FDA Quietly Delays Stricter Rules On E-Cigarettes, Cigars

The Food and Drug Administration has handed a temporary victory to e-cigarette and cigar companies, quietly deciding to delay enforcement on some recently finalized rules that impose stricter oversight on these tobacco and nicotine products. 

The FDA proposed these rules in April 2014 and finalized them nearly a year ago. If they are ever implemented, they will require manufacturers of all newly regulated products to show that these items meet public health standards set forth in the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009, and (in most cases) receive marketing authorization from the FDA.

The cigar industry [PDF] and e-cigarette makers [PDF] filed separate lawsuits against the FDA in 2016 to challenge these rules. The government had been fighting these cases, but this week told the court that a number of the disputed rules are being delayed.

According to filings [PDF] provided to the court on Monday, the FDA has agreed to a three-month postponement of rules.

The FDA will “extend and defer enforcement of all future compliance deadlines under the Rule for cigar and pipe tobacco products for three months,” the filing states.

The vaping and tobacco industry had sought the three-month delay on the rules in order to give the “new leadership personnel at the Department of Health and Human Services to more fully consider the issues raised in this case and determine how best to proceed.”

However, it should be noted that the postponement only covers a handful of rules that was set to take effect from May to August.

Under the postponement:
• Manufacturers of cigars will not have to submit plans for how warnings will be randomly displayed and distributed on packages and rated on advertisements to the FDA.

• Manufacturers will not have to submit information on what ingredients are contained in e-cigarettes and cigars.

• Manufacturers will not have to stop introducing products with labels that include descriptions such as “light,” “low,” or “mild.”

The Washington Post reports that provisions of the rule implemented prior to May 10 are not affected by the postponement.

Additionally, the three-month window will not affect a number of rules that are expected to take effect later this year and in 2018.

That’s not to say those rules can’t change before their implemented. The Post notes that it is unclear how the Trump administration will address provisions that take effect after this summer.

The Post notes, however, that several administration officials have ties to the tobacco industry, including recently confirmed FDA head Scott Gottlieb who served on the board for an e-cigarette firm until May 2016.

Lawmakers have also taken steps of their own to weaken the FDA’s e-cigarette regulations. Last week, California Rep. Duncan Hunter introduced the Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017.

The proposed bill would reverse rules that deemed e-cigarettes as tobacco products, giving the FDA authority to regulate the products before they enter the market. Instead, the FDA would oversee vaping devices and e-liquids using “commonly accepted industry manufacturing standards.”

by Ashlee Kieler via Consumerist