What FDA Regulation of Tobacco Products Really Means

The "Family Smoking Prevention and Tobacco Control Act" amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA authority to regulate the manufacturing, marketing and sale of tobacco products. Tobacco products would not be regulated under the "safe and effective" standard currently used for other products under the agency's purview, but under a new standard – "appropriate for the protection of the public health."

This law will restrict marketing and sales to youth – One year after being signed into law, specific restrictions on youth access and marketing will go into effect. The FDA also has the authority to take additional actions in the future to protect the public health. These regulations:

  • Ban all outdoor tobacco advertising within 1,000 feet of schools and playgrounds
  • Ban all remaining tobacco-brand sponsorships of sports and entertainment events
  • Ban free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons or proof of purchase
  • Limit advertising in publications with significant teen readership as well as outdoor and point-of-sale advertising, except in adult-only facilities, to black-and-white text only
  • Restrict vending machines and self-service displays to adult-only facilities
  • Require retailers to verify age for all over-the-counter sales and provide for federal enforcement and penalties against retailers who sell to minors

Grant FDA authority to restrict tobacco marketing – The Secretary of Health and Human Services (HHS) is given authority to develop regulations that impose restrictions on the advertising and promotion of a tobacco product consistent with and to the full extent permitted by the First Amendment to the Constitution. These regulations would be based on whether they would be appropriate for the protection of the public health. This authority gives the agency the flexibility to respond to inevitable tobacco industry attempts to circumvent restrictions.

Require detailed disclosure of ingredients, nicotine and harmful smoke constituents – Tobacco companies are required to provide the FDA with information about their products. This information allows the agency to determine how best to reduce the harm they cause and to better educate the public about the health effects of tobacco use and the dozens of toxic substances in tobacco products. For example, tobacco companies are required to disclose to the FDA the ingredients in each existing tobacco product by brand and by quantity in each brand, including all smoke constituents. They must also inform the FDA of any changes to the product.

Allow FDA to require changes to tobacco products to protect the public health – The FDA has the authority to require changes in current and future tobacco products, such as the reduction or elimination of harmful ingredients, additives and constituents, if it decides that these changes would protect public health. FDA is also granted the authority to change nicotine yields; only Congress can ban nicotine from the product.

Strictly regulate "reduced harm" claims about tobacco products – This law prohibits the use of descriptors, such as "light", "mild" and "low," to characterize a product on labels or in advertising. In addition, a manufacturer must first file an application and receive an order before they market any tobacco product as presenting a "modified risk." FDA has authority to review the marketing of such products and determine if the applicant demonstrates that the product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole – taking into account both users of tobacco products and persons who do not currently use tobacco products.

Require bigger, stronger health warnings – The Family Smoking Prevention and Tobacco Control Act mandates that warning labels cover the top 50 percent of the front and back of a package of cigarettes. Under the law, the FDA will also issue regulations that will require the tobacco companies to put graphic warning labels on their products in the future. Warnings must bear the word "warning" in capital letters and 17-point type, and the FDA is empowered to revise labeling requirements including text and format size. The same warning labels are required in advertising and must comprise at least 20% of the advertisement's area. The authority to revise the labels will allow the agency to require labels based on the best available evidence of effectiveness without new action by Congress.

Fully fund FDA regulation of tobacco products through a user fee on manufacturers of cigarettes, cigarette tobacco and smokeless tobacco – The law allocates payment of all tobacco product-related FDA costs among the manufacturers of cigarettes, cigarette tobacco and smokeless tobacco products sold in the United States, based on the manufacturers' respective shares of the entire U.S. tobacco product market.