HOLLY J. BAYNE,  ESQ.

FOUNDER

BIO

Holly Bayne brings extensive business and marketing experience in the "functional" food, dietary supplement and cosmetic industries to the practice of law. Ms. Bayne launched her legal career at the law firm of Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug firm in the country, where she routinely advised companies on diverse legal and regulatory issues. In May 2001, Ms. Bayne founded The Law Office of Bayne & Associates and has successfully represented and defended companies in FDA and FTC enforcement proceedings, Customs matters and industry self-regulatory proceedings.

Ms. Bayne has spoken nationally and internationally on issues concerning the regulation of food, medical food, dietary supplement and botanical products, and has written numerous papers and articles pertaining to these issues. 

Ms. Bayne earned her law degree in 1996 from the University of San Francisco, where she was awarded Best Oral Argument in Moot Court Competition. Ms. Bayne received her undergraduate degree from the University of California at Berkeley (1980), magna cum laude, where she was elected to Phi Beta Kappa. 

 

Before entering law school, Ms. Bayne worked primarily within the dietary supplement and cosmetic industries.  Most recently, she served as a marketing manager for a California-based manufacturer of nutritional and herbal supplements. While an industry marketing executive, Ms. Bayne participated in grass-roots lobbying efforts in support of industry legislation that was enacted into law as the Dietary Supplement Health and Education Act of 1994.

 

Ms. Bayne is admitted to practice law in the District of Columbia and California and is also a member of the American Bar Association.

Publications

 

D. John Hendrickson, Holly J. Bayne, et. al; Ad-Infinitum; "Legal Checklists for the Advertising Industry" FDA-Regulated Products, (2015).

 

Ad-Infinitum: Legal Checklists for the Advertising Industry provides a practical overview of the legal issues faced by advertising executives and counsel, with a chapter written by Ms. Bayne covering FDA-regulated products.

 

Holly J. Bayne, One Case, two takes: Shooting Back -Natural Immunogenics Corp. v Newport Trial Group, NBJ, The Dark Issue, 2016. 

 

Cassandra A. Soltis & Holly J. Bayne, Avoiding U.S. Litigation, World of Food Ingredients, Feb. 2013.   

 

William Soller, PhD, Holly J. Bayne, Christopher Shaheen, HerbalGram, American Botanical Council, Myths of an Unregulated Industry Dispelled, Issue: 93 Page: 42-57 (2012).

 

An in-depth article that discusses the perceived falsehood that dietary supplements are unregulated and details FDA’s legal and regulatory authority as sufficient to protect public health and safety.

 

Holly J. Bayne, FDA Issues Final Rule Banning Use of Aloe and Cascara Sagrada in OTC Drug Products, HerbalGram, 56 Legal & Regulatory Update, (2002).

 

On May 9, 2002, FDA issued a final rule banning the use of aloe and cascara sagrada as laxative ingredients in OTC drugs. This article looks at the reasons why and discusses implications for the dietary supplement industry.

 

Holly J. Bayne, The Food and Drug Administration’s Proposed Rule on Health-Related Claims in Dietary Supplement Labeling, 15 Food, Drug, Cosmetic and Medical Device Law Digest 113 No.3 (Sept. 1998).

 

Addresses FDA’s proposed rule in April 1998, defining the types of health-related statements the agency considers permissible for the labeling of dietary supplements.

 

Holly J. Bayne, Regulatory Update on the Federal Trade Commission’s Regulation of Dietary Supplement Advertising, 4 Nutrition Business Journal (Mar. 1998).

 

Holly J. Bayne, Regulatory Update on Dietary Supplement Health and Education Act, 3, Nutrition Business Journal (Dec. 1997).

 

Holly J. Bayne, Regulatory Outlook: Recent Regulatory Issues with Analysis and Industry Impact, Potency Limits Would Be Worst-Case Scenario for Codex Draft Guidelines, 3 Nutrition Business Journal (Jan./Feb. 1997).

 

Holly J. Bayne, Jeffrey N. Reinhardt, Comments to FDA, Request for Issuance of a Re-Proposed Rule to Provide a Rational Definition of the Term “Antioxidant” According to Current Scientific Agreement, Comment to Food and Drug Administration, Proposed Food Labeling; Nutrient Content Claims: Definition of “High Potency” and Definition of “Antioxidant” for use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, Docket NO. 95N-0347 (June 7, 1996).

 

Holly J. Bayne, Regulatory Impact Analysis of H.R. 1951: The Food and Dietary Supplement Consumer Information Act of 1995, People for Pure Food, pub. (Feb. 1996).

 

 

Speeches & Presentations

 

Navigating FDA & FTC Regulatory Risks, What Every TCM Practitioner Should Know, 3rd Annual American TCM Congress, Tyson’s Corner, Virginia (Sept. 16, 2017).

 

Moderator, AG Panel, 19th Annual NBJ Summit, St. Regis Resort, Dana Point, CA. June 13-16, 2016.

