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FDA Weighs Role Overseeing the Marijuana Trade

Lee said manufacturers and retailers in Denver will receive at least two unannounced inspections from investigators this year. So far, she said they have found violations very similar to those found in the non-marijuana food industry, such as problems related to temperature controls and hygienic practices.

The scope of the violations to date seems in line with those found in traditional food industries, Lee added. But the marijuana companies also face unique challenges.

“I think this industry, probably more so than the regular food industry, is more likely to come across employees who don’t have a food service background,” she said.

While Lee doesn’t see the lack of federal involvement as problematic for her department, opponents of marijuana legalization are alarmed by the overall harm that could come from edibles. Rep. John Fleming, R-La., said the FDA has to figure out how it’s going to protect the public, citing cases where children have eaten marijuana products and gotten sick.

“Now you have a very active substance that can be put into food, that can get into the hands of children, people across state lines and the FDA is saying, ‘Well, you know, we’re not involved in it,’” he said. “That’s a huge problem.”

Kevin A. Sabet, cofounder of Project SAM, which opposes marijuana legalization, said he thinks it’s just “a matter of time” before the FDA takes action. He’s skeptical that state regulations will do enough to protect public health and maintained that the FDA has twin duties in the edibles and research realms.

“We cannot leave it to state regulators who are for the first time in history dealing with these issues,” Sabet said.

Still, Marler said he’s unsure whether the FDA could have jurisdiction over the edible products if they do not cross state lines. And advocates for ending the federal prohibition on marijuana say its treatment under federal law makes it hard for the federal government to regulate the drug.

Bill Piper, director of national affairs for the Drug Policy Alliance, said that’s why the federal ban should be repealed, maintaining that prohibition is the absence of regulation and control. He also noted that, at this point, any kind of FDA involvement would likely be inconsistent with the Obama administration’s policy of largely leaving regulation to the states.

“I would be surprised if the FDA tried to exert authority as long as it’s a Schedule I drug,” Piper said.

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