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 Public Policy 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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IFST Issues China’s First Plant-Based Meat Standard

By: Muyun Hu On December 25, 2020, the Institute of Food Science and Technology (“IFST”) issued China’s first plant-based meat standard T/CIFST 001-2020 (the “Standard”). The Standard will take effect on June 25, 2021. The Standard is a group standard issued by a government sponsored industry association and adopted by its members.[1] Group standards can ...

FDA Publishes Materials Clarifying Food Traceability Proposed Rule

In September 2020, FDA released its Food Traceability Proposed Rule, which would impose additional traceability recordkeeping requirements on persons who manufacture, process, pack, or hold foods on FDA’s newly-created Food Traceability List (FTL). FDA has since held three public meetings on the proposed rule, during which stakeholders have raised various ...

Bite-Sized Brexit: What You Need to Know

The EU-UK Trade and Cooperation Agreement (EUTCA) reached on December 24th is a wide-ranging and complex agreement. Our Brexit Task Force offers these "bite-sized" recordings to give a snapshot of what you need to know in each area. Though the EUTCA provides the overall architecture of the future relationship in a number of areas, much of the detail must still ...

Singapore just became the first nation to approve cell-cultured meat for human consumption

Brian Sylvester spoke with The Counter about Singapore’s approval of cell-cultured meat for human consumption, the first country to do so. Mr. Sylvester says several major issues remain unresolved for now. For instance, while FDA already regulates cells cultured for biomedical use, it does not yet stipulate how similar practices should be used for food ...

FDA Holds Public Meeting on Food Traceability Proposed Rule

On November 6, 2020, the Food and Drug Administration (FDA) held the first of three public meetings regarding its Food Traceability Proposed Rule. The proposed rule, which is required by section 204 of the Food Safety Modernization Act (FSMA), would impose additional traceability recordkeeping requirements on entities that manufacture, process, pack, or hold ...

Lawyers: Congress, not FDA, will legalize CBD in supplements

Natural Food Products Insider included Miriam Guggenheim’s remarks from the "Now, New, Next" conference about the legalization of CBD products through Congress, not the FDA. Ms. Guggenheim doubts that FDA would be the one to make CBD a lawful dietary ingredient in supplements. “It will happen from Congress. It’s possible that FDA will make a little clearer ...

FDA Discusses First 100 Days of its “New Era of Smarter Food Safety”

Yesterday, the Food and Drug Administration (FDA) held a webinar to discuss key actions it has taken since releasing its New Era of Smarter Food Safety Blueprint on July 13, 2020. FDA’s New Era of Smarter Food Safety is an initiative that aims to modernize, enhance, and streamline the agency’s approach to food safety through the use of technology and other ...

Cell-Cultured Meat Startups, NAMI, Urge USDA to Gather More Data Before Issuing a Proposed Rule on Labeling

Brian Sylvester is quoted in Food Navigator regarding the USDA’s labeling of cell-cultured meats. Mr. Sylvester says that he didn't think an Advance Notice of Proposed Rulemaking (ANPR) would extend the timeline in a meaningful way. “Instead, it could actually be an efficient means of collecting needed data sooner rather than later to lay the foundation for a ...

What's in a Name? FDA Requests Info on Labeling of Cell-Cultured Seafood

Brian Sylvester spoke with Food Navigator about the labeling of cell-cultured seafood. Mr. Sylvester says, “USDA has not yet invited public comment on the labelling of cell-cultured meat & poultry but is expected to do so in due course. It is reasonable to expect that USDA will ultimately put out a similar request and will collaborate with FDA on reviewing ...

Five Things You Need to Know About OEHHA’s Proposed Rule Exempting Acrylamide-by-Cooking From Prop 65

On August 4, 2020, OEHHA, the California agency in charge of Prop 65 announced a proposed regulation that, when final, would exempt from Prop 65 products containing listed chemicals introduced through cooking or heat-processing. Acrylamide has been the most widely targeted chemical created through cooking, but the proposal would also provide a mechanism for ...

