Will Humble Prevention, Tobacco, Wills Blog

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.

Will Humble Prevention, Public Health Law, Tobacco, Wills Blog

Michigan Health Department to Ban Sale of Flavored E-Cigarettes

This week Governor Whitmer of Michigan ordered the Michigan Department of Health and Human Services to ban the sale of flavored electronic cigarettes. 

Last week the Department declared that youth vaping constitutes a public health emergency, triggering the directive. The ban will covers both retail and online sales of flavored e-cigs as well as preventing misleading marketing of vaping products, including the use of terms like “clean,” “safe,” and “healthy”.  Besides sweet flavors, the prohibition will also apply to vaping products that use mint and menthol flavors.

The new rules will go into effect as soon as the health department issues rules later this month.  The initial ban will last 6 months.  In the mean time the health department will develop permanent regulations banning flavored e-cigarettes.  The ADHS has an ongoing social media campaign, but additional policy interventions are clearly needed.

Below is a link to a webinar series by the Western Region Public Health Training Center.  I really need to view these in the next couple of weeks- you might want to as well.

Will Humble Firearm Safety, Prevention, Wills Blog

APHA Urges Congressional Leaders to Act on Firearm Violence Prevention Legislation 

APHA sent a  letter to House and Senate leaders urging Congress to take immediate action on three key proposals to address the epidemic of gun violence in the U.S. In the letter to House and Senate leaders, the letters urge Congress to enact three critical and commonsense policies already under consideration that would create major progress in reducing the toll of firearm violence. These policies include:

1) appropriating $50 million through the FY 2020 Labor, Health and Human Services, Education, and Related Agencies appropriations bill for public health research on firearm morbidity and mortality prevention;

2) enacting legislation requiring universal background checks, such as H.R. 8, the Bipartisan Background Checks Act; and

3) enacting legislation that allows the removal of firearms from those deemed potentially harmful to themselves or others through the issuance of extreme risk protection orders, or ERPO, such as H.R. 1236/S.506, the Extreme Risk Protection Order Act.

The joint letter urges Congress to work to enact these important proposals upon their return to Washington, D.C., following the summer congressional recess. We shall see.

Here’s how you can urge your member of Congress to act on key gun violence prevention legislation.

Will Humble Prevention, Professional Development, Public Health, Wills Blog

UA and Pima County Launching an Academic Health Department

The UA Mel and Enid Zuckerman College of Public Health and the Pima County Health Department have created an Academic Health Department with the goals of enhancing public health education, training and research to improve community health in Pima County.

Some of the elements of the Academic Health Department will include an expansion of internship opportunities at the Health Department for UA Zuckerman College of Public Health students; research poster forums featuring projects developed by interns; training for internship preceptors, faculty advisers, graduate coordinators and undergraduate advisers; and a fellowship program.

There will also be a Mini Public Health School, which will be a monthly lecture series featuring presentations by faculty members and health department staff discussing their research and community-based projects. 

Members of the AHC core team from the UA Zuckerman College of Public Health are: Dr. Rosales and Emily Waldron, community engagement and outreach coordinator. From the Pima County Health Department: Bob England, MD, MPH, interim director; Julia Flannery, organizational development program manager; Paula Mandel, deputy director; and Kristin Barney, MA, division manager. 

For more information, about the Academic Health Department, please contact Dr. Cecilia Rosales at [email protected], (602) 827-2205.

Will Humble Maternal Health, Vaccination, Wills Blog

CDC’s Public Health Grand Rounds on Maternal Immunizations

Join CDC as they present their next Public Health Grand Rounds session on maternal immunizations on September 18. Pregnant women should routinely receive the Tdap (pertussis) vaccine and the influenza vaccine, as recommended by the Centers for Disease Control and Prevention (CDC). These vaccines have been shown to provide significant benefits to mother and baby. Watch live September 18 at 1:00pm ET on either of CDC’s live streaming platforms.

Will Humble Medicaid, Prevention, Public Health, Return on Investment, Wills Blog

Aligning the Roles of Medicaid and Public Health

Aligning the Roles of Medicaid and Public Health

Medicaid and public health partnerships play an important role in advancing a statewide approach to improving health and reducing health disparities. Collaboration and shared priorities between agencies can play a super important role in improving outcomes.

