On August 8, 2016, the FDA finalized a rule to regulate all tobacco products including e-cigarettes and ENDS (Electronic Nicotine Delivery Systems). It requires all products that were introduced after February 15, 2007, to be submitted to the FDA for review within two years. Both big tobacco companies and small e-cigarette retailers lobbied against it. For more information about this regulation, please visit https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm506676.htm.
However, a recent bill passed by the U.S. House of Representatives is said to weaken this FDA rule and represent the victory for the $4.4 billion vaping industry in the country. Republican Representative Duncan Hunter of California proposed the bill, and it is called ‘Hunter’s Bill.’ It would reverse the Obama administration’s rule which deemed e-cigs as tobacco products that should be subjected to strict governing regulations.
The main goal of ‘Hunter’s Bill’ is to exempt vaping devices from the FDA rule. Vaping retailers say that letting their products undergo the process of FDA review and approval is expensive and time-consuming. The bill is very timely as Donald Trump’s administration is cutting regulations across the board. It also adds momentum to a series of legal and legislative efforts by tobacco and vaping companies to contradict the FDA regulation.
Moreover, Congress is pushing Dr. Scott Gottlieb to lead the FDA. Gottlieb has a positive opinion about vaping; he said that it might be a good alternative for smokers. In fact, he has a financial interest in the vape shop Kure.
What is the Hunter’s Bill All About?
- It modifies the Family Smoking Prevention and Tobacco Control Act (TCA), mandating the FDA to be reasonable in regulating vape products.
- It requires e-liquid makers to abide by the existing standards of the American E-liquid Manufacturers Standard Association (AEMSA) until permanent standard are created.
- It requires manufacturers of vaping devices to follow strict electronics and battery standards.
- It requires all vape products to have serial or lot numbers.
- It allows the FDA to prohibit advertising and marketing to minors.
- It prevents states and municipalities from deeming e-cigs and ENDS as tobacco products which usually leads to the creation of unreasonable product restrictions.
- It supports the FDA to conduct an inspection of all manufacturing facilities of vape products. Manufacturers that do not comply with federal rules will be penalized.
- It requires the FDA to rank nicotine products by comparative risk and to submit a report to the Congress about it.
- It requires the FDA to recommend harm reduction strategies for nicotine and tobacco users.
Cole-Bishop’s Versus Hunter’s Bill
The Cole-Bishop’s Bill is similar to the Hunter’s Bill. Congressman Tom Cole and Congressman Sanford Bishop introduced legislation to ensure sensible regulations for e-cigarettes. Named as the ‘FDA Deeming Authority Clarification Act of 2017’, it amends the FDA to change the predicate date for newly ‘deemed’ tobacco products, impose reasonable regulations for vapor products and establish product standards for vapor batteries.
This bill could be added as a rider to the Agriculture Appropriations Bill; it is the vaping industry’s best chance to derail the FDA regulation. If it does not push through, everything will be back to square one. Even worse, vaping businesses will begin closing in large numbers.