Medical devices; preemption of state product liability claims--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding preemption of State and local requirements applicable to medical devices. This action is being taken to clarify and codify the agency's longstanding position that available legal remedies, including State common law tort claims, generally are not preempted under the Federal Food, Drug, and Cosmetic Act (the act).     

The FDA may not regulate tobacco products as "drugs" or as "medical devices"

Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA. He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy. Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation. Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.     

Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation

The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.     

Food labeling: health claims and labeling statements; dietary fiber and cancer; antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart disease; folate and neural tube defects; revocation. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revoking its regulations codifying the agency's decision not to authorize the use of health claims for four substance-disease relationships in the labeling of foods, including dietary supplements: Dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and the claim that 0.8 milligram (mg) of folate in dietary supplement form is more effective in reducing the risk of neural tube defects than a lower amount in conventional food. This action is being taken in response to a decision of the U.S. Court of Appeals for the D.C. Circuit invalidating these regulations and directing FDA to reconsider whether to authorize the four health claims. This action will result in the removal of the regulations but does not constitute FDA authorization of the four claims. FDA is completing its reconsideration of the claims and expects to issue decisions on all four claims by October 10, 2000.     

Preemption of local smoke-free air ordinances: the implications of judicial opinions for meeting national health objectives.

Elimination of state laws that preempt local antismoking ordinances is a national health objective. However, the tobacco industry and its supporters have continued to pursue state-level preemption of local tobacco control ordinances as part of an apparent strategy to avoid the diffusion of grassroots antismoking initiatives. And, an increasing number of challenges to local ordinances by the tobacco industry and persons supported by the tobacco industry are being decided in state supreme courts and courts of appeals. The outcomes of seemingly similar cases about the validity of local smoke-free air ordinances vary significantly by state. This paper examines the common and unique aspects of the decisions and the potential implications of court rulings on preemption for future state tobacco control efforts and achievement of national health objectives around the elimination of preemption. Using a search strategy developed for the Centers for Disease Control and Prevention's State Tobacco Activities Tracking and Evaluation (STATE) System, cases where a state or federal appellate level court made a finding on the validity of a local smoke-free air ordinance or regulation were identified in 19 states. In contrast to previous studies, we found that cases in approximately half of states were decided for local governments. We also found that across the states, courts were considering similar factors in their decisions including the extent to which: (1) the local government possessed the authority to pass the ordinance, (2) the ordinance conflicted with the state constitution, and (3) state statutes preempt the ordinance.     

Public information; communications with state and foreign government officials--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing communications with State and foreign government officials. The proposed rule would permit FDA to disclose confidential commercial information to international organizations having responsibility to facilitate global or regional harmonization of standards and requirements. These disclosures would, in almost all instances, occur only with the consent of the person providing the confidential commercial information to FDA. The proposed rule would also streamline the process for FDA officials to disclose certain nonpublic, predecisional documents (such as draft rules and guidance documents) to State and foreign government officials. The proposal does not alter current procedures for sharing documents that contain confidential commercial information. These changes are intended to facilitate information exchanges with State and foreign governments and certain international organizations.     

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.     

Further amendments to general regulations of the Food and Drug Administration to incorporate tobacco products. Final rule

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.     

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.     

Medical devices; preemption of state product liability claims--FDA. Withdrawal of proposed rule

The Food and Drug Administration (FDA) is announcing that it is withdrawing a proposed rule that published in the Federal Register of December 12, 1997 (62 FR 65384), relating to medical device preemption of State product liability claims. FDA is making this withdrawal because of concerns that have been raised regarding the interplay between the FDA Modernization Act of 1997 (FDAMA) and the proposed rule.     

Progestational drug products for human use; requirements for labeling directed to the patient. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revoking its regulation requiring patient labeling for progestational drug products. Patient labeling had been required to inform patients of an increased risk of birth defects reported to be associated with the use of these drugs during the first 4 months of pregnancy. FDA concluded that, based on a review of the scientific data, such labeling for all progestogens is not warranted. In addition, the diversity of drugs that can be described as progestational and the diversity of conditions these drugs may be used to treat make it inappropriate to consider these drugs a single class for labeling purposes. This action is intended to provide consumers with more appropriate labeling for certain drug products.     

Revisions to labeling requirements for blood and blood components, including source plasma. Final rule

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.     

Options for state and local governments to regulate non-cigarette tobacco products

Most tobacco control laws were written to address the scourge of smoking--particularly smoking cigarettes. As a result, these laws frequently exclude non-cigarette tobacco products, which are becoming more prevalent on the market. These regulatory gaps jeopardize public health by increasing the possibility that these products will be used--particularly by minors and young adults. This article examines gaps in regulation using five products as case studies: dissolvable tobacco products, electronic cigarettes, little cigars, snus, and water pipes. In addition, this article presents policy options that state and local governments can adopt to regulate these products more effectively, including regulations relating to price, flavors, youth access, use in public places, point-of-sale warnings, and marketing. Furthermore, this article contains extensive discussion of the recently adopted federal Family Smoking Prevention and Tobacco Control Act, which both limits and expands the power of state and local governments.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Teen smoking behavior and the regulatory environment

Professor Hersch argues that most state regulations aimed at fighting teen smoking have had little or no effect. She provides evidence that despite widespread age restrictions on purchasing tobacco, most teens do not consider it difficult for minors to purchase tobacco products within their community. She also presents evidence demonstrating a strong correlation between smoking rates and perceptions about the addictive nature of smoking. These findings suggest that facilitating greater awareness of the addictive power of cigarettes could be effective in curbing teen smoking. She explores the potential for parental restrictions on limiting teen smoking, but provides indications that parents are not well informed about their children's smoking behavior. Finally, she examines the recent FDA regulations, which, she says, are merely a continuation of the traditional methods of attacking adolescent smoking, and are unlikely to have a significant effect.     

Amendments to general regulations of the Food and Drug Administration. Direct final rule

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.