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202.626.8383
  • Education
    • J.D., cum laude, Georgetown University Law Center, 2002
    • B.A., magna cum laude, Cornell University, 1996

By working with clients to navigate the complex world of federal food and drug regulation, Anne Spiggle helps clients focus on their individual business objectives. Anne believes she can best enable clients to achieve their goals by taking a multi-faceted, “think-out-of-the-box” approach that considers the client’s needs from both regulatory and public policy angles. She has developed a broad range of regulatory experience, representing clients in connection with the development, promotion and sale of:

  • Foods
  • Dietary supplements
  • Prescription and over-the-counter drugs
  • Cosmetics
  • Medical devices
  • Animal feed
  • Consumer products

Anne’s representation of clients includes significant experience on a wide range of regulatory and public policy matters involving the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC) and other federal and state health and safety regulatory agencies. This experience includes counseling clients on regulatory requirements, assisting clients in responding to regulatory enforcement actions, and helping clients engage in the regulatory process through preparation of regulatory submissions (such as Citizen Petitions, New Dietary Ingredient submissions and comments on agency rulemakings).

Anne also counsels clients on advertising and promotion-related issues, as well as on reporting adverse events and carrying out product recalls. She assists clients in conducting regulatory due diligence on corporate transactions and private equity investments. Drawing on her years of experience engaging with regulators, law makers, and industry, Anne is able to think creatively to provide clients with practical advice and fresh perspective.

FDA

  • Assisted client in preparation and submission of comments addressing FDA implementation of the Food Safety Modernization Act.
  • Assisted multiple clients in assessing “new dietary ingredient” status of dietary supplement ingredients.
  • Counseled client in preparation for FDA inspection of manufacturing facilities.
  • Counseled client in handling cosmetic product customs detention.
  • Submitted trade complaint regarding marketing of unapproved new drugs.
  • Routinely provide comprehensive label review and regulatory compliance analysis.
  • Represented drug company in submission of extensive comments addressing reimportation of prescription drugs.

FTC/NAD

  • Counsel clients on compliance issues related to advertising and promotion in mainstream media, online, and in social media.
  • Successfully defended dietary supplement company’s advertising claims before the National Advertising Division (NAD) of the Better Business Bureau.

CPSC

  • Routinely submit 15(b) filings with the CPSC and coordinate product recalls on behalf of consumer product companies and retailers.
  • Successfully defended company against CPSC challenge regarding appropriate age-grading of consumer products.
  • Advise multiple companies on compliance with the Consumer Product Safety Improvement Act of 2008 (CPSIA).

Transactional Work

  • Represented numerous private equity funds in conducting regulatory due diligence on corporate transactions.
  • Routinely conduct due diligence on FDA-regulated companies.
eAlerts Alerts
November 12, 2015
eAlerts Alerts
September 10, 2015
podcast icon Podcasts
April 13, 2015
text icon Publications & Presentations
How Can the Federal Government Prevent Some Tobacco Product Manufacturers from Evading Taxes and Avoiding FDA Regulation?
FDLI's Food and Drug Policy Forum
Author
May 25, 2011
text icon Publications & Presentations
Compliance with SEC Disclosure Requirements: Practical Pointers for Publicly Traded, FDA-Regulated Companies
Regulatory Affairs Focus
May 2004