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- Home
- Practices and Industries
- Regulatory and Public Policy
- Food, Drug, and Device
- Food Beverage and Dietary Supplements
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.
Food Contamination Litigation
Successfully warded off potential California Proposition 65 lawsuits regarding 4-MEI in sodas and lead in juices, and successfully represented companies in litigation regarding lead in chocolate and mercury in tuna.
Health Benefit Claims Investigation
Defense of beverage manufacturer in FTC investigation of substantiation for health benefit claims in advertising.
Deceptive Marketing and Consumer Protection Defense
Defense of beverage marketer against allegations of deceptive marketing under the District of Columbia Consumer Protection Procedures Act.
Health Benefit Claim Substantiation Defense
Successfully defended the substantiation for health benefit claims made by a food manufacturer facing a challenge before the NAD.
FDA Food Labeling Comments
Prepared influential comments to FDA on behalf of major food trade association clients regarding front-of-pack (FOP) labeling and potential changes to the Nutrition Facts panel.
FSMA Advocacy
On behalf of a major food trade association, helped influence the development of the FDA Food Safety Modernization Act (FSMA) to minimize unnecessary and costly burdens on industry.
Animal Welfare Act Investigations and Compliance
Defense of administrative compliance actions and investigations brought by the USDA under the Animal Welfare Act and assistance with conducting internal investigations related to such actions.
Animal Health Product Import Issues
Representation of animal food and drug clients in connection with FDA and USDA import detentions, import refusals, re-exportations and destructions of refused imports, and successful petitions for removal from FDA Import Alerts.
Animal Health FDA Enforcement
Assist animal health companies successfully respond to FDA enforcement actions, including Warning Letters and Form 483 observations.
Animal Feed and Pet Food Ingredient Regulation
Working with pet food and animal feed companies on preparing and filing GRAS notifications, food additive petitions and AAFCO feed ingredient definition applications for animal feed and pet food ingredients.
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.
Food Safety and Health Benefits Claims Advocacy and Implementation
Helped influence the development of the FDA Food Safety Modernization Act (FSMA) to minimize unnecessary and costly burdens on industry, and represent clients with respect to food safety laws, health benefits claims, and compliance matters.
New Animal Health Business Development
Assist client in designing, planning, and establishing a significant new animal health business.
EU and U.S. Food Regulatory Requirements and Approvals
Advising a range of Irish companies on EU and U.S. food regulatory requirements and compliance.
Co-lead counsel for POM Wonderful
Co-lead counsel for POM Wonderful in landmark advertising litigation with FTC concerning health claims for food products.
FDCA Amendments Legislation
Representation of industry stakeholders in negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
October 2, 2019, Covington Alert
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.
September 18, 2019
<div data-experience="5d7aafbe36cb1c0021630fa5"> 📄 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 ...
Former FDA lawyer: DSHEA largely 'a success'
August 23, 2019, Natural Products Insider
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 ...
History of FDA Oversight of Dietary Supplements
August 15, 2019, Natural Products Insider
Peter Hutt spoke with the Natural Products Insider podcast about the FDA’s role over the decades in regulating dietary supplements and efforts to impose restrictions that were stymied time and again.
FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday
May 30, 2019, CNBC
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.”
November 6, 2018
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 ...
September 26, 2018, Covington Alert
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
June 27, 2018, Nutralngredients
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 ...
June 26, 2018, The Rose Sheet
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
June 25, 2018, Inside Health Policy
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 ...
June 20, 2018, Covington Alert
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”).
June 14, 2018, Covington Alert
Today, FDA issued a guidance document announcing its intention to add eight new isolated or synthetic non-digestible carbohydrates (NDCs) to the regulatory definition of “dietary fiber."
May 18, 2018, Covington Alert
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.
May 4, 2018, Covington Alert
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 ...
March 30, 2018, Covington Alert
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, ...
March 5, 2018, Covington Alert
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 ...
February 27, 2018, Covington Alert
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
January 30, 2018, Covington Alert
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
January 22, 2018, Covington Alert
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
January 16, 2018, Covington Alert
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, ...
