Loophole in Tobacco Regulation Bill Is a 'Gift' To Tobacco Companies

WASHINGTON — A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval.

The House last month overwhelmingly passed the legislation, which for the first time would empower federal public health authorities to regulate tobacco. Some tobacco foes say the bill's 21-month escape clause would let companies start marketing cigarettes and other products in the development pipeline before the Food and Drug Administration has fully ramped up to regulate them.

"It is an opportunity for the companies to continue to put products on the market without a pre-market evaluation by the FDA," Mitch Zeller, who headed the agency's tobacco office during the Clinton administration, said. That office was disbanded after the Supreme Court ruled in 2000 that the FDA did not have the authority to regulate tobacco, a decision that provided the motivation for the current bill.

Mr. Zeller, who said he still considers himself a strong supporter of the legislation, nonetheless called the loophole "unfortunate" and said it seems to be a "gift" to the tobacco companies.

The office of Senator Kennedy, a Democrat of Massachusetts, a main author of the bill, disagreed. The provision is in the bill to give the FDA some breathing room to set up its new tobacco division, not a favor to the industry, Mr. Kennedy's staff said.

The legislation represents a compromise among major anti-smoking groups and some tobacco companies, including Philip Morris USA, the nation's largest. The bill has the support of a majority of senators, but it's unclear whether it will become law this year because the Bush administration has threatened a veto.

The much-debated clause would not apply to all new products, only to those that are similar — or "substantially equivalent" — to ones that were on the market when the bill was introduced in 2007. The provision is in Sec. 910 of the 200-page bill.

It would let tobacco companies begin selling a new product provided they file a report with the FDA showing why the new product is similar to an existing one. That could be done at any time in the 21 months after enactment of the legislation. If the FDA later disagreed, it could still yank the product off the market.