(January 25, 2006, Silver Spring, MD) — You may think you’re on the right side of the fine line between structure-function claims and disease claims, but federal regulators are closely inspecting where you are. The Food and Drug Administration (FDA) has stepped up enforcement activities against unlawful drug claims and unsubstantiated structure function claims by supplement companies. And for egregious claims, FDA is able to obtain disgorgement of sales dollars. In addition, FDA are now putting holds on ingredients and products being imported into the U.S., based on product claims on company websites.
Recent enforcement actions against supplement companies:
- FDA says products are drugs — one website described its products as “… just the ticket … to relieve a headache, to alleviate a sinus infection, to fight allergies …” and “cleanses … toxic buildup that unwanted yeasts, such as Candida, live off of in the intestines.” FDA warned the company that these claims make the products unapproved new drugs.
- FDA may now levies fines, big fines — FDA’s newly established right to demand restitution for consumers was upheld in court recently; specifically, $109 million to be paid by the company. Who’s next?
- Structure-function claim unsubstantiated — an FDA warning letter stated that claims have been reviewed “and have concluded that they are not supported by competent and reliable scientific evidence.”
AHPA’s upcoming tele-seminar, Substantiation for Dietary Supplements — How to Ensure Dietary Supplement Product Claims Are Truthful, Legal & Documented, will supply advice from a panel of experts who are actively involved in all aspects of claim substantiation for dietary supplements. This is a unique opportunity to ask your specific legal, regulatory, and scientific questions. The seminar, Friday, March 3, features these speakers:
- 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.
The session begins at 1:00 pm ET / 12:00 noon CT / 11:00 am MT / 10:00 am PT and runs for approximately two hours. The cost of participation is $195 (AHPA Members) / $495 (non-members) per connection. The cost includes an unedited transcript and a Certification of Completion, an important addition to cGMP compliance training and personnel files; additional certificates cost $25 each.
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 that will be read in an anonymous fashion during the Q&A session. If you have questions for the panel in advance of the event, please email them to Robin Gellman: [email protected].
Please fax the online registration form ( http://www.ahpa.org/06_03_AHPAClaimsTeleSeminar.pdf) to: 301-588-1174, and please email Robin Gellman at [email protected]. Registration takes place in advance only; the deadline is February 23. Once registered, a confirmation email will include all pertinent materials and instructions (including the tele-seminar dial-in number). If you have any questions, please contact Robin Gellman at [email protected] or 301-588-1171, x106.
The American Herbal Products Association (AHPA) is the only national trade association devoted solely to herbal issues. Representing the responsible center 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