Pubdate: Fri, 11 Oct 2019
Source: Wall Street Journal (US)
Copyright: 2019 Dow Jones & Company, Inc.
Author: Scott Gottlieb


Doctors have linked a tragic wave of lung injuries and deaths to the
vaping of tainted marijuana concentrates. The episode reveals the
dangers created by the federal government's decadelong refusal to
challenge state laws legalizing pot and promoting risky uses of its

The Obama administration announced in 2013 that it wouldn't enforce
federal drug laws in states that had legalized pot use. The following
year, Congress started attaching legislative riders to budget bills to
prevent the Justice Department and other agencies from enforcing
federal laws banning marijuana use in the 33 states that have made
weed legal. The Trump administration has tried to reverse some of
these policies. In 2018, then-Attorney General Jeff Sessions rescinded 
Obama administration guidance giving U.S. attorneys discretion not to 
enforce federal drug law in states that have legalized marijuana. But the 
White House has been reluctant to challenge popular state policies 
directly. As a result a large pot industry has bloomed in recent years, 
and a dangerous market in cannabis concentrates, such as the ones 
responsible for the vaping deaths, has proliferated.

According to an analysis by health officials in Wisconsin and
Illinois, about 87% of those recently injured said they had vaped
tetrahydrocannabinol, or THC, the main psychoactive ingredient in
marijuana, from prefilled cartridges purchased from "informal sources" 
during the three months before they developed symptoms. A majority of the 
victims said they used THC every day.

Data from state marijuana dispensaries show that inhalation of these
liquid concentrates from a vaping device is now the second most common way 
to consume THC, exceeded only by the old-fashioned way. Because the vape 
cartridges are prefilled, users don't know what they're getting. To 
prepare the concentrates, dodgy suppliers are known to add ingredients to 
thicken the liquids, since viscosity is seen as a measure of the 
concentrate's potency. But these emulsifiers, including vitamin E acetate, 
can be deadly if inhaled into the lungs. The liquids can also contain 
pesticides and other contaminants that, when heated, produce gases that 
can directly injure the lungs.

Yet the Justice Department remains unwilling or unable to enforce
existing federal laws, even on matters not specifically mentioned by
the congressional budget riders. The feds are also reluctant to
regulate this market. Exerting partial oversight over the riskiest
products would effectively signal the end of federal marijuana
prohibition. Justice officials see such a step as politically
controversial, even as it becomes clear that a blanket ban is no
longer politically practicable.

The result is an impasse. Federal agencies exert little oversight, and 
regulation is left to a patchwork of inadequate state agencies. The weak 
state bodies sanction the adoption of unsafe practices such as vaping 
concentrates, while allowing an illegal market in cannabis to flourish.

The Food and Drug Administration might be able to exert oversight on
some vaping hardware. The FDA has jurisdiction over "components and
parts" used to vape derivatives of tobacco. Manufacturers selling
devices for cannabis often make vague claims that their products are
intended for use with extracts and leaves, which could include
nicotine and tobacco. This might give the FDA a hook over the THC
vaping pens that are enabling most of the harm.

But such an assertion of authority might be hard for the FDA to
sustain without clear laws and firm political support. So many state
legislatures have legalized marijuana that the U.S. is well past the
point of blanket prohibition. But mounting evidence of the
public-health consequences from regular marijuana use, especially
among children and expectant mothers, should give politicians pause.
Studies show that regular use of THC affects memory, executive
function and psychological well-being. The recent lung injuries and
deaths confirm the market has become a Wild West of potent and shadowy

THC is currently illegal under federal law. Right now there's no
middle ground allowing federal agencies to scrutinize these compounds for 
their manufacturing, marketing and safety.

A feasible compromise would require Congress to take marijuana out of the 
existing paradigm for drug scheduling, especially if Congress
wants to allow carefully regulated access for uses that fall outside
FDA-approved drug indications. The ship has probably sailed on
legalization for recreational use. But regulation of the potency of
THC compounds, the forms they take, how they're manufactured, and who can 
make purchases ought to be possible.

Research challenging bogus medical claims or establishing legitimate
clinical uses for THC is thin on the ground. Getting legal access to
marijuana for federally sanctioned drug research requires cumbersome
registration and record-keeping. The supply also has to come from a
tightly regulated source controlled by the feds. Scientists say the
product is substandard. It's also meaningfully different-in potency
and other features-from what most people use in states where pot is

Any federal regulation would need to be backed up with oversight and
vigorous enforcement to keep a black market from continuing to
flourish and causing these lung injuries. Expanding access to
marijuana for legitimate medical research would allow more scientists 
either to validate or dispel the myriad claims about marijuana's 
therapeutic usefulness. Whatever medical claims are made should be subject 
to the same federal standards applied to other drugs.

The protracted hand-wringing over federal cannabis policy must stop.
The tragic spate of fatalities related to vaping of pot concentrates
means the time has come for Congress and the White House to stop
blowing smoke and clear the air.

Dr. Gottlieb, a resident fellow at the American Enterprise Institute, 
served as commissioner of the Food and Drug Administration, 2017-19. He 
consults with and invests in drugmakers.
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