- Legal Standards – Do your company’s dietary supplement claim substantiation files stand up to the legal standards?
- Evidence – Is there enough evidence to back your claim(s) should one of your products come on the radar screen of a federal regulator closely monitoring supplement claims and accompanying literature?
- Millions in Fines – For egregious claims, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) may now obtain court orders to force companies to pay millions of dollars in fines.
- Imports on Hold – FDA now holds ingredients and products being imported into the U.S., based on product claims on company websites.
As the FDA and FTC step up legal enforcement activities against unlawful drug claims and unsubstantiated structure/function claims by supplement companies, American Herbal Products Association (AHPA) will hold an educational tele-seminar on March 3: Substantiation for Dietary Supplements — How to Ensure Dietary Supplement Product Claims Are Truthful, Legal & Documented.
The tele-seminar will supply advice and documents from a panel of experts who are actively involved in all aspects of claim substantiation for dietary supplements. This is a unique opportunity to get your specific legal, regulatory, and scientific questions answered.
- Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel — will outline what's at stake for your company in today’s regulatory climate as federal agencies scrutinize supplement claims.
- Richard Cleland, Esq, Assistant Director for the FTC's Division of Advertising Practices — will review recent enforcement actions against supplement companies for false or misleading claims and highlight the “Red Flags” that FTC looks for.
- David Mark, PhD, President of dmark consulting LLC, — will discuss claim substantiation and accumulating data and information to support supplement claims.
- Josef Brinckmann, VP of Research and Development for Traditional Medicinals — will discuss how he has created substantiation files for traditional use claims.
Date: Friday, March 3, 2005 Time: 1:00 pm ET / 12:00 noon CT / 11:00 am MT / 10:00 am PT (runs for approximately two hours).
Cost of participation: $195 (AHPA Members) / $495 (non-members) per connection. Includes an unedited transcript and a Certification of Completion, an important addition to cGMP compliance training and personnel files; additional certificates cost $25 each.
Useful Materials: In advance of the seminar, by email you will receive all speaker presentations and other very useful guidance documents pertaining claim substantiation.
Call Logistics: In advance of the seminar, you will receive an email with call-in logistics, along with the 1-800 number.
Questions for the Panelists: In addition to hearing the speakers make their presentations, this will be your opportunity to have your questions answered. Some participants have already sent in questions. For instance:
- Do I need to have a clinical trial in the substantiation file for each product? How much substantiation is enough?
- Can I have third-party articles on my product website? How far away does the information need to be if the articles contain disease claims? Is it true that they can be “3 clicks” away from the products?
- What are the “buzz words” or conditions that are currently on the radar screens of the FDA and FT C as they monitor our products? Menopause? Diabetes? Arthritis?
If you have questions for the panel in advance of the event, please send them to Robin Gellman via email: [email protected].
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. 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/06_03_AHPAClaimsTeleSeminar.pdf) to 301-588-1174. Once registered, you will receive a confirmation email. Several days prior to the tele-seminar, you will receive by email all pertinent materials and instructions (including the tele-seminar dial-in number). For more details, please contact Robin Gellman via email or phone (301-588-1171, ext. 106).
The American Herbal Products Association (AHPA) is the only national trade association devoted solely to herbal issues. Representing the core of the botanical trade -- 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 quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.