Tobacco Documents Online

\ Issue Brief - H.R. 5041 Ingredients Under H.R. 5041, each tobacco product would be required to bear on the package label a complete statement of the product ingredients in descending order of prominence. (Sec. 7(b)(1)(B)). This provision is inconsistent with current tobacco ingredient reporting requirements, would threaten public dis- closure of trade secret information and would mandate far broader ingredient disclosure than that required for food, drugs or other consumer products. For these reasons, the ingredient disclosure provision of the bill should be rejected. Under the Comprehensive Smoking Education Act, enacted in 1984, cigarette manufacturers are required to provide the Secretary of Health and Human Services on an annual basis "a list of the ingredients added to tobacco in the manufacture of cigarettes." 15 U.S.C. S 1335a(a). Congress considered the disclosure of cigarette ingredient information on this basis to be adequate to permit the federal O government to initiate the toxicologic research necessary to W measure any health risk posed.by the addition of ingredients ~ to cigarettes during the manufacturing process. ~ N

2 The Secretary, in turn, is directed to transmit to Congress periodic reports summarizing research activities con- cerning possible health effects of such ingredients and the findings of such research. 15 U.S.C. S 1335a(b)(1). Each year since 1986, the six major cigarette manufacturers have jointly submitted ingredient lists to the Secretary as required by the 1984 legislation. The most recent list was submitted just this past December. HHS is understood to have under development the first ingredients report mandated by the 1984 legislation. There is no reason to abandon the existing review mechanism or to conclude that it is inadequate. Because information concerning the ingredients used to manufacture particular cigarette brands is so competitively sensitive, Congress provided in the Comprehensive Smoking Education Act that the ingredient information supplied to the Secretary "shall be treated as trade secret or confidential information." Such information is exempt from disclosure under the Freedom of Information Act and criminal penalties are established for the unauthorized disclosure of such information. 15 U.S.C. S 1335a(b)(2)(A). In 1984, Congress considered and rejected public disclosure of tobacco ingredient information. Tobacco industry witnesses explained that cigarette manufacturers use a variety of ingredients to enhance flavor and appearance and

3 preserve shelf life, and these ingredients have long been recognized as trade secrets.-Y Congress responded by providing trade secret protection to the ingredient information submitted to HHS. The reasons for protecting against public disclosure of tobacco ingredient information remain equally compelling today. The proposed blanket label disclosure of tobacco ingredients would not only endanger trade secrets, but it is also contrary to the ingredient disclosure requirements for food, drugs and other consumer products. Congress explicitly has exempted flavorings, colorings and spices used in food from label disclosure under Sec. 403 of the FD&C Act, 21 U.S.C. § 343. It requires the FDA, moreover, to establish further exemptions from disclosure for food ingredients "to the extent that [disclosure] is impractical, or results in deception or unfair competition." Ibid. See, e.g., 21 C.F.R. § 101.100(a)(3)(1989)(exempting "incidental additives," including processing agents and substances migrating in trace amounts from packaging, from disclosure). There are similar ingredient labeling exemptions for cosmetics and drugs. 1/ Comprehensive Smoking Prevention Education Act: Hearings on H.R. 5653 and H.R. 4957 before the Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 97th Cong., 2d Sess. 355 (1982)(testimony of Edward A. Horrigan, Jr.).

By contrast, under H.R. 5041, a tobacco ingredient for which label disclosure would be required would include "any substance the intended use of which results, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise* affecting the character- istics of any tobacco product." (Sec. 15(6)). This broad ingredient definition would include colors, flavors and frag- rances and processing aids and other incidental additives. The vast majority of ingredients added to tobacco in the manufacture of cigarettes are colorings, flavorings and fragrances, or incidental additives (such as processing aids), which would be exempt from disclosure under Sec. 403 of the FD&C Act or FDA regulations, or otherwise would qualify for exemption from disclosure on trade secret or impracticality grounds. There is a specific cigarette ingredient reporting mechanism under current law. That system should not be abandoned in favor of one that exposes trade secrets and that mandates broader public disclosure than that required for food, drugs or other consumer products.