Browsing by Subject "food and drug law"

Now showing 1 - 3 of 3
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    The Benefits of Regulatory Friction in Shaping Policy
    (FDLI, 2016) Winters, Diana R. H.; Robert H. McKinley School of Law
    The regulation of food, drugs, and controlled substances in this country is exceedingly complex. Local, state, and federal regulation coexist, and common law remedies supplement positive law. Strata of regulation are necessary because patterns of production and consumption vary by region and demographic, while federal regulation provides regulatory uniformity across the United States. As localities struggle to sustain autonomy in response to local preference while working within a centralized system, and federal agencies struggle to maintain regulatory uniformity to foster a national marketplace, we see interaction and friction between regulatory spheres. While this friction usually becomes apparent through a lens of adversity, it is also a space of foment for policy change and democratic engagement. In this Paper I explore this productive space by looking at several recent instances of action by states in food, dietary supplements, and controlled substances regulation that highlight this friction. An analysis of these actions and the challenges to them provides an opportunity to view the interaction between different levels of regulatory authority and to discuss implications of the judicial review of these enactments. We see complex and shifting alliances working to change policy, and we see benefits in the push and pull caused by these actions.
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    Intractable Delay and the Need To Amend the Petition Provisions of the FDCA
    (2014) Winters, Diana R. H.; Robert H. McKinney School of Law
    Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened. This Article analyzes two examples of FDA inertia and compares private enforcement under the Food, Drug, and Cosmetic Act (FDCA) to more successful private party activity under several environmental statutes. These comparisons highlight several weak spots in the FDCA that contribute to the difficulties faced by private party oversight in attempting to compel FDA action. The Article then proposes solutions suggested by these problems. Congress should amend the Act to include more specific petition provisions with statutory deadlines and to strengthen the general citizen petition provision of the FDCA. Interested parties should also be able to petition the Office of Information and Regulatory Affairs (OIRA) for the review of the denial of rulemakings. These steps will restore the vitality of a critical part of the administrative enforcement scheme — private party oversight — and thereby benefit both the public health and the regulatory state.
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    The Magical Thinking of Food Labeling: The NLEA as a Failed Statute
    (2014) Winters, Diana R. H.; Robert H. McKinney School of Law
    This Article examines the failures of the Nutrition Labeling and Education Act of 1990 (NLEA) and argues for its partial repeal. The NLEA was intended to improve the quality of information available to consumers about the food they bought and ate, but it is ineffective and inefficient. At the time of the Act’s passage, awareness of the association between diet and health was increasing, and clear and accurate information about food was seen as a critical but simple way to provide people the opportunity to improve their health through nutrition. The information available to consumers, however, is confusing and opaque — even when presented in a manner compliant with the NLEA. The Act has two parts. First, it mandates disclosure of certain nutrition facts. These include the “Nutrition Facts” box that consumers have become used to seeing on packaged food. Second, it regulates claims made about how nutrients in the food affect human health (called “health claims,” and “nutrient content claims”) to ensure that such claims are based on scientific information. While the first part has succeeded in providing consumers with the mandated information, the second part has failed. Health claims on food are no more trustworthy than they were before the NLEA was passed, and may actually be less so. Indeed, health outcomes directly related to nutrition have worsened dramatically since 1990. While one of the goals of the NLEA was to foster uniformity in food labeling regulation, the amount of litigation regarding food labeling has increased, resulting in conflicting rulings regarding the continued vitality of state law in this arena. This confusion has diminished the valuable role that state law can, and was intended to play in this arena. Moreover, the regulatory strategy of mandated information disclosure is itself weak. Even if the statute were perfectly written, so as to ensure that only claims supported by the best and most current scientific information were available to consumers, it is not certain whether the provision of clear and accurate nutritional information to consumers would actually be a factor in improving health. The Article advocates for the repeal of the health and nutrient content claim provisions of the NLEA. True policy improvement in the food-labeling scheme will not come about through incremental improvements to the NLEA’s health and nutrient content claims provisions. This problem should be dealt with by the states.