USDA Proposes Rule on Strengthening Organic Enforcement

On August 5, 2020, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a proposed rule that would amend the USDA organic regulations in an effort to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. The proposed changes come in response to concerns about the ...

FDA Launches New ERA for Smarter Food Safety Blueprint

On Monday, FDA rolled out its Blueprint for Smarter Food Safety; Modern Approaches for Modern Times. The Blueprint had been nearly ready for release several months ago, but was delayed when Covid-19 required FDA to divert its resources to responding to the pandemic. The Blueprint is intended to enhance and streamline the prevention of and response to food ...

FDA Releases Guidance on COVID-19 CGMP Considerations for Drug Manufacturers

Drug manufacturers have responded to the COVID-19 pandemic by adopting critical measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, they have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and ...

CBD companies get hit with wave of class action lawsuits

Miriam Guggenheim spoke with Politico about the proliferation of CBD retailers and manufacturers and the wave of recent class-action lawsuits. Ms. Guggenheim says, “It's an area of uncertainty. I do think this is an area where FDA has primary jurisdiction, and the courts should allow at least the questions of the legality of CBD or hemp extracts to be determined ...

FDA and USDA Publish MOU to Prevent Interruptions at FDA-Regulated Food Facilities

Earlier this week, FDA and USDA issued a Memorandum of Understanding (“MOU”) establishing how the two agencies will communicate and collaborate with respect to the potential invocation of the Defense Production Act (“DPA”). The agreement outlines how the agencies will determine whether USDA will exercise its presidentially-delegated DPA authorities over ...

Second Circuit Uses Preemption to Extinguish Slack-Fill Class Action

Slack-fill class actions have been proliferating. The vagaries of the definition of “nonfunctional slack fill” have made food, candy, and cosmetics manufacturers easy prey. But after the Second Circuit’s May 11 decision in Critcher v. L’Oréal USA Inc., slack-fill claims against cosmetics manufacturers will be harder to bring. Courts are now more likely to find ...

U.S. business takes on burden of testing employees for coronavirus

Christopher Hanson is quoted in the Financial Times regarding the private sector’s undertaking of COVID-19 testing for its employees. Mr. Hanson notes that diagnostic testing “presents an array of regulatory considerations” in the U.S., such as checking whether a test has been approved by regulators. He says that even in the U.S. “the landscape is changing ...

Food and drug regulatory specialists help turn vodka into sanitizer

Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests. Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the ...

FDA Submits CBD Report to Congress

Yesterday, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on the agency’s evaluation of potential regulatory pathways for CBD products, as well as a description of how FDA expects to proceed moving forward. In its report, FDA summarized the landscape surrounding CBD drugs, dietary supplements, foods, cosmetics, and vape ...

3 Alternative Protein Trends To Watch In 2020

Brian Sylvester noted in Forbes that litigation of alternative proteins was a trend to watch in 2020. Mr. Sylvester says these cases “could influence the ongoing regulatory conversation at the federal level around new standards of identity for both plant-based and cell-cultured meat."

Senate Bill Takes Aim at Cell-Cultured Food Labeling

Brian Sylvester spoke with Food Quality and Safety about a bill aimed at safeguarding accurate and transparent labeling of food products created using animal cell-culture technology. Mr. Sylvester says, “When it comes to food tech, both the FDA and USDA have accommodated new innovations into the existing regulatory framework for years: I think this is absolutely ...

Regulatory Questions Remain As FDA's CBD Report Deadline Looms

Jessica O'Connell spoke with Inside Health Policy about the FDA's plan to remove adulterated cannabis products from the CBD market. Ms. O'Connell says, "There’s a range of products out there that aren’t compliant, and FDA only has so many resources and can only enforce so much. I think one difference here that might be helpful is that there are these robust ...

FDA Issues CBD Consumer Update and Warning Letters

Yesterday, the Food and Drug Administration (FDA) published a consumer update on its ongoing analysis of the safety of products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). FDA also issued warning letters to 15 companies for selling CBD-containing products in violation of the Food, Drug, and Cosmetic Act (FD&C Act). These ...

