Monday, August 10, 2009

08/10/09 - FDA Promises More Enforcement

0.  Blog &News
1.  Comments on Stronger FDA Enforcement
2.  Vitamin Lawyer Webinars

  1. 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.

Three Weeks to Save Health Freedom Campaign:
www. healthfreedomusa. org/?p=3209

Quote of the Week from the Commissioner of Food and Drugs -  “Now is a good time to reassess whether you have … [a compliance] effort in place.”

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

[Please note: all URLs in this memo are "broken" with spaces inserted after the www. to avoid the memo being treated as "spam" by certain email service providers.]


1. Comments on Stronger FDA Enforcement

Margaret Hamburg, M.D.
Commissioner of Food and Drugs

“…a strong FDA enforces the law.

Every company with products or activities under FDA’s jurisdiction has a duty
to comply with the law… to meet the standards that the FDA has set to protect
the public. I have been impressed by the commitment to compliance that many
companies have made – both in terms of their corporate culture and their
investment in compliance systems.

Our goal is for all companies to make and implement such a commitment in order
to prevent harm to the American people. We have a responsibility to clearly
articulate and explain our rules and regulations, but a key part of the strategy
to support private sector compliance is effective enforcement against violations
of the law.

Effective enforcement has many clear benefits to public health.

It enables FDA to intercept unsafe or fraudulent products promptly… and
prevent additional harm.

By holding violators accountable, enforcement deters others who would put the
public at risk or prey upon vulnerable consumers.

Visible and clearly explained enforcement actions inform members of the public
about potential dangers.

And enforcement helps industry too – by maintaining a level playing field for
safe products. Making sure that offenders are held legally accountable prevents
companies from having to choose between doing the right thing and staying

The solution is a commitment to compliance backed by a strong compliance
program. Now is a good time to reassess whether you have such an effort in


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:

[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).


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

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