The In-House Counsel Forum on Manufacturing, Marketing and Distributing

Dietary Supplements, Nutraceuticals & Functional Foods

Tuesday, May 15, 2007

About

Prepare your manufacturing and marketing practices for increased regulatory scrutiny

In its last minutes, the 109th Congress - with its passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act - transformed the largely unregulated supplement, nutraceutical, and functional food industry into one that will subjected to greater regulatory scrutiny with respect to adverse event reporting. At the same time, the FDA is expected to release the long-anticipated cGMP guidelines for the dietary supplement industry sometime this year. Meanwhile, the FTC is taking a closer look at the advertising claims made by supplement manufacturers and entering multimillion dollar consent decrees with those who advertise unsubstantiated claims.

Now is the time to reassess the complete legal and compliance picture

American Conference Institute's premiere publication from In-House Counsel Forum on Manufacturing, Marketing, and Distributing Dietary Supplements, Nutraceuticals and Functional Foods will provide you with the essential information you need to navigate this rapidly changing regulatory regime. Get first-hand, practical insights from industry counsel and executives on the unique legal and business concerns facing the dietary supplement and functional food industry. They will help you:

  • Comply with new Federal adverse event reporting requirements
  • Prepare for a compliance audit of the complete manufacturing process of supplements from "cradle to grave"
  • Draft review, evaluate and substantiate health claims, qualified health claims, nutrient content claims, structure/function claims and dietary guidance claims for the FDA
  • Review labels, packaging and advertising to withstand increased FTC scrutiny
  • Withstand peer scrutiny of marketing practices, substantiating claims for self-regulation in the NAD, and defending an NAD arbitration hearing
  • Review functional food products for compliance with the GRAS standard

Contents & Contributors

About

Prepare your manufacturing and marketing practices for increased regulatory scrutiny

In its last minutes, the 109th Congress - with its passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act - transformed the largely unregulated supplement, nutraceutical, and functional food industry into one that will subjected to greater regulatory scrutiny with respect to adverse event reporting. At the same time, the FDA is expected to release the long-anticipated cGMP guidelines for the dietary supplement industry sometime this year. Meanwhile, the FTC is taking a closer look at the advertising claims made by supplement manufacturers and entering multimillion dollar consent decrees with those who advertise unsubstantiated claims.

Now is the time to reassess the complete legal and compliance picture

American Conference Institute's premiere publication from In-House Counsel Forum on Manufacturing, Marketing, and Distributing Dietary Supplements, Nutraceuticals and Functional Foods will provide you with the essential information you need to navigate this rapidly changing regulatory regime. Get first-hand, practical insights from industry counsel and executives on the unique legal and business concerns facing the dietary supplement and functional food industry. They will help you:

  • Comply with new Federal adverse event reporting requirements
  • Prepare for a compliance audit of the complete manufacturing process of supplements from "cradle to grave"
  • Draft review, evaluate and substantiate health claims, qualified health claims, nutrient content claims, structure/function claims and dietary guidance claims for the FDA
  • Review labels, packaging and advertising to withstand increased FTC scrutiny
  • Withstand peer scrutiny of marketing practices, substantiating claims for self-regulation in the NAD, and defending an NAD arbitration hearing
  • Review functional food products for compliance with the GRAS standard

Contents & Contributors

The 110th Congress: Perspective and Outlook
Andrew Fish, Consumer Healthcare Products Association (Washington, DC)

How Much More Supplement Regulation?
Eugene Lambert, Covington & Burling (Washington, DC)

Current Legislative and Regulatory Issues
Daron Watts, Sidley Austin LLP (Los Angeles, CA)

CGMP’s For Dietary Supplements
Daron Watts, Sidley Austin LLP (Los Angeles, CA)

Preparing for New Legislation and Regulations and the 100th Congress
Mike Greene, Council for Responsible Nutrition (Washington, DC)

Adopting Good Manufacturing Practices in Anticipation of New Guidelines
Mark A. LeDoux, Natural Alternatives International, Inc. (San Marcos, CA)

FDA Regulation of Health-Related Claims in Marketing Dietary Supplements & Functional Foods
Holly Bayne, Manhattan Advertising & Media Law (New York, NY)

A Closer Look at FDA Regulations for Preparation and Market Placement of Dietary Supplements and Functional Foods
Marc Ullman, Ullman, Shapiro, Ullman (New York, NY)

Intellectual Property Considerations When Bringing Supplements to Market
John Garvey, Foley & Lardner LLP (Boston, MA)

Protecting Brands and Managing Trademark Concerns in Marketing Supplements
Michael Mangelson, Stoel Rives (Denver, CO)

Protecting Brands and Managing Trademark Concerns in Marketing Supplements
Joel Rothman, Seiden, Alder & Matthewman, P.A. (Boca Raton, FL)

Supplement Branding Pitfalls – Risks in Branding: Product Types, Implicit Claims
Cameron Smith, Herbalife International of America, Inc. (Los Angeles, CA)

Self- Regulation and Advertising Of Dietary Supplements, Nutraceuticals & Functional Foods
David Mallen, Council of Better Business Bureaus, Inc. (New York, NY)

Developing a Self-Regulation Program for Dietary Supplement Advertising
Steven M. Mister, Council for Responsible Nutrition (Washington, DC)

Meeting FTC’s Substantiation Requirements
Anne V. Maher, Kleinfeld, Kaplan & Becker (Washington, DC)

Marketing Health Products in Risky Regulatory Waters
Kerry O’Brien, Federal Trade Commission (San Francisco, CA)

Reporting Adverse Events: Practical Considerations and Concerns For Complying With The AER Act
Paul Bolar, Pharmavite LLC (Mission Hills, CA)

Special Concerns for Manufacturing and Marketing Functional Foods
Suzan Onel, K&L Gates (Washington, DC)

Direct Selling and Multilevel Marketing: How Not to be a Pyramid
Kevin Grimes, Grimes and Reese (Boise, ID)

Preparing Nutritional Supplement Products for Worldwide Distribution
James Prochnow, Greenberg & Trauig (Denver, CO)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0