In This Issue of the AHPA Report
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The Official Publication of the American Herbal Products Association June 2010 www.ahpa.org Volume 25, Number 6 In this issue of the AHPA Report You Need to Know 2 • New Members • Upcoming AHPA Seminar: cGMP Compliance Series: Meeting Specifications __ Establishing Identity & Vendor Qualification Special Topics 4 • Health Claims Ruling a Win for First Amendment and Commercial Speech by Anthony L. Young, Esq., Partner, Kleinfeld Kaplan & Becker and AHPA General Counsel • NOP Responds to NOSB Recommendation for National Organic Personal Care Standard by Katia Fowler, Director of Communications, American Herbal Products Association Legal & Regulatory 7 • Senators Hatch, Harkin Introduce “Dietary Supplement Full Implementation and Enforcement Act of 2010” • GAO Report Finds Heavy Metals in Herbal Supplements at Levels That Do Not Raise Safety Concerns for FDA • Warning Letter Review FDA’s First cGMP Warning Letter Goes to Herbal Supplement Manufacturer By Anthony L. Young, Esq., AHPA General Counsel Animal Supplements (NOT) and Drug Claims for Supplements By Anthony L. Young, Esq., AHPA General Counsel • Quick Round Up Communications Update 11 • AHPA Media Scan: Notable “herbal headlines” and “AHPA in the News” Calendar of Botanical Events 13 Botanical Science Update 16 • Meetings Attended Oxford’s International Conference on the Science of Botanicals You Need to Know New Members TOPICS: Mr. Young will explain the relevant cGMP regula- tions and their background as well as how FDA has addressed Nature’s Wonder Naturopathic Our office offers a profes- Vendor Qualification and Material Handling in inspections sional dynamic set of adjunctive services in our community to date. He will also describe how manufacturers should ad- with a practice that is limited to alternative and complementary dress issues such as indemnification and out of specification medicine consulting and research. We specialize in Naturopathic materials in their contracts with suppliers. Consulting and Research Biofeedback, Nutrition, and Electro Physiological Reactive measures. We are the area’s Steven Dentali, Ph.D. - Chief Science Officer, AHPA: A natural only Board Certified Naturopath (CTN) with certifications products chemist with a focus on botanicals, Dr. Dentali has been with 15 years experience along with over 30 years experience with AHPA for over 8 years and has worked in the natural products in paramedicine. Website: www.natwonders.com/ industry for 20 years. TOPICS: Dr. Dentali will explain the specific requirements Upcoming AHPA Seminar: regarding establishing the identity of your dietary ingredi- cGMP Compliance Series: Meeting ents, discuss and define regulatory terms such as “scientifi- Specifications – Establishing Identity cally valid method” and “fit for purpose”, provide background & Vendor Qualification on how to determine what method or methods to use to es- tablish identity, identify resources, and review the skills/ On June 17, AHPA’s tele-seminar cGMP Compliance Series: training required for analysts conducting identity testing. Meeting Specifications – Establishing Identity & Vendor Qualification will contain presentations from industry experts who will provide Margaret King, Senior Director QA/QC, Metagenics: With over detailed and practical information on how dietary supplement com- 20 years of industrial experience in QA/QC, laboratory, manufac- panies can address the GMP in regards to identity and vendor quali- turing, facility inspections, validations, and product development of fication – two of the most burdensome and yet nebulous aspects of natural products, Ms. King is responsible for compliance with the regulations. cGMP and International regulations for the company’s US and Belgium manufacturing facilities, as well as for liaison with regula- Whether your company uses whole herbs, cut herbs, powders, or tory agencies at Metagenics. She has also developed the company’s liquids/extracts as components/dietary ingredients, you shouldn’t overall quality management system for meeting FDA’s cGMP com- miss this opportunity to learn what these highly successful compa- pliance regulations. nies and individuals have done to meet the DS-GMP requirements. TOPICS: Ms. King will provide practical information on the usage of an outside (3rd party) lab for identity testing & Presenters & Key topics to be covered: other related considerations, including defining the scope of Tony Young, Esq. - Partner, Kleinfeld, Kaplan & Becker: AHPA testing/methods, contractual arrangements, timelines, QA General Counsel Tony Young has over 35 years experience practic- involvement, pitfalls & benefits of 3rd party testing, OOS or ing food and drug law and counseling clients on compliance with