 

Panelist, Ten Things We would Change About DSHEA, CRN Symposium on Dietary Supplements. Dana Point, CA.  (Oct. 28, 2016)

 

State of Supplement Industry: Legal Challenges, NBJ Webinar, Dec. 16, 2015.   

 

Moderator, Table Top Discussion, Challenges to Product Claims from FTC, NAD & Class Action Lawsuits, GMA Science Forum, National Harbor, MD (April 12-15, 2015).

 

Regulatory Enforcement of Claims: Don’t Let Your Website and Digital Marketing Sink Your Company, Nutrition Industry Association (NIA) West, Los Angeles, California, (Oct. 29, 2013).

 

Substantiating “Natural” & Health-Related Claims: A New Age of Scrutiny, IFT Wellness Conference, Chicago, Illinois, (Feb. 27, 2013).  

 

Developing Structure/Function Claims that Conform to FTC’s Substantiation Requirements: Establishing a “Reasonable Basis,” ABA Section of Litigation Food Supplements First Annual Workshop, Atlanta, Georgia (Feb. 17, 2011).

 

Ethical Considerations in the Labeling of Biologically Active Foods: Navigating the Regulatory Mine Field, ABA/Food Supplements Annual Workshop, (2011).
 

Current Regulatory Environment for Dietary Supplements, American College of Nutrition, 49th Annual Meeting, Arlington, Virginia (Oct. 4, 2008).

 

A Closer Look at FDA Regulations for Preparation and Market Placement of Dietary Supplements and Functional Foods, The In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals & Functional Foods, San Francisco, California (May 15-17, 2007).

 

Health-Related Marketing of Conventional Foods & Functional Foods: Nutrient Content Claims, Introduction to Food Law and Regulation: Understanding How the Government Regulates the Food Industry, FDLI, Washington, D.C., (Jan. 24-25, 2005).

 

Dietary Supplement/Functional Food Industry: Challenges and Opportunities for the Technology Transfer Community, AUTM Annual Meeting, Phoenix, AZ (Feb. 3, 2005).

 

U.S. Regulation of Dietary and Herbal Supplements, Longjiang River Health Products Media Conference, New York City, New York, (Jan. 21, 2004).

 

Substantiating Dietary Supplement Advertising Claims: How Much Science Enough, NNFA Marketplace, Las Vegas, NV (June 6, 2001).

 

Regulations and Standards for Nutraceuticals in the United States, NutraPhex 2000 Conference & Exhibition for Pharmaceutical and Nutraceutical Manufacturers, Amsterdam, Netherlands (Oct. 13, 2000).

 

Maximizing Growth Opportunities in an Uncertain Regulatory Climate: A Current Perspective on the Use of Health-Related Claims in the Promotion of “Functional” Foods, Growth Opportunities in Functional Foods and Beverages, International Quality & Productivity Center, Chicago, Illinois (Apr. 26-28 2000).

 

Regulatory Requirements for Health-related Claims in the Labeling of “Functional” Foods, American Oil Chemists’ society 90th Annual Meeting & Exposition, Orlando, Florida (May 9-12, 1999).

 

Food and Drug Administration and Federal Trade Commission Regulation of “Nutraceuticals,” American Pharmaceutical Association 146th Annual Meeting & Exposition, San Antonio, Texas (Mar 5-9, 1999).

 

Developing Structure/Function Claims That Conform to FTC’s Substantiation Requirements: Establishing a Reasonable Basis,” Meeting Regulatory & Legal Challenges in Promoting Dietary Supplements, Infocast, Washington, D.C. (Dec. 2-4, 1998).

 

Developing Structure/Function Claims That Conform to FTC Requirements, IBC, USA Conferences, Meeting Regulatory and Legal Challenges in the Promotion of Dietary Supplements, Washington, D.C. (Apr. 30-May 1, 1998).

 

The Regulation of Botanicals in the United States—The Dietary Supplement Health and Education Act of 1994 Ushers in a New Era, Phytomedicines Development: Botanicals for the Twenty-First Century, Drug Information Association, Cape Town, South Africa (Feb. 24-26, 1998).

Cassandra Soltis, ESQ.

Of Counsel

BIO

Cassandra Soltis brings extensive in-house and law firm experience to Bayne and Associates, counseling on regulatory issues involving foods, dietary supplements, drugs, medical devices, and cosmetics, including product development, marketing claims, and FDA/FTC compliance.

 

Ms. Soltis started her legal career at Hyman, Phelps & McNamara, P.C. (HPM), where she and Ms. Bayne were colleagues. Ms. Soltis advised manufacturers and marketers of foods, dietary supplements, devices and cosmetics on a variety of FDA and FTC regulatory matters. Most recently, she worked as in-house counsel at Starbucks Coffee Company, where she routinely advised on FDA, FTC, USDA, and CPSC issues, including food labeling and marketing claims, FDA food facility registration and reportable food requirements, food/consumer product recalls, regulatory inspections of food facilities, product development, and compliance with FSMA. Before practicing law, Ms. Soltis worked as a Legislative Assistant at the Center for Science in the Public (CSPI).

