The Food and Drug Administration announced in April proposed new regulations that would cover for the first time e-cigarettes as well as other tobacco products, including pipe tobacco, cigars and waterpipe (hookah) tobacco. Electronic (or e-cigarettes) have become a huge billion dollar industry which had escaped federal oversight until now. As tobacco remains the leading cause of death and disease in this country, this expanded FDA oversight is an important moment for consumer protection.
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in 2009, the rule sets forth additional tobacco products that would be “deemed” to be subject to FDA regulation. “This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius.
Under the proposed rule, makers of these tobacco products would, among other requirements:
- Register with the FDA and report product and ingredient listings;
- Only market new tobacco products after FDA review;
- Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole;
- Not distribute free samples;
- Have minimum age and identification restrictions to prevent sales to underage youth;
- Include health warnings on the products; and
- Prohibit vending machine sales, unless in a facility that never admits youth.
E- cigarettes resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn a liquid that usually contains nicotine and flavorings, into an aerosol that is inhaled by the user. Over the last few year e-cigarette usage has exploded, with a doubling of e-cigarette use from 2011 to 2012 among middle and high school students and adults (18-34), according to the Centers for Disease Control (CDC) figures.
Of concern to public health experts is that e-cigarette makers appear to be targeting youth. E-cigarette makers spent $39 million on ads from June through November 2013, much of it on programming targeting youth, the anti-tobacco organization Legacy found. The fear is a whole new generation of people will become addicted to nicotine.
Of note to anti-smoking advocates is that the proposed rule does not contain any proposal to ban flavors in e-cigarettes or cigars. They worry that e-cigarettes sold in flavors such as bubble gum and gummi bear will entice teenagers and children. Public health experts say 90 percent of smokers start by the age of 20.
There are also was no suggestion in the proposed rule to restrict the marketing of e-cigarettes, as is done for regular cigarettes, which are banned from television advertising. According to Legacy, while cigarette advertising is prohibited on television, it is currently fair game to use television to promote electronic cigarettes. Using broadcast and online advertising has allowed the e-cigarette industry to promote its products in a way that has broad reach.
While the proposed regulation takes some very important steps to protect public health by regulating these new tobacco products, especially e-cigarettes, it is essential that FDA continue to look at what further regulation is needed to ensure these products are not marketed to youth.
The proposed rule will be available for public comment for 75 days. The FDA is particularly interested in comments on how cigars should be covered by the rule, and how e-cigarettes should be regulated.
For more information:
Proposed rule: Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming)