Plan your year of Food Laws & Regs!

 Online graduate courses:

Summer 2021 (May 17 - August 19, 2021)

• Food Laws & Regs in China

Fall 2021 (September 1 - December 17, 2021)

• International Food Laws & Regs
• Food Laws & Regs in the U.S.
• Food Laws & Regs in the E.U.
• Food Laws & Regs in Latin America (Not offered again until fall 2023.)
• Global Animal Health, Food Safety, and International Trade
• Regulatory Leadership in Food Law (Newly enhanced, read more below.)
• The Law of the Produce Safety Rule

Spring 2022 (January 10 - May 6, 2022)

• International Food Laws & Regs
• Food Laws & Regs in the U.S.
• Food Laws & Regs in Canada
• Codex Alimentarius, the World Food Code
• Wine, Beer, and Spirits Laws & Regs (Not offered again until Spring 2024.)
• Law of the FSMA Preventive Controls for Human Food Rule

Online Undergrad Summer Course in Food Law

An online summer course in Food Law, just for undergrads! Do you have a future food scientist in your life? This Michigan State University course is open to students at other universities and around the world. Please help us spread the word to undergrads and interns. Learn more about the course and tuition here. 

IFT Food Laws & Regulations Division Travel Scholarships

IFT Travel Scholarships for food science students open March 2, 2020 and closes March 30, 2020. 

The IFT Laws & Regulations Division initiate a new travel scholarship this year. The $800 awards are to attend the IFT20 Expo and the division event at IFT20. Applicants must be an IFT Student Member and of the member Food Laws and Regulations Division, but if not a member, can join today. Student membership is a bargain and a great investment. 

FDA Reopens Comment Period on General Principles for Food Standards Modernization

The U.S. Food and Drug Administration (FDA) is reopening the comment period on a 2005 proposed ruleto establish a set of general principles for the agency to use when considering whether to establish, revise, or eliminate a food standard of identity. 

The 2005 proposed rule included 13 general principles for food standards modernization. With the development of new types of food products and the most recent nutritional science, the FDA is taking a fresh look at existing standards of identity. FDA states, “The goals of food standards modernization are to protect consumers against economic adulteration; maintain the basic nature, essential characteristics and nutritional integrity of food; and promote industry innovation by giving manufacturers the flexibility to produce healthier foods.”

FDA Extends Compliance Deadline for New Nutritional Labeling Rules

FDA issued final rules to implement changes to the nutrition labeling and serving size regulations in May 2016. Compliance with the new requirements was initially set for July 26, 2018 (July 26, 2019 for small manufacturers). In May 2018, FDA issued a final rule extending the compliance dates to January 1, 2020, for manufacturers with $10 million or more in annual food sales and January 1, 2021, for manufacturers with less than $10 million in annual food sales.

FDA announced that it will effectively extend the compliance deadline again  during the first six months following the January 1, 2020 compliance date.   FDA stated it will  “work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.” 

Trump Calls for Streamlined Regulation of Genetically Engineered Food

President Trump signed Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products on June 11, 2019. The order directs federal agencies to streamline regulations and guidance documents regarding products of agricultural biotechnology. 

The impact of the executive order will idepend on the actions of the federal agencies. The regulatory system must not only ensure the safety of new biotechnology but also must foster public confidence in that safety. Avoiding undue regulatory burden is important, but simply deregulating genetic engineering could result in loss of public confidence in genetically engineered foods. 

FSIS Proposes Elimination of Dual Net Content Labeling

The USDA Food Safety & Inspection Service (FSIS) proposed amending its labeling regulations to remove the requirement for dual declaration of net contents on packages that contain more than one pound or one pint but less than four pounds or one gallon. Under the proposal, meat and poultry packages in these ranges would be allowed to express contents in one of the avoirdupois units of measure instead of both. For example, the net weight could read, “56 oz.” or “3.5 lbs.” rather than “56 oz. (3.5 lbs.)” 

In its preamble to its proposal FSIS states, “If the proposed changes are finalized, FSIS expects the net weight and content requirements will be clearer and there will be fewer . . . questions and less misunderstanding of the net weight and content requirements.” 

