1. Standard Operating Procedures
2. Vitamin Lawyer Webinars
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- Blog & News – New Vitamin Lawyer Video
NEW VITAMIN LAWYER VIDEO – 45 Minute Interview
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Three Weeks to Save Health Freedom Campaign:
www. healthfreedomusa. org/?p=3209
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
Late breaking news: NJ vitamin company LaneLabs prevails in FTC motion case: “‘This is not a case of a company making claims out of thin air,’ stated the opinion. The court highlighted the fact that LaneLabs had hired a compliance officer and had also sought expert advice to interpret the scientific evidence it used to back its claims. ‘LaneLabs found a product and obtained scientific evidence that the product is efficacious. LaneLabs then consulted experts who opined that the research supporting the product and the product itself were good,’”
Clearly, SOPs and Substantiation are really important! Read all about it on my blog:
vitaminlawyerhealthfreedom.blogspot. com/2009/08/dietary-supplement-court-victory-in-nj.html
[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
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- Are Your Papers in Order – SOPs
As the LaneLabs court victory shows, YOUR PAPERS MUST BE IN ORDER! The Vitamin Lawyer’s Standard Operating Procedures (SOPs) format for natural products distributors has been updated to reflect recent increased FDA and FTC oversight of the industry. One new SOP has been added, regarding Change Controls (documenting when and how you adopt and change SOPs is also an SOP!) and several have been extensively updates, including new sections in Quality Controls regarding claims and substantiation. An outline for your Compliance Note Book is included.
Remembering the “Quote of the Week” from my last eMemo, the new Commissioner of Food and Drugs said, “Now is a good time to reassess whether you have … [a compliance] effort in place.”
Standard Operating Procedures are a primary part of that compliance effort.
If I have already provided you with your SOPs, please email me (with SOP) in the subject line and I will forward you the revised format.
If you don’t already have your SOPs in order, WHY NOT? My standard fee for customizing the format for you is one hour.
And here is a teaser: Compliance Note Book outline:
(1) A copy of the product label
(2) Copy of the Notice(s) of Structure and Function Claims
(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
Do you need your SOPs? Please email me with “New SOP” in the subject line.
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2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84
[3] Bringing New Natural Products to Market
Held: May 10, 2009 – This Webinar is Archived.
(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 with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102
"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!
[4] Sustainable IRA
Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)
Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested). With eBook.
Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95
Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .cohttp://www.healthfreedomusa.org/?p=507m
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