As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol manufacturers, are seeking to produce alcohol-based hand sanitizers using certain food grade materials, or to produce alcohol to be used in production of such sanitizers. In recent days, federal agencies such as the Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have relaxed certain regulatory requirements for the production of alcohol-based hand sanitizers, in part, to respond to the call for food grade materials in such hand sanitizer products. This post provides a brief overview of the recently issued guidance, reflecting updates made to the FDA policies as of March 27 and to the TTB policies as of March 26.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, D.C.

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands…

Partner, Washington, D.C.

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).

Photo of Joe Levitt Joe Levitt

Partner, Washington, D.C.

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience…

Partner, Washington, D.C.

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience puts clients in the best position to succeed.  In the private sector, Joe was on the ground floor when Congress developed the landmark FDA Food Safety Modernization Act (FSMA). Joe was also a leading voice for the food industry when the FDA developed regulations that all food companies must now follow. No one can help navigate the labyrinth of FDA’s FSMA regulations better than Joe and his team, and no one can better put your company in the driver’s seat when the FDA inspector knocks on your door for your first FSMA inspection.

Joe adeptly handles high visibility recalls and compliance actions. If a company finds itself in trouble with the FDA, they need someone with a deep insider’s understanding of what works and what doesn’t. Joe knows what the agency expects in the compliance arena, and the bar clients will be expected to meet. He can communicate his client’s position calmly and effectively to the FDA so the matter gets put behind them. His record of “helping startups and multinational companies… survive Food and Drug Administration investigations and avoid import bans that could shutter the companies,” led to Joe being named a Law360 Food & Beverage MVP (2016).

Joe is among the most decorated officials in FDA history, with his achievements being recognized by multiple U.S. presidents, cabinet secretaries, and FDA Commissioners. He maintains close working relationships with senior FDA officials and has served as the Board Chair of the FDA Alumni Association.

Photo of David Horowitz David Horowitz

Partner, Washington, D.C.

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the FDA to help clients anticipate and navigate regulatory challenges, and participating in the policy-making process.

As Deputy General Counsel at…

Partner, Washington, D.C.

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the FDA to help clients anticipate and navigate regulatory challenges, and participating in the policy-making process.

As Deputy General Counsel at HHS (2010-2017), David oversaw and coordinated legal services in support of FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and international and emergency preparedness programs. His work focused on FDA regulatory policy and litigation. During his tenure at FDA – which included five years as head of the Office of Compliance for drugs, and three years as Assistant Commissioner for Compliance Policy – David played a leadership role in major initiatives, including the modernization of FDA’s approach to pharmaceutical manufacturing quality and the agency’s efforts to develop and implement a more scientific, risk-based approach to inspection and enforcement.

Over the course of his career at HHS and FDA, David developed substantial knowledge pertaining to FDA law and policy, with particular emphasis on pharmaceuticals, compliance, and the application of administrative law. He also developed a deep understanding of the institutions, organizational structures, procedures, and cultures through which regulatory policy and compliance decisions are considered, developed, and implemented across all branches of government, including Congress and the courts, as well as various components of FDA, HHS, Office of Management and Budget, Department of Justice, and the White House.

Photo of Veronica Colas Veronica Colas

Senior Associate, Washington, D.C.

Veronica Colas counsels clients on the regulations and policy issues affecting food companies from farm to table. She represents all segments of the food industry, including manufacturers, retailers, restaurants, and food service companies, as well as their trade associations.…

Senior Associate, Washington, D.C.

Veronica Colas counsels clients on the regulations and policy issues affecting food companies from farm to table. She represents all segments of the food industry, including manufacturers, retailers, restaurants, and food service companies, as well as their trade associations.
Veronica provides clear advice and practical solutions for compliance with labeling, advertising, and safety regulations from the Food and Drug Administration (FDA), U.S. Department of Agriculture, and Consumer Product Safety Commission.

A core part of Veronica’s practice is helping clients develop new products, label claims, advertising materials, and promotional campaigns, with a keen awareness of today’s litigation environment. She has a deep understanding of both current and forthcoming food labeling and production requirements, from nutrition and menu labeling, to the regulatory issues surrounding genetically engineered foods and organic food production.

Veronica also has significant experience in helping clients navigate regulatory enforcement challenges, such as Warning Letters, import detentions, and investigations by the Federal Trade Commission, Department of Justice, Congress, and state Attorneys General. She works closely with trade associations and food companies to craft comments and develop strategies in response to agency rulemaking and other public policy issues. She is a frequent speaker and contributor to industry publications.

Photo of Brendan Quinn Brendan Quinn

Associate, Washington, D.C.

Drawing on his deep experience in the performing arts and the food and beverage industries, Brendan Quinn focuses his practice on all features of a brand’s intellectual property (IP) portfolio to ensure maximum protection of his clients’s IP rights.

Brendan…

Associate, Washington, D.C.

Drawing on his deep experience in the performing arts and the food and beverage industries, Brendan Quinn focuses his practice on all features of a brand’s intellectual property (IP) portfolio to ensure maximum protection of his clients’s IP rights.

Brendan advises clients throughout the life cycle of their brand – from advertising review, trademark and copyright prosecution, and portfolio management through enforcement and litigation of these rights before federal courts and the U.S. Patent and Trademark Office (USPTO).

Brendan also assists alcohol beverage clients not only with their IP matters, but also with regulatory compliance, stemming from an internship at the Alcohol and Tobacco Tax and Trade Bureau (TTB) where he assisted with labeling approval and the agency’s geographic indication of origin program.

While at the Georgetown University Law Center, he served as a law fellow for the legal writing curriculum and received The Center for Computer-Assisted Legal Instruction (CALI) Excellence for the Future Awards for earning the highest grades in his trademark and unfair competition law and advertising law courses.