Deadline near, FDA braces for flood of data on anti-tobacco plan Proposal aims to cut tobacco use by youngsters

January 02, 1996|By NEW YORK TIMES NEWS SERVICE

With just hours left before tonight's midnight deadline for public comments on its plans to regulate cigarettes, snuff and chewing tobacco, and with more than a half-million responses already in hand, the federal Food and Drug Administration is bracing for a last-minute flood of submissions, from impassioned postcards to industry documents more easily measured in pounds than pages.

The FDA's sweeping proposal is aimed at halving the number of young tobacco users in the next seven years. It would restrict advertising and marketing, ban vending-machine sales and require that tobacco manufacturers, as a group, pay $150 million annually for anti-smoking advertising.

Among those filing their responses today will be the Tobacco Institute, which represents the collective interests of the tobacco companies; corporate giants like Philip Morris and R. J. Reynolds, a subsidiary of RJR Nabisco, and retail and advertising groups.

Many leading anti-smoking activists, medical societies and education groups such as the American Heart Association, the American Lung Association and the American Cancer Society will file responses, as will a coalition of state attorneys general led by Richard Blumenthal of Connecticut

"We strongly support the FDA," Mr. Blumenthal says in a letter that had the backing of a majority of the attorneys general by Friday.

The largest submission headed the FDA's way today is from the Tobacco Institute, based in Washington, which is filing more than 4,000 pages. The document challenges the agency's right to regulate the industry or impose certain restrictions on it. The industry also is challenging the accuracy and quality of research that the FDA has cited to support its plans.

The industry group also is complaining that the FDA relied on some information that it did not make public. If true, that could be a basis for attacking the rule in court.

Anti-smoking groups are nearly unanimous in their support of the agency, but many want more. Some will argue for more money for anti-tobacco education and for tougher measures to be adopted as soon as two years after the rule takes effect, if smoking among youths is not declining. The FDA has proposed a seven-year wait.

Michael Cummings, the senior research scientist at the New York State Department of Health's Roswell Park Cancer Institute in Buffalo, wrote to the agency that the biggest shortcoming in the proposal was setting the 20-cigarette pack as the minimum size that could be sold. Mr. Cummings said studies indicated that making the minimum a 10-pack carton would make smoking too expensive for many teen-agers.

President Clinton made the new regulations a high priority when he announced the proposal last August. More than 3 million adolescents smoke cigarettes and another 1 million use smokeless tobacco products, according to a 1994 Surgeon General's report.

Surveys suggest that mostteen-age smokers want to quit but cannot. Other research suggests that youths are especially susceptible to advertising and that smoking among youths is increasing even as adults are cutting back.

Today's deadline clears the way for the FDA to start a crucial phase of the rule-making process: constructing a record of how the agency considered and acted reasonably in response to complaints about its plans. But the sheer number of filings could delay the final rule until after the election.

The agency also faces legal hurdles. Suits have been filed in federal court in Greensboro, N.C., by tobacco companies, advertisers and retailers challenging the FDA's authority to regulate tobacco.

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