Thursday, March 12, 2009

03/12/09 - FDA Enforcement Threat Level Rises…

0.  News  -  Costs and Risks…
1.  FDA Official’s Comments at Expo West
2.  Webinar Series Archives and Plans

0. VL Blog News

A. Costs of getting a Health Claim approved in the EU now believed to be in excess of $6 million (Euro 5 million) and to take 6 months to two years.

See: nutraingredients. com/Regulation/Health-claim-dossiers-cost-5m-says-DSM/?c=gbrnO2ewSG1X%2FtLolfh2%2FA%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

And here is the current status of Health Claims in the EU:
efsa.europa. eu/EFSA/efsa_locale-1178620753812_article13.htm

B. Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

http:// vitaminlawyerhealthfreedom.blogspot. com/2009/03/pandemic-risk-alert.html

[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]


1.  FDA Honcho Promises More Rigid Enforcement of GMPs

FDA’s Brad Williams stated that boosted funding means FDA inspectors may be about to “saturate the field” according to his comments at Expo West. The FDA Dietary Supplements Program Manager spoke with Shane Starling of The video of their discussion can be seen at:

nutraingredients-usa. com/Industry/FDA-we-will-enforce-GMPs/?c=gbrnO2ewSG1jP7DYIvsGew%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Bottom line:

“GMPs are a brand new rule… increased inspections last year, more this year… this time next year [when even the smallest companies will have to comply] will have even more inspections … informed by new administration that FDA is about to receive much more money and will be able to saturate the field with inspectors… a large increase in our force out there… largest supplements firms shouldn’t have a problem funding, but some mom and pop operations will be lost… recommends that small firms band together so the new rules don’t break their backs… burden on manufacturer to make sure ingredient suppliers comply.  The plan for this rule is that we will enforce it… we want to help people comply…”


2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

A. Bringing New Natural Products to Market

Date: April 17, 2009
Time: 8:00 PM EDT (approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook and a private forum for additional communcations.

The sign-up link will be posted in early April at: www. healthfreedomusa. org/?page_id=2002

In the meantime, you can email me at with “Webinar” in the subject line to reserve your place.

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

B. CAM Advanced Healthcare Practitioner SOPs

Date: 02/26/09 [Archived]
Time: 8:00 PM EST (approximately 2 hours)

You can see the archived webinar at:
vital-connection. com/ethical-legal-considerations-course-february-26th-2009/

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

All Webinars include useful eBooks of forms and other information that will help you organize.


Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com