Natural Products Insider – Regulatory Updates – June 15, 2011

June 15, 2011 By

NPF Notifies FTC, FDA of Non-Compliant Ads

WASHINGTON –The Natural Products Foundation (NPF) alerted FTC and FDA of 13 non-compliant advertisers that have failed to amend marketing materials after being contacted by NPF’s Truth in Advertising program. NPF representatives met with Richard Cleland, FTC, Gary Coody, FDA, and other FDA representatives to request the regulatory agencies take action against those companies.

Both agencies said they would review the material provided by NPF relating to non-compliant advertisers who had either failed to respond or otherwise make sustentative efforts to come into compliance.

Marc Ullman, of Ullman, Shapiro & Ullman LLC, NPF legal advisory council chairman, led the meetings. He was joined by NPF president John Gay and NPF board member David Brown, CEO of LifeVantage Corporation. The meetings focused on the recent progress of NPF Truth in Advertising efforts. Over the past 12 months, the Truth in Advertising initiative has mailed 77 warning letters to companies marketing dietary supplements making drug and disease claims. A majority of advertisers contacted under the Truth in Advertising program have brought their language into compliance.

May 27, 2011

Research and Markets Releases Int’l Regs Report

DUBLIN—Getting products in larger markets such as the United States and Europe as well as in emerging markets such as Brazil and Korea can be key to a nutraceutical and functional food company’s growth. But it also comes with significant regulatory challenges due to the variance between countries active in the marketplace. To help address this issue, market data firm Research and Markets released a book, “Nutraceutical and Functional Food Regulations in the United States and Around the World,” that explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures

Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, “Nutraceutical and Functional Food Regulations in the United States and Around the World” provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area, according to the firm.

The book offers an overview of nutraceutical and functional food regulations around the world; discusses the important of GRAS (generally recognized as safe) status and the Dietary Supplements Health and Education Act of 1994 (DSHEA) regulations; provides insight on quality manufacturing techniques, cGMP (current good manufacturing practices) and standardized analytical techniques; includes advise on overcoming regulatory hurdles; addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance, highlights anti-terrorism safety assurance through traceability; and explores the significance of intellectual property, trademark and branding on marketing.