FDA to Regulate All Tobacco Products

Early in May, the US Food and Drug Administration (FDA) increased its regulation of tobacco products; previously only cigarettes, cigarette tobacco, smokeless tobacco and roll your own tobacco were regulated under the Family Smoking Prevention Tobacco Control Act of 2009. However, the new Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act has greatly expanded the number of tobacco products that can be regulated by the FDA. These new products include: e-cigarettes, dissolvables, pipe tobacco, hookah, cigars, and novel and future products.

This is an important step for public safety. Tobacco use causes the highest number of preventable deaths in the United States per year, and the use of tobacco products such as e-cigarettes and hookah is increasing especially among youth. There are many who believe e-cigarettes and hookah are a “healthier” option to smoking a traditional cigarette.

This belief is decidedly untrue. The use of e-cigarettes, or hookah is not any healthier than smoking a traditional cigarette. Often times they have the same health risks as cigarettes do and in addition carry their own specific health risks. E-cigarettes are flavored and these flavors can attract youth to using these products. As part of the regulations, the FDA has stated its desire to forbid any flavoring in any type of tobacco product. Using e-cigarettes increases the risk of accidental or intentional poisoning due to ingestion or inhalation of the liquid in the e-cigarette.

Hookah causes many of the same types of health risks as do traditional cigarettes. Nevertheless, there are several health risks that are specifically associated with smoking hookah. One hookah smoking session can cause a user to absorb more harmful substances than smoking one cigarette. Hookah is also associated with a risk of infections as the mouthpiece is shared among a group of people.

Comparative Health Risks

Thanks to the FDA regulations, however, e-cigarettes, hookah and other similar products are now treated in the same manner as cigarettes. The FDA will now be able to:

· Review tobacco products that are not yet on the market

· Help to prevent misleading claims made by tobacco product manufacturers

· Evaluate the ingredients of tobacco products and how they are made

· Communicate the potential risks of tobacco products

There are also new rules and regulations for manufacturers, importers and retailers of tobacco products.

· Registering manufacturing establishments and providing product listings to the FDA;

· Reporting ingredients, and harmful and potentially harmful constituents;

· Requiring premarket review and authorization of new tobacco products by the FDA;

· Placing health warnings on product packages and advertisements; and

· Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“ …e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase)…” US Food and Drug Administration

E-cigarette and hookah usage by youth has increased dramatically; there are several special provisions included in the new regulations that specifically target youth. Tobacco products cannot be sold to minors (under the age of 18), and to prevent this from occurring photo identification is required when purchasing tobacco products. Tobacco vending machines are forbidden except in adult-only buildings, and finally no free samples of tobacco products can be given out.

This new regulation is a huge step in the fight to product public health from the harms of smoking. The regulations will go into effect on August 8th, 2016.


Tobacco Control Legal Consortium

CDC Fact Sheet: Hookah

CDC Fact Sheet: Cigarettes

American Lung Association

US Food and Drug Administration

Sara Garzia

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