Food, Beverage and Dietary Supplements

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Covington draws on nearly a century of experience in food and beverage law to help our clients achieve their marketing and business goals while managing regulatory and litigation risks. Our attorneys provide a full range of services to assist our clients in all aspects of product development, safety, labeling, and promotion, as well as overarching nutrition and public health policy considerations, in the United States, Europe, China, and elsewhere across the globe.

We advise leading food, beverage, and dietary supplement companies and trade associations on the broad range of issues that may arise from product conception through promotion.

Product and Ingredient Safety

We help our clients establish the safety of their products and ingredients, including through GRAS determinations, food and color additive approvals, new dietary ingredient analyses, and assessments of food biotechnology and nanotechnology. Covington attorneys are leading experts on the Food Safety Modernization Act (FSMA) and FDA’s new implementing regulations. When problems arise, our experts help companies navigate through product recalls and market withdrawals with minimal business disruption or damage to brands.

Labeling, Claims, and Marketing Considerations

We help our clients convey the attributes and benefits of their products in a compelling and compliant manner, helping them craft and substantiate health benefit claims, successfully securing FDA-authorized health claims, and analyzing the most advantageous regulatory category for their products – conventional food or beverage, dietary supplement, medical food, or food for special dietary use.

Import and Export

When products are detained at the border, we help secure their release in a timely manner to preserve the marketability of the goods. We also facilitate the export of foods across the globe by helping to secure appropriate export certificates and to ensure compliance with the requirements of the foreign markets.

Global Market Access

Where regulators in various parts of the world attempt to restrict the sale or importation of our clients’ products, we help challenge or defeat restrictions that are not based in sound science, including by leveraging the expertise of our colleagues in our International Trade and global Public Policy and Government Affairs practices.

Enforcement, Litigation, and Legislation

Where enforcement actions or litigation arise, our attorneys successfully represent clients before the FDA, FTC, NAD, and in litigation at the state and federal levels. We also take advantage of legislative opportunities and manage legislative risks, including through our representation of a number of major food and dietary supplement trade associations, for whom we help influence regulatory and legislative policy from a broad industry platform.

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Representation of an international beverage company in LCIA and UNCITRAL arbitrations

Representation of a leading Caribbean-based international beverage company in an LCIA arbitration against the former controlling shareholders of a major European-based company that was acquired by our client and in successfully handling a London-sited UNCITRAL arbitration administered by the LCIA.

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USDA Releases Questions for Input on the National Bioengineered Disclosure Standard Proposed Rule

Today, USDA’s Agricultural Marketing Service (AMS) released 30 questions to gather input from stakeholders that it will use in drafting a proposed rule as required by The National Bioengineered Food Disclosure Standard enacted last year on July 29, 2016 (click here for Covington’s client alert). By statute, AMS has two years--until July 29, 2018--to establish a national disclosure standard and the procedures necessary to implement the standard.

The “Regulatory Freeze”: What it Means for Key Food Regulatory Initiatives

On Friday, President Trump (through his Chief of Staff) issued a memorandum directing all federal agencies to place a freeze on new or pending federal regulations so that the Trump Administration can review them. This alert explains the scope of this action and analyzes its potential impact on key food regulatory initiatives.

Chinese Government Issues Policy to Slim Distribution Chain of Pharmaceuticals

On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from the distributor to the end hospital. The policy applies only to drugs, but some provinces reportedly have been implementing similar policies for medical devices.

FDA Issues Draft Guidances on Nutrition Labeling

Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of quantitative amounts of vitamins and minerals, and label format. Notably, it does not address the issue of dietary fiber, which FDA defined for the first time in the new nutrition labeling regulations. Nor does it extend the current earliest compliance deadline of July 26, 2018.

Six Covington Lawyers Named Law360 MVPs

WASHINGTON—Law360 has named six Covington lawyers as MVPs in their respective practice areas. The awards single out lawyers from across various practice areas based on their “success in high-stakes litigation, complex global matters, and record-breaking deals.” The Covington lawyers recognized as Law360 MVPs are: Shara Aranoff, International Trade. Ms. ...

Food & Beverage MVP: Covington's Jessica O'Connell

Law360 selected Jessica O’Connell as a 2016 Food & Beverage MVP and profiled her involvement in FDA’s decision to review its “healthy” labeling regulations after convincing the agency to refrain from taking legal action against Kind LLC over allegedly misleading labeling of snack bars. According to O’Connell, her intimate understanding of the FDA was helpful as ...

Global Enforcement of the Nagoya Protocol in Life Sciences Industries

In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the regime and uncertainty over its requirements.

FDA Issues Dietary Fiber Guidance and Scientific Review of 26 Fibers

On November 22, FDA issued two long-anticipated dietary fiber documents that inform its May 2016 revisions to the nutrition information required to appear on food labels: the Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30) (Draft Guidance) and the Science Review of Isolated and Synthetic Non-Digestible Carbohydrates (Science Review). FDA also provided a webpage with Questions and Answers for Industry on Dietary Fiber (Dietary Fiber Q&A).

FDA Releases Draft Guidance on “Disclosure Statement” Provisions of Four FSMA Rules

Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances in which FDA would expect covered entities to utilize the “disclosure statement” provisions, explains how the covered entity should describe the identified hazard, and discusses what type of documents may be used for the disclosure statement. Additionally, FDA reminds industry stakeholders that the entity receiving such a disclosure statement is responsible for taking appropriate steps to ensure that the identified hazards are controlled before the food reaches the consumer.