The Association of State and Territorial Health Officials recently put together this interesting and easy to listen to 30 minute podcast that highlights opportunities to  leverage each agency’s respective roles and resources through the CDC’s 6|18 Initiative.  Here are some links to additional resources regarding these kinds of partnerships:

Will Humble Marijuana, Wills Blog

Retail Marijuana Voter Initiative: My First Impressions

A group of Medical Marijuana Dispensary operators have completed statutory language for a retail marijuana and marijuana law criminal justice reform voter initiative. I’ve been able to go through the Initiative language a couple of times now. The statutory language is 16 pages long- and there are a lot of provisions…  but below are some of my initial impressions from a public health perspective:

Good Things

  • Employers would still be able to have drug-free workplace policies and can restrict marijuana use by staff.

  • Driving while impaired (to the slightest degree) by marijuana would still be illegal.

  • The governance structure is decent. It’s with an executive branch agency- ADHS (the 2016 Initiative created would have created a self-serving commission).

  • I mostly like the criminal justice reform parts for possession of less than an ounce. Possession up to 2.5 oz is a reduced penalty. Possession of more than 2.5 oz (with some exceptions for home cultivation) appear to be left where they are as a Class 6 felony. Currently, possession of very small amounts of marijuana (w/o a MM Card) are a class felony 6. Convictions impair people’s ability to earn a living – placing stress on families because of low wages and limiting the ability of folks to support kids and families and pay child support etc. – basically impairing self-sufficiency. AZ is one of a very very few states with possession of small amounts being a felony, this Initiative would fix that.

  • I like the conviction expungement provisions for the same reasons as above- and the expungement process is reasonable and not a free-for-all.

  • The labeling and packaging requirements are reasonable.

  • The testing requirements make sense too.

  • The restrictions on advertising are pretty good.

The Bad Things

  • There are no penalties for persons over 21 that give or buy marijuana for people under 21. This is a major shortcoming. There’s no disincentive for older people to buy for people under 21. There are small penalties and low-grade misdemeanors for people under 21 that misrepresent their age to people over 21 for the purpose of buying marijuana – but no penalty for the older person whatsoever.

  • The buy age in the Initiative is 21 years old. Data suggests that the buy age should be 25 years old. Brains continue to develop up to age 24 (25 in males). Data suggest that marijuana is more harmful and is more likely to cause longer term behavioral health problems when people start using before 25 y.o. Here’s a new Surgeon General Advisory from this week on the subject.

  • The Initiative would allow the ADHS to regulate potency but prohibits the agency from limiting doses to less than 10mg. 10mg is a good “ceiling” regulation but a bad “floor” regulation. Having said that- dispensaries would still be able to produce edibles that are less than 10mg and sell them – it’s just that the ADHS can’t regulate below 10mg.

  • The excise tax is a good idea – but the funds don’t go toward public health or youth marijuana prevention programs. There’s a one-time distribution ($10M) to the ADHS from the existing medical marijuana fund for public health stuff, but nothing after that. There should be some excise tax funds going to prevention campaigns- in particular youth prevention. A lot more of the excise tax should go toward preventing the downside of the policy decision- e.g. preventing kids from using marijuana.

  • Some excise funds should go to the AZ Biomedical Research Commission to study the effects of this policy intervention.

  • The law would let people cultivate up to 6 plants or 12 per household. While there are some requirements for locking the plants away from kids in houses- enforcing that will be next to impossible and diversion to kids would happen for sure with basically no checks in the system.

  • The existing medical-marijuana dispensaries would have a corner on the market in perpetuity. This is anti-competitive and permanent. Current medical marijuana dispensaries will be allowed to apply to the ADHS for a license to run a retail marijuana store in early 2021. It’s possible that there could be a few more stores that open eventually, but not many, because the total number is limited to about 130 total (10% of the number of pharmacies in AZ). Existing medical marijuana dispensaries, with a handful of exceptions, would essentially be the only stores that exist. ADHS would regulate the program.

  • The Initiative appears to tie the hands of local authorities in setting zoning restrictions (although the League of Cities and Towns would be a better expert).

Will Humble Climate Change, Wills Blog

EPA Proposes Eliminating Methane Capture Regulations

This week the EPA proposed new rules that would reverse regulations adopted by the Obama administration requiring the natural gas industry to prevent fugitive methane gas releases. The existing rules were adopted during the previous administration as a measure to slow the emission of greenhouse gases causing climate change.

