The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food. This webcast reviews the recent article describing the system, including original analysis of pre- and post market safety standards for various categories and subcategories of substances and their uses; assigning the more than 10,000 substances currently allowed in human food to those categories; and analyzing FDA's review of more than 1,900 petitions and notifications received from 1990 to 2010.
Overall, federal agencies made approximately 40% of the 6,000 safety decisions allowing substances in human food. These decisions allowed an estimated 66% of the substances currently believed to be used in food. Manufacturers and a trade association made the remaining decisions without FDA review by concluding that the substances were generally recognized as safe (GRAS). In the late 1990s, FDA moved from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions and posting the results of the review on the agency's website. This shift appears to have encouraged manufacturers to submit their decisions to FDA for review but has limited public opportunity to provide input.
Product Developers, Company Management, Sales & Marketing Personnel, Plant Production Personnel, Quality Assurance Managers and Supervisors, Food Safety Specialists, Product manufacturers, Research Staff, Regulators, Academics, Students
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05/23/12 12:00 PM
Martin James Hahn
Hogan & Lovells US LLP
Martin Hahn’s practice focuses on a wide variety of regulatory issues affecting many different segments of the food industry, essentially from farm to table. He assists companies in complying with the numerous statutes, regulations and guidance documents implemented by the Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA), and with the advertising requirements of the Federal Trade Commission (FTC).
Martin has experience in virtually every segment of the food industry, including food ingredients, food packaging materials, seafood, juice, bottled water, dairy products, frozen foods, snack foods, acidified foods, low acid canned foods, baked goods, nuts, infant formulas, meat, poultry, and many others. His clients include large multi-national companies as well as small privately held start-up companies and numerous trade associations.
Martin’s undergraduate degree in Food Technology combined with his food industry experience makes him uniquely positioned to help clients navigate the myriad of regulatory issues confronting their businesses. He has a thorough understanding of the Hazard Analysis Critical Control Point (HACCP) requirements and helps his clients develop their HACCP programs, procedures, and monitoring records that will survive the rigor of a regulatory inspection. This experience has proven invaluable as he counsels clients on the new requirements that FDA will be implementing under the Food Safety Modernization Act (FSMA).
In instances when a client has released into commerce a potentially violative product, Martin assists his clients in determining whether a recall is necessary or advisable and if so, helps manage all aspects of the recall. He also assists clients in managing factory inspections and in preparing the response to any observations noted by regulators during the inspection.
Martin also has extensive experience in managing enforcement actions such as Warning Letters, import alerts, injunctions, and responses to FTC investigations of advertising practices. His working knowledge of the underlying legal requirements and thorough understanding of the food manufacturing process allows him to assist clients in responding to and resolving the underlying issues that resulted in the enforcement action.
In addition to a strong working knowledge of the relevant regulatory requirements applicable to the formulation and manufacture of foods and dietary ingredients, Martin also assists companies in complying with the various requirements that apply to the promotion of these products. He has an excellent working knowledge of the myriad of regulations and guidance statements applicable to the label and labeling of foods. He assists his clients in developing creative ways to promote foods in a manner that complies with these various requirements. In instances when consumption of a food or a substance in food has been shown to have a positive effect on health, Martin helps clients determine whether the health benefits should be conveyed through a “structure or function” claim, which does not require any premarket authorization, or through a health claim or qualified health claim. He has helped clients receive FDA authorization for several health, qualified health, and nutrient content claims, including the qualified health claim regarding the relationship between the omega-3 fatty acids, DHA and EPA, and a reduced risk of coronary heart disease. Martin has been actively involved in issues presented by food allergens since the mid-1990’s and helps clients comply with the requirements imposed by the Food Allergen Labeling and Consumer Protection Act (FALCPA) and with the allergen controls imposed under FSMA.
Martin also helps companies determine the regulatory status of the various foods and food ingredients that will be used in the formulation of their products. When companies develop a new food or dietary ingredient, he will help the company determine whether a premarket authorization is necessary and if so, provides assistance in preparing the submission that will be needed to satisfy the regulatory review process. Martin has helped numerous clients obtain FDA and FSIS authorization to market new food additives, generally recognized as safe (GRAS) food ingredients, color additives, new dietary ingredients in dietary supplements, and food contact substances for use in food packaging materials.
