- FDA to Take over Tobacco Regulation
- July 15, 2009
- Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
Federal lawmakers have passed a landmark bill that grants the Food and Drug Administration wide-ranging regulatory control over the packaging, manufacturing, and marketing of tobacco products.
President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law on June 22. President Obama cosponsored the bill as a senator.
The new law will give the FDA sweeping oversight of the $150 billion tobacco industry. Specifically, the law provides for:
- Restrictions on marketing and sales to youth, including a ban on all outdoor tobacco advertising within 1,000 feet of schools and playgrounds; a ban on all remaining tobacco-brand sponsorships of sports and entertainment events; a ban on free giveaways of non-tobacco products with the purchase of a tobacco product; a limit to black-and-white text-only advertising in publications with significant teen readership as well as outdoor and point-of-sale advertising, except in adult-only facilities; and a restriction on vending machines and self-service displays to adult-only facilities.
- Granting the FDA specific authority to restrict tobacco marketing.
- Requiring detailed disclosure of ingredients, nicotine, and harmful smoke constituents.
- Requiring bigger and better health warnings on packaging.
- Funding FDA activity through a user fee on manufacturers of cigarettes, cigarette tobacco, and smokeless tobacco, allocated by market share, much like the user fee pharmaceutical companies pay.
- Strict regulation of “reduced harm” products, which would prohibit the use of descriptions such as “light,” “mild,” and “low” to characterize a product on labels or in advertising. A manufacturer must file an application and receive an order before it markets any tobacco product as presenting a “modified risk.”
The country’s No. 2 and No. 3 tobacco manufacturers, R.J. Reynolds and Lorillard, opposed the bill, arguing that it helps market leader Philip Morris, which is owned by Altria Group. The bill was reportedly drafted, in part, with the input of Philip Morris, which earned $25 billion in revenue in 2008, compared with RJR’s $8.8 billion and Lorillard’s $4.2 billion 2008 revenue.
Why it matters: The law will subject the tobacco industry to a host of new regulations, some of which will probably face First Amendment challenges in court. Supporters, however, say they took care to meet free speech requirements in drafting the law.