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April/
May 2000

FDA
Rules
Overturned

Staff Report

Having failed to retain itís Presidentially-bestowed authority, the issue of FDA regulation of tobacco has moved to Congress, where itís immediate future is foggy, but a long-range mandate is clear.

When the U.S. Supreme Court handed down its decision in March that the Federal Drug Administration does not have the authority to regulate tobacco- either as an addictive drug or otherwise - the issue was thrust back onto center stage, after having spent months removed from the public radar.

This being a major election year has all but guaranteed that the politically-charged issue will serve as an effective campaign tool. But the odds that any of the recently proposed legislation granting the FDA formal regulatory authority over tobacco will actually pass in either the Senate or the House of Representatives is far less clear, however.

In the 5-4 ruling, the court said the FDA reached beyond its delegated authority in its attempts to regulate cigarettes and smokeless tobacco. The ruling was a major rebuke to President Clinton and his high-profile effort to curb youth smoking.

"Five years ago, the FDA put forward an important proposal to protect children from tobacco by eliminating advertising aimed at children and curbing minors access to tobacco products," the President said in a White House statement. "I call upon the leadership of Congress to take up the bipartisan Frist-McCain legislation."

Such leadership support appears to be absent, however. Senate Majority Leader Trent Lott and House Majority Leader Dick Armey, who have aggressively fought previous efforts to regulate the tobacco industry, said they remain opposed to any move that gives the FDA more authority.

"I donít think they do a very good job with what theyíre doing now without more requirements being dumped on them," Lott said following the Supreme Court ruling.

Many believe that in the absence of leadership support, passage of tobacco legislation before the elections this fall is unlikely. But recent trends also suggest that there may no longer be any "smart money" when its comes to accurate prediction-making.

Consider the tact of Health and Human Services Secretary Donna Shalala, who set aside her standard pro-regulation arguments, and urged lawmakers to grant FDA oversight of tobacco if for no other reason than itís a "political winner."

"Itís an election year. Are you for protecting kids or arenít you?" Shalala said in an interview.

Indeed, Presidential contenders Vice President Al Gore and Texas Gov. George W. Bush have both said that Congress should act to reign in cigarette makers and tobacco ads aimed at children.

Rhetoric and calls for doing the right thing aside, deciding the fate of such a tempestuous issue in an election year may in the end temper the chances of passage. It may simply be too dangerous a gamble for candidates to risk votes in tobacco-producing states for an issue that despite popular support, has not galvanized into a passionate voter issue on the pro-regulation side.

"I donít know that anything is going to happen this year," says Norm Sharpe, president of the Cigar Association of America, which is monitoring each new congressional proposal, and with good cause. Cigars will certainly be included in any version of tobacco regulation that is eventually passed, Sharpe believes. And that would spell considerable problems for specialty tobacco retailers if the former FDA rules were implemented as they previously stood - the ban on all self-service tobacco displays alone would reshape the face of cigar shops nationwide. FDA Rules No Longer in Effect The Supreme court ruling was as far from unanimous as could be, with five justices declaring that the FDA reached beyond its authority in 1996 when it reversed its own decades-old policy and moved to crack down on cigarette sales to minors. Four justices dissented, but the decision is final.

In December, Justice OíConnor said regulating smoking "just doesnít fit" within the agencyís authority. Chief Justice William H. Rehnquist and Justice Antonin Scalia were similarly skeptical then - partly because after it was created in 1938, the FDA maintained it had no authority to regulate smoking, then switched its position in 1996, news reports said. Justice David H. Souter sided with the government in dissenting from the majority, along with Justices John Paul Stevens, Stephen G. Breyer, and Ruth Bader Ginsburg.

The ruling immediately invalidated the FDA programs relating to tobacco.

Federal health officials notified states that it was terminating a program of random checks that determined whether retailers were selling cigarettes to minors. Violators were warned or fined, and recently their names were posted on the FDA web site. The checks were part of a sweeping initiative President Clinton announced in 1996 when the FDA asserted authority to regulate tobacco as a drug. Some portions of the FDA rules - those curbing advertising and marketing - were never implemented, voluntarily delayed while the tobacco industry challenged their legality in court.

State laws prohibiting tobacco sales to minors traditionally were not strictly enforced. In the meantime, other restrictions were formally agreed to as part of the massive industry settlement with state Attorney Generals. Ironically, it has been estimated that as little as 7% of the settlement funds received by participating states has been allocated to reducing youth smoking.

Congress Has the Ball
Now it is up to Congress to decide how much regulation of tobacco - and what kind - the government should impose.

Rep. Henry Waxman, Democrat, Calif., introduced the first bill immediately following the Supreme Court ruling. Entitled the "Child Tobacco Use Prevention Act of 2000," the legislation would not only establish FDA jurisdiction over tobacco products and formally validate all of the FDA regulations - including those never implemented - but also establish performance objectives to reduce child tobacco use, create national smoke-free policies, and allocate $500 million for a national public awareness campaign to discourage the use of tobacco products.

Others quickly followed suit, virtually guaranteeing a congressional debate on tobacco policy. In the Senate, Tom Harkin, Democrat, Iowa; Bob Graham, Democrat, Fla.; and Lincoln Chafee, Republican, R.I., introduced their own bill.

"Our legislation will reaffirm the FDAís authority over tobacco products," stated Senator Harkin (D-Fla). "It will classify nicotine as a drug and tobacco products as drug delivery devices. It will allow the FDA to implement a public health standard in its review and regulation of tobacco products."

"It will include sensible advertising limits, as well as other important provisions of the original FDA ruleÖwe are still finalizing some of the details."

Senator Jack Reed, Democrat, R.I., was set to introduce legislation granting the Heath and Human Services secretary the authority to regulate the manufacture and distribution of tobacco products.

In the House, Michigan Democrat John Dingle and Iowa Republican Greg Ganske unveiled their own bill.

Waxman recognizes that time is indeed running out during the current legislative session, and could seriously hamper Congressís ability to deal with such a comprehensive bill. In an attempt to delay debate on more controversial elements of a national tobacco policy, while quickly "restoring" the FDAís regulatory jurisdiction on tobacco, the Senator introduced a second bill. The streamlined version only authorizes the FDA to regulate tobacco products, leaving the remaining issues open for future action.

Whether the complexity of the issue, combined with industry lobbying efforts and robust debate will prevent legislative action this year remains to be seen.

Phil Schiliro, Waxmanís chief aide, said from Capitol Hill, "Up here, itís like the stock market. You just canít predict."

Highlights: FDA Tobacco Rules Invalidated by Supreme Court

Passed in 1996, and instituted in Feburary 1997, the following FDA rules are no longer in effect as a result of the Supreme Court ruling on March 21:

  • Classification of cigarettes as drug delivery devices.
  • Retailers prohibited from selling cigarettes, loose cigarette tobacco, or smokeless tobacco to anyone under the age of 18. ( Most states have passed their own minimum purchase age legislation, in some cases with higher age requirements.)
  • Retailers must check photo ID of tobacco-buying customers under the age of 27.
  • Compliance checks contracted by the FDA with the states.
  • Civil money penalties levied on retailers in violation of compliance checks.


SMOKESHOP - April 2000