Food Law

Consumer Product Safety Regulation

Consumer complaints are often the first indication that a product may be unsafe. Failure to take timely action can subject a firm to substantial penalties and risk allowing unsafe products on store shelves.

Our team is positioned to serve as counsel not only in those pivotal frantic moments, but also well before they occur – with advice on the impact of regulations, how to develop programs to reduce risk, and what to do should disaster strike. We have more than 30 years of experience advising on consumer protection regulations on products spanning from wearable technologies and consumer electronics to infant and children’s products and toys.

Food Compliance and Enforcement

There is a focus on food safety and inspection at all food processing and distribution levels. And there is an increasing regulatory and competitive scrutiny of food and dietary supplement activities.

Food and beverage companies benefit from the experience and perspective we have gained from participating in the development of laws and regulations with which you must comply and in responding to compliance and enforcement related actions whether from regulators, state entities, competitors, or class action lawyers.

We can advise you on how to produce and process your products in accordance with applicable manufacturing and labeling requirements, market your products most effectively without violating labeling and advertising rules, consistently monitor regulatory compliance, shape and influence future policy issues, and respond if another entity alleges non-compliance.

Food and Beverages

From well-established conglomerates to niche startups, we live and breathe (or rather, eat and drink) this space.

The world of food and beverage is an exceptionally complex landscape of legislative concerns and regulatory guardrails. Our Food and Beverage team has honed its know-how alongside some of the most transformational brands in this space for more than 40 years.

We advise the world’s top food and beverage producers, manufacturers, and retailers, as well as startups, trade associations, and nonprofits. Every single stage of the production and distribution cycle has unique impacts on the business strategies of our clients – and that’s precisely where we thrive.

Food Recalls

When a food company experiences a crisis – a foodborne disease outbreak, possible bioterrorism threat, product recall, food product tampering, government enforcement activity, or even a natural disaster – it needs a multidisciplinary approach to crisis management. Along with the disaster comes allegations and blame, and you can often be faced with calls for government action or congressional or agency scrutiny. You need quick assessments and careful responses, and you need damage control.

Our lawyers help you prepare for and manage a crisis situation, foster the opportunity for measured response, and ensure that appropriate actions are taken by the government in the wake of the event. With our far-reaching experience and contacts, our lawyers provide not only legal and regulatory counsel in crises but also frequently serve as members of companies’ crisis management teams.

Food Labeling, Promotion, and Advertising

Scrutiny of your labeling and promotion efforts continues to increase, and it can be difficult to stay on top of compliance and litigation trends. Keeping your finger on the pulse of regulatory changes to labeling and promotion of your food or beverage product can often be tricky. Having a solid strategy is essential in order to avoid a Warning Letter or other enforcement action – and to manage the risk of a class action claim. Our lawyers closely track all of the latest changes to food labeling requirements, including the proposed rule on front-of-package nutrition labeling, the manner in which nutrition information is presented on the label, the changes to the definition of “gluten free” and “healthy” claims. We will help you safely and effectively market your products, including advising on beneficial health, nutrition, ingredient, production, and other claims. We not only understand the regulations, but have also been intimately involved in writing them and understand the food science behind them as well. We help clients avoid litigation over their labeling claims, both when companies are developing claims, and in the event of a threatened or filed lawsuit, where we can help negotiate a favorable resolution.

Food Legislation and Regulatory Policy Development

In a complex global market, it’s essential for companies to anticipate, assess, and respond to a host of domestic and international regulatory challenges. With significant experience in virtually every major market, our food and agriculture team can help navigate cross-border regulatory issues and achieve a competitive advantage while minimizing compliance risks. Many of our lawyers are former government officials, including former members of the U.S. House of Representatives, the European Commission, and the Legislative Affairs Commission of the Chinese National People’s Congress.

Our experience in the public sector, as well as in private practice, enables us to successfully guide clients through the labyrinth of global regulatory issues. We help with regulatory compliance through representation, document drafting, and keeping tabs on developments in regulatory agencies, both domestic and international.
We also keep clients abreast of changes in food safety laws and restrictions, such as those for labeling foods developed through biotechnology and restrictions on the use of bovine materials over concerns about “mad cow” disease.

