Wednesday, May 20, 2009

05/20/09 - GMPs effective next month…

0.  News  -  Vitamin Lawyer on Twitter!
1.  Guest Message on GMPs
2.  Webinar Series Archives

0. Blog News –

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[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. GMPs coming to you…

By: Jeffrey S. Bliss

“The GMP Final Rule for Dietary Supplements is in full force. The next upcoming compliance dates are June 10th thru the 25th, 2009. Is your company ready to meet the obligations of the rule?

Can you show the FDA that every product you carry is made according to GMP requirements?

As a distributor and holder of dietary supplements, you are fully responsible for what you do in-house as well as for anything that is done on your behalf by manufacturers, packagers and labelers. Given that you have the ultimate responsibility for showing your products comply with GMP rules, what are the steps you need to take to ensure you're ready for an FDA inspection?

Think about the below.

The need to establish written specifications for each product
How to demonstrate your products comply with those specifications
The functions of quality control personnel
Requirements for ID testing of dietary ingredients and finished products
And Much More!

The bigger the company you are, the quicker the FDA will notice you. Much of what will transpire from all this is that those who are operating in an un-ethical manner will find it very hard to continue to do business. It is highly recommended that you have the right people on your side in your efforts to establish, grow, and continue your business.”

Vitamin Lawyer Comment: Jeff Bliss has a good point there. The Vitamin Lawyer SOP (Standard Operating Procedures) focuses on your company’s marketing and claims. Jeff’s focuses on the GMPs… you need both!


2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:

Go to www. VitalConnectionUniversity .com

At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.

Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.

A. CAM Advanced Healthcare Practitioner SOPs

Date: 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

B. Bringing New Natural Products to Market

Date: 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 and a private forum for additional communications.

Sign up through link at: www. healthfreedomusa. org/?page_id=2002

"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!

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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.


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

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