Susan D. Brienza, Ph.D.

Shareholder

emailsbrienza@rcalaw.com
phone602.440.4885
fax602.257.6985
Legal Secretary: Gina Zamora
emailgzamora@rcalaw.com

Biography

Susan Brienza helps clients navigate complex federal laws relating to the manufacture, labeling, marketing, and sales of conventional foods, dietary supplements, pet supplements, organic foods, "functional foods," sports drinks, cosmetics, "cosmeceuticals," aromatherapy, over-the-counter drugs, homeopathic drugs, medical devices, and medical foods. Food and drug law issues include: import/export and detention matters; new dietary ingredient (NDI) Notifications; CA Prop 65 issues; third-party scientific literature; self-affirmed GRAS status; and formal comments to the FDA on Draft Guidances and Proposed Rules. In addition to regulatory compliance in FDA matters, Ms. Brienza also counsels clients in advertising law—in all areas of marketing: print ads, websites, TV and radio ads, infomercials, telemarketing, consumer testimonials, expert endorsements, contests and free offers, and (of course) social media promotions.

Before practicing law, Ms. Brienza was a university professor in stylistics and 20th Century American and British literature at Carnegie-Mellon and UCLA. She brings her proficiency in language to her regulatory compliance practice in crafting permissible and persuasive descriptions and claims for clients to employ in labels, labeling and advertisements of their products, including patient information sheets and healthcare brochures. As a practicing attorney, she has shared both her regulatory expertise and real world client counseling experience with Arizona State University law students, as a frequent guest lecturer in Biotechnology and Nanotechnology courses.

Her practice includes advising clients as to compliance with Federal Trade Commission (FTC) law and United States Department of Agriculture (USDA) regulations, as well as Food and Drug Administration (FDA) laws and regulations. For instance, Ms. Brienza has evaluated label claims, advertising claims and disclaimers for organic cosmetics, natural toothpastes, and for GMO foods. Given the broad reach of the FTC jurisdiction, she has also evaluated and crafted claims, offers, disclaimers, and disclosures for house sales, financial and investment services, and other goods and services. In addition to regulatory compliance and enforcement matters, Ms. Brienza assists in litigation, with particular focus on cease and desist disputes, product liability, and false advertising cases. Her legal work since 1997 has also included white-collar criminal defense work and lobbying/public policy matters, e.g., for a manufacturer of organic meats and for coalitions of supplement and medical food companies.

Clerkships

  • Hon. Richard Matsch, U.S. District Court for the District of Colorado, 1992-1993