Martin monitors new developments impacting the food industry, including the private law suits that have been filed against the food industry under California’s Proposition 65 and state consumer protection laws. He and the firm’s litigators have represented numerous clients in responding to these private actions.
Martin is one of four editors for the FDLI publication, “Food and Drug Law and Regulation.” He has presented numerous speeches on food labeling, food allergens, factory inspections, FSMA, and food safety. He is a frequent speaker for programs sponsored by the Food and Drug Law Institute and the Food Allergy Research and Resource Program.
Martin received a B.S. in Food Technology from the Ohio State University (1986), where he graduated cum laude with Honors, and a J.D. from Northwestern University (1989). He is a member of the D.C. Chapter of the Institute of Food Technologists and is an associate member of the Association of Food and Drug Officials and a member of the District of Columbia Bar.
Dr Haley Curtis Stevens
The Kellen Co
I am the President of the Calorie Control Council, a non-profit trade association in the light and reduced-calorie food and beverage industry, in Atlanta, GA. I also serve as the Executive Director of a non-profit trade association, in the food ingredients world. I work closely with the FDA, the WHO, and other international regulatory bodies on a daily basis, as well as manage and oversee the day to day operations of these two associations.
Neal Fortin is Professor and Director of the Institute for Food Laws & Regulations at Michigan State University. The Institute provides a distance education program in international food law via the Internet. Mr. Fortin is also an affiliate professor of law at the Michigan State University College of Law and an adjunct professor at the University of Minnesota Public Health Institute.
Mr. Fortin teaches United States Food Law, International Food Law, Codex Alimentarius, Food and Drug Law, and Nutrition Law and Policy. He is prolific and respected author and lecturer on matters related to food. Some of his publications are available at: https://www.msu.edu/~fortinne/publications.htm. His textbook, FOOD REGULATION: LAW, SCIENCE, POLICY, AND PRACTICE, is available from Wiley & Sons (www.foodregulation.us).
Food law, food labeling, dietary supplement regulation, nutrition law and policy, food safety, food advertising
The Pew Charitable Trusts
Neesha R. Kulkarni is a Senior Associate on the Pew Health Group’s Food Additives Project, an initiative examining the strengths and weaknesses of the current U.S. federal regulatory system as it pertains to the safety of chemicals commonly added to food. The project evaluates the adequacy of the underlying laws, policies, and science used to determine the potential risks posed by those substances. Ms. Kulkarni was most recently a Legislative Associate at Friends of the Earth where she worked to develop legislation and nation-wide clean vessels standards to cut air and greenhouse gas emissions from cruise and commercial shipping and to stop pollution discharges from cruise ships. Prior to joining Friends of the Earth, Neesha worked as a Legislative Assistant in the U.S. House of Representatives, where she handled environmental, health, agriculture, and immigration policy. She holds a Juris Doctor from Tulane University Law School with a certificate in Environmental Law and European Legal Studies and a bachelors degree from Georgetown University.
Thomas G Neltner
Tom Neltner, J.D., C.H.M.M., is Director of the Food Additive Project in the Pew Health Group at the Pew Charitable Trusts. Neltner is a chemical engineer, practicing attorney, and Certified Hazardous Materials Manager with experience in state government, chemical manufacturing, small business support, academia, and public interest advocacy. Before joining the Pew Health Group in May 2010, he managed the Natl. Healthy Homes Training Center and Network for the Natl. Center for Healthy Housing. The Training Center—funded by the U.S. Environmental Protection Agency (EPA), U.S. Dept. of Housing and Urban Development (HUD), and U.S. Centers for Disease Control and Prevention (CDC)—builds public health capacity for health and housing professionals. Neltner managed a network of more than 25 training partners across the United States. Most of the training partners are cooperative extension services or schools of public health. As a volunteer for the Sierra Club, he worked on various issues involving chemicals in commerce, including air fresheners, formaldehyde in wood products, lead and cadmium in children’s products, and certain surfactants.