Horizontal Approaches to Food Standards of Identity Modernization

FDA hosted a public meeting on September 27, 2019 entitled “Horizontal Approaches to Food Standards of Identity Modernization.” The purpose of the meeting was to discuss changes FDA could make across food standards to afford manufacturers greater flexibility and to facilitate innovation.

The Nagoya Protocol at Its 5th Anniversary: Legal Lessons Learned in the Pharmaceutical, Food and Cosmetics Sectors

📄 Download PDF of Client Alert The Nagoya Protocol on Access and Benefit Sharing is the main global mechanism to regulate the access and utilization of biological resources. The agreement entered into force nearly five years ago, on October 12, 2014, as a supplement to the 1992 Convention on Biological Diversity Today, 118 countries are a contracting party ...

Former FDA lawyer: DSHEA largely 'a success'

Peter Hutt spoke with the Natural Products Insider podcast in the second part of a discussion about the FDA’s role over the decades in regulating dietary supplements and efforts to impose restrictions that were stymied time and again. Mr. Hutt says, “FDA has not done adequate enforcement against [companies that put prescription drug ingredients in dietary ...

FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday

Miriam Guggenheim spoke with CNBC about the increasing interest around CBD. Ms. Guggenheim says, “Interest continues to skyrocket. It is mainstream, interest is mainstream. It is not fringe anymore, which doesn’t mean mainstream companies are ready to jump in. But they want to be prepared to do so once the legal landscape is clarified.”

FDA Announces Final Guidance on Nutrition and Supplement Facts Labels

Last Friday (November 2, 2018), FDA announced the availability of its final guidance, "Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry." The guidance is in the form of a Q&A that presents FDA's position on the ...

FDA Publishes Guidance on “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls”

This morning (September 26, 2018), FDA announced the availability of a draft guidance for industry and FDA staff, “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls,” that explains how and when FDA intends to publicize retail consignees that may have received recalled human or animal foods.

ACI Dietary Supplements Regulatory Forum: A 'New' FTC, Changing Supplements Facts panels, and Navigating Retailer Demands

Miriam Guggenheim spoke at the Legal, Regulatory, and Compliance Forum on Dietary Supplements and is quoted in a NutraIngredients article. Guggenheim said that a popular question she gets from industry clients around new dietary ingredients (NDIs) is whether or not an ingredient can be classified as ‘old.’ Despite lobbying from trade associations, Guggenheim ...

FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence

Miriam Guggenheim spoke at the American Conference Institute and Council for Responsible Nutrition's Legal, Regulatory, and Compliance Forum and is quoted by The Rose Sheet in an article regarding FDA's current draft guidance on new dietary ingredient (NDI) notifications. According to Guggenheim, the agency has little priority, and limited resources available ...

FDA's Intentional Food Adulteration Guide Offers Flexibility, Expert Says Details Needed

Jessica O'Connell is quoted in an Inside Health Policy article regarding FDA's draft guidance aimed at helping the food industry reduce the risk of intentional adulteration. According to O'Connell, industry has had some concerns about how prescriptive the food defense plans would be and how burdensome recordkeeping would be. She adds that many companies already ...

FDA Releases the First of Three Draft Guidances on FSMA’s Food Defense Requirements

Today (June 20, 2018), FDA published in the Federal Register the availability of the first four chapters of a nine-chapter draft guidance (“IA draft guidance”) intended to address the requirements in its final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”).

FDA Extends the Compliance Date for Removal of Partially Hydrogenated Oils From Food

FDA announced that it has extended the June 18, 2018 compliance date for removal of industrially-produced partially hydrogenated oils (PHOs) from food. Simultaneously, FDA announced that it had denied approval a 2015 food additive petition (FAP) on limited uses of PHOs.

