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FDA Weighs Role Overseeing the Marijuana Trade

Colorado’s and Washington’s decision to legalize marijuana for adults has left federal regulators in an awkward position, with the drug still illegal under federal law. But while the Food and Drug Administration has been largely absent from the new retail scene, the agency appears to be leaving the door open to taking action on food products that contain marijuana if public health is threatened.

Opponents of marijuana legalization anxious that current regulatory efforts are being left to the states would cheer the agency’s involvement. However, supporters of regulating marijuana in a manner similar to alcohol say they don’t expect the FDA to step in unless it is legalized on a nationwide level.

“I don’t see any way that the FDA gets involved in food products that contain marijuana,” said Dan Riffle, former director of federal policies for the Marijuana Policy Project.

Whether the agency intervenes — and how — would depend on specific circumstances, including how a food product is classified, according to a FDA spokesman.

A product containing marijuana that is intended to diagnose, cure, mitigate, treat or prevent disease is legally classified as a drug. It would only be subject to the agency’s regulatory authority over food products if it’s “properly classified” as a food under the Food, Drug and Cosmetic Act, said spokesman Jeff Ventura.

“The fact that a product takes a form that is associated with a food (such as a brownie or a lollipop) does not mean that the product is properly classified as a food under the Federal Food, Drug, and Cosmetic Act,” he said in an email. “In order to be classified as a food under the FD&C Act, a product must meet the relevant statutory definition.”

Ventura said the agency would consider many factors in deciding whether to act, including agency resources and the threat to the public health. The FDA may also consult with its federal and state counterparts, he noted.

The agency’s comments come amid concerns that people are getting sick from accidentally consuming marijuana edibles or exceeding the recommended dosage. News reports out of Colorado have linked at least one death to edibles and described a rise in children coming into the emergency room after accidentally eating marijuana-laced products.

Beyond the effects of the marijuana itself, there are also safety concerns about any foods that contain the drug. Bill Marler, an attorney in foodborne illness cases, said there have already been reports of those kinds of violations in Colorado and said the state is realizing it’s going to have to subject the products to additional scrutiny.

“I think they’re starting to go, ‘Oh wow, they have more than marijuana in it,’” Marler said. “I think they’re going to start looking at it like they’re another food product.”

Danica Lee, food safety section manager for the Denver Department of Environmental Health, said the city has been applying its food safety regulations to those companies and is treating them just like it would any other member of the food industry. The Colorado Department of Revenue has also released rules for marijuana-infused products that include components that address food safety, she noted.

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.