Food Regulation, 2nd edition, is now available!

The second edition of Food Regulation is now available.  It contains over 25 percent new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense. The text provides an in-depth discussion of the federal statutes, regulations, and agencies involved in food regulation. After an introduction to the history of food regulation, it covers current food regulations, inspection and enforcement, international law, and more. 

With explanation of the policies and food science behind the law, the text is designed for both food scientists and lawyers. Yet the book remains accessible to students and professionals alike. This is an excellent text for food science and food law and a practical reference for food industry professionals, consultants, and others. 

I hope you find it appetizing. If you would like more information, the Table of Contents is available here.  A copy of Chapter One is available here.  

To order from the publisher, click here. 

To order from Amazon, click here. 

To order the iBook, click here. 

VQIP Guidance Released

FDA has just released its Guidance for Industry: Voluntary Qualified Importer Program. The Food Safety Modernization Act (FSMA) directed FDA to create the Voluntary Qualified Importer Program (VQIP), which is a voluntary, fee-based program that is intended to expedite the review and importation of food for participants in the program.

To be eligible to participate in the VQIP, an importer must be importing food from a facility that has been certified by a third-party auditor accredited under FSMA and such certification must accompany the imported food. An importer that wishes to participate must submit a notice and application to FDA. The specific requirements for participation are outlined in the FDA guidance document.

A hat tip to David Acheson on his excellent summary and comments, You Can Now Expedite Entry of Your Imported Foods … If You Meet All Eligibility Criteria.

FDA to Revise the Nutrient Content Claim “Healthy”

The Food and Drug Administration (FDA) announced the start of a public process to redefine the “healthy” nutrient content claim for food labeling.

Under the food labeling rules, “healthy” and similar terms are generally an implied nutrient content claim. 21 C.F.R. § 101.65(d). A food must meet certain requirements to be eligible for the “healthy” claim.

FDA acknowledges that the 1993 regulation for “healthy” as a nutrient content claim is in need of an update. The latest nutrition science and the current dietary recommendations, among other things, has shifted from recommending diets low in total fat to now draw distinctions among the types of fat (unsaturated fats vs. saturated fats and trans fat) in the diet.

While FDA is receiving comments and reconsidering the regulation defining “healthy,” FDA states, “Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement discretion in the interim with respect to some of the existing criteria for the nutrient content claim “healthy” if the alternative nutrient criteria described below are met.”

FDA Guidance: Use of the Term “Healthy” on Food Labels and FDA’s Enforcement Discretion

Specifically, FDA’s Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, provided that: (1) The amounts of mono and polyunsaturated fats are declared on the label and (2) the amounts declared constitute the majority of the fat content.

The definition for “healthy” also includes a nutrient contribution criterion. Healthy dietary patterns not only restrict nutrients that increase risk of chronic disease, but also help assure nutrient adequacy to ensure sufficient intake of nutrients that are important in sustaining body function and reducing the risk of disease. The current definition of “healthy” focuses on foods providing a good or excellent source of nutrients for which there had been public health concern in 1993: vitamin A, vitamin C, iron, calcium, and dietary fiber.

Nutrient intakes have shifted over time, however, and vitamins A and C are no longer nutrients of public health concern. FDA now recognizes vitamin D and potassium as nutrients that should be encouraged in the diet, in addition to iron, calcium, and fiber.

Therefore, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium.

FDA has requested information and comments docket number FDA–2016-D–2335  FDA also asks for input on issues related to the “healthy” claim, including:

• Is the term “healthy” most appropriately categorized as a claim based only on nutrient content?
• What types of food, if any, should be allowed to bear the term ‘‘healthy?”
• What nutrient criteria should be considered for the definition of the term “healthy?”
• What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
• What is consumers’ understanding of the meaning of the term “healthy” as it relates to food?

Information and comments must be submitted to FDA by Jan. 26, 2017.

United States v. Decosters Decision

Yesterday, July 6, the Eighth Circuit upheld the United States v. DeCoster three-month prison sentences and $100,000 fines for Austin “Jack” DeCoster and Peter DeCoster, respectively the owner and chief operating officer of Quality Egg, LLC. Over the years, several salmonellosis foodborne illness outbreaks were associated with eggs from DeCoster farms. In a 2010 outbreak that resulted in the present case, nearly 56,000 were sickened.

