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- Home
- Professionals
- Jessica P. O'Connell
Drawing from more than a decade of experience both working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. She assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of all FDA-regulated products. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention. Chambers USA reports that Ms. O’Connell has “fantastic regulatory insight and understanding.”
Ms. O’Connell works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives. She has engaged with Congress on cosmetic and drug legislative efforts and alternative meat and other food labeling requirements and has represented clients in both FDA and FTC investigations, including negotiating consent decrees, and in matters before the NAD. Ms. O’Connell has specific expertise regarding the federal and state legal landscapes surrounding the development and marketing of products containing cannabidiol (CBD), the regulatory framework for alternative protein ingredients and products, Proposition 65, organic labeling, and claim substantiation requirements, as well as newly implemented manufacturing and supply chain requirements under FSMA.
Previously, Ms. O’Connell served as an Associate Chief Counsel in FDA’s Office of Chief Counsel, until 2014. While at FDA, Ms. O’Connell counseled various components of FDA and HHS on a broad range of legal issues, and including FDA’s implementation of FSMA and agency actions regarding product marketing claims and intended use, food additives and GRAS status, cosmetics and color additives, medical foods, and foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Ms. O’Connell provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.
- Counsels clients during crises such as outbreak investigations, consent decree negotiations, civil investigative demands, regulatory inspections with adverse findings, product recalls, and pathogen contamination incidents, including a significant FDA, CDC, and state investigation of a Hepatitis A outbreak linked to an imported food product.
- Provides regulatory and policy guidance regarding the development of food, dietary supplement, medical food, OTC drug, cosmetic, and CBD containing products, from formulation to labeling, marketing, and website design, including strategies for minimizing risk of consumer fraud or class action litigation and compliance with state requirements such as Proposition 65.
- Assisted multiple clients in successfully responding to marketing claim challenges before the NAD and the Advertising Self-Regulatory Council.
- Advised client in engagement with FDA regarding warning letter about labeling claims that led to successful resolution of all issues; assisted in developing a related citizen petition requesting that FDA update its “healthy” food labeling regulations consistent with current nutrition science.
- Provides advice regarding the federal and state legal landscape surrounding the development and marketing of CBD products, including engagement with FDA on critical regulatory and scientific issues.
- Represented multiple clients – both corporations and individuals in their personal capacity – in consent decree negotiations with DOJ and FDA.
- Advises clients on bioengineering labeling and related claims, including on potential approaches to compliance with new federal biotechnology labeling requirements.
- Assists clients in complying with new FDA Food Safety Modernization Act and Nutrition Facts Label requirements.
- Successfully petitioned for removal of clients and clients’ suppliers from FDA Import Alerts, and assisted a number of clients in obtaining releases of imported products held by FDA.
- Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
- Conducts regulatory due diligence evaluations for mergers and acquisitions.
Pro Bono
- Advises research institutions and advocacy groups on regulatory strategy for efforts to expand reproductive rights and access.
- Serves as General Counsel to the Hemp and Cannabinoid Science Institute.
- Advises standard setting organizations regarding the development of critical standards for sustainability in food manufacturing.
Memberships and Affiliations
- Food & Drug Law Institute, Cannabis-Derived Products Committee, Member
Previous Experience
- U.S. Food and Drug Administration, Associate Chief Counsel
January 21, 2021, Covington Alert
Consumer products companies have been facing a surge of mislabeling lawsuits in the District of Columbia. These lawsuits are exploding in part due to recent court decisions that purport to grant “tester” plaintiffs—individuals and organizations that purchase products simply to test whether the representations about a product are true—a right to sue on behalf of ...
January 13, 2021, Covington Alert
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 ...
December 23, 2020, Covington Alert
On December 21, 2020, the United States Department of Agriculture (USDA) released an Advanced Notice of Proposed Rulemaking (ANPR) to seek comment on a contemplated regulatory framework that, if finalized, would transition to USDA portions of the Food and Drug Administration’s (FDA’s) pre-existing animal biotechnology regulatory oversight. In particular, USDA ...
December 18, 2020, Food Safety News
November 11, 2020, Covington Alert
Yesterday, FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”) issued a draft guidance regarding the voluntary labeling of sesame when used in flavoring or spice or in a food declared by another name, such as tahini. The Federal Register notice will officially be published on Thursday. We briefly summarize the draft guidance below to help inform ...
