Sponsored by
 |
Friday, October 24
8-8:50am
Location: Casanova 603
Making Sure Your GRAS is Covered: The Right Way to Bring Your Ingredient to Market as a “Food”
Dietary supplement ingredient suppliers frequently look to expand
their market and increase their sales by crossing over into the food
marketplace. Many companies think this is an easy process, and all they
need to do is create a document certifying they believe their ingredient
is GRAS (Generally Recognized As Safe). However, the process isn’t that
simple. This panel will examine the correct way to go about preparing a
self-GRAS affirmation, and the options available to companies interested
in undertaking this process. This panel will also discuss common
mistakes that can lead to failure to gain market acceptance or even
create issues with FDA. The recent work by these panelists on the
attainment of self-GRAS status for SweetLeaf® brand stevia will also be
examined. The evolution in the quality and quantity of scientific
information surrounding stevia, the steviol glycosides as a class, and
stevioside and rebaudioside A as specific component sweeteners will be
covered.
Speakers:
 James A. May is the founder and CEO of United
American Industries Inc., dba Wisdom Natural Brands®, producer of
SweetLeaf® Stevia products, Wisdom of the Ancients’ teas, and Instant
Wisdom® instant teas. Originally learning about the herbs from the
natives of Paraguay, May is now a recognized authority on several South
American herbs. He introduced stevia, yerba mate, and other health
generating herbal products to the United States in 1982, and is
considered one of the world’s foremost authorities on these herbs,
including Pau d’arco (Lapacho) and their abilities to generate healing
within the human body.
 Robert S. McQuate, Ph.D., is CEO and
co-founder of Oregon-based GRAS Associates LLC, a consulting firm with a
strong FDA heritage that focuses on food ingredient safety matters. GRAS
Associates convenes independent expert panels that produce rigorous GRAS
evaluations and also assists clients with new dietary ingredient and
color additive submissions to FDA. Dr. McQuate specializes in business
development applications for innovative food ingredients that are of
interest to clients, and also serves as an expert witness in food
ingredient litigation matters. He began his regulatory career within
FDA's GRAS Review Branch prior to serving in technical management in the
private sector with The Dial Co., and subsequently as science director
with the National Soft Drink Association. While in the private sector,
Dr. McQuate addressed numerous high visibility food safety issues
including caloric and non-nutritive sweeteners, color additives, and
caffeine.
 Marc Ullman, Esq., partner at Ullman, Shapiro
& Ullman LLP, represents clients in matters relating to FDA and Drug
Enforcement Administration (DEA) matters, regulatory issues, FTC
proceedings and litigation. His practice includes representation
relating to FDA compliance including labels, labeling, claims, good
manufacturing practices, as well as a number of complex proceedings with
the FDA relating to the agency’s powers under the Dietary Supplement
Health and Education Act (DSHEA) of 1994. Ullman has also worked with
clients on the successful preparation of material for submission to the
FDA in support of New Dietary Ingredient notifications. In addition, he
has counseled numerous clients in matters relating to compliance with
FTC substantiation requirements, as well as representing clients in FTC
investigations of advertising practices. He has been specializing in
Food & Drug law since 1997, when he joined Bass & Ullman as counsel to
that firm after spending the first 10 years of his career with a
boutique practice career specializing in white-collar criminal defense
matters.
|