Publications

  • "13 Questions to Ask Yourself About Marketing Claims to Help Avoid an FTC Enforcement Action," June 2016
  • "Dietary Supplements Regulated by 25-plus FDA, FTC Guidelines," March 2016
  • "Jarrow Formulas and Delegation Meet With FDA," VitaminRetailer.com, November 2015, Featured in Article
  • "Jarrow: There is a NY State Agenda for 'Supplement Safety' Legislation," NutraIngredients USA, Quote Source, March 2015
  • "Recent FTC Guidelines on Internet Privacy and Security: What are Your Responsibilities?," BBB Bulletin, Winter 2013
  • "Summary of March 12, 2013 FTC Guide, 'Dot Com Disclosures'," In The Know: LEGAL EASE, June 2013
  • "FTC Guide, Summary of March 12, 2013 'Dot Com Disclosures'," March 2013
  • "Blog on Medical Foods," Personalized Lifestyle Medicine Institute, February 2013
  • "Jarrow Formulas' Response to the 7/1/12 Chicago Tribune Article on GMPs: The Real Statistics Show Supplement Safety," NutraIngredients USA, August 2012
  • "FTC Guidelines & Social Media Advertising," Newsletter of American Advertising Federation-Metro Phoenix, January 2012
  • "Detailed Comment to the FDA: Responding to the NDI Draft Guidance," Jarrow Formulas, Inc., Co-Author, December 2011
  • "Dietary Supplements: GMPs," newhope360.com, Spring/Summer 2011
  • "Medical Foods Boom Along With Baby Boomers," Functional Ingredients, February 2010
  • "What to Watch out for in MedWatch Forms for AER Reporting," Natural Foods Merchandiser, September 2009
  • "Brienza's Legal Briefs: A Few Regulatory Updates," Natural Foods Merchandiser, August/September 2009
  • "Chapter 5: FDA Regulation of Foods and Supplements," Nanotechnology & FDA-Regulated Products: The Essential Guide, 2009
  • "Supplement Safety: Safeguards for Consumer Confidence," Natural Foods Merchandiser, March 2009
  • "The Greening of Advertising: FTC Revises its ‘Green Guides' for Environmental, Renewable and Sustainable Claims," Natural Foods Merchandiser, October 2008
  • "Nanotechnology and Supplements: Tiny Particles and Small Changes in FDA Law," American Herbal Products Association Report, October 2008
  • "Sex, Lies and Supplements," newhope360.com, April 2008
  • "Nanotechnology: Background on the Science and the Current Approach of the Food and Drug Administration," FDLI's 1st Annual Conference on Nanotechnology Law, Regulation and Policy, Co-Author, February 2008
  • "Reporting to Reestablish Supplement Safety: AER Reporting Requirements," Natural Foods Merchandiser, December 2007
  • "The Nanotech Revolution: The Next Big Thing is Ultra Small," ColoradoBiz Magazine Legal Briefing Special Section, Co-Author, October 2007
  • "Smoothing Out Confusing Cosmetic Claims," Behind the Label issue of Natural Foods Merchandiser, July 2007
  • "NanoNaturals: Will FDA Regulate New Nanotech Products?," New Trends issue of Natural Foods Merchandiser, January 2007
  • "Watch Your Words in Signage and Shelf-Talkers," Expo East Issue of Natural Foods Merchandiser, October 2006
  • "Your Results May Vary: Disclaimers and Disclosures," Behind the Label Issue of Natural Foods Merchandiser, July 2006
  • "Keeping an Eye on Supplements," Denver Business Journal, May 2005
  • "Skin Deep: Aloe Vera in Cosmetics and 'Cosmeceuticals'," Aloe Today, Winter 2004
  • "Functional Cosmetics? Cosmetic Drugs? Cosmeceuticals? - Skin Creams Turned Inside Out," Natural Foods Merchandiser, September 2004
  • "Medical Foods - A Unique FDA Product Category," Aloe Today, Fall 2004
  • "The Foundations of Dietary Supplements Law," Natural Foods Merchandiser, March 2004
  • "Section 5 Literature for Scientific, Medical Information Re: Therapeutic Value of Aloe Supplements," Aloe Today, October 2003
  • "Word of Mouth: Using Testimonials and Endorsements to Sell Supplements," Natural Foods Merchandiser, September 2003
  • "FTC Law and Supplement Advertising: Who's Minding The Store?," Aloe Today, September 2003
  • "Dietary Supplements and Disease Treatment? Not on Labels, But Yes - With Section 5 Literature," Natural Foods Merchandiser, August 2003
  • "The Recent Phenomenon of 'Functional Waters'," Natural Foods Merchandiser, March 2003
  • "Got Soy? Soy Protein Health Claim and Soy Supplement Menopause Claims," Natural Foods Merchandiser, November 2002
  • "National Organic Standards? Yes! Organic Dietary Supplements? Yes!," Natural Foods Merchandiser, October 2002
  • "Homeopathic Drugs: When Similar Substances Can Either Hurt or Heal," Natural Foods Merchandiser, July 2002
  • "LEGISLATIVE UPDATE: A Snapshot of Capitol Hill," Natural Foods Merchandiser, January 2002
  • "New Regulation on Structure and Function Claims for Dietary Supplements," Natural Foods Merchandiser, July 2001
  • "How to Handle an FDA Inspection," Natural Foods Merchandiser, January 2001
  • "FTC Law and Supplement Ads," Natural Foods Merchandiser, May 2000
  • "Regulatory Compliance Question & Answer," Natural Foods Merchandiser, 1999

