FDA is delaying the enforcement date of a final rule that extends the agency's regulatory authority over tobacco products to include electronic cigarettes, cigars, pipe tobacco, and water pipe tobacco, according to court documents filed Monday, Juliet Eilperin reports for the Washington Post.
FDA last year issued a final rule that requires cigar and e-cigarette producers to register with FDA. The rule also requires tobacco companies to:
- Provide FDA with a list of ingredients used in their products; and
- Submit their products for regulatory review.
In addition, the rule requires tobacco companies to include health warnings on packages and in advertisements for their products and prohibits tobacco companies from:
- Advertising their products as "light" or "mild" without explicit consent from FDA; and
- Giving out free samples of the products.
The rule also imposes retroactive premarket reviews, requiring manufacturers of affected products to receive FDA approval of products that entered the market after Feb. 15, 2007, to continue selling them
Vaping and tobacco industry trade groups, including Cigar Association of America and several e-cigarette companies, filed lawsuits against the federal government challenging the rule. The groups recently requested a three-month delay in the rule's enforcement to allow "new leadership personnel" at HHS time to consider the rule and its implications.
According to the Post, the Department of Justice (DOJ) in two cases filed by vaping and tobacco industry groups challenging the rule also had called for an enforcement delay.
DOJ says FDA has delayed enforcement
DOJ in court documents filed Monday in Alabama and Washington, D.C., said FDA is postponing certain enforcement deadlines established under the final rule that were set to take effect May 10 or later.
According to the Post, the delay gives manufacturers more time to submit plans for putting addictiveness warnings on their products and providing information on what ingredients are contained in e-cigarettes and cigars. In addition, manufacturers will have more time to comply with the rule's requirement that they remove "light" or "mild" from their products.
However, parts of the rules that were implemented last year—including provisions that prohibit the sale of e- cigarettes, cigars, pipe tobacco, and water pipe tobacco to people under age 18—remain in effect.
According to the Post, the Trump administration has not indicated how it will handle the final rule, but industry officials are optimistic because many lawmakers have shown their support for looser regulations. Tobacco Vapor Electronic Cigarette Association (TVECA) President Ray Story said the administration likely will "curb regulation[s], because it's bad for business."
Matthew Myers, president of the Campaign for Tobacco-Free Kids, criticized the delay, saying it "means that the public will continue to lack the information about what products are on the market, what effect they're having and what's in them." He added, "From a pure public health standpoint, there's been no factual change from the overwhelming public record that prompted promulgation of the rule."
In contrast, David Howard, a spokesperson for Reynolds American Services Company, in a statement praised the delay, saying the final rule "appl[ies] antiquated regulations on a category that did not exist when those regulations were passed." He added that Reynolds would prefer "a regulatory framework based on level of risk, one that enables responsible innovation of products that may present less risk compared to cigarettes" (Eilperin, Washington Post, 5/3).
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