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Office of the Press Secretary

For Immediate Release August 21, 1996
                           PRESS BRIEFING
                           BY MIKE MCCURRY

The Briefing Room

3:50 P.M. EDT

MR. MCCURRY: All right. I'm saving myself 400 phone calls. So I can entertain any questions you have.

As those of you who were here last week know, the Food and Drug Administration sent last week, whatever day it was that I announced it earlier -- and it was posted in the Register -- sent the proposed final rule on tobacco to the Office of Management and Budget for review as is customarily done. That's being reviewed in the office of Regulatory -- OIRA. What is OIRA? Office of Information of Regulatory Agency.

Anyway, it's at OIRA. The review of the final rule between the OMB and the FDA is proceeding satisfactorily as far as we know. We're not aware that they've encountered any difficulties in looking at it. But that review continues. If it is complete -- once it is complete, the President does intend to fulfill the objective that he outlined in August of 1995, which would restrict the access and appeal of tobacco products for minors. But he would announce that only when the review by the OMB is complete, and as of now, it is not complete.

Q He hasn't made a decision?

MR. MCCURRY: Well, he made a decision a long time ago, which was to seek a proposed rule that would accomplish his objective of protecting the health of American children and to --

Q Do you expect this review to be done by --

MR. MCCURRY: -- protect them from the addictive qualities of tobacco.

Q Do you expect a review to be done by Friday?

MR. MCCURRY: I would not rule that out.

Q Was the report correct on CNN that you would make an announcement Friday that would --

MR. MCCURRY: That's not been decided. I mean, it's certainly been discussed, but not been decided.

Q His options here are to either accept it or to send it back for rewriting?

MR. MCCURRY: He could -- if there are any problems that are developing or if the OMB analysis suggests some issue the President should review, he could seek changes in the rule.

Q And this is a rule that has to be public?

MR. MCCURRY: As I said, our understanding is that he's proceeding directly.

Q Can you just describe -- the rule classifies tobacco as a drug for certain purposes or how does --

MR. MCCURRY: Nicotine is a drug that is regulated in some fashion. The proposed rule -- I cannot and will not and do not discuss the content of the final rule. And I would caution anyone reporting on this. Remember, you do not know what is in the final rule. And I would be very careful in writing about this --

Q Well, what's the proposed rule?

MR. MCCURRY: I would be very careful in writing about this substantively that you make clear that what you know at this point is what was in the proposed rule, and it was made public back at the beginning of the regulatory process.

Q And what is that?

Q That's the President's --

MR. MCCURRY: Yes. Go back to the clips from August. It was everything we announced in August of 1995.

Q But we don't know what is --

MR. MCCURRY: We don't know what's in the rule that's not been reviewed by the OMB now and I will not discuss that. The proposed rule at the time declared that smokeless tobacco and cigarettes were delivery devices for the drug nicotine. And that was the basis, the jurisdictional basis upon which you would then curb advertising and do the other things --

Q And what's the practical effect of that for smokers and the users of smokeless tobacco?

MR. MCCURRY: For adult users, no practical effect. For minors, all the things that were proposed in the rule that the President put forward in August.

Q But you're not telling us whether or not that's even in the final proposal?

MR. MCCURRY: I'm saying you don't know what's in the rules, so just be careful in writing about it.

Q The rules are all aimed at young people, right, Mike? The final rules are all aimed at controlling nicotine to young people?


Q That's correct, okay.

Q Why are we here? (Laughter.)

MR. MCCURRY: Because Mr. Blitzer just went on and broke the story -- breaking news, CNN. And I'm rolling it back. (Laughter.)

Q Are you rolling it back or are you just fooling around?

Q I don't think you're rolling it back.

MR. MCCURRY: Not much.

Q Not much? He's going to act on Friday, right?

