Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: MONDAY, March 28, 1994                   TAG: 9403280047
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-7   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium

FDA CHIEF SHOCKS MANY ON TOBACCO

It was merely the latest controversy for the fiery Food and Drug Administration commissioner. Now the public is waiting to see if the pediatrician who cracked down on everything from orange juice to powerful drug makers will really rein in the $60 billion tobacco industry.

"There is no greater public health issue," Kessler insists.

But critics say this time Kessler has gone too far.

"It's another example of Kessler seizing an issue to advance his agenda, which is to make the public think Doc Kessler is Mr. Enforcement," said Kim Pearson, a Washington lawyer who publishes an FDA-watchdog newsletter.

Kessler doesn't think that's bad; it's an image he has cultivated in his three years as head of the agency charged with protecting Americans from bad food or medicine. In that time, he has:

Seized orange juice mislabeled "fresh."

Banned silicon breast implants because of evidence they were sickening women, although he later allowed some for reconstructive surgery.

Cracked down on drug makers that don't follow FDA manufacturing guidelines, saying the lapses could compromise product safety. The biggest company hit so far is Warner-Lambert, which in August briefly halted production at a loss of millions of dollars.

Prohibited makers of dietary supplements from issuing unproven health claims.

But Kessler says a lack of authority sometimes hinders him. The FDA can't force the recall of contaminated products, can't even look at company records to see if food is properly chilled.

And that question of authority may halt his quest to regulate nicotine. To do so, Kessler must prove tobacco companies intentionally control nicotine levels to cause or sustain addiction.

While he's careful to say he hasn't proven that yet, he told Congress on Friday that he's getting close.

"The public may think of cigarettes as no more than blended tobacco rolled in paper, but they are more than that," he said. "Some of today's cigarettes may in fact qualify as high-technology nicotine delivery systems."

But he wants Congress' guidance, because naming nicotine a drug would force him to ban most tobacco products. "Millions of Americans would suffer nicotine withdrawal," he warned.

"It's not clear he's committed himself to anything," said Dr. Sidney Wolfe of Public Citizen's Health Resources Group, which monitors the FDA. "But if he doesn't believe FDA has the authority, he should say so," and ask Congress for help.