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
November 9, 2020, Covington Alert
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 ...
October 27, 2020, Covington Alert
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 ...
October 20, 2020, Covington Alert
FDA has taken two notable actions regarding the sugars declaration in the Nutrition Facts Label (NFL) and Supplement Facts Label (SFL). On Friday, the agency released a final guidance regarding the declaration of allulose, confirming that this monosaccharide need not be included in the declaration of “Total Sugars” or “Added Sugars,” though it must be included ...
September 22, 2020, Covington Alert
Yesterday, FDA released a proposed rule that, if finalized, would impose additional traceability recordkeeping requirements for certain high-risk foods. This rulemaking is required by section 204 of FSMA, and is an additional action in FDA’s ongoing FSMA implementation. FDA proposes to establish a “Food Traceability List” (FTL) that would enumerate certain foods ...
September 15, 2020, Covington Alert
The first half of September has seen two major regulatory updates from USDA’s Food Safety and Inspection Service (FSIS). First, on September 14, 2020, FSIS published a proposed rule to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products, which specifically proposes that FSIS will cease evaluating ...
August 7, 2020, Covington Alert
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 ...
July 24, 2020, Covington Alert
On July 24, 2020, the United States Department of Agriculture’s Agricultural Marketing Service (“AMS”) published proposed updates to its list of bioengineered (“BE”) foods. Under the National Bioengineered Food Disclosure Standard (“NBFDS”), manufacturers, importers, and certain retailers must make a BE disclosure for foods on this list or foods containing ...
July 22, 2020, Covington Alert
Yesterday, the Food and Drug Administration (FDA) issued draft guidance describing the agency’s thinking on topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. While the draft guidance is limited to drug development and does not address other types of products, some of FDA’s thinking may ...
July 16, 2020, Covington Alert
On July 15, the 2020 Dietary Guidelines Advisory Committee (DGAC) released its final report to the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), outlining its recommendations for the 2020-2025 Dietary Guidelines for Americans (Dietary Guidelines). The Dietary Guidelines, a joint effort of HHS and USDA, provide the ...
July 15, 2020, Covington Alert
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 ...
July 10, 2020, Covington Alert
On July 8, the Food and Drug Administration (FDA) submitted a report to Congress describing the results of the agency’s sampling and testing of products in the CBD marketplace. The Further Consolidated Appropriations Act, 2020 required FDA to perform the study to help determine the extent to which such products are mislabeled or adulterated. In this report, FDA ...
July 7, 2020, Covington Alert
On July 2, 2020, USDA’s Agricultural Marketing Service (“AMS”) published final guidance documents and FAQs to assist companies in complying with the National Bioengineered (“BE”) Food Disclosure Standard (“NBFDS”). Under the NBFDS, a responsible party need not make a BE disclosure for a BE food if the party can show (1) the food is sourced from a non-BE crop or ...
June 4, 2020, Covington Alert
Today, FDA issued updates to its guidance document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),"("Temporary Policy") and related guidance document, that primarily provide more detailed information about potential ethanol sources for companies seeking to prepare hand sanitizer or ...
May 26, 2020, Covington Alert
On May 22, 2020, FDA issued a temporary policy permitting manufacturers to use existing labels even if they need to make minor ingredient changes due to supply chain disruptions caused by the COVID-19 public health emergency. Limited shortages and other disruptions in the supply of food ingredients have already occurred, and manufacturers may experience ...
May 22, 2020, Covington Alert
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 ...
May 21, 2020, Covington Alert
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 ...
May 4, 2020, Covingotn Alert
Since Covington’s last client alert on developments for the food industry during the COVID-19 public health crisis, the Occupational Safety and Health Administration (“OSHA”) and the Centers for Disease Control and Prevention (“CDC”) have posted a number of updates of interest to the industry. Additionally, President Trump has issued an Executive Order ...
April 27, 2020, Covington Alert
Since Covington’s last client alert on developments for the food industry during the COVID-19 public health crisis, FDA and USDA have posted a number of updates of interest to the industry.