Under the proposal released this week the EPA would no longer specifically regulate the transmission and storage of the potent greenhouse gas… but treat it like a routine volatile organic compound. 

The rules proposed this week would eliminate the current requirements that require the industry to prevent methane releases at transmission and storage of methane at compressor stations, pneumatic controllers, and underground storage vessels (basically- the transmission and storage segment of the industry).  The proposed regulations would also eliminate methane emission limits from the transmission and storage segment of the industry. 

Methane (CH4) is a very powerful greenhouse gas. It absorbs much more energy than carbon dioxide (CO2) and is 30 times more potent as a greenhouse gas.  Methane has a half-life in the atmosphere of about 10 years (much less than CO2) but has a powerful impact during that time.

The U.S. oil and gas industry emits 13 million metric tons of methane from its operations each year (emissions of methane are about 2.3% of the production).  Most of these “fugitive” emissions came from leaks and equipment malfunctions in the transmission and storage of the gas- the very sector that the proposed rules deregulate. 

The climate impact of these leaks is roughly the same as the climate impact of carbon dioxide emissions from all U.S. coal-fired power plants.  [R.A. Alvarez el al., “Assessment of methane from US oil and gas supply chain”, Science (2018).]

In their comments this week – EPA officials stated that the industry has a powerful incentive to stop fugitive emissions of methane without regulation because they lose product via leaks. That argument only holds when the cost of fixing the leak is less expensive than the short-term cost of lost product.

Here’s a link to EPA’s proposed rules.  Public comment isn’t open because it’s not published in the Federal Register yet.  Once it’s published, there will be a 60-day comment period.  I’ll keep following this and put the link to the comment site in a future public health policy update.  The comments page – when available – will be at www.regulations.gov.

Editorial Note: In addition to the public health impacts from climate change caused by the obvious things like worse storms, water shortages, decreased agricultural output, impacts to assets from sea level rise (oceans are already 20cm higher then they were in WWII), and the geopolitical implications that these disruptions will cause from increased  conflicts, refugee crises and widespread social dislocation would almost certainly increase – climate change also causes a diversion of resources toward adaptation, diverting public and private resources from more efficient uses of capital.

This results in long-term decreased GDP growth and investment and capital losses. For example, the expected value of a future with 6°C of warming represents present value losses worth US$43trn—30% of the entire stock of manageable assets (the current market capitalization of all the world’s stock markets is around US$70trn).

The reason I mention this – is that as public health officials – we often focus on those direct public health impacts that are resulting and will continue to result from climate change. Convincing decision makers that aren’t partucularly interested in public health that the the climate crisis is serious and requires immediate aggressive interventions requires a variety of arguments. Here is an interesting, if dense, analyis recently published by The Economist.

Will Humble Medical Marijuana, Prevention, Wills Blog

U.S. Surgeon General’s Advisory:

Marijuana Use and the Developing Brain

The US Surgeon General (Jerome Adams MD) Issued  a concise advisory this week  that emphasizes the health risks of marijuana use in adolescence and during pregnancy. He released the Advisory in response to recent increases in access to marijuana and in its potency, along with misperceptions of safety of marijuana endanger our most precious resource, our nation’s youth.

Will Humble Vaccination, Wills Blog

AzDHS Immunization Action Plan:

Recommendations for Increasing Immunization Coverage Rates in Arizona

Immunization coverage rates in Arizona continue to fall. The ability for parents to opt their child out of vaccination is simple and is being done more frequently in Arizona. This has resulted in families and communities being at increased risk for vaccine preventable diseases. 

The ADHS recently led a stakeholder group that explored interventions and activities that could help to stop and reverse this negative trend and increase vaccine coverage rates across all Arizona communities. The group developed a report that included the following goals:

  1. Improve vaccine education to professionals who will interact with parents

  2. Implement public information campaigns to promote vaccination

  3. Evaluate the effectiveness of current vaccine education pilot in reducing exemptions

  4. Ensure private providers continue to provide childhood vaccination services

  5. Determine best practices for improving vaccination coverage

  6. Partner with the Department of Education to increase school vaccination rates and compliance

The team put together a 15-page report that includes recommendations to address each goal.  I couldn’t find a copy of the report on their website, but somebody sent me a copy. The recommendations are mostly educational or administrative- no major policy recommendations (like eliminating the personal exemption).  Take a look.  Sounds like we will be seeing more details about these goals and recommendations in the coming months.

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