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  Federal Food Allergen Labeling & Consumer Protection Act Seminar

December 2, 2005

This AHPA tele-seminar features 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.

What you will learn from these experts:

  • Anthony Young, Esq, of Kleinfeld, Kaplan and Becker, LLP, & AHPA’s Legal Council — discusses the law, its history and the significance of compliance from a legal and regulatory perspective
  • Robert S. Donofrio, MS,Director of the microbiology and molecular biology laboratory, NSF International — outlines various testing methods for the allergens listed in the law, and advises how to set up testing and compliance program within your company
  • Mary Hardy, MD, Member of the Human Nutrition Division at the UCLA-based David Geffen School of Medicine, and Medical Director of Cedars-Sinai Integrative Medicine Program — with her extensive training in botanical and western medicines, she gives a clinical perspective on the risks of food allergens and the risk of non-compliance
  • Rhonda Kane, MS, RD, Consumer Safety Officer with the FDA — reviews "FDA’s Q & A on the Food Allergen Labeling and Consumer Protection Act", which she co-authored
  • Robert J. Moore, PhD, Team Leader for Compliance and Enforcement in the Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling and Dietary Supplements, FDA — answers questions about compliance and FDA enforcement of the new law

Materials in this packet include:

  • Text of the Food Allergen Labeling and Consumer Protection Act of 2004, and related FDA guidance 
  • 10-page NSF International template: Dietary Supplements In-Plant Audit Checklist
  • List of Allergen Test Kits, arranged by major allergen groups, that includes details on detection limits, equipment requirements, cost and time requirements
  • Bibliography of key articles on food allergen research and findings
  • Course Outline, Speakers’ Presentations & Bios
  • Transcript, and answers to questions posed by attendees
  • Audio file

Member Price: $220.00

Non-Member Price: $520.00


  Living with Proposition 65: Preventative Measures & Defending Against a 60-Day Notice

October 18, 2010

As much as 30% of the national sales of dietary supplements may be to California consumers - but companies that market in that state may encounter high penalties for non-compliance with a California law known as Proposition 65. The focus of this law for the supplement class has been on the warnings required for products that may inadvertently contain small amounts of heavy metals, such as arsenic, cadmium, and mercury, and especially lead. As of October 2010, over 100 companies in the supplement & sports nutrition categories have received 60-day notices alleging the presence of lead (and in some cases arsenic) above the very low level allowed under Proposition 65 and failure to provide required warnings. Learn what your company can do to protect itself from a Proposition 65 complaint. And if you have already received a 60-day notice, learn what your options are at this point.

  • Proposition 65 - the basics.
  • Options to protect your company.
  • What to do if you have received a 60-day notice.
  • Q&A: Obtain answers to your questions about Proposition 65

Take advantage of the expertise of these speakers:

  • Melissa Jones, Esq, Greenberg Traurig
  • Stan Landfair, Esq, McKenna, Long & Aldridge, LLP
  • Trent Norris, Esq, Arnold, Porter, LLP
  • Michael McGuffin, AHPA

Materials in this packet include:

  • Presentation files from the webinar
  • An unedited transcript of the AHPA event
  • Audio file

Member Price: $220.00

Non-Member Price: $520.00

  FDA's NDI Guidance: What You Need to Know

July 19, 2011
 
The FDA released the draft New Dietary Ingedient (NDI) guidance on July 5, 2011. AHPA's educational seminar, featuring presentations from AHPA President Michael McGuffin, General Counsel Tony Young, former FDA insider Bill Frankos, Ph.D., and a panel of legal experts with experience filing over 30 NDI notifications, assists with understanding the key elements of the guidance and how it will impact businesses in the supplement industry. Discussion topics include historical background, FDA's rationale during the development of the guidance, general business impact, GRAS status and NDI, and the potential impact to specific categories such as probiotics, nanotechnology, and others.

Take advantage of the expertise of these speakers:

  • Jim Prochnow, Esq, Greenberg Traurig
  • Tony Young, Esq, Kleinfeld, Kaplan & Becker
  • Ashish Talati, Esq, Amin Talati
  • Paul Rubin, Esq, Patton Boggs
  • Alan Feldstein, Esq, Collins, McDonald & Gann
  • Michael McGuffin, AHPA

Materials in this packet include:

  • Presentation files from the webinar
  • Audio file

Member Price: $220.00

Non-Member Price: $520.00

  Shelf Life Statements on Dietary Supplements

May 22, 2008

The new Good Manufacturing Practice regulations for dietary supplements require that manufacturers with shelf life statements on their labels have appropriate scientific substantiation. However, expiration dates are not required by the rule, and the cGMPs released in June provide little to no guidance as to what qualifies as scientific substantiation. Manufacturers are left wondering whether it is in their best interest to provide a shelf life statement and, if so, what the appropriate testing programs are for substantiating shelf life – a daunting and difficult task for manufacturers and marketers of herbal products. 