January 11, 2018, Covington Alert
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
June 28, 2017, Covington Alert
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 ...
January 23, 2017, Covington Alert
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.
January 23, 2017, Covington Alert
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 ...
January 5, 2017, Covington Alert
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
January 3, 2017
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
December 20, 2016, Law360
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 ...
December 7, 2016, Covington Alert
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 ...
November 30, 2016, Covington Alert
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 ...
November 2, 2016, Covington Alert
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 ...
September 27, 2016, Covington Alert
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” ...
August 31, 2016
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 ...
August 25, 2016
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 ...
August 17, 2016, Covington Alert
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 ...
August 15, 2016, Covington Alert
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) ...
July 18, 2016, Covington Alert
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 ...
July 14, 2016, Bloomberg BNA
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. ...
June 30, 2016, Covington Alert
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 ...
June 2, 2016, Covington Alert
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 ...
May 31, 2016, Covington Alert
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
May 25, 2016, Law360
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 ...
May 23, 2016, Covington Alert
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, ...
May 16, 2016, Covington Alert
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 ...
April 7, 2016, Covington Alert
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 ...
January/February 2016, Update
November 25, 2015, Covington Alert
November 17, 2015, Covington Alert
November 17, 2015, Covington Alert
November 17, 2015, Covington Alert
April 28, 2014, Covington E-Alert
February 21, 2014, Covington E-Alert
February 5, 2014, Covington E-Alert
FDA Issues Guidance Documents Relating to Liquid Dietary Supplements and Substances Added to Foods
January 16, 2014, Covington E-Alert
September 24, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
August 8, 2013, Covington E-Alert
July 30, 2013, Covington E-Alert
June 25, 2013, Covington E-Alert
May 17, 2013, Covington E-Alert
January 10, 2013, Covington E-Alert
Biennial Registration for Food Facilities to Begin Soon, Despite Uncertainties About Requirements
September 27, 2012, Covington E-Alert
August 16, 2012, Covington E-Alert
April 24, 2012, Covington E-Alert
October 24, 2011, Covington E-Alert
June 10, 2011
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 ...
May 25, 2011, Covington E-Alert
April 29, 2011, Covington E-Alert
April 6, 2011, Covington E-Alert
April 4, 2011, Covington E-Alert
February 2, 2011, Covington E-Alert
January 25, 2011, Covington E-Alert
January 3, 2011, Covington E-Alert
IOM Holds First Phase II Committee Meeting on Front-of-Package Nutrition Rating Systems and Symbols
October 29, 2010, Covington E-Alert
October 25, 2010, Covington E-Alert
October 14, 2010, Covington E-Alert
FDA Issues Draft Guidance Regarding Implementation of the New Federal Menu Labeling Requirements
August 25, 2010, Covington E-Alert
June 10, 2010, Covington E-Alert
May 13, 2010, Covington E-Alert
April 29, 2010, Covington E-Alert
April 22, 2010, Covington E-Alert
April 12, 2010, Covington E-Alert
March 23, 2010, Covington E-Alert
March 10, 2010, Covington E-Alert
December 16, 2009, Covington E-Alert
June 19, 2009, Covington E-Alert
February 5, 2009, Covington E-Alert
February 2, 2009, Covington Advisory
January 28, 2009, Covington E-Alert
January 26, 2009, Covington E-Alert
January 9, 2009, Covington E-Alert
January 7, 2009, Covington E-Alert
November 14, 2008, Covington E-Alert
August 8, 2008, Covington E-Alert
August 1, 2008, Covington E-Alert
December 26, 2007, Covington E-Alert
December 7, 2007
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 ...
November 28, 2007, Covington E-Alert
November 26, 2007, Covington E-Alert
September 3, 2007, Covington E-Alert
May 2, 2007, Covington E-Alert
April 17, 2007, Covington E-Alert
January 29, 2007, Covington E-Alert
December 14, 2006, Covington E-Alert
December 7, 2006, Covington E-Alert
November 10, 2006, Covington E-alert
July 7, 2006, Covington E-Alert
March 7, 2006, Covington E-Alert
February 10, 2006, Covington E-Alert
December 19, 2005, Covington E-Alert