 

Ms. Soltis has written numerous articles and blogposts on the regulation of foods and drugs, and has also spoken nationally on such matters. She was a 2017 Leadership Council on Legal Diversity (LCLD) Fellow, and served as Co-Chair of Starbucks’ Law and Corporate Affairs Pro Bono Committee. Her pro bono work includes projects with the Campaign for the Fair Sentencing of Youth and the Innocence Project Northwest.

 

Ms. Soltis is a graduate of The Ohio State University Moritz College of Law and earned her undergraduate degree, summa cum laude, from The Ohio State University. She also has a master’s degree in exercise science, with a focus in nutrition, exercise, and eating behaviors, from The George Washington University. She is admitted to practice law in Washington, D.C.

Publications

 

C. Soltis & H. Bayne, “U.S. Food Claim Litigation,” The World of Food Ingredients (Mar. 2013).

C. Soltis & H. Bayne, “Regulation of Health-Related Claims in the United States,” The World of Food Ingredients (Apr./May 2012).

C. Soltis & H. Bayne, “Substantiating Health-Related Claims in the United States: An Update and Comments from Experts,” The World of Food Ingredients (Sept. 2012).

C. Soltis, “Food Fight: Who Will Win the Battle Over Front-of-Package Labeling?” Update – Food and Drug Law, Regulation, and Education (Jan./Feb. 2012).

C. Soltis, “Weighing in on Claims,” The World of Food Ingredients (Dec. 2010).

C. Soltis, “Nutrition Policy Impact,” Nutrition Insight 2010 (Aug. 2010).

J. Fleder & C. Soltis, “Advertising and Promotion: FDA Is Not the Only Cop on the Beat,” Update Food and Drug Law, Regulation, and Education (July/Aug. 2010).

C. Soltis, “Dying to Be a Supermodel: Can Requiring a Healthy BMI Be Fashionable?” Journal of Contemporary Health Law and Policy (Fall 2009).

J. Fleder & C. Soltis, “Diet and Weight-Loss Ads – Fat Targets for FTC Action,” Update – Food and Drug Law, Regulation, and Education (July/Aug. 2007).

C. Soltis, “Between a Rock and a Hard Place: FDA’s Regulation of Dietary Ingredients in Dietary Supplements,” Journal of Food Law and Policy (2007).

C. Soltis, “FDA Enforcement of the Food Allergen Labeling Law,” Regulatory Affairs FOCUS (Oct. 2006).

C. Soltis, “Further Protecting the Food Supply – FDA’s Final Rule on Recordkeeping Requirements,” Update – Food and Drug Law, Regulation, and Education (May/June 2005).

 

Speeches and Presentations

 

“Labeling Update: The Latest on the Nutrition Facts Panel, GMO Labeling, and FDA’s Definition of ‘Natural,’ ‘Healthy,’ and Other Terms,” ACI Food Law Conference, April 24, 2018, Chicago, IL.

 

“The Proposed Nutrition Facts Panel and Updated Dietary Guidelines: Are They Challenges or Opportunities for Industry’s Hot Button Issues?” IFT Annual Meeting and Expo, July 13, 2015, Chicago, IL.

 

“Current New Dietary Ingredient Regulations in the United States,” WorldNutra 2005, Oct. 17, 2005, Anaheim, CA.

 

“Nutrient Content Claims,” Food and Drug Law Institute Workshop titled “Introduction to Food Law and Regulation: Understanding How the Government Regulates the Food Industry,” Jan. 13, 2004, Washington, DC.

 

“History of FDA Regulation of Sunscreen/Suntan Products,” Dermal Clinical Evaluation Society's 18th Annual Education Seminar, Sept. 21, 2001, Teaneck, NJ.

KATE DUFFY MAZAN, ESQ.

Of Counsel

BIO

Kate Duffy Mazan brings a unique blend of experience in law and health care to Bayne & Associates. Kate has expertise in clinical research compliance and technology transfer in both the public and private sector.

 

In private practice, she has assisted a variety of companies and institutions in complying with federal and state laws and regulations governing the conduct of clinical trials. Kate has extensive experience in the negotiation of clinical trial agreements and the regulatory review of clinical research practices. Prior to entering private practice, Kate worked for nine years at the National Cancer Institute (NCI) within the National Institutes of Health. As a technology transfer professional at NIH she managed the intellectual property portfolio of NCI’s Natural Products Branch, negotiating CRADAs and international agreements with countries in Africa, Central and South America, and the Pacific rim. Kate also worked with scientists from several other institutes within NIH to develop a wide range of technology. She began her career at NIH as Chief of NCI’s Cancer Information Service  (CIS), a nationwide network of cancer information and education programs located at major cancer centers across the country. In that capacity she was responsible for developing a training program on the conduct of clinical trials to assist information specialists explain clinical research to patients and the public.

 

Kate holds a law degree from the Columbus School of Law at the Catholic University of America, Washington, D.C., a Master of Science in Public Health Administration from the University of Massachusetts Amherst, and an A.B. from Stonehill College, North Easton, Massachusetts. Kate is admitted to practice law in Virginia, Maryland, and the District of Columbia.