FDA takes a pass on CBD rules. Here’s why Northern California’s … – North Bay Business Journal

A recent federal decision to not regulate CBD in food has the cannabis industry up in arms because it allows an unregulated part of the business to thrive without oversight.

The U.S. Food and Drug Administration has said that if any regulation is needed, Congress should manage it.

FDA Deputy Commissioner Janet Woodcock went on to say in a Jan. 26 statement that CBD “raises various safety concerns, especially with long-term use.” Before reaching this conclusion, the federal agency created a working group to explore CBD as a food additive, which is already being manufactured in beverages and other products without regulation.

CBD (cannabidiols), the non-psychoactive compound compared to THC, is used for a variety of ailments such as joint pain. But the compound, derived from hemp or cannabis, is unregulated. In 2018, passage of the U.S. Farm Bill made hemp legal. But if the hemp plant contains more than 0.3% THC, which creates the “high” when consuming it, then it’s considered marijuana. And that’s illegal.

For years, Congress has failed to pass measures to change that, leading to the largely unregulated CBD-added market, with it showing up in various products from topicals to energy drinks.

California Assemblywoman Cecilia Aguiar-Curry, D-Davis, said the federal “indecision” about CBD has led her to consider sponsoring a bill that would legalize hemp-derived CBD as a food additive.

“I’m frustrated our state has to do what the federal government can’t do,” she told the Business Journal. “The interest is there. This could be a billion-dollar industry.”

She said that without regulation, the market is open to introduction of products laced with compounds not fully derived from the hemp plant.

Tiffany Devitt, government relations chief at a Sonoma County producer, CannaCraft, agrees that the line needs to be drawn between marketing pure CBD and chemically-laced products because it creates a stigma for the legal industry.

Devitt, who also serves on the California Cannabis Industry Association board, contends the FDA backing off from placing CBD under its wing says it’s “not capable of regulating CBD,” surmising the agency either lacks the will or the ability as a pharmaceutical-centric watchdog organization. Turning away from the task may negatively “create a gray zone.”

“What’s weird is the FDA seems to be grossly exaggerating the risk of CBD,” said Devitt, whose Santa Rosa company has developed a CBD-infused beverage called Hi-Fi Hops in partnership with Petaluma-based Lagunitas brewery.

Devitt cited studies such as the 2010 World Health Organization’s that deems CBD as being safe and effective in treating certain health conditions.

Although the FDA failed to act on determining whether CBD is safe and effective in food, the federal government is still interested in policing how it’s marketed. The mere threat of the federal government policing the food additive may prompt legal, organic producers to look over their shoulders, Devitt insists.

According to Lauren Mendelsohn, a cannabis-specialist attorney with the Sebastopol-based law firm, Omar Figueroa, the FDA does conduct occasional inspections of how CBD is marketed and packaged.

“It’s being policed to a certain extent. I’ve heard of warning letters going out to some (producers),” she said, pointing out the agency has declined to take on the bigger issue of fully regulating the marketing and distribution of the product.

“(The FDA’s indecision) felt like kind of a slap in the face,” she said.

The decision by the FDA comes at a time when polling suggests a majority of the American public is getting more comfortable with the idea of cannabis-related products.

A November 2022 Gallup survey revealed 68% of Americans support making cannabis legal for adults nationwide.

Thus far, 37 states have legalized at least its medical use — 21 of them for recreational purposes.

“Today’s announcement by the FDA underscores the urgent need for Congress and the Administration to take swift action to modernize federal cannabis policy and regulate CBD and other products appropriately and in harmony with the vast majority of states that have already legalized cannabis in some form,” National Cannabis Industry Association CEO and Co-founder Aaron Smith said in a statement following the Jan. 26 decision.

But other groups applaud the FDA’s decision as a health matter based on what some contend the public still doesn’t know about the substance.

“I’m happy to see the FDA take a position and express concern about CBD products. This is an important step forward in terms of safety,” said Jim Keddy, executive director of Youth Forward, a Sacramento-based group that is critical of what it contends is how the cannabis industry markets to kids.

Keddy agrees with “some concerns” from the legitimate CBD industry, but he argues more research is necessary.

But the arguments give all the more credence to the FDA needing to step in to distinguish between what’s safe and what’s not, some proponents say.

“Yes, consumers should care in theory that the FDA supports the guarantee that foods and supplements are safe,” said Martin Lee, director of Project CBD in Healdsburg, which advocates the safe use of CBD. “Congress already opened the door for this when they wrote the Farm Bill. We’re not against regulation. What we need is good regulation because many businesses use the regulatory vacuum to take advantage and mislabel (their products). We have no way of knowing what we’re getting.”

Susan Wood covers law, cannabis, production, tech, energy, transportation, agriculture as well as banking and finance. For 27 years, Susan has worked for a variety of publications including the North County Times, Tahoe Daily Tribune and Lake Tahoe News. Reach Wood at 530-545-8662 or susan.wood@busjrnl.com

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