What do you think? Will clarity be achieved by eliminating the dual listing? If clarity is the goal, wouldn’t it be simpler to list just in the largest whole unit? That is, wouldn’t it be simpler to always label three pounds as “3 lbs.” As proposed, three pounds would sometimes be “3 lbs.”, but sometimes “48 oz.”, other times “3 lbs. (48 oz.)”, and still other times “48 oz. (3 lbs.)”

You can let FSIS know what you think of their proposal. FSIS is asking for comments by June 17, 2019.

New Online Course: Food Regulation in China

Online Graduate Course: Food Laws and Regulations in China Updated curriculum for summer 2019   NEW RANGE OF TOPICS NEW TEAM OF INSTRUCTORS CLASS RUNS MAY 13 - AUGUST 15, 2019 Enroll Now This course is designed to provide students with an overview of various aspects of food law in China. Taught with an IFLR lead instructor along with various China food law experts from around the world, this redesigned course has been updated to reflect the latest laws and regulations and touches on emerging issues. Topics include: cultural, socio-economic differences compared to other countries/regions; organization of China's food laws, delegation of risk assessment and risk management roles and responsibilities in the Government of China; cross border and e-commerce issues; food labeling and claims permitted; novel food approval; genetic modification and; food additives and contaminants. Hot topics such as food safety, food fraud, and import-exportissues such as tariffs and liabilities toward consumers will also be addressed. This course will include various weekly readings, lectures, assignments, discussions with experts, and three quizzes. There will not be a final exam. Learn more at www.iflr.msu.edu. Contact iflr@msu.edu for assistance. Copyright © 2019 Institute for Food Laws and Regulations, All rights reserved. Our mailing address is: Institute for Food Laws and Regulations 474 S Shaw Lane, Suite 3385 Michigan State University East Lansing, MI  48824 Add us to your address book

New Online Course: Global Regulation of Food Contact Substances and Packaging

The course starts in January 2019.  More information is available at  https://goo.gl/ESzACq

Highly Concentrated Caffeine in Dietary Supplements

Products consisting of or containing only pure or highly concentrated caffeine have been linked to deaths and are deemed by FDA to represent a significant public health threat. FDA considers some of such dietary supplements to be adulterated under section 402(f)(1)(A) of the Food, Drug, and Cosmetic Act.

FDA, Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018).

First FDA Mandatory Food Recall Order

On April 3, 2018, FDA issued its first mandatory recall order for a food product. The order was issued to Triangle Pharmanaturals LLC for all its all food products containing powdered kratom. The order came after several products were found to contain Salmonella, and the company refused the agency’s request for a voluntary recall.

The Food Safety Modernization Act gave FDA the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. These requests by FDA are titled, “Notification of Opportunity to Initiate a Voluntary Recall,” but are sometimes called the “last chance letter,” because the letter provides the company with a last opportunity to issue a recall before FDA enforcement action.

Celebrating 20 years of advancing the understanding of food law at the Michigan State University Institute for Food Laws and Regulations

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 

FDA Extending Menu Labeling Compliance Date

FDA is extending the compliance date for its menu labeling rule by one year. Restaurants and other establishments covered by the menu labeling rule will have until December 1, 2016 to post calories and other information on their menus and menu boards, provide full written nutrition information in-store, and come into compliance with the rule’s other requirements.

The menu and vending machine labeling requirements are available here.

Oral Arguments in Challenge to VT Law on GE Labeling

The U.S. Court of Appeals for the Second Circuit will hear oral argument Thursday, October 8, in Grocery Manufacturers Assoc. v. Sorrell, on an appeal of the federal district court’s denial of a preliminary injunction. The injunction request was to delay effect of the new Vermont law. The law will require labeling of most foods that contain genetically-engineered ingredients. Unless enjoined, the law will take effect next July.

Neal Fortin's most recent publication, The U.S. Food Safety Modernization Act: Implications in Transnational Governance of Food Safety, Food System Sustainability, and the Tension with Free Trade, is available in the Duke Environmental Law & Policy Forum current issue.