USDA Issues Proposed Rule on National Bioengineered Food Disclosure Standard; FDA Extends Compliance Date for Nutrition Facts Label Final Rule

USDA and FDA each issued a long-awaited rulemaking document affecting food labeling. FDA issued a final rule extending the compliance date for the Nutrition Facts Label (NFL) Final Rule and the Serving Size Final Rule. For manufacturers with $10 million or more in annual food sales, FDA extended the compliance date for these rules from July 26, 2018 to January ...

FDA Commissioner Gottlieb Launches FDA’s New Nutrition Strategy

Yesterday (March 29), FDA Commissioner Scott Gottlieb kicked off the agency’s Nutrition Innovation Strategy in his keynote address, “Reducing the Burden of Chronic Disease,” delivered at the National Food Policy forum. The Strategy is intended to promote public health through improved nutrition, encourage industry innovation to create more healthful products, ...

FDA Issues Guidance on Dietary Fiber and Added Sugars and Announces “Next Steps”

On March 1, FDA issued several guidance documents related to the nutrition facts label (NFL) final rule, including: the long-awaited final guidance on the scientific evaluation of petitions requesting approval of ingredients as dietary fiber; a draft guidance on how to declare added sugars on honey, maple syrup, and certain cranberry products; a final guidance ...

Federal Judge Enjoins Prop 65 Glyphosate Warning

Yesterday (February 26, 2018), six days after hearing the motion, Judge William B. Shubb of the U.S. District Court granted, in part, a preliminary injunction, enjoining California’s Proposition 65 warning requirement for glyphosate. The court concluded that the Plaintiffs had demonstrated a likelihood of success on the merits that the State’s glyphosate warning ...

FDA Releases FSVP and Supply Chain Program Draft Guidances and Announces FSVP Enforcement Discretion

Last week (January 24, 2018), FDA issued a series of guidance documents and an enforcement discretion policy intended to help the food industry comply with the requirements of the Food Safety Modernization Act (FSMA). The documents further FDA’s goal to ensure that all food under its jurisdiction is produced under procedures that comply with its risk-based food ...

FDA Announces Broad Plan to Improve and Expedite Dissemination of Recall Information to Consumers

FDA announced the availability of a new draft guidance in last Friday’s Federal Register that Commissioner Gottlieb explains describes FDA’s policy on public warning and recall notifications, which “gives industry clear direction on how to navigate and work with the FDA to make sure recalls are communicated promptly,” and “will empower consumers by providing ...

FDA Announces “Nutrition Action Plan” while Stakeholders await Final Guidance on Nutrition Labeling

As we near the two year mark since FDA issued the new Nutrition Facts Label (NFL), stakeholders anxiously await FDA’s final NFL guidance, particularly FDA’s conclusions on the pending fiber petitions and other fiber ingredients. Although FDA proposed last fall to extend the July 26, 2018 compliance date until January 1, 2020 (for large companies and January 1, ...

FSIS Releases Proposed Egg Products HACCP Rule

On Tuesday, January 9, 2018, USDA’s Food Safety and Inspection Service (FSIS) released a proposed rule that would require egg products plants to develop and implement hazard analysis and critical control point (HACCP) plans, Sanitation Standard Operating Procedures (SOPs), and include safe-handling instructions on the labels of certain egg products.

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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” ...

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 ...

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 ...

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) ...

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

Q&A With Covington's Gerald Masoudi

Gerald Masoudi is featured in a Q&A with Law360 discussing the trends from food and drug matters and the recent updates from the FDA. In the first question, “What is the most challenging case you have worked on and what made it challenging?,” Mr. Masoudi says: “While I was chief counsel at FDA, I was involved in cases raising the question of whether ...

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

EU and U.S. Food Regulatory Requirements and Approvals

Co-lead counsel for POM Wonderful

Animal Feed and Pet Food Ingredient Regulation

Animal Health FDA Enforcement

Animal Health Product Import Issues

Animal Welfare Act Investigations and Compliance

FDCA Amendments Legislation

Food Safety and Health Benefits Claims Advocacy and Implementation

New Animal Health Business Development

Representation of an international beverage company in LCIA and UNCITRAL arbitrations

News and Insights (Showing 5 of 174) (Showing 174 of 174)