The FDA Tackles the Marketing of e-Cigarettes to Youths

The FDA announced this week that it is initiating a multi-pronged approach to try to curb the illegal sales of e-cigarettes to underage youths. That includes Juul, a vaping product popular with teens that looks like a flash drive (see this blog Apr. 14, 2018).

The FDA's current multi-pronged approach includes; 1) Identifying retailers that are selling e-cigarettes to minors and sending them warning letters, 2) working with e-bay to remove listings for Juul on its website, and 3) working to hold manufacturers of Juul and other e-cigarettes accountable for how their products are marketed and used.

Publicly, at least, Juul claims it is opposed to the use of its products by minors. But that claim is hard to square with Jull's youth-friendly product design and the kinds of flavors that the nicotine-containing "pods" come in.

It will be hard to curtail what many people might see as a relatively minor crime. We'll see how far the FDA gets with this.

First FDA-Approved Drug Derived from Marijuana

An FDA advisory committee has recommended the approval of a new drug, called Epidiolex, for the treatment of several types of epilepsy in children . If the FDA accepts the recommendation, Epidiolex will be the first FDA-approved drug to contain cannabidiol (CBD), a non-psychoactive substance purified from marijuana (cannabis).

Following the discovery that CBD had certain medical benefits, a number of states (30 at last count) legalized marijuana for certain medical purposes. Several other states legalized just the CDB extract. Relatively pure CBD is now widely sold over the internet for a host of medical and quasi-medical conditions, including as a sleep aid, an anti-anxiety treatment, an anxiety reliever, and even as a cure for certain types of cancer. But while some of these alleged benefits of CBD may be true, none has been proven by rigorous scientific studies. In addition, the purity and consistency of non-FDA-approved drugs sold over the internet can be suspect.

What makes Epidiolex different is that its developer and manufacturer has gone through the necessary testing to prove its medical efficacy. As a result, Epidiolex is poised to receive FDA approval for the treatment of two rare types of epileptic seizures. A distinct advantage of FDA approval is that patients with the forms of epilepsy targeted by the drug can be assured of the drug's purity and consistency of dose from one prescription to the next, because the drug will be produced according to best pharmaceutical practices.

With further testing, the FDA could expand the approved use of CBD to include other medical conditions. In the meantime (even if the FDA does eventually approve CBD, or even marijuana, for other uses), I doubt that marijuana-users will give up their favorite form of self-medication.

Juul Vaping Product Appeals to Minors

The latest fad among teenagers: Juul, a nicotine-containing vaping product that looks like a flash drive.  Teachers report that some students take them to school and have been caught smoking them in class.

Juul cannnot be sold legally to persons under the age of 21.  Juul is intended for adults who want curb their smoking habit, according to Juulvapor.com.  But if that's so, why did they design the device to look like a flash drive?  One has to believe that there is a reason for their strange design choice.  And why sell nicotine-containing "Juulpods" in flavors that appeal to kids, such as mango and fruit medley?

Aftermarket sellers of Jull-compatible pods containing nicotine were quick to see the kids potential in Juul; they now sell pods in flavors such as strawberry, blueberry, and watermelon.  Does anyone really believe that this product was designed solely for adults?

Non-Antibiotic Drugs May Contribute to Antibiotic Resistance

We've discussed on this site a number of times the role that antibiotics play in the development of antibiotic resistance. But it turns out that that's just the half of it; new research shows that some non-antibiotic drugs, including painkillers, antipsychotics, and drugs to combat high blood pressure, can also contribute to antibiotic resistance.

These findings are going to make efforts to combat antibiotic resistance harder than previously thought. Many drugs, such as those to combat high blood pressure, are meant to be taken for the rest of the patient's life; one can't just stop taking them because they may affect the bacteria in your gut. What to do?

If there is any good news in this latest research, it is that the tests revealed that a few drugs used to treat other diseases actually turned out to have some antibiotic activity as well, according to an article in the popular press on the subject. Perhaps some of these drugs could be tested further and then used to combat the increasing number of antibiotic resistant bacteria. But it's a long shot.

A Cancer Warning on Coffee?

Responding to a lawsuit from a non-profit toxic chemicals watchdog group, a superior court judge in California has issued a preliminary judgment that may ultimately require coffee roasters and sellers to post warnings that coffee may pose a cancer risk. How did it come to this?

Well, it turns out that during the coffee roasting process, a miniscule amount of a chemical called acrylamide is created. Acrylamide is on California's list of cancer-causing or toxic chemicals. And back in 1986, California voters passed Proposition 65, a law requiring businesses and sellers to inform consumers about any possible exposure to toxic or cancer-causing agents in their products. An exception to this requirement can be granted only if the seller can prove that the exposure (in this case, to coffee) poses "no significant risk". But how would Starbucks, for example, ever be able to prove a negative (a complete lack of risk, over a lifetime)? Do you think Starbucks is up to that task?

It's true that there's acrylamide in coffee, but the levels are orders of magnitude below levels that have ever been shown to be a risk factor for cancer. So is the judge's ruling an example of regulatory overreach? Is Proposition 65 functioning as intended? Where do we draw the line between protecting the public and scaring them needlessly? For more on this controversy, read an article by NPR here.

What do you think?