Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods

Monday, June 09, 2008

About

Dietary supplement and food regulation has exploded over the last year. In response to public and Congressional outcries for an active regulatory scheme to address the overall safety of dietary supplements and functional foods, the FDA responded in 2007 with the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Since the passage of the Act, the government has issued several guidances to industry over the past year clarifying the newly-imposed requirements for GMPs and adverse event reporting.

Outlining progressive deadlines for companies of various sizes, the final GMP rule requires companies to completely re-evaluate their manufacturing practices for safety and efficiency. Additionally, as companies begin to grasp the effect of the new adverse event reporting and recordkeeping requirements, dietary supplement manufacturers, packers, distributors, and retailers must completely re-assess their business practices to ensure procedures are in place at all levels for properly handling and reporting adverse events.

Faced with enforcement not only from the FDA, but also from the FTC, companies should also be revisiting product labeling and marketing procedures to ensure proper substantiation is provided for the use of particular health claims on dietary supplement, functional food and nutraceutical products. The FTC has earmarked the dietary supplement industry as an area of concern for the agency. As such, companies should be re-evaluating their current practices and procedures to avoid a product being taken off the market.

Understanding what the concerns are of each agency and how your company can establish a viable compliance program are paramount to keeping your product on the market and out of the regulatory crosshairs. Before your finalize your compliance protocol, have a look at this publication from the American Conference Institute’s 2nd Annual In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods Conference as our expert faculty provides you with the most up-to-date and efficient strategies for meeting the needs of the current regulatory environment in your industry.

Contents & Contributors

About

Dietary supplement and food regulation has exploded over the last year. In response to public and Congressional outcries for an active regulatory scheme to address the overall safety of dietary supplements and functional foods, the FDA responded in 2007 with the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Since the passage of the Act, the government has issued several guidances to industry over the past year clarifying the newly-imposed requirements for GMPs and adverse event reporting.

Outlining progressive deadlines for companies of various sizes, the final GMP rule requires companies to completely re-evaluate their manufacturing practices for safety and efficiency. Additionally, as companies begin to grasp the effect of the new adverse event reporting and recordkeeping requirements, dietary supplement manufacturers, packers, distributors, and retailers must completely re-assess their business practices to ensure procedures are in place at all levels for properly handling and reporting adverse events.

Faced with enforcement not only from the FDA, but also from the FTC, companies should also be revisiting product labeling and marketing procedures to ensure proper substantiation is provided for the use of particular health claims on dietary supplement, functional food and nutraceutical products. The FTC has earmarked the dietary supplement industry as an area of concern for the agency. As such, companies should be re-evaluating their current practices and procedures to avoid a product being taken off the market.

Understanding what the concerns are of each agency and how your company can establish a viable compliance program are paramount to keeping your product on the market and out of the regulatory crosshairs. Before your finalize your compliance protocol, have a look at this publication from the American Conference Institute’s 2nd Annual In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods Conference as our expert faculty provides you with the most up-to-date and efficient strategies for meeting the needs of the current regulatory environment in your industry.

Contents & Contributors

DIETARY SUPPLEMENT AER
Eugene Lambert, Covington & Burling LLP (Washington, DC)

ADVERTISING SELF-REGULATION AT NAD
Mark Levine, National Advertising Division (New York, NY)

DIETARY SUPPLEMENTS AND HEALTH PRODUCTS: FTC ADVERTISING ENFORCEMENT
Christine J. Lee, Federal Trade Commission (Washington, DC)

INDUSTRY RESPONSE: INSIGHTS AND STRATEGIES FOR ACHIEVING COMPLIANCE IN AN ERA OF HEIGHTENED REGULATION
Anthony L. Young, Kleinfeld, Kaplan and Becker, LLP (Washington, DC); American Herbal Products Association

EVALUATING AND FORECASTING THE REGULATORY AGENDA OF CONGRESS
Mark A. LeDoux, Natural Alternatives, Inc. (San Marcos, CA)

TOO MUCH [CLINICAL DATA] IS NOT ENOUGH: FOUR REASONS WHY
Cameron Smith, Herbalife International of America, Inc. (Los Angeles, CA)

DESIGN AND MANAGEMENT OF CLINICAL TRIALS FOR SUBSTANTIATING REGULATORY REQUIREMENTS
John W. Finley, Ph.D., A.M. Todd Company (Chalfont, PA)

EFFECTIVE AND COMPLIANT MARKETING IN A CLAIMS DRIVEN ENVIRONMENT
Todd Halpern, Venable LLP (Washington, DC)

EFFECTIVE AND COMPLIANT MARKETING IN A CLAIMS DRIVEN ENVIRONMENT
Kevin Boot, Embria Health Sciences (Cedar Rapids, IA)

STRENGTHENING CONSUMER CONFIDENCE AND PRESERVING THE REPUTATION OF YOUR PRODUCT THROUGH BRANDING AND TRADEMARK
Rick Kurnit, Frankfurt Kurnit Klein & Selz PC (New York, NY)

DIETARY INGREDIENTS – “NEW” VS. “OLD” STATUS
Frederick A. Stearns, Keller and Heckman LLP (Washington, DC)

FDA REGULATION OF NEW DIETARY INGREDIENTS: IMPROVING THE LIKELIHOOD OF FDA ACCEPTANCE OF A 75-DAY NEW DIETARY INGREDIENT NOTIFICATION
Eric D. Hargan, McDermott Will & Emory (Chicago, IL)

RE-EVALUATING NUTRITION LABELING IN LIGHT OF RECENT FDA INITIATIVES
Steven Shapiro, Ullman Shapiro & Ullman LLP (New York, NY)

TRENDS IN SUPPLEMENT LITIGATION AND STRATEGIES TO MINIMIZE LIABILITY
Robb W. Patryk, Hughes Hubbard & Reed LLP (New York, NY)

FOCUS ON CONSUMER LITIGATION: STRATEGIES FOR MINIMIZING LIABILITY
Amy R. Mudge, Arnold & Porter LLP (Washington, DC)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0