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After Inexcusably Long Delay, FDA Takes First Step to Regulate E-Cigarettes and Cigars

Agency Must Now Quickly Finalize Proposed Rule and Take Further Action to Stop Marketing and Flavors that Entice Kids
April 24, 2014

Washington, D.C. – Three years after first announcing plans to do so, the Food and Drug Administration today has finally issued a proposed rule to begin regulating electronic cigarettes, cigars and other tobacco products not currently under its jurisdiction.

This action is long overdue. It is a critical step for public health that the FDA has acted to extend its jurisdiction over tobacco products not already subject to its authority and proposed a regulatory framework for these products, including a prohibition on sales to kids, that will enable the FDA to take strong action in the future to protect the nation’s health. It is inexcusable that it has taken the FDA and the Administration so long to act. This delay has had serious public health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids, and their use has skyrocketed.

The FDA and the Administration must now move as quickly as possible to finalize this rule and do so within 12 months. The FDA must also quickly develop follow-up regulations that close gaps in the proposed rule by restricting marketing and flavors that appeal to kids. There can be no excuse for further delay.

The FDA today acted under a landmark 2009 law, the Family Smoking Prevention and Tobacco Control Act. The law gave the FDA immediate regulatory authority over cigarettes, smokeless tobacco and roll-your-own tobacco and authorized the agency to extend its jurisdiction to all other tobacco products.

It is good news for public health that the FDA has acted to apply key provisions of the 2009 law to e-cigarettes and other newly regulated tobacco products. These provisions:

  • Prohibit sales to children under 18, require retailers to verify age for all over-the-counter sales and provide for federal enforcement and penalties against retailers who sell to minors.

  • Restrict vending machines to adult-only facilities.

  • Prohibit free samples.

  • Require all tobacco products containing nicotine to carry an addiction warning and cigars to carry one of four other warnings as well.

  • Require disclosure of ingredients and documents related to health, and authorize FDA to request additional documents related to research and marketing.

  • Prohibit the introduction of new or changed products without prior FDA review and scientific evidence demonstrating that allowing a product is “appropriate for the protection of public health” (or that it is “substantially equivalent” to a product already on the market).

  • Prohibit manufacturers from claiming a tobacco product is less harmful or will expose a consumer to fewer harmful substances without first providing the FDA with scientific evidence supporting the claim and demonstrating that it will benefit public health as a whole, and not just individual tobacco users.

  • Authorize the FDA to set standards governing the content of tobacco products.

The FDA’s challenge, once the rule is finalized, will be to effectively enforce these provisions, including those prohibiting introduction of new or changed products or health claims without the scientific evidence that they will benefit public health.

The proposed rule does not ban flavorings in cigars or e-cigarettes that may appeal to youth or curtail any of the egregious marketing for e-cigarettes. The FDA must now move quickly to develop additional regulations addressing these important issues. These additional regulations should restrict marketing that appeals to kids, prohibit flavors that are attractive to kids and also require packaging for e-cigarettes that addresses the recent surge in nicotine poisoning cases related to e-cigarettes.

It is deeply disturbing that FDA has not asserted jurisdiction over so-called premium cigars and instead has just asked for comment on whether premium cigars should be included or entirely exempted. All cigars have been shown to cause disease. There is no justifiable public health rationale for exempting any category of cigars. This approach sets a terrible precedent, is unnecessary and should be dropped from the final rule. The FDA should have the authority to regulate all tobacco products to protect public health, and it has the flexibility to determine which regulations should apply to each category of products

The FDA was correct to require e-cigarettes to comply with the requirements governing new products or changes in existing products. The FDA’s decision to give e-cigarette manufacturers time to file the necessary applications makes it critical that this time frame not be extended and that FDA establishes a program to evaluate existing and new e-cigarettes rapidly so that potentially dangerous products do not remain on the market. In the interim, it is essential for FDA to require that e-cigarette manufacturers provide the agency with sufficient information about the contents of its products, research it has conducted on its products and marketing, and information about who is using its products and what impact these products are having on youth, current smokers and former smokers.

The proposed rule also asks for comment on whether FDA should consider an expedited pathway for review for applications for products that may be demonstrably less harmful than those tobacco products currently on the market. The provision requires careful scrutiny and analysis.

The proposed rule issued today is needed to close regulatory loopholes that tobacco companies have exploited to introduce new products and market them in ways that appeal to kids and undermine public health.

Like cigarette companies, e-cigarette makers claim they don't market to kids. But they're using the same themes and tactics tobacco companies have long used to market regular cigarettes to kids. Given these marketing tactics, it isn’t surprising that the Centers for Disease Control and Prevention (CDC) found youth e-cigarette use more than doubled from 2011 to 2012. The percentage of high school students who reported ever using e-cigarettes jumped from 4.7 percent to 10 percent. The CDC estimated that 1.78 million U.S. youth had tried e-cigarettes as of 2012. Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science.

While much attention has been focused on e-cigarettes, the growing use of cigars, including cheap, sweet-flavored cigars that appeal to kids, also poses a serious threat to public health. Between 2000 and 2013, cigar consumption increased by 114 percent, while cigarette consumption declined by 37 percent. According to national surveys, 17.8 percent of high school boys currently smoke cigars (i.e., large cigars, cigarillos and small cigars), and each day more than 2,700 kids try cigar smoking for the first time. When the 2009 law banned candy- and fruit-flavored cigarettes, tobacco companies aggressively marketed similarly flavored cigars that often look like and are smoked just like cigarettes.

Tobacco use is the nation’s number one cause of preventable death, killing 480,000 Americans and costing the nation at least $289 billion in health care bills and other economic losses each year. Effective FDA regulation of all tobacco products, without delay, is critical to protecting the nation’s health.