(Silver Spring, MD, November 18, 2005) -- Is your company ready to comply with the new Food Allergen Law that goes into effect on January 1, 2006? Get ready by attending the American Herbal Products Association's (AHPA) upcoming educational seminar, which will feature a range of experts on the legal, regulatory scientific, and medical aspects of the new law. This is your company’s chance to receive targeted and instructional information so that you can efficiently learn the relevant components of the law, become trained to set up a compliance program, and hear what is at stake if products do not meet the new policy.
The tele-seminar will be held at 12 noon, Eastern, on Friday, December 2.
The speakers and primary topics are as follows (brief speaker biographies are below):
Anthony Young, Esq., Kleinfeld, Kaplan and Becker, LLC & AHPA’s Legal Council, will discuss the law, its history and the significance of compliance from a legal and regulatory perspective.
Robert S. Donofrio, MS, NSF International, will outline various testing methods for the allergens listed in the law, and teach how to set up testing and compliance program within your company.
Mary Hardy, MD, Cedar Sinai, UCLA, with her extensive training in botanical and western medicines, will give a clinical perspective on the risks of food allergens and the risk of non-compliance.
Rhonda Kane, MS, RD, FDA, will review "FDA’s Q & A on the Food Allergen Labeling and Consumer Protection Act”, which she co-authored.
Robert J. Moore, PhD, FDA, will be available for audience questions about compliance and FDA enforcement of the new law.
In addition to hearing the speakers make their presentations, this will be your opportunity to ask your questions. Some of your colleagues have already sent in questions. For instance:
if there is a rare but known case of an allergic reaction to a plant part not listed in the law, does this need to be listed on the product label? What about the ragweed family?
If you have questions for the panel in advance of the event, please send them to: Robin Gellman: [email protected].
Other topics will include:
The origin and rationale of the new law.
The major food allergens required to be labeled.
The petition and notification process for exemption from food allergen labeling requirements.
Proper labeling of major food allergens present in dietary supplements.
AHPA’s tele-seminars are a convenient and cost-effective way to explore issues, gain insight and enhance knowledge. The tele-seminar is a live telephone conference call, limited to just two hours and 30 call lines, but as many staff members as you wish may listen on your speaker phone. To facilitate freedom to raise difficult issues, participants may email questions, which will be read in an anonymous fashion during the Q&A session.
AHPA’s tele-seminars are much less expensive than hiring an attorney or consultant to conduct such training: $195 per connection for AHPA member companies, and $495 per connection for non-member companies. The registration fee includes an unedited transcript of the training session and one Certificate of Completion, an important addition to cGMP compliance training and personnel files; additional certificates are $25 each.
Register today by faxing the online form (http://www.ahpa.org/05_12_allergen.pdf) to 301-588-1174. Once registered, a confirmation email will include all pertinent materials and instructions (including the tele-seminar dial-in number). For more details, contact Robin Gellman via email ([email protected]) or phone (301-588-1171, ext. 106)
Anthony L. Young, Esq, is a partner with the law firm Kleinfeld, Kaplan and Becker, LLP, Washington D.C., a firm that has counseled clients in the food, drug and allied industries for more than 50 years. Mr. Young also serves as General Counsel to the AHPA and to the Pharmaceutical Distributors Association. Mr. Young has practiced food, drug and environmental law since 1974. He advises and represents domestic and foreign food and supplement manufacturers, developers, and distributors with respect to compliance and defense of matters under the statutes enforced by the FDA, the Consumer Product Safety Commission, the FTC, the DEA, and the EPA. A member of the District of Columbia and California Bars, Mr. Young earned his law degree at Georgetown University Law Center.
Robert Donofrio, MS, is the director of the microbiology and molecular biology laboratory at NSF International, where he has been employed since 2000. His areas of expertise are in microbiology, laboratory technical operations, and biotechnology. His academic experience includes serving on the faculties of Penn State University and Kent State University where he taught microbiology and biotechnology, respectively. He earned his master's degree in microbiology at Duquesne University and is currently a doctoral candidate at Michigan Technological University. NSF International, an independent, not-for-profit organization, certifies products and writes standards for food, water, air, and consumer goods
Mary Hardy, MD, is a member of the Human Nutrition Division at the UCLA-based David Geffen School of Medicine, and has been the medical director of Cedars-Sinai Integrative Medicine Program since 2001. In addition to being a researcher at the RAND Corporation, she is an associate clinical professor at the USC Medical Center, and a founding board member of the Advisory Board of Naturopathic Medicine. She earned her medical degree at Louisiana State University. Her many publications include a wide range of topics related to complementary and alternative medicine and its applications for integrated health care, women's health, cancer, weight loss, and product quality and safety.
Rhonda Kane, MS, RD, Consumer Safety Officer, joined the FDA in 2000, and initially coordinated FDA reviews of new dietary ingredient premarket notifications. She now develops regulations and guidance materials on food standards and ingredient labeling, including food allergen labeling and gluten-free labeling. During the previous 21 years, Ms. Kane worked as a nutritionist/food program specialist for the USDA Food and Nutrition Service where she developed policies and regulations for food assistance and nutrition programs, most notably the Special Supplemental Nutrition Program for the WIC Program. A Registered Dietitian, she earned a bachelor's degree in Home Economics Education from Bridgewater College in Bridgewater, Virginia, and a master's in Nutritional Sciences from the University of Maryland, in College Park, Maryland.
Robert J. Moore, PhD, is Team Leader for Compliance and Enforcement in the Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling and Dietary Supplements, in the FDA’s Center for Food Safety and Applied Nutrition. Dr. Moore earned undergraduate degrees in Animal Nutrition from the State University of New York at Cobleskill and the University of Missouri. He earned a master's degree in Animal Nutrition at the University of Missouri and a PhD in Animal Science and Nutrition at Virginia Polytechnic Institute and State University. He completed post-doctoral research studies at the USDA Human Nutrition Research Center in Grand Forks, North Dakota. From 1988 to 1994 he served in the US Army as a research biochemist at US Army Medical Research and Development Command laboratories in Natick, Massachusetts and San Antonio, Texas. He joined FDA in 1994 and has worked primarily on dietary supplement enforcement and policy development activities.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org