Speaking Engagements

  • "Law and Technology Data Privacy Panel: Preparation Pre-Breach," Arizona Technology Council Annual Cybersecurity Summit, May 2016
  • "FTC is Watching Dietary Supplement Advertising," AZBio Phoenix Science Museum, February 2012
  • "Medical Foods: Current Regulatory Framework," Metagenics, Inc., February 2012
  • "Regulatory Framework for Medical Foods, Medical Foods Workshop, at World Health Forum," Harvard Medical School, October 2011
  • "Dietary Supplements are Regulated? Yes, by FDA and FTC," Arizona State University College of Law and Center for Science & Innovation, October 2011
  • "Making Safe Supplements Even Safer-NDI Notifications and GMPs," Natural Products Expo East, September 2011
  • "Risk Management & Legal Issues," FDLI's 2nd Annual Conference on Nanotechnology Law, Regulation and Policy, February 2009
  • "Nanotechnology In Supplements and Cosmetics: Benefits, Risk Assessment & FDA's Current View," International Institute for Environmental Risk Management, July 2008
  • "Collaborations for Financial Success: Universities Collaborating with Government and the Private Sector," Nanotechnology & Renewable Energy Summit, July 2008
  • "Nanotechnology in Supplements and Cosmetics: Benefits, Risks, FDA's Current View & Future Regulation," FDLI's 1st Annual Conference on Nanotechnology Law, Regulation and Policy, February 2008
  • "Nanotechnology and FDA Regulations," Rocky Mountain Nanotechnology Showcase Sponsored by Colorado Nanotechnology Alliance, September 2007
  • "Nanotechnology: FDA and EPA Developments," Connected Organizations for a Responsible Economy (CORE) and Colorado Nanotechnology Alliance (CNA), December 2006
  • "Natural Products and the Law," Naturally Boulder Day Conference, October 2006
  • "Healthy and Natural Eating: Functional Foods, Dietary Supplements and Organic Claims," Connected Organizations for a Responsible Economy CORE, May 2006
  • "A New Generation in Safety: Prescription Medical Foods," National Council of Prescription Drug Programs, March 2006
  • "U.S. Regulation of Dietary Supplements and Medical Foods," U.S. Food Law Seminar for the UK Food Law Group, January 2006
  • "FTC Law, Infomercials and Testimonials," New Hope Seminar Expo East 2005, September 2005
  • "The Future of DSHEA: Congressional and Regulatory Perspective," New Hope Seminar, Expo East 2005, September 2005
  • "Smart Supplement Claims Start with FDA Compliance," New Hope Seminar, Expo West 2005, March 2005
  • "Comments on the NDI Notification Process," American Herbal Products Association Meeting, Expo West 2005, March 2005
  • "The Regulatory ABC's of Cosmeceuticals," Estee Lauder Panel at Nutracon, March 2005
  • "Third-Party Educational Literature for Dietary Supplements," Expo West, March 2004
  • "The Use of the FDA-Authorized Health Claim Linking Soy Protein and Heart Health for Foods and Functional Foods," IV Latin American Health Congress, June 2002
  • "Bringing Soy into the Mainstream Market: Overview of FDA, USDA and FTC Regulations Concerning Soy Protein," ACI Functional Foods Conference, April 2002
  • "Is Aromatherapy a Therapy? When Does a Cosmetic Become a Drug?," Natural Products Expo East, September 2000
  • "Update on Structure/Function Claims for Dietary Supplements," Natural Products Expo East, September 2000
  • "Marketing Your Products Under the FTC's New Guidelines for the Dietary Supplement Industry," Nutrimarket Conference, March 1999

Memberships

  • Colorado Bar Association
  • Colorado Nanotechnology Alliance
  • Arizona Bar Association
  • American Herbal Products Association (AHPA), 1998-Present
  • Government Relations Committee of AHPA, 1999-Present
  • American Botanical Council, 2000-Present
  • United National Products Association, AZ Chapter, 2015-Present
  • American Advertising Federation, Metro Phoenix Chapter (now Phoenix Ad Club), Board Member, 2011-13
  • Dietary Supplement Marketers and Manufacturers Association, Co-Counsel for Regulatory Affairs
  • Advisory Board Member, Center for Law, Science & Innovation at Arizona State University College of Law, 2012-2013

Distinctions

  • Named to Colorado Super Lawyers in the area of Health Care, 2006, 2007, 2009
  • Patton Boggs Pro Bono Award, 1999
  • Colorado Women's History Project Award, 1997
  • Member of Inns of Court, Judge Arraj Chapter, in Denver, 1995-1997
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