Current Regulation and Standards for Foods and Cosmetics in Domestic and International Trade
This course will introduce students to the legal and regulatory systems that govern the production, labeling and distribution of foods and cosmetics, both domestically and internationally. The course will highlight key issues in the structure and application of foods and cosmetic laws and regulations in the United States and in critical international markets, including North America, Latin America, Europe and Asia. Students will also receive an introduction to the roles played by legal systems and lawyers in interpreting laws and regulations, adjudicating disputes and advancing policy. The course will be presented by practitioners who have represented regulated companies and will present industry as well as consumer and government perspectives.
Part 1: Introduction to the World of Law and Business
Week 1: The Legal and Regulatory Framework – World Systems
Students will be introduced to the overall legal and regulatory framework for food and cosmetic regulation, with a focus on the interplay and operation of world systems. The session will explore how responsibilities for oversight, enforcement and dispute resolution are allocated and sometimes shared among governmental, criminal and civil authorities. The role of voluntary selfregulation will be included in the discussion, with the goal of ensuring that students understand the sources and intersection of the laws, regulations, and self-governance systems that affect food and cosmetic businesses.
Week 2: The Role of Lawyers
Students will gain an appreciation of how the delivery of legal services helps ensure that businesses comply with applicable legal and regulatory obligations. Students will be encouraged to appreciate the mixed nature of business / legal projects, including regulatory compliance, due diligence, trade regulation, documentation and records management. The session will conclude with a discussion of the ways in which recalls and crisis management can not only ensure legal compliance but actually promote shareholder value in the long term.
Part 2: Introduction to Food and Cosmetic Regulation
Week 3: Food and Cosmetic Regulation
This session will introduce students to the U.S. and international frameworks for food and cosmetic regulation, including a short history of the emergence of food regulation in the United States. The role of the Food and Drug Administration and the U.S. Department of Agriculture will be explored, as well as the oversight systems in place via international treaties and scientific conventions, including, for example, the United States Pharmacopeia, the World Trade Organization and the cosmetic nomenclature systems maintained by the International Cosmetic, Toiletry and Fragrance Association.
Week 4: Labeling
This session will cover food and cosmetics labeling as regulated sources of information for consumers, as a marketing tool and as an instrument of policy. FDA labeling policies will be discussed, as well as the legal and regulatory requirements applicable to the principal display panel, nutrition facts and information panels. The session will explore in some detail the laws and regulations governing health and wellness claims – “healthy,” nutrient content claims, qualified health claims, structure-function claims and the applicable standards of substantiation, e.g., “significant scientific agreement.” The role of the Federal Trade Commission in setting standards for truthfulness and accuracy will be addressed, as well as the role of industry voluntary self-regulation of advertising.
Part 3: Safety Regulation and Consumer Protection
Week 5: Food Additives
Regulation of food additives, i.e., intentionally added ingredients, under the Food Drug, and Cosmetic Act will be discussed in some detail, with reference to the concept of “adulteration” and the role of FDA oversight concerning whether an additive can be deemed Generally Recognized As Safe (“GRAS”) for use in foods. The roles of the USDA and EPA in regulating pesticides and other chemicals will be discussed, as will be the disclosure scheme for potentially cancerous / toxic chemicals set forth by California’s Proposition 65. The session will also address international cosmetic ingredient safety standards and address issues in international regulatory registrations of food additive and pesticides.
Week 6: Unintended Contaminants
FDA’s approach to combating adulteration in manufacturing environments will be explored in some detail, including the legal underpinnings of FDA’s initiatives to prescribe specific methods for maintaining safety in connection with specific products such as low-acid canned foods and seafood products. The session will explore the role of outbreaks of food-borne illnesses and recalls, both domestically and internationally, as a trigger for food safety reforms. Students will come away with an understanding of what is required of manufacturing environments under the Food Safety Modernization Act (“FSMA”), the Food Allergen Labeling and Consumer Protection Act, and the applicable regulations and requirements.
Week 7: Presentation of Research Projects
Students should plan on outlining their research projects, discussing the key issues in application of the food and cosmetic laws and discuss these issues with the instructors and the class.
Part 4: Introduction to the Regulation of Marketing
Week 8: Economically Motivated Adulteration
The challenging issues of identifying and combatting economically motivated adulteration (“EMA”) will be explored in some depth, with a special emphasis on determining, with reference to statutory definitions in the FDCA, just what EMA is and what it is not. The discussion will include industry demands for developing food standards and the challenges presented by standard setting, as well as FDA’s current position that honest and complete labeling will resolve the issues. Students will be invited to consider, for example, to consider what is “honey” and “extra virgin olive oil.” International conventions will be discussed, as well as the approaches that have been taken in Canada and the European Union. The role of “naming” will be explored in preventing consumer confusion, and there will be a brief discussion of the Pom Wonderful case and juice nomenclature.
Week 9: Advertising
This session will explore FDA’s role in affecting standards for advertising and promotion of foods and cosmetics, as well as the interplay between these standards and the standards established by Federal Trade Commission Act. The session will explore the line between the “label” and “labeling” as well as the extent to which FDA standards and regulations affect advertising, including the resolution of advertising disputes. The Pom Wonderful v. Coca Cola case will be discussed as an example of the extent to which full regulatory compliance may or may not control the outcome of a competitive dispute. The class will include a brief overview of the First Amendment standards applicable to commercial speech, to the extent they place limitations on FDA's authority to regulate truthful but non-regulated statements in advertising and promotion.
Week 10: You’ve Been Sued!
The class will go into some depth on the extent to which “consumer litigation,” i.e., class action lawsuits have influenced consumer products labeling and food policy. The session will survey the types of claims that have come under scrutiny, as well as the role that social media plays in forming what consumers may believe about a product. The discussion will include whether there is a common understanding of such attractive terms as “natural” or “clean label.”
Week 11: Process Labeling
The discussion will review the various legal and policy issues raised when a food label emphasizes communications not about the food itself but about the system from which it originated; highlighted topics will include the standards governing country of origin, organic farming and GMO labeling. The session will explore the usefulness of third-party standard setting by the National Organic Program, the Non-GMO Project, the USDA’s Agricultural Marketing Service and others. The session will briefly highlight the key regulations relating to USDA organic certification and examine some of the issues facing USDA in connection with setting standards for GMO labeling. World Systems: The Challenges of International Trade
Weeks 12-13: International Regulatory Systems / Trade
These sessions will consider how the concepts discussed in the course are being treated under international regulatory regimes, including mature regulatory systems such as Canada, the European Union, Australia, New Zealand and Latin America, as well as the emerging regulatory systems of China and other Asian countries. The obligations of domestic importers under the Foreign Supplier Verification Program required under FSMA and applicable regulations will be explored, as well as the authority of FDA to block incoming foods and cosmetics on the grounds of adulteration and misbranding. The growing influence of retailers, e.g., Walmart, in influencing international food policy and standard setting will be briefly discussed, specifically with reference to international food safety auditing requirements that retailers impose on manufacturers and importers, e.g., the Global Food Safety Initiative and British Retail Consortium.
Weeks 14-16: Reporting Out
Students will be required to give a presentation on the findings of their research paper and/or the outcomes / results of their experiential learning activities. Time will be allotted for questions and answers from the instructors and class