International Regulatory Compliance

Hogan Lovells' international reach helps clients quickly respond to regulatory issues that transcend national borders. Our globally positioned lawyers and regulatory affairs specialists provide clients with counseling, document drafting and representation, and regulatory compliance, while closely monitoring developments in the European Commission, Council, and Parliament as well as initiatives of member country lawmakers and regulators. We keep clients up to the minute on food safety law developments and new requirements for labeling and traceability of foods and food components derived from biotechnology. Although much of our international work necessarily focuses on the EU, Canada, and Mexico, our lawyers and offices throughout the world are accustomed to providing similar counsel in Japan, China, and South America.

Medical Foods and Dietary Supplements

Certain foods and ingredients have been shown to be effective in managing disease and health-related conditions and supporting overall well-being. We advise clients on the legal parameters impacting foods and supplements used for managing health conditions. Our food lawyers can guide you, whether you manufacture medical foods or dietary supplement ingredients or use them in products. We help assess the regulatory status, safety, and compliance of your products, addressing any problems that may arise along the way. We routinely counsel clients on product classification issues, legal requirements for product safety, and claims made in labeling and advertising.

Our understanding of the legal requirements and underlying science allows us to help companies determine whether they should position their product as a medical food, food for special dietary use, conventional food, or a dietary supplement. We also assist clients in developing the data that are needed to substantiate claims and support the regulatory classification of the product.

Our extensive experience extends to frequent counseling on issues arising under the Dietary Supplement Health and Education Act, the Federal Trade Commission Act, and laws of interest to dietary supplement companies. We closely follow the FDA’s development of supplement regulations and policies as well as enforcement trends. Medical foods are a unique subset of foods that are specifically designed to meet the unique nutritional requirements that may exist for managing a disease or health-related condition. Medical foods must be administered under medical supervision, and the nutrients cannot be achieved through normal modification of the diet.

FDA Food Safety Modernization Act

The Food Safety Modernization Act touches almost every segment of the U.S. food system, from farmers to manufacturers to importers to transporters, and places substantial emphasis on designing systems that are preventive. It regulates the way foods are grown, harvested, transported, and processed, and grants the FDA powers such as expanded access to records and mandatory recall authority in limited instances.

We tap into our extensive experience to help you understand and comply with FSMA and how to navigate the rules and policies in implementing it. Our long history with representing food industry clients goes back to the origin of FSMA as a bill in Congress and throughout its legislative and regulatory development. We were closely involved in drafting, negotiating, and commenting on virtually every major provision of the law. Because of our long-term involvement, we are viewed by the food industry as the go-to source for up to date and accurate FSMA information.

Understanding the critical importance of the FDA’s rulemaking activities, we represent our clients in all aspects of its work, including preventive controls for human and animal food, foreign supplier verification and related import provisions, intentional adulteration, sanitary transportation, reinspection fees, inspection activities, and traceability provisions.

Crisis Management

When a food company experiences a crisis – a foodborne disease outbreak, possible bioterrorism threat, product recall, food product tampering, government enforcement activity, or even a natural disaster – it needs a multi-disciplinary approach to crisis management. Along with the disaster comes allegations and blame, and you can often be faced with calls for government action or congressional or agency scrutiny. You need quick assessments and careful responses, and you need damage control.

Our lawyers help you prepare for and manage a crisis situation, foster the opportunity for measured response, and ensure that appropriate actions are taken by the government in the wake of the event. With our far reaching experience and contacts, our lawyers provide not only legal and regulatory counsel in crises but also frequently serve as members of companies’ crisis management teams. 

Our experience includes a comprehensive understanding of food production, processing, and distribution, complemented by an encyclopedic knowledge of the laws and regulations that apply to all aspects of food manufacturing, distribution, and marketing; the ability to reach out to a network of federal and state regulators, technical experts, laboratories, and related experience through almost 30 years of involvement with the Association of Food and Drug Officials and its committees; and public relations management experience.

Enforcement Actions

Organizations facing USDA or FDA enforcement and related actions, including investigations, inspections, and Warning Letters, need lawyers with both extensive litigation experience and in-depth knowledge of the agency and its civil and criminal enforcement actions.

