Words matter. For example, when the head of the U.S. Food and Drug Administration (FDA) decries an “epidemic,” the media and state policymakers pay attention.
Unfortunately, sometimes public health officials creating fear mongering campaigns while ignoring real epidemics, including some that are killing children. Most frustratingly, some of these epidemics were created by a drug approved by FDA based on only “two clinical trials that demonstrated it was safe and effective.”
In 2016, FDA decided to regulate vaping devices through “deeming regulations.” With this, the agency blocked all new e-cigarette products from entering the market and banned claims of reduced harm as found by health groups such as Public Health England and the Royal College of Physicians.
Also in 2016, Cassidy Cochran’s family penned an obituary ending with “In lieu of flowers, please call or write your state representative and plead with them to make Naloxone available over the counter, without a prescription.”
Two years later, when FDA and the U.S. Surgeon General labeled youth e-cigarette use an “epidemic,” the obituary of Madelyn Linsenmeir went viral. In an equally heartbreaking final note, Madelyn’s family pointed to Purdue Pharma’s OxyContin as the beginning of a “a relationship with opiates that would dominate” the rest of the young woman’s life. Purdue has now been named a defendant in more than “1,000 lawsuits filed by state and local governments.”
No one in the vaping industry wants children using their products. These are a tobacco harm reduction (THR) tool that effectively delivers nicotine without the harms associated with combustible cigarettes. An estimated three million American adults have used these products to quit smoking. Moreover, e-cigarette advocacy groups and trade associations have self-imposed regulations to deter youth use, including the Smoke Free Alternatives Trade Association, Consumer Advocates for Smoke-Free Alternatives and the Vapor Technology Association.
In the past six months, FDA, which is in charge of “advancing public health,” has increased its fear mongering campaign against THR. As a result, numerous state legislators have introduced proposals threatening THR products, with hundreds of state bills aiming to tax, regulate, and even prohibit the sale and/or possession of these products.
Meanwhile, states are facing an unprecedented opioid epidemic. Eighteen years ago, then-Administrator of the Drug Enforcement Agency, Asa Hutchinson said OxyContin was a “looming battle ship on the radar screen.” In a 2002 U.S. Senate hearing, a witness relayed a message from a teenager to “take OxyContin off the market.”
It’s important to understand the FDA is specifically blocking e-cigarette manufacturers and retailers from providing truthful, science-backed claims that their products are significantly less harmful than combustible cigarettes.
Yet, the same agency allowed Purdue to market OxyContin with a “modified risk” disclaimer. Purdue marketed OxyContin as less addictive, with packaging stating “delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” This claim was allowed despite zero clinical trials being conducted to support this, and the sentence was “added to the label at FDA’s suggestion.”
Although U.S. public health regulators are threatening to shut down the e-cigarette industry, the opioid crisis is well into what the Centers for Disease Control and Prevention call the “third wave.” Although there is scant evidence that vaping leads to cigarette smoking, there is overwhelming evidence that prescription opioid use leads to heroin and/or fentanyl use, with approximately four out of five heroin users having previously used prescription opioids.
It is estimated that more than 49,000 Americans died from an opioid overdose in 2017. More than 130 people die everyday in the United States due to an opioid overdose. The cost of the opioid crisis to the United States “is $78.5 billion a year.”
It’s unfortunate that public health officials would decry THR products an epidemic, especially when parents are burying their children due to an epidemic started by a drug the FDA approved with very little restraints on the marketing and distribution of. No parent has penned an obituary claiming JUUL to be the cause of such utter devastation, but many have chosen to pen “passed away unexpectedly” in their children’s obituaries, undoubtedly ashamed. Public health officials should be ashamed, because their campaigns against THR products are increasingly ignoring the real epidemic facing youth in the United States.