In a 2–1 decision, the appeals panel ruled that even though the DeCosters did not know that the eggs they shipped had Salmonella, they “are liable for negligently failing to prevent the salmonella outbreak” and that jail time is appropriate. The Food, Drug, and Cosmetic Act “punishes neglect where the law requires care.” See United States v. Park, 421 U.S. at 671 (the eponymous case for the Park doctrine, also known as the “responsible corporate officer” doctrine).

This case was notable for the number of amici on behalf of the DeCosters: The Washington Legal Foundation, Cato Institute, Chamber of Commerce of the United States, Pharmaceutical Research and Manufacturers of America, and the National Association of Manufacturers. Recently there has been a concerted push for abolishing strict liability from all federal law, including the Park doctrine of the Food, Drug, and Cosmetic Act.

No matter how you feel about mens rea, the DeCosters are poor poster children for eliminating Park doctrine strict liability under the Food, Drug, and Cosmetic Act. Strategically, a proposal to eliminate strict liability that applies to the Park doctrine stakes out a weak position. It defends wrongdoers whose negligence causes tens of thousands of serious illnesses. It defends wrongdoers whose negligence causes the deaths among the most defenseless, children and the elderly. Be prepare to answer the grieving mother who lost a child or the widow or daughter who lost her father, who was a decorated WWII veteran or decorated Korean War veteran.

>> Hurry, registration is limited!

Food Law Current Issues Seminar

Michigan State University        East Lansing, Michigan

July 12-14, 2016

The MSU Food Law Current Issues Seminar provides practical education on current food legal and regulatory issues. The seminar covers cutting edge issues in international, transnational, and national food law and policy including FDA and E.U. food ingredient and safety regulations, U.S. advertising and labelling law, and globalized supply chain liabilities and management strategies. Speakers from the legal, food industry, and academic professions will present practical food law information and case studies.

This seminar is for a global audience in food regulatory work, including industry regulatory affairs, quality assurance, government officials, the legal community, advertising and marketing professionals, academics, and policy makers.

The course is offered in a collegial, intimate learning environment. Time will be allowed for questions and answers as well as informal discussions over lunch and coffee. In addition to the educational sessions, social activities are planned on a voluntary basis.

The cost for the course is $1345 until May 15th; after May 15th registration will be $1545.

For more information, click here

or

Register Online

The Faculty

P. Vincent Hegarty PhD, Founding Director/Professor Emeritus, MSU, Institute for Food Laws and Regulation

Elizabeth H. Dickinson, JD, Chief Counsel to the FDA [invited]

Leslie Bourquin, PhD, Professor of Food Science and Human Nutrition, Michigan State University

Stuart Pape, JD, Shareholder, Polsinelli

Charles Breen, Senior Consultant, EAS Consulting Group

Ken Odza, JD, Corporate Counsel, Food Safety, Kellogg Company

Robert Prevendar, MPH, Managing Director, Global Supply Chain Food Safety, NSF International

Daniel Dwyer, JD, Partner, Kleinfeld, Kaplan and Becker, LLP

Tim Slawinski, Emerging Issues Specialist, Michigan Department of Agriculture and Rural Development

Howard Sklamberg JD, Deputy Commissioner for Global Regulatory Operations and Policy, FDA [invited]

Francesco Planchenstainer, JD, PhD, Senior Regulatory & Food Law Specialist at Mead Johnson Nutrition

Robert Hollingworth, PhD, Emeritus Professor of Entomology, Michigan State University

Bill Marler, JD, Managing Partner, Marler Clark

Hannah Chanoine, JD, Counsel, O’Melveny & Myers; Lecturer-in-Law, Columbia University School of Law

Jennifer McEntire, PhD, VP, Science Operations, Grocery Manufacturers Association

John Spink, PhD, Assistant Professor and Director of the Food Fraud Initiative, Michigan State University

Shawn Stevens, JD, Food Industry Counsel LLC

Adam Ekonomon, JD, Director and Assistant General Counsel, Marketing and Regulatory, The J. M. Smucker Company

Mary Engle, JD, Associate Director for Advertising Practices at Federal Trade Commission

Kimberly Wingfeld, Director, Science Policy, Labeling and Standards, Grocery Manufacturers Association

Latasha Robinson, Branch Chief of Labeling and Dietary Supplement Compliance, FDA [invited]

Steve Steinborn, JD, Hogan Lovells, U.S., LLP

 Learn more about IFLR at: www.IFLR.msu.edu