Our lawyers include seasoned litigators. We regularly handle injunction and seizure actions, recalls, and crisis management. We also develop inspection policies and work to identify effective strategies to deal with counterfeit products and related security concerns. We routinely advise clients on how to manage facility inspections, address inspectional findings, respond to Warning Letters, and prepare for Regulatory Meetings with FDA.

We have a strong track record litigating all types of FDA and USDA challenges under the Administrative Procedure Act (APA), including authorization of marketing of competitor products and new regulatory burdens.

In addition, we have assisted clients involved in grand jury investigations, litigated to protect trade secrets in Freedom of Information Act (FOIA) lawsuits, and negotiated consent decrees of permanent injunction with the FDA and DOJ.

Biotechnology Regulation

With modern biotechnology presenting numerous challenges to food manufacturers, distributors, and retailers, as well as agricultural producers and technology providers, we provide international competence to companies seeking to develop and obtain government approval for new technologies, advice on labeling requirements, and review marketing and other materials for compliance with increasingly complex regulations.

Our capabilities extend beyond a comprehensive understanding of the intricacies of evolving U.S. law and regulations as administered by several government agencies to include advice on treaties such as the Biosafety Protocol of the Convention on Biodiversity and relevant World Trade Organization agreements as well as requirements of the EU and other countries.

Pre-market Authorizations

Getting your product ready for premarket review is a daunting task. There are a multitude of concerns for ensuring a positive outcome. Our lawyers, many of which have solid scientific background, have extensive experience in providing assistance in the various pre-market authorization programs. We can file the relevant dossiers on your behalf or assist you in reviewing the dossier and making recommendations to increase the likelihood of a favorable FDA review. We also often help draft the submission to FDA, organize pre-submission meetings with the agency, and correspond with agency staff regarding their review questions. Additionally, we can help you determine whether a food contact substance notification (FCN) is necessary. Our experience ranges from traditional food packaging materials to determining whether an FCN is appropriate for antimicrobial washes used for produce. We also will explore if a substance would be eligible for an exemption from FDA’s regulation as a food contact substance or food additive under the threshold of regulation. For new dietary ingredients, we can help you determine whether a new dietary ingredient notification (NDIN) is necessary.

We also help companies determine if a substance is authorized for use in animal feed. When authorization is required, we help you achieve the necessary clearances by providing the Center for Veterinary Medicine with the data that would result in their support of establishing an Association of Animal Feed Control Official (AAFCO) monograph for the new substance.

Seed and Plant Regulation

There are many intricacies within the Federal Seed Act, the Plant Variety Protection Act, seed and plant safety regulations administered by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service and the Environmental Protection Agency, Food and Drug Administration regulations of plant innovation technologies, related state statutes, and other regulations with which seed companies must comply. Managing all of the nuances can often be a daunting task.

Our lawyers are uniquely familiar with the food industry and its legal and regulatory needs. We are leaders in advising companies on the ins and outs of the many statutes and regulations governing seed production, as well as compliance with related international laws. We were intimately involved in the congressional process leading to the amendment of the Plant Variety Protection Act, as well as regulations implementing the statute. Additionally, we serve as counsel to the national trade association representing the seed industry.

We provide counsel on product approval, labeling requirements, product naming, the use of warranties and disclaimers in the sale of seed, and arbitration, as well as avoiding infringement of intellectual property. When needed, we draw upon intellectual property colleagues in obtaining patents and licenses, and in counseling you on your intellectual property rights.

Proposition 65

California’s Proposition 65 requires specific warnings on consumer products that expose Californian consumers to chemicals listed by the State as carcinogens or reproductive toxicants. Since its adoption in 1986, the Proposition 65 has materially changed the way foods and beverages are formulated and labeled. 
We leverage our attorneys’ legal and scientific knowledge in tackling issues related to compliance and enforcement with California’s Proposition 65 (Prop 65). Our experience with representing food industry clients on Prop 65 issues starts with acrylamide, a chemical that can be formed during food processing and found in many starch-rich food products.

We are at the forefront of counselling the food industry on the Prop 65’s listing of BPA, furfuryl alcohol, and glyphosate. We worked closely with many food companies and sector-specific food trade associations in developing proactive compliance strategies. Our long-standing relationship and representation of trade associations equip us with both the practical industry perspective and deep knowledge that enable us to provide Prop 65 compliance counselling in an efficient manner.