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Miriam J. Guggenheim

Partner

Washington +1 202 662 5235 mguggenheim@cov.com Download V-card

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Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and Congress. In recent years, Ms. Guggenheim has advised clients extensively regarding the federal and state legal landscapes surrounding the development and marketing of products containing cannabidiol (CBD). Chambers USA notes, Ms. Guggenheim is "incredibly sharp and very responsive" and a client reports, "I rely on Miriam tremendously to help me find ways forward in difficult and novel situations, and she never fails to deliver."

As the food industry faces new challenges – including the implementation of FSMA, new food labeling requirements including bioengineering disclosures and updates to Nutrition Facts, “clean label” and consumer transparency trends, and increasing consumer fraud litigation and Prop 65 demand letters – Ms. Guggenheim remains at the forefront of legislative and regulatory changes and food policy and litigation trends. She draws on this deep knowledge and insight to advise clients on all aspects of food development and marketing, from product ingredient sourcing and manufacturing considerations to food labeling and marketing.

For example, Ms. Guggenheim helps clients develop policies and procedures to implement new FSMA requirements, and advises clients in determining whether food ingredients are generally recognized as safe (GRAS) or whether dietary ingredients require new dietary ingredient (NDI) notifications to FDA. She helps many clients convey the health benefits of their products, including by successfully petitioning the FDA for approval of a number of health claims, and helps ensure that marketing claims are appropriately phrased and adequately substantiated. Ms. Guggenheim also advises clients regarding the most advantageous regulatory categories for the marketing of their products – whether as conventional foods, dietary supplements, or medical foods. Partnering with Covington colleagues in international offices, Ms. Guggenheim helps clients solve regulatory problems across the globe.

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Counseled numerous clients through recalls and market withdrawals, including on a global scale, to minimize business disruption, cost, and damage to brands.
Prepared 50-state surveys regarding the legal landscape surrounding the development and marketing of CBD products.
Provided strategic counseling to food and dietary supplement companies receiving warning letters from FDA, and drafted responses to such letters that succeeded in averting further enforcement action.
Provided regulatory and public health policy guidance regarding the development of a number of new food and dietary supplement products, from formulation to labeling, marketing, and website design.
Counseled clients regarding California Proposition 65 warnings and supply chain considerations.

Advised clients on bioengineering labeling and claims, including with respect to regulatory compliance and consumer fraud litigation risks.
Provided regulatory advice and due diligence on a multi-billion-dollar acquisition of a major dietary supplement company, and on many other mergers and acquisitions in the food and dietary supplement sectors.
Prepared submissions to FDA, the U.S. Congress, and local legislative bodies that documented the safety of caffeine in food and beverages and helped stave off restrictions on caffeinated products.
Provided strategic regulatory support in numerous food litigation matters.
Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
Successfully petitioned FDA for an exemption from the new Food Safety Modernization Act (FSMA) hazard analysis and preventive controls requirements for most warehouses and distribution facilities.
Advised clients regarding issues relating to marketing to children and prepared responses to FTC and CARU inquiries regarding such marketing.

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FDA Publishes Materials Clarifying Food Traceability Proposed Rule

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

FDA Issues a Draft Guidance on Voluntary Disclosure of Sesame as an Allergen

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 ...

FDA Holds Public Meeting on Food Traceability Proposed Rule

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

Key Issues for FDA in a Biden Administration

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 ...

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

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

The November Election and Implications at the FDA: Key Issues to Watch

The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...

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

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

FDA Finalizes Allulose Guidance and Requests Information on Other Sugars Metabolized Differently Than Traditional Sugars

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 ...

FDA Proposes FSMA Food Traceability Rule, Including High-Risk Food Categories

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 ...

USDA Updates: FSIS Proposes Significant Updates to Generic Label Approval Oversight, and Finalizes Rules on Modernizing Egg Inspection

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 ...

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

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

USDA Proposes Rule on Strengthening Organic Enforcement

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

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 ...

CBD companies get hit with wave of class action lawsuits

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

Eleventh Circuit Rejects "Fear of Glyphosate" Claim for Lack of Standing

On May 20, 2020, the Eleventh Circuit in Doss v. General Mills, Inc. held that a consumer who bought a box of Cheerios containing allegedly "ultra-low levels of glyphosate" lacked Article III standing to sue General Mills. "Fear of Glyphosate" class actions against food manufacturers of this type have become increasingly common. While Doss is unpublished, it is ...

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 ...

First Circuit Revives Claim That “100% Natural” Label May Be Deceptive for Products that Contain GMOs

On May 7, 2020, the First Circuit handed down Lee v. Conagra Brands, Inc., which reinstates a previously-dismissed complaint alleging that Wesson Oil labeled “100% Natural” is plausibly misbranded because it contains corn oil made with GMOs. Until now, GMO class actions have had a mixed reception in the district courts. Lee is the first circuit court decision to ...

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 ...

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 ...

How should facilities deal with COVID-19?

Miriam Guggenheim is quoted in National Products Insider regarding how food and drug facilities can manage the spread of COVID-19. Ms. Guggenheim says, “The FDA, from the perspective that this is not a food-borne illness and transmittable that way, has said that facilities will not have to shut down. The emphasis is on other employees, not the products you ...

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 ...

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.

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

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

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

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

States Could Take Bloom Off Growth Of CBD Supplement, Food Market

Miriam Guggenheim is quoted in HBW Insight regarding Congressional action to exclude hemp from the definition of “marijuana” in the Controlled Substances Act. Ms. Guggenheim says the change does not have a preemptive effect with states and creates confusion, even for some municipal governments. She adds, "The states have their own controlled substances laws and ...

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.

FDA Announces Final Guidance on Nutrition and Supplement Facts Labels

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

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

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

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

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

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

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

FDA 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.

Enforcement of the Nagoya Protocol in the Food, Drugs and Cosmetics sectors - state of play

The Nagoya Protocol to the Convention on Biological Diversity entered into force on 12 October 2014. It imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the cosmetics, food, pharmaceutical and other life science sectors. It now has more than 100 contracting parties, including the European Union.

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

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

FDA Commissioner Gottlieb Launches FDA’s New Nutrition Strategy

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

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

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

Federal Judge Enjoins Prop 65 Glyphosate Warning

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

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

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

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

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

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

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

FSIS Releases Proposed Egg Products HACCP Rule

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

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 ...

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 ...

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 ...

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

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...

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

This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through ...

House Clears GMO Labeling Bill as Eyes Turn to Rulemaking

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

FDA Stirs Debate Over Labeling Authority With Sugar Rule

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

FDA 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 ...

FDA Grapples with Nanotechnology

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals. These guidance documents reflect FDA’s understanding of nanomaterials as...… ...

Covington Promotes 10 Lawyers to Partnership

WASHINGTON, DC, October 1, 2009 — Covington & Burling LLP today announced that ten of its lawyers have been elected to the firm’s partnership effective today. The new partners practice in the corporate, litigation, and regulatory fields. The ten new partners and their practices are as follows: Marney Cheek (International) represents companies and trade ...

Lawyers credit FDA dietary supplements office for improved communications

Natural Products Insider included Miriam Guggenheim’s remarks from a recent event hosted by the Council for Responsible Nutrition. . Ms. Guggenheim, who served on a panel about areas in which the Office of Dietary Supplement Programs (ODSP) is faring well since its creation in December 2015, Ms. Guggenheim suggested the relationship has improved between ODSP ...

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Miriam J. Guggenheim

Representative Matters

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