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Jessica P. O'Connell

Partner

Washington +1 202 662 5180 jpoconnell@cov.com Download V-card

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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 FDA-regulated products. She also regularly counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.

Ms. O’Connell works closely with food, cosmetic, and OTC clients to develop labeling and advertising options that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives, and has specific expertise regarding organic labeling, “healthy” claims, and claim substantiation requirements. Ms. O’Connell has engaged with Congress on cosmetic legislative efforts and food labeling requirements, and has prepared comments on behalf of individual companies and trade associations to FDA, USDA, and the NOSB. She also has significant expertise in issues relating the implementation of the FDA Food Safety Modernization Act (FSMA) and has advised clients both within the United States and abroad on compliance with the range of new requirements under that legislation.

Previously, Ms. O’Connell served as an Associate Chief Counsel in FDA’s Office of Chief Counsel from 2008 to 2014. While at FDA, Ms. O’Connell counseled various components of FDA and HHS on legal issues related to conventional foods, dietary supplements, and cosmetics. Specifically, Ms. O’Connell worked closely on implementing various provisions of FSMA and provided legal advice on agency actions regarding allergen labeling requirements, food additives and GRAS status, cosmetics and color additives, food and dietary supplement labeling claims, 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 regarding FDA’s import and export activities for all FDA-regulated products.

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Counsel clients during crises such as outbreak investigations, regulatory inspections with adverse findings, product recalls, and market withdrawals, including a significant FDA, CDC, and state investigation of a Hepatitis A outbreak linked to an imported food product, pathogen contamination incidents, and allergen-related recalls.
Provide regulatory and policy guidance regarding the development of a number of new food, dietary supplement, medical food, OTC drug, and cosmetic 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 client in responding to a challenge of its food marketing claims submitted through 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.
Advise clients on GMO labeling and related claims, including on potential approaches to compliance with new federal biotechnology labeling requirements.

Assist clients in complying with new FDA Food Safety Modernization Act (FSMA) and Nutrition Facts Label (NFL) 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.
Provide regulatory support in commercial litigation matters relating to food safety and contamination issues and labeling and manufacturing requirements for FDA and FSIS regulated products.
Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
Conduct regulatory due diligence evaluations for mergers and acquisitions.

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Food & Drug Law Institute, Cannabis-Derived Products Committee, Member

U.S. Food and Drug Administration, Associate Chief Counsel

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 ...

AMS Proposes Updates to its List of Bioengineered Foods

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 ...

FDA Issues Draft Guidance on Quality Considerations for Clinical Research Involving Cannabis and Cannabis-Derived Compounds

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 ...

Dietary Guidelines Advisory Committee Releases Report with Recommendations for the 2020-2025 Dietary Guidelines for Americans

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 ...

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 Submits Report on CBD Marketplace Surveillance to Congress

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 ...

USDA’s AMS Publishes Guidance on BE Testing and Validation of Refining Processes

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 ...

FDA Updates Hand Sanitizer Enforcement Discretion Guidance to Provide More Information Regarding Ethanol Sourcing

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 ...

FDA Grants Flexibility for Minor Changes to Labeled Ingredients

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 ...

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 ...

COVID-19 Updates of Relevance to the Food Industry

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 ...

China and the United States Adjust Export/Import Policies on PPE

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 ...

COVID-19 Update for Food Companies Navigating Quarantine Disruption - March 30, 2020

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

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 ...

FDA Grants Nutrition Labeling Flexibility in Response to COVID-19 Pandemic

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 ...

Over-the-Counter Monograph Reform in the CARES Act

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 ...

COVID-19 Update for Food Companies Navigating Quarantine Disruption

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 ...

FDA Addresses Implications of Coronavirus for the Nation's Food Supply

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 ...

FDA Reopens Cannabis Docket

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 ...

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 ...

FDA Reopens Comment Period on General Principles for Food Standards Modernization

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 ...

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 ...

USDA Issues Hemp Production Interim Final Rule

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 ...

FDA Grants 6-Month Period of Enforcement Discretion for New Nutrition Labeling Requirements

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 ...

A New Era of Smarter Food Safety

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.

Flavor Labeling Litigation and What It Means for Your Business

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.

FDA Releases Two New FSMA-Related Documents

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 ...

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.

EPA Seeks Comment on First Set of Hemp Pesticides and Begins to Develop Hemp/CBD Pesticide Policy

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.

Update: FDA has extended the deadline to July 16, 2019 to submit comments to FDA's public docket on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds

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 ...

FDA Issues New Proposed Rule on Regulatory Requirements for Sunscreen Products

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.”

USDA Issues Final Rule on National Bioengineered Food Disclosure Standard

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.

U.S. Congress Passes the Farm Bill and Removes Restrictions on Hemp

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.

Covington Promotes 20 New Partners

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 ...

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.

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 ...

Cosmetic Regulatory Update: Key U.S. Issues for 2018

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

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.

FDA Issues Draft Guidance On Best Practices for Convening a GRAS Panel

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.

Recent Developments from the Trump Administration and Capitol Hill Impacting Food, Beverage, and Dietary Supplements

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

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 ...

President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces

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.

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.

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 ...

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 Final Guidance for Industry on Voluntary Qualified Importer Program for Food

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 ...

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 ...

Food attorneys consider ‘healthy’ claims

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.

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 Animal Food

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 ...

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 ...

The medical foods category has an uncertain bill of health

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, ...

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 ...

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Jessica P. O'Connell

Representative Matters

Memberships and Affiliations

Previous Experience

News and Insights (Showing 5 of 115) (Showing 115 of 115)

Accolades

COVID-19: Legal and Business Toolkit

Practices

Industries

Education

Georgetown University Law Center, J.D., 2006

Johns Hopkins School of Public Health, M.P.H., 2006

University of Virginia, B.A., 2000

Government Service

Judicial Clerkship

Bar Admissions