NOV/DEC 2004
Volume 10 - No. 4

SRNT Newsletter

November/December 2004, Volume 10, Number 4

The Latest on the FDA Tobacco Bill

by Mitch Zeller

Just before the SRNT Newsletter went to press, the U.S. Congress decided not to pass legislation granting the Food and Drug Administration (FDA) regulatory authority over tobacco products.

The Process and the Politics

The legislative situation was complicated. The FDA bill was added as an amendment in the Senate to an unrelated piece of legislation involving corporate tax relief. That bill also contained an amendment covering a massive buyout of tobacco farmers to be paid for by tobacco manufacturers. The House version of the corporate tax relief bill contained no FDA provision, and a farmer buyout amendment funded by taxpayers rather than the tobacco industry. The conventional political wisdom was that an FDA bill could not pass without a farmer buyout, and that a buyout bill could not pass without the FDA provisions. Call it a political marriage of convenience.

The conventional wisdom turned out to be wrong.

The House and Senate completed negotiations to work out differences between their respective bills. Over the objections of many Senators involved in the negotiations, the House and Senate agreed to remove the FDA provision and retain an industry-funded tobacco farmer buyout. The President is expected to sign the compromise bill passed by the House and Senate.

The Substance

Proponents of the FDA bill believe that this issue will be revisited by a new Congress next year. Because of that possibility, it is worth reviewing the key provisions in the FDA bill that passed the Senate this year. That bill would have granted the FDA broad authority over tobacco products, and restored the agency's 1996 rules limiting youth access to tobacco products and curtailing industry marketing to children. Key provisions in the legislation include:

1. Submission of Health Information

The FDA must receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent that the FDA identifies as harmful or potentially harmful. Companies must also provide the FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.

2. The Power to Enact Product Standards

One regulatory tool that the FDA has for other products is the authority to issue performance standards to prohibit or limit the allowable levels of substances in a finished product. The FDA is granted this power in the bill. Tobacco products that cannot comply with the levels established in product standards cannot be sold. Armed with the supporting science, product standards could enable the FDA to regulate the synergistic and reinforcing effects of various compounds in smoke, such as nicotine and acetaldehyde, or nicotine and menthol.

3. Pre-market Approval of New Products (with a catch)

Any product (even if only test-marketed) or product modification that was introduced after June 1, 2003 is considered a new product that must be approved by the FDA. The only way to get around this requirement is to demonstrate to the FDA's satisfaction that the new product is "substantially equivalent" to a pre-June 1, 2003 product. The bill defines "substantially equivalent" as a product that "has the same characteristics" as the product being compared to, or has different characteristics but "the product does not raise different questions of public health." "Characteristics" is defined as "materials, ingredients, design, composition, heating source, or other features of a tobacco product."

Under the bill, a product introduced up to 15 months after the bill is signed into law gets to remain on the market unless the FDA makes a determination that such a product is not substantially equivalent to a product marketed prior to June 1, 2003.

4. "Lights" and Similar Terms Banned; Mandatory Pre-market Evaluation of All Health-Related Claims

The bill bans the use of terms like "light," "low tar," "mild," and similar terms.
The bill requires any express or implied harm reduction claim, including an exposure reduction claim, to be evaluated by the FDA prior to marketing. Approval for such a claim is subject to a very high standard of scientific substantiation. Industry opponents of the bill, and public health advocates of expanded use of smokeless tobacco, have complained that the standard in this section is too high. Others argue that the rigorous nature of the standard set is in this section is one of the strengths of the bill as introduced.

5. FTC Test Method Discarded; Testing Authority Transferred to the FDA

The bill does away with the FTC testing method and orders the FDA to develop regulations to require testing and reporting of ingredients and smoke constituents by brand and sub-brand. The FDA then decides whether this information should be disclosed to the public in a way that will not mislead consumers about the risk of tobacco-related disease.

6. FDA Granted Authority Over Warnings on Packages and in Advertising

The bill gives the FDA the authority over warnings on tobacco packages and in advertising. A new set of rotating warnings is specified, including a warning that cigarettes are addictive. The FDA has the power to revise the label warnings and increase the size of the warning up to 50 percent of the front and rear panels. Warnings in advertising can also be revised, but cannot exceed more than 20 percent of the area of an advertisement.

7. Substantial Funding For the FDA Program Through Tobacco Industry User Fees

The entire FDA regulatory program is to be funded by tobacco industry user fees. The program budget grows from $85 million in Year 1, to $175 million in Year 2, to $300 million in Year 3 and subsequent years. A formula adjusts the program budget starting in Year 4 based upon changes in the Consumer Price Index or the federal government's overall basic pay schedule, whichever is greater.

Mitch Zeller is the Vice President for Policy and Strategic Communications with Pinney Associates in Bethesda, Maryland. Pinney Associates provides consulting services regarding treatments for tobacco dependence to GlaxoSmithKline Consumer Health Care. Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration.