Orange County Regulatory Affairs Discussion Group (OCRA)
Invites You to Join Us For
Dietary Supplements Updates:
What's on the Horizon in 2013
Wednesday, January 9, 2013
12:30 pm - 5:00 pm
Location:
Irvine Marriott
18000 Von Karman, Irvine, CA 92612
949-553-0100
Program Managers:
Rogelio Rodriquez
Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and
Intellectual Property, Herbalife International of America
Vicki Whitsitt, Manager, Scientific and Regulatory Affairs, Natural Products Association
Schedule
1:00 – 2:45 p.m.
Industry Update & What’s on the Horizon for 2013
Cara Welch, Ph.D., Vice President, Scientific & Regulatory Affairs, Natural Products Association (NPA)
Michael McGuffin, President, American Herbal Products Association (AHPA)
An industry update on regulatory activities that includes an update on current FDA activities including
GMP inspections, GMP challenges with botanical dietary Ingredients & SAERs & a look at what’s ahead
in 2013
2:45 p.m.
Break
3:00 – 3:45 p.m.
Testing and Laboratory Challenges
Timothy Stewart, Ph.D., Consultant, QSD Consulting Group
3:45 - 4:30 p.m.
When to Call in the Experts
Cameron Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs & Intellectual
Property, Herbalife International of America
4:30 – 5:00 p.m.
All presenters
Open Q&A with Speaker Panel
Registration fee includes snacks, parking and access to electronic presentations (if approved by speakers
for distribution).
About the Speakers
Michael McGuffin was honored in 2010 for over 20 years of dedicated service, having served as the President of the
American Herbal Products Association (AHPA) and a member of the Board of Trustee's for 10 years prior. He has
been active in the herbal industry since 1974, having owned both retail and manufacturing businesses in this field.
A leading expert on dietary supplement regulation, Mr. McGuffin has been published in scholarly and scientific
journals, including the Food and Drug Law Journal and Clinical Pharmacology & Therapeutics, and also wrote the
highly-lauded publication AHPA’s Annotated Final Rule on Dietary Supplement cGMP (2007). Additionally, Mr.
McGuffin served as Managing Editor of AHPA's Botanical Safety Handbook (1997) and Herbs of Commerce, 2nd
edition (2000). He speaks frequently on dietary supplement regulation in the U.S. and abroad.
Mr. McGuffin has represented the herbal industry at state and federal hearings on herbal regulatory issues. He has
served as a member of the FDA's Food Advisory Committee Working Group on Good Manufacturing Practices for
Dietary Supplements (1998-99), the FDA's Food Advisory Committee's Dietary Supplements Subcommittee (2003-5)
and currently serves on California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup and
the Advisory Board of the USC School of Pharmacy Regulatory Science Master's Degree Program. He also serves
on the boards of the American Herbal Pharmacopoeia, the American Association of Acupuncture and Oriental
Medicine, and United Plant Savers.
Mr. McGuffin was awarded the Cliff Adler “Heart in Business” award in 1994 and the Nutrition Business Journal
Award for Efforts on Behalf of Industry in 2004. Mr. McGuffin has been quoted in a variety of news publications such
as the New York Times, the Washington Post, U.S. News & World Report and Newsweek and has made
appearances on ABC's Nightline, National Public Radio, and ABC Radio.
Cameron B. Smith, J.D., Senior Director, Regulatory, Government & Industry Affairs & Intellectual Property
Herbalife International of America
Cameron Smith has worked for Herbalife for eleven years and is one of the Company’s in-house attorneys. In
addition to managing and protecting the Company’s intellectual property portfolio and handling a range of
government-affairs responsibilities, he is the counsel of first resort for regulatory questions about foods, dietary
supplements, and cosmetics, as well as product-related advertising and marketing issues. Admitted to practice in
California, Louisiana, and Mississippi, Cameron earned his law degree at the University of Mississippi School of Law
and his undergraduate degree at the University of Pennsylvania.
Timothy Stewart, Ph.D.,. QSD Consulting Group
Dr. Stewart is a consultant for the dietary supplement industry. He specializes in cGMPs by designing, testing and
writing white papers specific to the product. He was previously the Quality Control Manager at Paragon Laboratories
where he was responsible for daily supervision and support for the QA/QC department along with overseeing
production of approximately 25 dietary supplements per week.
He spent five years as a research assistant at USC, where he completed his Ph.D. in Chemistry and has 18 peer
reviewed publications. He was also a research assistant at Harvard Medical School for two years.
Cara Welch, Ph.D., Vice President, , Scientific & Regulatory Affairs Natural Products Association
Dr. Welch assists natural product industry members to implement policies in response to government initiatives in the
regulatory and policy arena, and works with members of Congress and their staff, officials in the Food and Drug
Administration (FDA), and other agencies whose actions have direct impact on the natural products industry.
Additionally, she is responsible for advising association members on regulatory, safety, nutrition and health issues.
Finally, she directs strategy development and provides guidance of the NPA Scientific and Regulatory programs,
including the association’s Natural Certification for Personal Care and Home Care Products and Dietary Supplement
GMP Certification.
Prior to joining the NPA, Dr. Welch studied at the department of Medicinal Chemistry at Rutgers University, under the
direction of renowned plant biologist Dr. James E. Simon working on African botanicals and medicinal plants. She
also studied with NPA Burton Kallman award winner Dr. Koji Nakanishi through the National Science Foundation’s
Research Experience for Undergraduates (REU) award program. She earned her M.S. in Chemistry from the
University of Iowa under Dr. James B. Gloer and her B.A. in Chemistry from Dordt College. She is a member of the
American Chemical Society, American Society of Pharmacognosy and serves as a peer-reviewer for editorial boards.
OCRA REGISTRATION INSTRUCTIONS
Dietary Supplements Updates:
What's on the Horizon in 2013
Wednesday, January 9, 2013
Be sure to log on or create a new user profile before registering: http://www.ocra-dg.org/
MULTIPLE REGISTRATIONS: Our system is set up for one registration at a time. To register
multiple people from your company, you can simplify the process by faxing us a cover page on
your company letterhead listing the names of your attendees along with their title and email
address and credit card payment. Please let us know if you want us to process your credit card or
hold it until we receive a check.
SINGLE REGISTRATION: Log on to the OCRA Web site with your username and password or
create a new user profile: http://www.ocra-dg.org/
Once you are logged on, click on "Register for a Meeting" on the right-hand side of the page. Next
click on the meeting for which you would like to register, then follow the online instructions. You
will receive an immediate confirmation.
If paying by personal or company check: Please register online, then fax your credit card details
on your company letterhead to 949-266-8461 to hold your spot. Mail your check made payable to
OCRA to the following address:
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-266-8461
Email: ksyre@cox.net
OCRA's non-profit Federal Tax ID# 33-0630455
Payments and Cancellation Deadline:
For a refund, please cancel by emailing Kimberly Syre (ksyre@cox.net) by January 2, 2013. If you
have reserved a space but do not attend, your payment MUST be remitted.
OCRA REGISTRATION FORM
Dietary Supplements Updates: What's on the Horizon in 2013
Wednesday, January 9, 2013
This document can be used as a registration form. Fax this one-page registration form with credit
card information to: (949) 266-8461. Please check type of card:
______VISA
______ MASTERCARD
Card #:
______ AMERICAN EXPRESS
Expiration Date:
Name on Card:
Signature:
Name badges will be provided at the on-site registration desk. If you would like a receipt prior to
the event, please use the Online or PayPal payment option. Submit one copy for each person
attending.
Registration Rate is:
$ 135 – OCRA Members
$ 185 - Non-members (includes OCRA membership for one year)
$ 75 - Government and students*
*Student Rate is for full time students only. Student ID and copy of current class schedule
required to register.
Your Contact Information:
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LAST NAME:
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DRIVING DIRECTIONS:
Irvine Marriott John Wayne Airport
18000 Von Karman Avenue, Irvine, CA 92612
Phone: 949-553-0100
From OC/John Wayne Airport:
Exit airport on Michelson Drive. Go straight to Von Karman Avenue and turn Left onto
Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel
is on the left hand side.
From Long Beach Airport
or LAX - Los Angeles International Airport:
Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right
onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and
Left at the stop sign. The Marriott Hotel is on the left hand side.
From Ontario International Airport:
Take 10 West (San Bernardino Freeway) to the 57 South (Orange Freeway). Take 57
South to the 5 South (Santa Ana Freeway). Take 5 South to the 55 South (Newport Beach
Freeway) and then to 405 South (San Diego Freeway). Exit Jamboree, turn Right off ramp.
Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz
and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Downtown Los Angeles:
Take 5 South (Santa Ana Freeway) to 55 South (Newport Beach Freeway). Take 55 South
to 405 South (San Diego Freeway). Exit Jamboree and turn Right off the ramp. Turn Right
onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and
Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Diego:
Take 5 North (Santa Ana Freeway) to 405 North (San Diego Freeway). Exit Jamboree and
turn Left off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman
Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left
hand side.
From San Bernardino/Riverside:
Take 91 West (Riverside Freeway) to 55 South Freeway (Newport Beach Freeway). Take
55 south to 405 South Freeway (San Diego Freeway). Exit Jamboree Road, turn right off
ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right
onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
It is recommended that you look up driving directions from your own starting point.