MR. MCCURRY: He said Clinton was going to announce it on Friday. I'm just saying we will not announce it until the review is complete. And the review, in fact, is still going. In fact, the FDA had some experts over here today. It's not inconceivable that they might still find a problem that would make any discussion of a Friday announcement a moot point. So distinguish between plans and a decision.

Q So would it be fair to say that the White House plans to have an announcement as early as Friday?

MR. MCCURRY: If it is complete -- it's possible for Friday if the review is complete and if the rule is accepted as final. But, remember, A, you don't know what's in the final rule unless you've sourced that out somewhere else; and, B, it may not -- in the final, final analysis there may be something that is a complication --

Q But is it fair to say --

Q He hasn't signed off on a final rule. He may do it by Friday.

MR. MCCURRY: Has not signed off on a final rule. He would announce -- his plan is to announce that when he does that.

Q But has planning started for some sort of an event on Friday here at the White House?

MR. MCCURRY: We do plannings all the time. We've got all these things on the calendar.

Okay, that's it.

Q Wait a second. The FDA Administration has 90 days to deal with this once it -- so you're not under time pressure?

MR. MCCURRY: From the receipt of the proposed final rule we had 90 days, which would expire, I believe, on November 11th.

Q So why would the President do it now?

MR. MCCURRY: He would do it when it's ready, when the OMB's analysis is complete.

Q And the impact on minors, it would make it illegal for minors or make it illegal for people to sell it?

MR. MCCURRY: There's a series of restrictions proposed on access to -- if you go back to -- you reported on this, no doubt, in August, when he proposed it. At the time the proposed rule had curbs on -- you could only buy a product if you were a minor in face-to-face counter transactions that prohibited the distribution -- it had certain restrictions on advertising and on accessibility of vending machines. There were a whole series of things, if you go back and look at our --

Q Mike, the FDA officials who came here today, who did they meet with?

MR. MCCURRY: They met with OMB -- it was just lawyer -- probably lawyers or regulatory guys.

Q They didn't meet with the White House?

MR. MCCURRY: No, it was OMB. They were meeting. This is the OMB review of the rule.

Q And what meetings has the President had on this issue?

MR. MCCURRY: None. When they are done with the analysis, he will be presented with the analysis, and if he accepts the rule our intention will be to announce it.

Q He hasn't discussed this at all in any sit-down meetings about pre-convention planning?

MR. MCCURRY: He discussed the effort to curb tobacco use by young people all the time. It's an important subject.

Q But he hasn't discussed this decision and how it would fit into the roll after the convention?

MR. MCCURRY: He has not had a discussion about OMB's final review of the final rule.

Q But has OMB signed off on it?

Q -- had a discussion about making a tobacco announcement sometime between now and the convention?

MR. MCCURRY: We have discussions about stuff on the calendar all the time.

Q Can we say he's leaning toward accepting the recommendation of the FDA?

MR. MCCURRY: Well, his intent all along was to promulgate a rule that would accomplish the health policy objectives he outlined. So that was true a year ago.

Q Has OMB signed off on --

Q As far as you know, without specifics, the FDA recommendation, does it comply with what the President's goal was?

MR. MCCURRY: Yes. What I said when I announced this last week, I said that the rule that had been conceived at the OMB was designed to fulfill the President's health care objectives in curbing tobacco use by young people.

Q So, clearly, without telling us what's in the final rule, you're saying he's leaning towards approving?

MR. MCCURRY: I didn't say that very carefully so I didn't advance the story further than I wanted to.

Q Who would be subject to some kind of punishment for this? Would it be the tobacco companies or the distributor of cigarettes?

MR. MCCURRY: States implement the law. These are regulatory matters that individual -- I mean, they apply to a range of vendors, manufacturers of vendors, advertisers, people who transact in the sale of tobacco products. That's all regulated by the state level, but it would have to be regulated consistent with --

Q And all of this involves rule-making, not passing any federal laws?

MR. MCCURRY: No, this is a rule making procedure. This is not a legislative proposal.

THE PRESS: Thank you.

END 4:10 P.M. EDT