April 21, 2020, Covington Alert
Since Covington’s last client alert on substantive FDA developments for the food industry during the COVID-19 public health crisis, the agency has posted a number of updates of interest to the industry.
April 6, 2020, Covington Alert
This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...
March 30, 2020, Covington Alert
On March 28, 2020, the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) updated its March 19, 2020 “Essential Critical Infrastructure Workforce” advisory list. These updates largely focus on clarifying which workers CISA considers to be essential, which may be helpful for the human and animal food industries. At the same ...
FDA Issues Fact Sheet on Safely Distributing Unused Human Food for Animal Food Use During COVID-19
March 30, 2020, Covington Alert
On Friday, March 27, 2020, FDA’s Center for Veterinary Medicine (CVM) issued a Fact Sheet on “Safely Distributing Unused Human Food for Animal Food Use During COVID-19.” The advisory accompanying the Fact Sheet explains that because of COVID-19-associated restrictions on in-store dining, certain businesses may have surplus food that, if not usable for human ...
March 27, 2020, Covington Alert
As numerous restaurants have shut down or limited their service in response to state and local public health orders, many food manufacturers and foodservice distributors have excess inventory on hand that is labeled for use in restaurants, but not for retail sale. Yesterday, in response to industry requests for labeling flexibility in order to shift such ...
March 27, 2020, Covington Alert
On March 27, 2020, Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Subtitle F of the CARES Act would significantly change FDA’s regulations of over-the-counter (OTC) monograph drugs subject to OTC Drug Review. Congress had introduced earlier versions of the bill, with the latest bill, S. 2740 – Over-the-Counter ...
March 24, 2020, Covington Alert
Over the past several weeks, states and localities across the country have implemented wide-ranging quarantines and curfews meant to slow the spread of COVID-19. Some of these measures have impeded food companies’ efforts to manufacture and distribute critical goods to their intended destinations. Even as the federal government underscores the importance of food ...
March 19, 2020, Covington Alert
Over the past forty-eight hours, FDA has issued a range of helpful information about the potential implications of COVID-19 for the food supply, including the agency’s current position regarding food safety and COVID-19, guidance concerning supplier verification onsite audit requirements, and an announcement that FDA has suspended routine surveillance facility ...
March 11, 2020, Covington Alert
FDA has reopened the comment period indefinitely for its public hearing on products containing cannabis or cannabis-derived compounds.In doing so, FDA is seeking scientific data and information on cannabis and cannabis-derived compounds, particularly cannabidiol (CBD). On May 31, 2019, FDA hosted a public hearing on “Scientific Data and Information About ...
March 6, 2020, Covington Alert
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 ...
February 21, 2020, Covington Alert
Today, the Food and Drug Administration (FDA) announced in the Federal Register that it is reopening the comment period for its 2005 proposed rule regarding the modernization of its food standards of identity. FDA’s standards of identity establish detailed requirements regarding the composition and manufacturing of food products. The Agency promulgated most of ...
January 9, 2020, Inside Health Policy
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 ...
November 26, 2019, Covington Alert
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 ...
October 31, 2019, Covington Alert
Today, the U.S. Department of Agriculture (USDA) issued the long-awaited interim final rule (“the rule”) establishing regulations for a domestic hemp production program. The rule provides clarity for hemp growers and related businesses and is a critical next step after the passage of the 2018 Farm Bill last December. Among other things, the rule outlines ...
October 24, 2019, Covington Alert
Yesterday, FDA announced that it will grant a 6-month period of enforcement discretion for manufacturers to meet the agency's new nutrition labeling requirements. In an updated Q&A on FDA's webpage for Industry Resources on Changes to the Nutrition Facts Label, FDA added the following: I understand that FDA has received multiple requests from manufacturers to ...
October 24, 2019, Covington Alert
FDA hosted a public meeting on October 21, 2019 entitled “A New Era of Smarter Food Safety.” The purpose of the meeting was to obtain stakeholder input on the Agency’s food safety initiative launched in April 2019 and inform a strategic blueprint expected to be issued in early 2020.
October 18, 2019, Covington Alert
Vanilla-flavored yogurt, ice cream, almond and soy milk have all been caught in the crosshairs recently, targeted by more than a dozen class action lawsuits filed since May 2019 by the same New York-based law firms Sheehan & Associates and Reese LLP.
