannabis-derived oils, creams and capsules, which is legal in New York and across the country because it lacks marijuana’s psychoactive element.

Yet concerns about bogus CBD marketing and products threatening users have ignited calls for U.S. Food and Drug Administration oversight, a potential turning point for the CBD industry on pace to hit $16 billion in sales by 2025, experts say.

The CBD craze exploded after Congress passed the Farm Bill last year, which made some cannabis plants legal and loosened restrictions on the use of the CBD hemp products that contain less than .3% THC, the psychoactive element, USA TODAY Network reported.

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.

So far, federal regulators have only approved medical grade CBD for treating severe epilepsy, handling other CBD products claiming to treat everything from anxiety and insomnia to pain and depression similar to nutritional supplements.

Some companies touting cannabidiol as a cancer cure, however, received warning lettersfrom the Food and Drug Administration, suggesting a pending crackdown on CBD medical claims.

What follows is an analysis of the CBD industry in New York as part of the USA TODAY Network’s ongoing investigation of the cannabis economy.

CBD’s New York rise

From humble beginnings in legal weed states like Colorado, the CBD boom in New York recently put hemp goods on shelves everywhere from health spas and fashion boutiques to vape shops and bodegas.

Meanwhile, online shoppers have plenty of CBD choices through retailers like Amazon. Pharmacy giants Walgreens and CVS in March also announced plans to offer CBD at hundreds of stores, 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.

In addition to poor quality controls, confusion about the legality of selling CBD-infused food and drinks has some consumers and legitimate businesses awaiting further clarification from state and federal regulators.

Robert Posenato, co-founder of Hudson Valley CBD, which sells hemp products online as well as to five stores in New York, is one of the supporters of FDA oversight of the industry.

“It’ll help some of those bad companies fall off along the wayside, and those who aren’t testing or following ethical procedures will disappear,” he said.

A CBD business story

Posenato’s tale of becoming a cannabis entrepreneur seemingly overnight underscored the CBD gold rush underway.

He started out last year buying CBD products from Colorado and having them shipped to his Tuckahoe apartment in Westchester County, where they got labeled before heading off to retailers or online customers.

Hudson Valley CBD's overall sales hit $100,000 in its first year, prompting a relocation to an East Rutherford, New Jersey office last month, said Posenato, who hopes to quit his day job in tech for Konica Minolta and focus on cannabis despite growing competition.

As a CBD user, Posenato banks on telling his story to sell products and distance the brand from the industry’s shady underbelly.

“I personally don’t walk out there and tell anybody it’s a cure-all that’s going to fix everyone’s problems,” he said.


Having switched from taking pharmaceutical anti-anxiety drugs, the 32-year-old aspiring cannabis mogul described CBD as a milder alternative.

“It’s not going to fix, alleviate or cure any pain, anxiety or stress, but the true honest to God way it works is... to make that pain, anxiety or stress more manageable. It’s almost like turning the volume down,” said Posenato, who also takes medical marijuana for back pain stemming from a car crash.

Hudson Valley CBD’s quality controls include testing the products it buys from a company called Ubix through laboratories in Colorado based on that state's regulations, Posenato said. Its creams, capsules and tinctures cost between about $45 and $89.

CBD shoppers should look for a certificate of analysis that details potency and testing results that ensure products are free of residual solvents and heavy metals, he added.

In addition to supporting FDA oversight, Posenato backs legalizing recreational pot in New York, notwithstanding the powerful cannabis companies' track record of taking over marketplaces in other states.

“Recreational coming to the state only gives me additional locations to try to get my product into view,” he said. “I really don’t see it as a downside to my business.”

National debate

The Food and Drug Administration, or FDA, is holding a key public hearing on May 31 regarding its regulation of cannabis and cannabis-derived products, such as CBD.

A USA TODAY Network review of the 550-plus hearing comments submitted online to the FDA offered a glimpse into the high-stakes battle.

An overwhelmingly majority of comments supported keeping CBD products widely available, as well as legalizing cannabis in general. Some were anonymous, and others included names that are difficult to verify due to a lack of details, such as state of residence.

Pro-CBD comments included business owners selling cannabis-infused drinks and oils, as well as self-identified consumers reporting it treated everything from high blood pressure to skin rashes.

Some of the anecdotal praise for cannabis evoked the cadence of infomercial testimonials.

My skeptical 76-year-old Italian mother had aches and pains until I gave her cannabis, one comment read, and my chocolate Labrador got antsy for long car rides, but then I gave him some cannabis and now he calmly looks out the window like a good dog.

Comments calling for tighter regulation, or outright prohibition, mainly focused on concerns about tainted cannabis products hitting shelves. Some described unsavory cannabis marketing pushing products like snake oil salesman on the Wild West carnival circuit.

“Just make all of it legal and regulated so harmful or adulterated products are kept out,” one comment read.

Yet detailed and harrowing stories of medical grade cannabis being used to treat epilepsy, chronic pain and post-traumatic stress disorder are also peppered throughout the stream of mostly pro-marijuana comments.

Some supporters still called for improved regulation of packaging, labeling and testing standards. Others requested that CBD products be treated like herbal supplements and vitamins that are far more loosely regulated than pharmaceutical drugs.

Meanwhile, as clinical research slowly catches up with anecdotal praise, some medical professionals were cautiously optimistic about the potential benefits of CBD during the Association of Health Care Journalists conference earlier this month.

“It’s probably not going to be magic, but it’s probably not going to be the devil’s oil,” said Dr. Brent Bauer, director of the Mayo Clinic Complementary and Integrative Medicine Program. “It’s probably going to be somewhere in-between and some patients will benefit from it.”

For further details about the FDA hearing on May 31, visit its website here.

Originally Published 6:00 a.m. EDT May 20, 2019

Updated 1:44 p.m. EDT May 20, 2019