FDA Issues Enforcement Discretion Guidance and Requests Public Comments on Use of “Healthy” in Food Labeling

Today, the Food and Drug Administration (FDA) issued a guidance document communicating its intent to exercise enforcement discretion regarding certain uses of “healthy” in food labeling for products that do not meet FDA’s current “healthy” regulatory requirements but that contain predominantly “good fats” or are a good source of certain nutrients (“healthy” guidance). FDA also, separately, requested public comment on the use of the term “healthy” in food labeling, including as a nutrient content claim, and in particular in response to a citizen petition that KIND LLC submitted to FDA last December requesting changes to FDA’s “healthy” regulation (“healthy” notice). FDA has committed to redefining “healthy” to reflect current dietary recommendations and nutrition science.

Leading FDA Lawyer Joins Covington's Life Sciences Practice

LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act (FSMA). The PC rule generally requires all FDA-registered domestic and foreign food facilities to establish and implement a food safety system, documented in a written food safety plan that is prepared by a preventive controls qualified individual (PCQI) and includes an analysis of hazards and implementation of risk-based preventive controls (PCs).

FDA Issues a Final Rule on Substances Generally Recognized as Safe (GRAS) for Their Intended Use in Food

This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through regulation, the voluntary notification program that has been running as an interim pilot for nearly two decades. It also modernizes the regulations in a few key respects, sweeping out obsolete provisions about a GRAS petition process that is no longer used and replacing them with a description of the voluntary GRAS notification procedure already familiar to the food industry.

FDA Issues a Revised Draft Guidance on New Dietary Ingredients Used in Dietary Supplements

On August 11, 2016, FDA published its long-awaited revised draft guidance on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Like the 2011 draft it replaces, the revised draft guidance is intended to help a dietary supplement company decide (1) whether a substance is a dietary ingredient; (2) when a new dietary ingredient (NDI) notification is required before a dietary ingredient can be used; and (3) how to prepare and submit an NDI notification.

FDA Issues Final Rule for Registration of Food Facilities

On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA and already in effect under that law, and adds some new requirements.

House Clears GMO Labeling Bill as Eyes Turn to Rulemaking

Miriam Guggenheim is quoted in a BNA article regarding legislation passed by Congress creating a national standard for food makers to disclose genetically-modified ingredients. According to Guggenheim, while there is considerable will in the administration to resolve the GMO labeling issue, agency resources would also play a role in the rulemaking timeline. ...

Impact of Brexit on Food and Drink Regulations

Last week, the UK voted to leave the European Union in an advisory referendum. The impact of Brexit on food and drink regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. But we have set out key considerations on this below based on two proposed models being discussed.

FDA Issues Draft Guidance on Voluntary Sodium Reduction Targets

On June 1, 2016, the FDA announced draft guidance on voluntary sodium reduction targets that could have a substantial effect on food manufacturers and restaurants. The Draft Guidance proposes short-term and long-term targets for various categories of commercially processed, packaged, and prepared foods, as well as recommended upper bounds for sodium in each food category. Although voluntary for industry participants, the new sodium targets may have a significant impact on food product formulations.

FDA Issues Final Rule to Protect Food from Intentional Adulteration

On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA), which will become new 21 C.F.R. Part 121. The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the first time, domestic and foreign food facilities will be required to complete and maintain written food defense plans assessing their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.

FDA Stirs Debate Over Labeling Authority With Sugar Rule

Miriam Guggenheim is quoted in a Law360 article regarding the FDA’s new rule requiring companies to include information about added sugars on nutrition labels. According to Guggenheim, "There will be those who assert that FDA has not met its First Amendment burden to justify the compelled commercial speech." She continues, "A number of recent cases have ...

FDA Issues Final Rules on Changes to Nutrition Labels

On Friday, May 20, 2016, FDA issued two final rules to revise the nutrition labeling requirements for conventional foods and dietary supplements—the first major revisions to the nutrition labels since they were originally required over 20 years ago. Recognizing a shift in the average American’s consumption habits and understanding of the Nutrition Facts label, the two rules include changes to the content and format of the Nutrition Facts label, as well as to the reference amounts that determine the serving sizes of conventional foods. FDA also finalized conforming changes to the Supplement Facts label.

FDA Finalizes Guidance for Industry about Medical Foods

Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety requirements. This alert provides a brief background about the legal framework for medical foods and a high-level summary of the guidance, and highlights key differences between the draft guidance and final guidance.

FDA Publishes Final Rule on Sanitary Transportation of Human and Animal Food

Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use industry best practices that are likely already in place concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to satisfy the requirements in the final rule. These requirements also align in part with the hazard analysis and risk-based preventive controls requirements for food facilities that were established in FDA’s preventive control final rules for human food and animal food released earlier this year.

Chambers USA Recognizes Covington with 123 Individual, 45 Practice Nods

WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...

Covington Secures D.C. Circuit Victory Dismissing Class Action Against Milk Sellers

WASHINGTON, DC, December 7, 2007 — The U.S. Court of Appeals for the D.C. Circuit has affirmed the dismissal of a class-action lawsuit challenging the absence of warning labels on milk informing consumers of the purported risks of lactose intolerance. Covington & Burling LLP successfully represented the defendants, which included Giant of Maryland, Nestle ...

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Food, Beverage and Dietary Supplements

Representative Matters

Food Contamination Litigation

Health Benefit Claims Investigation

Deceptive Marketing and Consumer Protection Defense

Health Benefit Claim Substantiation Defense

FDA Food Labeling Comments

FSMA Advocacy

Animal Welfare Act Investigations and Compliance

Animal Health Product Import Issues

Animal Health FDA Enforcement

Animal Feed and Pet Food Ingredient Regulation

Representation of an international beverage company in LCIA and UNCITRAL arbitrations

Food Safety and Health Benefits Claims Advocacy and Implementation

New Animal Health Business Development

FDCA Amendments Legislation

Co-lead counsel for POM Wonderful

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