Friday, May 13, 2016

Up in smoke: will new regulations kill vaping?

By Stephanie Reid

Vaping” is a term few would have recognized just 10 years ago. However, given the vast body of public information supporting the notion that traditional cigarettes are a deadly combination of carcinogens and addictive additives, many smokers turned to the novel electronic cigarette (e-cigarette), which provides the sought-after nicotine of a cigarette without the harmful smoke (though the jury is still out on how safe they actually are). In its basic form, an e-cigarette provides the user with a nicotine-laced vapor (hence, “vaping”), which the user then inhales like the smoke of a tobacco cigarette.

However, unlike the traditional cigarette—which is pretty much banned in public spaces everywhere in the United States—the laws and restrictions that apply to vaping have been much less clear. Is it considered smoking? Do smoke-free zones include e-cigarettes? Can e-cigarettes be sold to minors? These questions, and many more, have puzzled users and lawmakers alike. Fortunately, the US Food and Drug Administration (FDA) provided somewhat clearer restrictions on May 5, 2015, releasing a 499-page regulatory guide governing the sale and use of e-cigarettes.
E-cigarettes muddle the rules
By and large, a healthy percentage of smoke-free laws were enacted in the 1990s and early 2000s—well before the advent of the e-cigarette. Accordingly, these statutes were not drafted with vaping in mind. For example, the Annotated Code of Maryland (Section 2-106(b)(4) and 5-312defines “smoking” as follows:
“Smoking” means to use or carry any lighted:
(a) Cigar;
(b) Cigarette;
(c) Pipe; or
(d) Other tobacco product of any kind.
For the e-cigarette smoker, this statute inevitably leads to confusion as to whether vaping is, in fact, a form of smoking under the law. There is no explicit inclusion of an e-cigarette in the list of banned products. Also, the statute refers to a device that is “lighted,” as opposed to the electronically powered e-cigarette.
The inception of e-cigarettes followed the enactment of federal policy prohibiting the sale of cigarettes to minors, leaving a gaping legal loophole as to whether children can lawfully purchase and/or use electronic cigarettes.
States take a stand
Over the past several years, a number of states took the initiative to expressly address the issue of vaping within the context of statutory smoking bans, with the following states specifically including “e-cigarettes” in the list of banned products in “100 percent smoke-free venues”:
  • Connecticut
  • Delaware
  • Hawaii
  • Maine
  • North Dakota
  • New Jersey
  • Oregon
  • Utah
In addition, approximately 16 states enacted e-cigarette regulations in one form or another, with many taking aim at specific areas wherein e-smoking is not permitted. These restrictions range from a complete e-cigarette ban on public school grounds (including college campuses) to prohibitions against vaping on public transportation. Moreover, several Midwestern states specifically banned e-cigarettes on department of corrections property, while a handful of states enacted legislation to ban vaping on state fairgrounds.
The federal government’s response
On May 5, 2016, the FDA issued a “Final Rule” on the definition of “tobacco products” as listed in the Food, Drug, and Cosmetic Act (which has historically regulated tobacco use and smoking in general). In its ruling, the FDA reiterates the efforts it has made to curtail the use of tobacco over the past several generations, as along with the well-established correlations between smoking and a number of deadly diseases. Likewise, the FDA asserted that it did not want to see yet another generation of children grow up to become addicted to cigarettes, and the department fears that the vaping trend may entice children to try smoking as the next logical step.
Under the new regulations, which appeared in the Federal Register on May 10, 2016, all e-cigarettes must come complete with explicit warning labels as to the dangers of tobacco use. Further, sale of e-cigarettes is limited solely to adult consumers, and merchants can face hefty fines and penalties for selling these products to minors. In addition, the FDA plans to implement the following controls on the e-cigarette industry:
  • Enforcement actions against misbranded e-cigarette products
  • Pre-market ingredient disclosure
  • Registration and licensure of e-cigarette manufacturing facilities
  • Prohibition against free samples
The rules will take effect in roughly August of 2016, and come after nearly 10 years of unregulated e-cigarette sales and production. While many applaud the new rules as necessary to protect public health, opponents contend that the FDA’s regulations will cost thousands of hours and millions of dollars in compliance measures.
Particularly ignited over the issue, the American Vaping Association stated that these laws are not so much regulation as they are an outright prohibition, given the FDA’s cost-prohibitive application and oversight procedures. Other critics charge that the FDA rules will force small “vape shops” out of business, calling them just one more example of government regulations that have untoward impact on small businesses. Still others fear that the new rules will steer consumers back to more-harmful traditional tobacco products, and thereby compound the US smoking problem to levels worse than before.
The battle appears set to continue for some time as the health impacts of these products reveal themselves, and legislation adapts to take up the slack.

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