Naomi J. L. Halpern

Counsel
Naomi's practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration.
Naom Halpern, Counsel, Washington, DC at Arent Fox

Naomi's practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA) with respect to pharmaceuticals (including branded, generic prescription, and over-the-counter drugs), medical devices, foods, cosmetics, and dietary supplements, as well as those involving oversight by the US Department of Agriculture (USDA) of food safety and labeling. She also advises on the laws and regulations relating to consumer products administered by the US Consumer Product Safety Commission (CPSC).

Client Work

Naomi counsels manufacturers and distributors of prescription and over-the-counter drugs, biologics, medical devices, food products, dietary supplements, cosmetics, and consumer products on FDA, USDA, and CPSC regulatory issues relating to all phases of product development and commercialization. Such counseling includes premarket authorizations where applicable, labeling, advertising, and packaging compliance, evaluating and advising with respect to marketing strategies for new products, reporting and recordkeeping requirements, clinical trial requirements, recalls and market withdrawals, drug and device listing and registration, user fees, and orphan therapy issues. She is also experienced in assisting with rulemaking and enforcement proceedings.  

She has extensive experience in regulatory due diligence associated with corporate transactions, as well as assisting  FDA-, USDA- and CPSC-regulated clients in handling threatened or filed class action litigation related to product claims or regulatory compliance status. The following is a sampling of Naomi’s counseling and representation experience:

FDA - FOOD
  • Counseled clients on all aspects of food safety and the possible need for recalls and market withdrawals, including recalls of meat- and poultry-containing sandwiches, dairy products, produce and grain products, for reasons related to food-borne pathogens, insect infestation, allergen labeling, pesticide residues, and deliberate tampering.
  • Advised on the necessity of making submissions to the Reportable Foods Registry.
  • Prepared responses to FDA 483 inspections and Warning Letters, including regulatory objections to labeling claims.
  • Negotiated release of FDA detained food, drugs, and cosmetics.
  • Counseled clients concerning compliance with FDA and state laws pertaining to labeling and advertising claims, structure/function claims, health claims, nutrition information, and ingredient listings.
  • Provided counseling on hazard analysis and critical control point (HAACP) systems.
FDA - DRUGS, BIOLOGICS, AND MEDICAL DEVICES
  • Assisted companies with the development of FDA regulatory pathways for novel medical technologies and device combination products (device/drug and device/biologic).
  • Assisted clients with the preparation of marketing applications (PMA and 510(k)), requests for designation, and pre-Investigational Device Exemption (IDE) applications. 
  • Counseled clients on post-approval/clearance issues such as adverse event reporting, recalls, and QSR compliance. 
  • Prepared responses to FDA 483 inspections and Warning Letters, including regulatory objections to labeling claims.
USDA
  • Advised on recalls of USDA-regulated products, including undercooked chicken tenders used in pasta dish and salads, and ready-to-eat chicken wraps potentially contaminated with listeria.   
ADVERTISING
  • Reviewed proposed advertising copy and marketing materials, for print media, television, or social media, for regulatory compliance.
  • Reviewed substantiation for claims made in advertising and marketing materials.
  • Counseled companies with respect to green, organic, natural and healthy claims.
  • Advised on, drafted, and responded to, competitor complaints such as cease-and-desist letters, and proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureaus.
  • Reviewed infomercial scripts for cosmetic devices to ensure regulatory compliance.
CONSUMER PRODUCT SAFETY
  • Advised on recall and enforcement proceedings.
  • Assisted in the preparation and filing of Section 15(b) defect reports with CPSC.

Previous Work

Prior to joining Arent Fox, Naomi was a partner in the Washington office of a New York-based law firm specializing in intellectual property and regulatory law and counsel at a Washington-based boutique law firm specializing in FDA and USDA law.

Professional Activities

Naomi is a member of the American Bar Association and the Administrative Law and Regulatory Practice Section. Naomi also serves on the Medical Device Advisory Board for FDAnews.

Publications, Presentations & Recognitions

  • "Anti-Aging Products Are Not Drugs! Does the withdrawal of Import Alert 66-38 signal a change of heart at the US Food and Drug Administration?" Happi Magazine (February 2018). 
  • “Medical Product Advertising & Promotion, Social Media Do’s and Don’ts," FDAnews (January 2018).
  • "FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know," Today's Wound Clinic (December 2016).
  • “180-Day Exclusivity: Forfeiture Decisions by FDA,” FDLI Update: Food and Drug Law, Regulation and Education (September/October 2009).
  • “Update on Statutory Requirements for Handling Citizen Petitions Seeking To Delay Generic Approvals,” FDLI Update: Food and Drug Law, Regulation and Education (July/August 2008).
  • “Implications of DHHS Medical Privacy Rule for Pharmaceutical and Medical Device Manufacturers,” FDLI Update: Food and Drug Law, Regulation and Education (November/December 2002).
  • “Medical Privacy Compliance and Healthcare Marketing,” Medical Marketing & Media (May 2002), co-written with Karen Harned.
  • “FDA Regulation of Telemedicine Devices,” Food and Drug Law Journal (1997), co-written with Peter Reichertz.

Life Beyond the Law

When not working, Naomi spends most of her time with her family. Additionally, she volunteers regularly at Open Table community supper programs and food pantries in Sudbury and Concord, Massachusetts. In any remaining spare time, Naomi enjoys art classes, reading, hiking, gardening, rooting for the Orioles, and playing with her Cavalier King Charles Spaniel.

  • Industries
  • Bar & Court Admissions
    • District of Columbia Bar
    • Maryland Bar
    • Massachusetts Bar
  • Education
    The George Washington University Law School
    JD
    ,
    with honors, Member of The George Washington University Law Review
    ,
    1992
    University of Michigan
    BA
    ,
    with high honors and with distinction
    ,
    1985