HHS Agencies Begin to Engage on E-Cigarette Lung Injuries... and what’s the Root Policy Cause of the Vaping Epidemic?

Late last week the CDC issued an Advisory about their investigation of a multi-state outbreak of severe pulmonary disease associated with e-cigarette product (devices, liquids, refill pods, and/or cartridges) use. As of September 6, 2019, over 450 possible cases of lung illness associated with the use of e-cigarette products have been reported to CDC from 33 states. As of Friday, there had been 5 deaths have been confirmed in California, Illinois, Indiana, Minnesota, and Oregon.

CDC also developed a case definition to classify cases consistently.  State and county health departments will now be able to use the new case definition to determine if cases are confirmed or probable (after examining the medical records of suspected cases and consulting with the clinical care team to exclude other possible causes).

Unlike nationally reportable conditions like communicable diseases, these cases require clinicians and public health to interview patients to determine product use and individual behaviors- which means that there’s no active surveillance system to look for injuries like these.  With more health departments and emergency departments actively looking, it’s certain that more cases will be identified, and we should be able to learn more about what’s actually happening and why pretty soon.

There aren’t enough data yet to determine what specifically might be causing the cases but many of the samples tested by the states contained significant amounts of Vitamin E acetate. Vitamin E acetate is in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.

While the FDA and CDC don’t have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury, they urged consumers to not use vaping products that might contain Vitamin E acetate (but I couldn’t find out how consumers would be able to tell that). The statement also said that “… no youth should be using any vaping product, regardless of the substance”.

FDA “Intends to” Better Regulate Flavored Vaping Products

Today the US Department of Health and Human Services Secretary announced that: “… the FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon.”  I guess we’ll learn more about that the Federal Register in the weeks to come.

Today’s announcement that FDA intends to do more came out after preliminary numbers from the National Youth Tobacco Survey showed a continued rise in the rates of youth e-cigarette use, especially among the non-tobacco flavors that appeal to kids.  In particular, the preliminary data showed that more than 25% of high school kids are current (past 30 day) e-cigarette users in 2019 and the overwhelming majority cited the use of popular fruit and menthol or mint flavors.

Sadly, nothing in the HHS or FDA materials from today suggested that they intend to use any of their authority to tightly regulate the advertising and marketing of e-cigarettes. That fact that they were silent on that makes me believe that that might not be in the cards.

Arizona Policy Interventions Last Legislative Session were Unsuccessful

One of the key public health policy interventions that could make a dent in the vaping epidemic here in Arizona was last year’s SB 1363 Tobacco Product Sales (Tobacco 21) sponsored by Senator Heather Carter.  The bill would have classified electronic cigarettes as a tobacco product (allowing it to be regulated like tobacco – including covering it in the Smoke Free Arizona Act) and moving the buying age for cigarettes and electronic cigarettes to 21 years old.  Sadly, that bill never got a hearing at the Legislature.

So, What’s the Root Policy Cause of the Vaping Epidemic?

In short, it’s judicial branch interpretations of the FDA’s authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act.

In June 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which gave the FDA the power to regulate the tobacco industry. Under the Act, nicotine and cigarettes can’t be banned but flavorings like fruit or mint can.  Additionally, the law required new tobacco products seeking to enter the market to meet FDA pre-market standards (including electronic cigarette regulation). The statutory language left open the possibility that electronic cigarettes may be able to be regulated as a nicotine delivery device- and as such could have required a prescription.

The FDA exercised that authority by directing the U.S. Customs and Border Protection to reject the entry of electronic cigarettes into the US on the basis they were unapproved drug delivery devices.

A series of lawsuits then followed FDA’s decision. In a December 2010 landmark decision in the Smoking Everywhere v. FDA case, the U.S. Court of Appeals in Washington ruled the FDA can only regulate e-cigarettes as a tobacco product (e.g. that e-cigs can’t be regulated as a nicotine delivery device- which could have included a prescription requirement). The court said that if therapeutic claims are made then the FDA might be able to regulate e-cigs as a nicotine delivery device.  That order is here and the 25-page decision is here.

In a subsequent ruling in December 2010, the appeals court also ruled against the FDA in a 3–0 unanimous decision, finding that the FDA can only regulate e-cigarettes as tobacco products. The judges ruled that such devices would only be subject to drug legislation if they are marketed for therapeutic use – E-cigarette manufacturers had successfully proven that their products were targeted at smokers and not at those seeking to quit.

Editorial Note: Here lies the root cause of why we are where we are right now.  Had the judges found that the FDA had the authority to regulate e-cigarettes as a nicotine delivery device- they could have required a prescription (for smoking cessation purposes) on e-cigs and the marketing wildfire that resulted in the addiction of a generation of young people to high levels of nicotine could have been averted. 

Following those court rulings, in April 2011 the FDA announced it will regulate e-cigarettes like traditional cigarettes and other tobacco products under the Food Drug and Cosmetics Act, however, they never exercised their authority to regulate the marketing and advertising of e-cigarettes, and here we are…  in the middle of a teen and young adult vaping epidemic.