Allay Founder Speaks on the FDA, Cannabis Regulations and cGMP on The GrowthOp

This is an excerpt from an article found on The GrowthOp FULL ARTICLE

Kim Stuck, the first cannabis and hemp specialist for a major metropolitan public health authority in the U.S., disposed of about US$28 million ($35 million) worth of cannabis products in 2015.

She was working in Denver, at the time, and there was no specific code the companies behind the products flouted. In fact, they weren’t aware they had done anything wrong.

“At the time they were following the health department laws which didn’t have enough regulations in place yet,” Stuck tells The GrowthOp from Oregon.

“The companies that had to destroy product didn’t know they were doing anything wrong at the time because of the lack of detailed regulations. But at the end of the day it didn’t matter because a contaminated product is a contaminated product and it had to be disposed of.”

After that, she stopped counting the losses.

“It was too depressing,” she says.

Two years later, she started her own company, Allay Consulting, a compliance strategy and services provider serving the global cannabis, hemp and psychedelic industries.

Compliance, while seemingly a dreary topic, is a critical part of normalizing these emerging industries, Stuck says. 

“The less black eyes on the industry, the better the industry is going to do.”

Six years after that depressing year, Stuck says the mature markets are now operating in a “completely different world.” Back then, she was encountering problems nearly every day.

“When I first started going into places I was running into really huge issues with health and safety,” Stuck says, highlighting grows with black mould on the walls, or rusted-out homemade extraction equipment, or the rampant use of pesticides.

She also faced an uphill battle just getting in the door at many facilities. 

“In the beginning, I would show them my badge and they were just completely scared,” Stuck says. “Back then a lot of these companies were coming from a legacy market and they weren’t used to being regulated. They weren’t used to having people with badges in their facilities walking around.”

After some time, and a few delicate conversations, those relationships began to change and the realization set in that Stuck and other regulators were not seeking to destroy emerging businesses but were there to protect public health and the industry as a whole.

But as more U.S. states legalize, Stuck says some of those same issues are popping up again in new jurisdictions.

“Many of these companies have never thought about food safety, or OSHA (Occupational Safety and Health Administration) in their entire lives,” she says. “They don’t know what they don’t know, and so they kind of scramble and think that maybe they’re doing the right thing, but aren’t really sure, and most of the time they’re not.”

She adds, though, that there are a lot of “really good companies that realize that they don’t understand it all” and are eager to establish standards and regulatory practices, even without federal oversight.

The U.S. Food and Drug Administration (FDA) has the authority to regulate products containing cannabis or cannabis-derived compounds but has yet to issue federal guidelines. That’s not to say they are totally asleep at the wheel. The agency monitors health claims made by cannabis companies, especially as it relates to CBD , but the industry has repeatedly called for stronger regulation.

Last year, the FDA released a report that tracked the cannabinoid content of CBD products for six years and found that nearly half of all products tested were mislabeled.

“It’s high time for the FDA to regulate CBD as a dietary supplement and food additive,” the U.S. Hemp Roundtable stated in response to the report. “The agency’s current public stance not only impairs hemp farmers and small businesses; an unregulated marketplace poses real health and safety concerns.”

Stuck agrees.

“The FDA themselves are not actually regulating it which is absolutely insane from a public health standpoint,” she says. “It baffles me every day. But, you know, it kind of is up to the industry, right? They need to step up and say, ‘Hey, we’re going to abide by these standards whether they’re required or not. And, obviously, we wouldn’t need to be in business if we didn’t have companies that we’re doing that.”

For consumers that might be concerned about which products to buy, Stuck advises going with companies that have Good Manufacturing Practices (GMP) certification. 

Once a company gets GMP certified, they receive a logo that can be used online or on marketing materials. Companies put it on their websites or issue press releases announcing the certification.

Unfortunately, Stuck adds, some companies falsely claim they are GMP certified. “The reason this falls through the cracks is because there is no FDA oversight to put a stop to it,” she adds.

“As a consumer myself, I only buy products from GMP certified facilities. As much as I love the industry, and obviously it’s my life, I’m very careful about what I consume because of the lack of regulation that is taking place from a health and safety standpoint.”

To achieve GMP certification , companies need to meet principles governing things like facility design, staff training, record-keeping and beyond. In the U.S., GMP is mandated by the FDA for pharmaceuticals and other manufactured products.

It’s a costly process, that takes a lot of time, but Stuck believes that the FDA will mandate the certification for cannabis products, eventually. The companies that have already achieved GMP will be ahead of the competition, she adds.

Allay also maintains a vetted list of GMP-certified U.S. companies on its website.

Much of the work the company does is based on future prospects, mainly federal legalization and preparing companies for that moment. She admits that some people don’t want to hear about safety in the industry but underscores its importance in moving cannabis forward.

“It kind of flies under the radar because I think people don’t want to hear about it and they don’t want to post about it and it kind of hurts the industry,” she says. “But that’s the problem, it does hurt the industry. It makes cannabis look like it’s not safe when it absolutely is, it is as safe as every other wholesale food. We just need to follow the guidelines that are in place, even if they’re not actually required.”


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