The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.
However, the issue is receiving bipartisan support and FDA regulatory experts expect more action to develop over the coming months.
Dr. David Gortler is a professor of pharmacology at Georgetown University and an FDA regulatory affairs expert. He was the FDA policy advisor to the Ted Cruz presidential campaign, and a former medical officer for the U.S. Food and Drug Administration.
He says the FDA should do more to regulate vaping products.
“The FDA was given statutory authority to regulate all forms of vaping including e-cigarettes, vapes, e-liquids, e-cigars, e-pipes and e-hookahs in August 2016, but to date, the FDA isn’t doing enough to actively oversee it and protect vulnerable Americans,” Gortler told FDA Reporter.
He also said the current state of regulatory affairs allows for a great deal of uncertainty when it comes to vaping products. People may vape thinking it’s safer than smoking, he said.
“A lot of the vaping devices and liquid inhalant material is made overseas," Gortler said. "It is fair to say we don’t know everything that is being placed into the vaping material because nobody, including the FDA, is testing the liquid to see what’s in it and/or the concentrations. People are led to believe vaping is a safer alternative to smoking tobacco.”
He likens the current situation to patent medicines and the use of laudanum in the late 1800s.
“Back before the Pure Food and Drug Act of 1906, people were taking unlabeled 'vitamin elixirs' with either no list of ingredients or an incorrect list of ingredients on a daily basis thinking it was okay for their health. It turns out that these elixirs contained alcohol and opium and whatever else manufacturers felt like putting in there,” Gortler said.
He said that’s why truth in labelling regulations and the Pure Food and Drug Act of 1906 began; the American public demanded reforms after reading exposes and reports of manufacturing conditions in the meat industry. These laws laid the basis for modern federal regulation of the food and drug industries.
“I think it should be a lot more closely regulated, because right now nobody knows what’s in it,” Gortler said. “We are regressing back to pre-1906 America, and our own century-old Pure Food and Drug Act.”
On the other side of the debate, the Consumer Advocates for Smokefree Alternatives Association (CASAA) writes that current FDA regulatory proposals would ban 99 percent of the vaping products on the market, and that those who cite safety concerns over vaping products ignore the very real dangers of tobacco.
“There are many studies on e-cigarettes with a range of conclusions being presented," CASAA states on its website. "CASAA notes that well-designed and well-executed studies have consistently found e-cigarettes to be significantly less harmful and at least as effective, if not more so, than current alternatives to smoking.”
Alex Clark, spokesperson for CASAA, says bans on vaping products, flavored or otherwise, will not help the debate.
"Pushing production and sale of vapor products into an unregulated and unlicensed marketplace is likely to expose people of any age to more risk," Clark told FDA Reporter. "In an underground market, there are no good manufacturing protocols or product standards being followed. There would be no motivation for unlicensed sellers to check IDs and there’s no accountability if consumers start getting injured."
He pointed out that vaping manufacturers are currently working with the FDA to improve the industry.
"The industry is meeting several compliance deadlines like registering as manufacturers, registering all of the products they make, and registering ingredient lists with the FDA," Clark said. "These are critical bits of information that allows the FDA to conduct inspections and alert manufacturers to the need for a recall, if such an action were necessary."