To help manufacturers and marketers comply with GMPs, the American Herbal Products Association offers an information-packed tele-seminar, "Shelf Life Statements on Dietary Supplement Labels."

 

You’ll have a chance to gain regulatory, legal and scientific insight from these knowledgeable speakers:

 

¨      Anthony Young, Esq., general counsel to AHPA and a partner with the law firm Kleinfeld, Kaplan and Becker, LLP, Washington D.C. , will explore the dietary supplement cGMP implications of providing shelf life statements on dietary supplement products. Tony has practiced food, drug and environmental law since 1974. He advises and represents domestic and foreign suppliers, manufacturers and marketers and serves as AHPA General Counsel

 

¨      Michael McGuffin , president of AHPA, is the spokesman for the herbal products industry before state and federal agencies and has twice served on a working group and a subcommittee of FDA’s Food Advisory Committee. Michael’s presentation will address shelf life statements on dietary supplements from a regulatory and practical perspective.  Michael recently authored the association’s highly praised Annotated Final Rule on Dietary Supplement cGMP.

 

¨      Jeff Stassi, program manager for dietary supplement testing at Covance Laboratories, acts as a primary liaison for dietary supplement clients as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements. He has over 22 years of experience in laboratory operations and client management and has set up testing programs for hundreds of clients within the dietary supplement supply chain. Jeff will address concerns and answer questions related to the execution and substantiation of stability studies.

Course materials include:

  • Audio file of the AHPA event
  • An unedited transcript of the AHPA event

  • Member Price: $220.00

    Non-Member Price: $520.00

  cGMP Compliance Series: Adverse Event Reporting: Strategies for Compliance

October 16, 2007

AHPA presents strategic regulatory, medical and legal perspectives to help companies comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect December 2007 and requires dietary supplement manufacturers to file serious adverse event reports (AERs) with the Food and Drug Administration. In addition to reviewing the regulation and FDA’s guidance document, AHPA provides practical documents and insights from these expert speakers:

  • Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel — reviews your legal obligations under the new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In addition to reviewing FDA’s guidance document, he will also describe how the law differentiates a serious AER from an AER and a customer complaint and explain required reports and recordkeeping requirements.
  • Michael McGuffin,AHPA’s President — focuses on how companies should communicate with their customers and how to use the current MedWatch form.  He will also discuss the information needed to create a complete record of each report and add his insights into the FDA guidance.
  • Tieraona Low Dog, MD, Director of Education for the Program in Integrative Medicine at the University of Arizona, Clinical Assistant Professor in the Department of Medicine and a Clinical Lecturer for the University of Arizona College of Pharmacy —explains important considerations when recording adverse event history, including how to focus on the clinical course of the reported event, medical history, recording concomitant use of other medical products and other relevant medical information.

Questions they answer include:

  • How do we communicate AER information to our contracted manufacturer? Who should take those calls? Who should follow up afterwards?
  • Can we handle this task in-house, or do we need to contract someone?
  • Which MedWatch form should we use? None of them are really for dietary supplement or OTC products.
  • We don’t have doctors on staff, so how (and who) decides if an AER is serious?
  • How much should we follow-up after an adverse event is reported? 
  • Do we have to show our AER files to FDA during inspections? 
  • How can we get accurate information, and how much of their medical history is important?
  • What should we tell our health food store and practitioner clients? 

Support documents to help your company comply with the law include:

  • “AER vs. Customer Complaint” — a decision-making flow chart
  • Mandatory MedWatch form and facsimile MedWatch form
  • “Quick Glance Advice about Mandatory Reporting”
  • AHPA’s instructive form for recording information concerning an adverse event associated with dietary supplement product use

Member Price: $220.00

Non-Member Price: $520.00

 



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AHPA greatly appreciates the support of its sponsors, but acknowledgement of these companies is not an endorsement, recommendation, or warranty by AHPA of any company or its products or services, and AHPA has no responsibility for any transaction entered into with any of these companies.