non-conforming issues, and usage of 3rd party labs as part of FDA requirements. a vendor qualification program. The AHPA Report, the official voice of the American AHPA Staff Send inquiries, comments or requests to: Herbal Products Association (AHPA), is published monthly as a service to AHPA members and friends Michael McGuffin, President American Herbal [email protected] of the herbal products industry. The material Products Association contained in this publication is for the information Steven Dentali, PhD, Chief Science Officer 8630 Fenton Street, Suite 918 of AHPA members. Although the information [email protected] Silver Spring, MD 20910 is believed to be correct, AHPA disclaims all Devon Powell, Chief Operations Officer Phone: 301-588-1171 responsibility for any damage or liability that [email protected] Fax: 301-588-1174 may result from any reliance on the information Email: [email protected] contained in this publication. Katia Fowler, Director of Communications [email protected] Website: www.ahpa.org Articles may not be reproduced or reprinted without written permission from AHPA. © copyright 2010, AHPA June 2010 • Page 2 Angela Kwong, Quality Manager, Traditional Medicinals: Ms. REGISTRATION DEADLINE: Wednesday, June 16, 2010 Kwong is responsible for the implementation of DS-GMP at TELE-CONFERENCE SEMINAR DATE/TIME: Traditional Medicinals, and has over 20-plus years of experience Thursday, June 17, 2010 from 1-3pm EST with biopharmaceutical companies specifically in drug develop- REGISTRATION INFO: ment, quality systems, clinical and commercial manufacturing. In Secure internet registration by clicking the link above these roles, Ms. Kwong was frequently charged with the selection COST & GENERAL: and management of key contract suppliers for both API’s and paren- teral drug products. Over the years, she has built strong, positive re- $195 per line for AHPA member companies (unlimited participants!) lationships and successfully managed both US and international suppliers. $495 for non-members Includes an unedited transcript (to review later & for TOPICS: Ms. Kwong will discuss the critical components of training libraries) developing a strong supplier management program. Includes one Certification of Completion (for training and Rupa Das, Vice President of Global Quality & Compliance, BI personnel files) Nutraceuticals: Ms. Das has over 15 years of Quality and Regulatory Additional certificates available – $25 each (for training and Compliance management experience in the Dietary Supplement personnel files) and Personal Care Product Industries. She was key in the develop- Optional CD recording available – $25 (great for your ment and implementation of quality programs such as Identilok® training library) and the global vendor qualification program which assures high quality botanical ingredients to the market. AHPA’s tele-seminars are a convenient and cost-effective way to explore issues, gain insight, and enhance knowledge on what’s TOPICS: Ms. Das will provide information on vendor qual- important to your business. You will be provided with practical, ification from the perspective of the supplier, with a focus on useful documents and information and the opportunity to have common mistakes manufacturers make in their programs your particular questions answered by the experts. Please note, the and efforts, as well as discuss OOS issues. registration fee is charged per phone connection, but as many staff REGISTER ONLINE https://connect.computility.com/form/index. members as you wish may be conferenced in or listen in on your php?id=b2c61eb446a96337fed92f51460e76c1) speaker phone. June 2010 • Page 3 Special Topics application of that statute ran afoul of the First Amendment which Mr. Emord sought to be applied because FDA set standards for Health Claims Ruling a Win for First health claims too high. Amendment and Commercial Speech In this decision, the District Court parsed the scientific data to cut By Anthony L. Young, Esq., Partner, Kleinfeld Kaplan & Becker and through what it characterized as conclusory and unexplained evalu- AHPA General Counsel ations by FDA. FDA cannot deny a health claim where a disclaimer would work. And like many administrative law cases, the District On the one hand, you would think that Jonathan Emord, the attor- Court sends the case back to FDA to consider in light of its decision. ney who has championed the First Amendment in FDA’s evaluation Back to the briar patch goes the claim, to be considered in light of of health claims, would have tired at his Don Quixote-like efforts to another good First Amendment commercial speech decision. And get his clients health claims through FDA’s keyhole. Similarly, you in the news, Jonathan Emord promised he would seek to have FDA would think that FDA (the Bill of Rights here starts