The product recall by Denver-based marijuana cultivator Bonsai Cultivation reminds us all of the unique regulatory dynamic facing the cannabis industry. In this case, the cultivator – working with state officials – pulled marijuana products off the market because they may contain elevated yeast and mold counts. The recall followed a Denver Department of Public Health & Environment examination of dried marijuana samples.
This series of events is not far off how we would expect a similar matter to play out at a federal level with the FDA – only the federal agency has not provided clear direction and regulatory guidance around cannabis and CBD products. At least not yet.
While the marijuana industry waits for clarity on the FDA’s position related to cannabis, former Commissioner Scott Gottlieb recently said the federal government should regulate state marijuana programs. In his opinion, states “don’t have the capacity to both police what’s being sold in their so-called legal dispensaries as well as shut down the black market.” With that in mind, he shared his vision for a regulatory framework: one in which the FDA and other agencies such as the Drug Enforcement Administration (DEA) “could regulate what’s being sold for the potency, for the manufacturing, for the ingredients, for the claims that are being made.”
But there’s a long way to go before state and federal regulations are aligned.
In the meantime, we’ve written a whitepaper that shares our perspective and opinions on the challenges facing the industry, and what companies involved in the supply chain – from cultivator to retailer – should do to prepare for a cannabis crisis. Here’s a few of our topline thoughts:
Because of federal inaction to date, it’s tempting to think that there will be no federal regulatory violations. But take caution. Consequences could be substantial for companies that make a misstep. In fact, any consumer report or evidence of a product on the market, legally or illegally, that causes consumer harm is likely to draw scrutiny and potentially heavy-hitting response from regulators. Just take a look at what Juul is facing as regulators catch up with what had been an unregulated business.
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