Exponent’s Food and Chemicals Practice (formerly
Novigen Sciences, Inc.) is
uniquely qualified to help clients achieve their GRAS (Generally
Recognized As
Safe) objectives. Our multidisciplinary scientific expertise
is augmented by our senior staff
members’ years of experience with the food industry
and its suppliers, the FDA, and other regulatory
agencies.
We provide flexible, responsive, cost-effective assistance
for all kinds of ingredients. The support
we provide ranges from specific expertise to augment the
client’s
own resources, to comprehensive
“
turn-key” GRAS assistance, including strategy, literature
searches, data evaluation, expert panels,
Notifications, and FDA liaison.
Exponent’s services
include:
- Searches of the worldwide scientific and trade
literature
• GRAS feasibility evaluations, including strategies
for overcoming limitations in available information
- Documentation of history
of use
- Expert panels, including identifying qualified
experts and coordinating/facilitating their
deliberations
- Preparation and submission of GRAS
notifications and liaison with FDA and USDA
- Customized assessments of
historical, current, and/or anticipated dietary intakes
using
Exponent/Novigen’s special software, a wealth
of information available from U.S. and
international sources, and creative, FDA accepted
methodologies
- Critical review of available toxicology and
medical/epidemiology literature, including
statistical analyses
Among our satisfied clients are the companies that make
the world’s best known brands, their
suppliers, legal counsel, and trade associations. Our recent
GRAS projects include:
- For a manufacturer of food ingredients, we
evaluated the potential impact of process
changes on safety and GRAS status
- For a law firm, we developed a methodological
framework for assessing the potential GRAS
status of selected herbal ingredients in foods
- For the producer of an ingredient
having functional advantages in both FDA- and USDA regulated
products, we developed a GRAS
Notification based on “scientific procedures” and
coordinated FDA and USDA review
- For a processed food company, we critically
reviewed the scientific literature, performed a “
gap analysis” of data needs, and developed a
strategy for GRAS determination of an ingredient
- To assist an investor group with their business
plan and SEC filing, we evaluated available data
and literature, obtained reviews by outside
experts, and assessed the feasibility and timeline
for the GRAS status of a microorganism intended
as a probiotic
top |
