Intertek helps bring first natural carbohydrate control ingredient to market

27 Aug 2014

Bridgewater, USA - Intertek (www.intertek.com), a leading provider of quality and safety services to industries worldwide, assists PharmaChem Laboratories Inc. (PharmaChem) in achieving Generally Recognized As Safe (GRAS) status for their product “Phase 2”. Under the Federal Food and Drug Act, the introduction of a new food ingredient to the U.S. marketplace is permitted for substances determined, by qualified experts, to have adequately shown to be generally recognized as safe under conditions of their intended use.
 
Dr. David Bechtel, Vice President, Intertek Scientific & Regulatory Consultancy, states “Phase 2 is the first natural carbohydrate control ingredient claiming to support weight loss that has received GRAS status. In a market where innovation is essential, understanding global regulatory compliance and achieving timely approval is vital to a products success.  The GRAS recognition will make this client’s product even more attractive to those developing food for weight conscious consumers.”
 
Experts from Intertek were responsible for the completion of PharmaChem’s GRAS dossier for submission to the Food and Drug Administration (FDA). In order to attain GRAS status, it was necessary to present detailed information and analysis on the product’s composition, and safety evidence.  Upon submission, the FDA confirmed that it had no questions regarding the analysis. The analysis confirmed that Phase 2 is safe to add to foods and beverages aimed at the healthy weight loss market.
 
Intertek helps companies resolve complex scientific, toxicological and safety issues. The global business develops scientific and strategic regulatory and compliance plans, and facilitates timely regulatory global approvals. Intertek experts successfully minimize client risk through their broad expertise and depth of knowledge of toxicology, product safety, and risk assessment principles, as well as the regulatory approval processes that govern products that touch a vast range of industries in jurisdictions around the world.  They do more than address scientific questions and assist with regulatory compliance; they also provide clients with a competitive advantage.

To learn more about the regulatory services offered by our scientific and regulatory consultants and from the larger Intertek organization, please visit https://www.intertek.com/scientific-regulatory-consultancy/.

Contacts:

For Market Inquiries:
Dr. David Bechtel
Vice President, New Jersey Office
Intertek Scientific & Regulatory Consultancy
Tel.:+1 (908) 429-9202
Email: david.bechtel@intertek.com

For Media Inquiries:
Tracy Veale
Marketing Manager
Global Health, Environmental & Regulatory Services
Intertek Life Sciences
Direct:  905-286-4182
Email: tracy.veale@intertek.com

About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide.
Visit www.intertek.com