Friday, July 22, 2005

New Analysis Questions Whether FDA Legislation Would Effectively Preempt State and Local Clean Indoor Air Efforts

A new analysis of the proposed FDA tobacco legislation being released today on The Rest of the Story questions whether the bills presently before Congress would effectively preempt or undermine state and local efforts to regulate secondhand smoke by allowing FDA to set a standard for secondhand smoke. The analysis was written by Billy Williams, a member of the Lay Advisory Board of the Flight Attendant Medical Research Institute (FAMRI).

The analysis points out, through a careful reading of the legislation (H.R. 1376), that the bill effectively gives FDA the authority to set a standard for secondhand smoke, by granting FDA authority to regulate any and all tobacco smoke constituents. At very least, the legislation is likely to be perceived by state and local policy makers as occupying the field of regulation of secondhand smoke. In this way, the bill will effectively preempt or at least undermine state and local efforts to regulate secondhand smoke, even though the bill does not explicitly preempt such measures.

by Billy J. Williams

There is no need to speculate about Philip Morris’ goal in supporting FDA legislation of tobacco products because the company’s major goal is clearly stated on the company’s website where the company states:

“We want to work with public health officials and the federal government to establish a federal standard regulating secondhand smoke in public places.”[1]

Now, everybody knows that the FDA legislation does not say that it provides authority for the FDA to set a federal standard for secondhand tobacco smoke. However, it appears that only Philip Morris and I are aware of one of the rules of statutory construction that applies to the FDA legislation, so I want to review that rule.

As stated by the United States Supreme Court: “If Congress has explicitly left a gap for the agency to fill, there is an express delegation of authority to the agency to elucidate a specific provision of the statute by regulation.”[2]

Now, let us look at the gap that Congress left for Philip Morris to ride its Trojan Horse. It is important to note just what Congress prohibited the FDA from doing because the FDA has the authority to issue tobacco product standards in all other areas.

(3) POWER RESERVED TO CONGRESS.—Because of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard— (A) banning all cigarettes, all smokeless tobacco products, all little cigars, all pipe tobacco, or all roll your own tobacco products; or (B) requiring the reduction of nicotine yields of a tobacco product to zero, Congress expressly reserves to itself such power.[3] [Emphasis added].

Since Congress did not expressly prohibit the FDA from setting a standard for secondhand tobacco smoke, let us see if there is any language in the legislation that would permit the FDA to set a secondhand tobacco smoke standard.

(3) TOBACCO PRODUCT STANDARDS.—The Secretary may adopt tobacco products standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This finding shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product . . . [Emphasis added].

(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—A tobacco product standard established under this section for a tobacco product—

(A) shall include provisions that are appropriate for the protection of the public health, including provisions where appropriate— (ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; . . . [Emphasis added].

(B) shall, where appropriate for the protection of the public health, include—(i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;[4] [Emphasis added]

We only have to answer one question to determine if the FDA legislation authorizes a standard for secondhand tobacco smoke. The question is: “How do you protect the public health and set a tobacco product standard for the constituents for smoke in a tobacco product without also setting a standard for exposure to secondhand tobacco smoke?” The answer is that you can’t.

Furthermore Section 917, PRESERVATION OF STATE AND LOCAL AUTHORITY, states, in pertinent part: (a) In General (1) Preservation. Nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of . . . a State or political subdivision of a State . . . to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to . . . exposure to . . . use of tobacco products. . .”

Therefore, the FDA legislation clearly permits the FDA to set a standard for secondhand tobacco smoke. Since the legislation requires that the benefits to the users of the products be considered, the standard for secondhand tobacco smoke will not be zero. Although the standard will not preempt state or local smoking laws or ordinances, it will be a problem for tobacco control.

Those who support this FDA legislation have put the saddle on Philip Morris’ Trojan Horse and cinched it up without realizing that we are going to have to step in the manure from the Trojan Horse.

[1] Philip Morris USA, Policies, Practices & Positions, Regulation of Public Place Smoking.

[2] Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843-44, 104 S.Ct. 2778, 2782 (1984).

[3] S. 2461, page 60.

[4] S.2461, pages 53-55.

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