Politics
Former FDA Head Hints Feds Should Regulate Marijuana To Protect Public Health
The former head of the Food and Drug Administration (FDA) said this week that conflicting state and federal marijuana laws have created an oversight gap that is exacerbating an outbreak of vaping-related lung injuries, and he indicated that federal regulations may be necessary to resolve the issue.
Scott Gottlieb said in a series of tweets over the weekend and in a TV appearance on Monday that he is concerned about permissive state policies that allow for the use of cannabis by adults but at the same time pointed out that current restrictive federal laws are inhibiting regulators’ ability to oversee manufacturing of marijuana products. It remains to be seen what the former FDA commissioner would specifically propose to address the problem legislatively, however.
On Twitter, he acknowledged that illegal vape cartridges, including those containing THC and CBD, appear to be behind a spike in lung issues that have injured hundreds and killed at least five people throughout the U.S. in recent weeks. Experts believe the problem is associated with the use of unapproved ingredients such as Vitamin E acetate, which can be deadly when inhaled.
“We have a dangerous State-Federal conflict when it comes to THC,” he wrote on Sunday. “States legalize THC behind permissive laws but have little capacity or interest in properly regulating it, and for Feds, it’s still schedule 1. Then states point fingers when problems arise.”
It looks like there are at least three different manifestations of vaping-associated pulmonary injury: lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia. Most will likely be related to illegal THC and CBD products and perhaps counterfeit nicotine e-cigs.
— Scott Gottlieb, MD (@ScottGottliebMD) September 8, 2019
“Permissive state laws on recreational THC and our conflicted attitude toward cannabis create a lot of risk,” he added. “These products and vape pens sold to aerosolize stuff other than nicotine (and thus probably not regulated by FDA) fall into dangerous gap where there’s no proper oversight.”
These are important questions based on the current information we have from these tragic case reports. We must also differentiate between illegal vapes and e-cigarettes; the latter which generally denotes a nicotine containing ENDS product that is subject to FDA regulation.
— Scott Gottlieb, MD (@ScottGottliebMD) September 8, 2019
During an appearance on CNBC’s Squawk Box, the former FDA head said that the “challenge with CBD and THC is that they’re not really regulated by anyone right now.”
“The states allow these things to be legally sold within states, but they’re not regulated by FDA,” he said. “FDA would only regulate a vaping product if it’s a nicotine-containing vaping product that’s derived from tobacco. That’s their legal hook. These are falling within a regulatory gap so states aren’t doing regulations.”
“I think we’re going to have a federal reckoning here.”
He said “states have passed laws that are far too permissive allowing recreational use of these products” and simultaneously, “it’s far too difficult to get access to legitimate products to do proper research.”
“I think we need a federal reckoning where we make it easier for people to get access to cannabis if they want to do legitimate medical research and try to make medical products out of these things. But these state laws that allow this widespread recreational use where it’s getting into the hands of kids and pregnant moms, that’s a real public health concern. In the states that have moved ahead, they’ve allowed all of these products to flood their markets, but they don’t have an FDA, they don’t have proper oversight, so these illegal vapes are getting onto the market.”
Though Gottlieb has not explicitly called for federal cannabis legalization, which would presumably empower FDA to exercise its regulatory authority in the same way it does for products like tobacco, he has repeatedly recognized that the status quo is not working and will continue to present challenges.
I’ll be coming up on @SquawkCNBC to discuss tragic lung injuries related to vaping what appears – based on available information – to be largely illegal products, perhaps containing THC and CBD. These products may fall in a regulatory gap, with nobody overseeing them properly. pic.twitter.com/l86DgtEYN0
— Scott Gottlieb, MD (@ScottGottliebMD) September 9, 2019
He said on Saturday that it’s “not clear FDA can regulate vape pen not sold for use with tobacco nicotine” and that “Congress may need to expand FDA’s authority.”
Legally sold nicotine based e-cigs are not harmless. But most of these severe cases, so far, appear to be symptoms that can occur when either oils or lipid-containing substances enter lungs. This points to illegal products that are being cut with dangerous chemicals as a culprit.
— Scott Gottlieb, MD (@ScottGottliebMD) September 7, 2019
Even if most lung-injury cases are traced to chemicals used to emulsify THC or CBD into illegal vaping “juices,” it doesn’t let legally sold, nicotine-based e-cigs off the hook. They must do more to ensure safety of their products by engaging review process and ending youth use
— Scott Gottlieb, MD (@ScottGottliebMD) September 7, 2019
Marijuana Moment reached out to Gottlieb and the American Enterprise Institute, where he’s a resident fellow, for comment, but no reply was received.
This isn’t the first time that the former commissioner has punted to Congress on cannabis issues. Following the federal legalization of hemp and its derivatives, Gottlieb said that congressional action may be necessary in order to develop alternative regulations allowing for CBD to be introduced into the food supply or as health supplements.
What’s less certain is what kind of legislation would be able to expand FDA’s ability to regulate non-tobacco vape products while marijuana remains a prohibited Schedule I drug.
Legalization would very simply put cannabis within FDA’s realm, but the furthest Gottlieb has come to publicly supporting marijuana reform is stating that there are valid reasons to decriminalize the plant. That was for criminal justice-related reasons, however, and not public health or regulatory factors.
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