October 7, 2019, Covington Alert
FDA has been active on the FSMA front, and released two new documents over the last few days. Last Friday, October 4, the Agency issued a draft guidance regarding establishing and implementing a recall plan under 21 CFR 117.139, the provision of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC Human ...
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.
EPA Seeks Comment on First Set of Hemp Pesticides and Begins to Develop Hemp/CBD Pesticide Policy
September 3, 2019, Covington Alert
The Agricultural Improvement Act of 2018 (the 2018 Farm Bill) has created a rapidly-expanding market for hemp-derived products by legalizing the cultivation of hemp, which can be processed to make a variety of goods, including cannabidiol (“CBD”) products.
June 6, 2019, Covington Alert
Last Friday (May 31, 2019), FDA hosted a public hearing on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” The hearing followed FDA’s notice in the Federal Register on April 3, 2019, announcing the public hearing and establishing a public docket to obtain information related to cannabis and cannabis-derived ...
February 22, 2019, Covington Alert
Yesterday, FDA issued a much anticipated updated proposed rule on regulatory requirements for over the counter (OTC) sunscreen products. The proposed rule, if finalized, would require significant formulation changes in a number of marketed products that contain sunscreens, including both “beach products” and “cosmetic drugs.”
December 21, 2018, Covington Alert
Today, USDA published its long-awaited final rule that establishes the requirements for disclosing bioengineered (BE) foods.1 This alert briefly summarizes the final definition of BE food, the foods that are subject to the BE disclosure, the required BE disclosures, the recordkeeping requirements, and the rule’s implementation and compliance dates.
December 13, 2018, Covington Alert
On December 12, 2018, the House passed H.R. 2, the Agricultural Improvement Act of 2018 (“the Farm Bill”). The vote follows the Senate’s passage of the bill on December 11, 2018. If President Trump signs the bill, it would change the regulatory status of hemp and hemp products.
Spotlight on Nutrition Facts Label Compliance – A Guide for Compliance
October 16, 2018, Momentum Food & Beverage Exchange, Chicago, IL
Impactful Consumer Claims – Will FDA’s Planned Overhaul of Food Claims Move the Needle as Consumers Look for Other Benefits
October 3, 2018, RAPS Regulatory Convergence, Vancouver BC
Modernizing Regulations for Specialized Foods: A Multi-Stakeholder Approach
October 3, 2018, RAPS Regulatory Convergence, Vancouver BC
Covington Promotes 20 New Partners
October 1, 2018
WASHINGTON—Covington has promoted 20 lawyers to its partnership. “This group covers a wide range of the firm’s most important practices and reflects the ongoing imperative of continuing to build and expand our strengths and to position the firm most effectively to be vibrant in the years ahead,” said Timothy Hester, Covington’s chair. "The size of our class is a ...
Innovative Foods: How are they Regulated?
September 26, 2018, Food Advertising, Labeling, and Litigation Conference: For the Food and Dietary Supplement Industries, Washington, DC
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.
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."
USDA’s Proposed Bioengineered Food Disclosure Standard – Key Issues and Next
June 14, 2018, FDLI Webinar
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 ...
Food Standards of Identity: Enforcement and Compliance Issues
April 12, 2018, Food and Drug Law Institute Food Enforcement and Compliance Conference, Washington, DC
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 ...
Prop 65 – Key Updates and Hot Topics
February 2018, Food Policy Impact Conference
January 24, 2018, Covington Alert
As we begin 2018, the cosmetic industry marketing products in the United States faces a range of legal and regulatory considerations – from labeling and marketing claims to ingredient safety and environmental issues. This alert for our cosmetic clients analyzes federal regulatory activities in 2017 and summarizes key issues to consider for 2018, including ...
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.
November 17, 2017, Covington Alert
Earlier this week, FDA issued a long-anticipated draft guidance on best practices to follow when convening an expert panel to evaluate whether a substance is “generally recognized as safe,” or GRAS, under the conditions of its intended use in food.
