FDA Regulations Are Coming, and the Industry Must Prepare. Here’s How.

So, if you’re in the industry, you’d better get your ducks in a row to prepare for scrutiny from the feds – not just your immediate state – lest you face a disastrous product recall or quarantine.

What could go wrong? Think: pesticide and mold contamination. Heavy metal contamination. Lead. Pesticide infestation. Incorrect dosing. Allergens. Rust particles. Human hair. Worried about these things. You may need some expert help. But who ya gonna call?

Kim Stuck hopes it will be her company Allay, a cannabis/CBD consulting firm in Denver. “We help owners sleep better at night. We’re a compliance-consulting firm,” Stuck, 36, said in a recent interview.

Her credentials and those of her five employees seem impressive. All are former state regulators – Stuck herself was one of the first in Colorado, the first state to legalize, recreational marijuana, in 2012. Stuck started her regulator job in 2014, then founded her company in 2017, with what seems a boisterous start: Revenues reached a million dollars last year; offices were set up in Denver and Portland, Ore.; and Stuck now averages 40 or so clients at a time.

She says she has competitors, but they mostly work on “slivers” of what Allay does; in fact the company often teams up with those competitors.

And state regulation? It’s rarer than you’d think. “Many state and local health departments actually haven’t gotten involved in this industry at all at this point, which is rather disheartening,” Stuck said. The result: ”I’d say 80 percent of the products that are on the shelf have never seen a health inspector in their life.”

That’s disturbing, she said. “It’s the government’s job to protect the public from things going into their food chain. It’s kind of scary.

Scary is right. In February, Canada had a recall of moldy gummies – that’s right, gummies.

And Canada is not alone. “I have endless stories,” Stuck said of her years in consulting. In 2015, she said, “I think I disposed of $28 million dollars’ worth alone, just due to a recall of pesticide issues.” Growing a couple of plants in your basement is pretty safe, she acknowledged, but growing on a grand scale can produce powdery mildew, thrips and aphids (“Aphids love cannabis.”) She’s gone after growers making extracts who hadn’t cleaned and sanitized in between runs for a full year. Eventually, she saw pesticides get written into Colorado’s regulations after the problem became clear. She estimated that pre-regulation, she’d found pesticide contamination in levels up to 56 percent.

Then there’s mold. “I’ve walked into grows [cultivation facilities] that have literally a carpet of mold growing on the floor,” Stuck said. Molds can produce mycotoxins, created by certain kinds of fungi and potentially carcinogenic. A colleague of Stuck’s ordered a particularly large mold-based recall in Colorado. “People were opening up pre-rolled joints, and the entire joint was covered in mold,” Stuck said.

Then there’s the cross-contamination that can occur in another part of the industry, dispensaries, which store bud in jars. Customers come in, open the jars to smell and inspect the product and breathe into it. Some dispensaries have sent those jars back to a grow facility, which then ground up the contaminated bud into products.

Less icky sounding but just as important in Stuck’s consulting work is her focus on factors like faulty equipment and clients’ level of GMP, or Good Manufacturing Practices  promulgated by the FDA. Speaking of that key federal agency, “The FDA hasn’t given any kind of guidance, which I think if kind of crazy,” she said. “The industry really, really needs guidance.” She believes that the regulations to come will closely mirror CFR 11 and CFR 117, which regulate supplements and food. Risk-mitigation methods will also figure in, Stuck predicted, “because cannabis is a very, very different from any other crop.”

And contaminated cannabis is also very costly: A freezer “full of steaks that have gone bad” might prompt a recall and $20,000 fine, Stuck said. But even a small amount of contaminated cannabis oil, small enough that she could pick it up and carry it out the door, might command a $100,000 fine.

What can growers and manufacturers do to avoid such outcomes? Stuck concluded with five essential tips:

• Follow FDA regulations, which GMP is based on. “Any good company is going to be following FDA regulations right now… if they’re not ready [for the FDA regulations] they’re going to be really far behind their competition.

Thorough cleaning and PPE for staff are part of a smart prevention strategy.

• Follow worker safety practices. A hazard communication plan is essential, Stuck said, adding, “OSHA inspectors are beginning to knock on doors, and they’re the highest-fining department out there.”
• Label products correctly, because, Stuck said, having to have packaging reprinted is expensive.
• Avoid product recalls. Product recalls happen to almost everyone due to errors, Stuck said: So have a recall plan in place and train your staff to know what to do.
• Avoid health claims. “You can’t say that ‘CBD cures covid,’ because we actually don’t know yet,” Stuck said. Testing and human trials must precede health claims. “I shout from the rooftops not to do health claims,” the consultant said.