FDA, USDA, and EPA: Inter-Agency Overlap and Jurisdictional Boundaries
November 9, 2017, Webinar
Federal Cosmetics Reform Legislation – what’s happening and what it means for cosmetics companies
November 2017, PCPC Emerging Issues Conference
Navigating Regulatory Requirements for Ingredients in These Times of Transition: Moving Forward with ODIs as Industry Awaits NDI Final Guidance
October 1, 2017
September 8, 2017, Covington Alert
As part of the Trump Administration’s move towards regulatory efficiency, FDA announced yesterday and published today in the Federal Register, the opportunity for public input on the Administration’s comprehensive review of its regulations.
The Food Industry’s Current & Future Regulatory Environment
September 2017, Cargill Sweetness Summit
July 26, 2017, Covington Alert
A few interesting developments took place in Washington DC last week that are relevant to the food, beverage, and dietary supplement sectors. Last Thursday, July 20, 2017, the Trump Administration published its Spring 2017 Unified Agenda with the aim to significantly limit agency activity. The same day, the Senate Appropriations Committee proposed a FY 2018 ...
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 ...
Claims Substantiation Master Class
May 25, 2017, ACI Food Law & Regulation Forum
Beyond the Label: Dealing with Practical Implications of the New Nutrition Facts Label
May 24, 2017, ACI Food Law & Regulation Forum
The Food Industry’s Current and Future Regulatory Environment
May 23, 2017, 2017 Protein Trends & Technology Seminar
President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces
February 28, 2017, Covington Alert
On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Executive Order” or the “Order”). The Order is one of several actions the Trump Administration has taken concerning regulatory reform since inauguration.
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 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 ...
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 14, 2016, Covington Alert
On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...
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 ...
Food attorneys consider ‘healthy’ claims
September 16, 2016, Food Chemical News
Jessica O’Connell participated in the Food and Drug Law Institute’s Food Advertising, Labeling, and Litigation Conference and is quoted in a Food Chemical News article regarding “healthy” claims. According to O’Connell, FDA considers “healthy” not to be an implied nutrient content claim when it refers to general dietary guidance.
US Legal Framework Governing Specialized Nutritional Products & Recent Enforcement Trends
September 2016, RAPS Regulatory Convergence
The Hullaballoo about ‘Healthy’ - A Case Study
September 2016, FDLI Food Advertising, Labeling, and Litigation Conference
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 18, 2016, Covington Alert
Nineteen years after first publishing its proposal, FDA published in yesterday’s Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in human and animal food. This Alert addresses the final rule as it applies to food for animals. For an analysis of how the final rule will affect human food, see our Alert “FDA ...
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 ...
July 28, 2016, Food Dive
Jessica O’Connell spoke at the IFT expo and is quoted in a Food Dive article regarding medical food products. O’Connell, commenting on how companies have tried to develop medical food, said the most common warning letters sent out by the FDA since 2006 use the words no “distinctive nutritional requirement” for the disease or condition. She added that since 2009, ...
Legal Framework Governing Medical Foods & Recent Enforcement Trends
July 2016, IFT Annual Meeting
FDA Final Rules Updating Nutrition Labeling Requirements: Key Issues for Industry
June 22, 2016, Webinar
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 ...
Menu and Vending Machine Labeling: A review of FDA’s Final Rules
February 2016, Food Litigation ExecuSummit
The Regulation of Cosmetics
February 2016, FDLI Introduction to Food Law & Regulation Conference
January/February 2016, Update
November 25, 2015, Covington Alert
November 17, 2015, Covington Alert
November 17, 2015, Covington Alert
November 17, 2015, Covington Alert
GMO Labeling and Litigation Update
September 24, 2015, FDLI Food Advertising and Litigation Conference
September 18, 2015, Covington Alert
September 17, 2015, Covington Alert
July 28, 2015, Covington Alert
7/27/2015, Covington Alert
June 8, 2015, Covington Alert
June 3, 2015, Covington Alert
Medical Foods: Recent FDA Activity & Oversight
November 7, 2014, Council for Responsible Nutrition Annual Conference
September 23, 2014, Covington E-Alert
September 23, 2014, Covington E-Alert
September 23, 2014, Covington E-Alert
2006, 12 J Public Health Manag Pract 340
2005, 68 J Environ Health 44
2004, 2 Biosecur Bioterror 73
- Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2018-2020)
- The Best Lawyers in America, FDA Law (2021)
- Law360, Food & Beverage MVP (2016)

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