Monday, April 19, 2010

04/19/10 - The Politics of Food and Supplements; Connections

0.  Blogs &; News – Vitamin Lawyer Update Memo again…
1.  Free Speech Bill… for supplements!
2.  Obamacare and CAM
3.  Natural Clinical Trials Center
4.  Archived Vitamin Lawyer Webinars
5.  Vitamin Lawyer connections…

Blogs & News –
After an absence of over a month… here is the latest Vitamin Lawyer Update Memo. My goal is to contact you all about twice a month, so my apologies! The past year’s Memos are about to be posted on my Archive Blog, http:// vitaminlawyerarchives.blogspot .com (check there in about ten days).

Recent issues of this Memo have covered such topics as Recent Trends in FDA Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net

Dr. Rima Recommends: new web site with information regarding the Wellness Center that Dr. Rima E. Laibow MD is opening in Panama at the end of May: www .DrRima .net – I will be in Panama for the Grand Opening (the Provincial Governor is cutting the ribbon) for the event. If anyone wants to travel to Panama for a week and see the Valley of the Moon, a small party of interested people will be joining me for the trip; please let me know if you are interested ASAP

[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.]


1. Free Speech Bill for Natural Products, etc.

Free Speech About Science – New Bill Introduced
www .foodnavigator .com/content/view/print/283409

The Bill makes the following provisions:

* Allows dietary supplements and healthy foods to cite legitimate scientific research
* Provide a clear definition of the types of research that may be referenced by growers and manufacturers
* Ensures that referencing such research does not convert a food or dietary supplement into an “unapproved [and therefore illegal] new drug”
* Retains the authority of FDA and FTC to pursue any fraudulent and misleading statements.


2. Obamacare and CAM

Here is what the NPA (Natural Products Association) has to say about the new law:

“Industry groups are highlighting benefits that may flow to the dietary supplements and complementary and alternative medicines (CAMs) sectors as a result of the landmark Patient Protection and Affordable Care Act that has been passed by Congress.

The Bill will make it more difficult for the mainstream medical community to discriminate against CAMs and is likely to provoke schemes that will promote  the use of certain dietary supplements.

According to the Natural Products Association, ‘community health center
demonstration projects’ will establish programs to:

* Give omega-3 oils to those suffering cardiovascular problems
* Give omega-3 oils to pregnant women
* Give vitamin D and calcium to the elderly

“We are hugely excited by these measures,” said Dan Fabricant, PhD, the NPA’s vice president of scientific and regulatory affairs.”

I remain opposed to nationalized health care and hope for the quick repeal of the new law, but, we must always consider the impact of such laws on CAM practices. If the NPA is correct, this law is a “two edged sword” that may offer some hope for continued acceptance of CAM practices.

Further: we find J. Emord, Esq. in agreement with us:

“But Virginia-based food industry attorney, Jonathan W Emord, was critical of the legislation.

“By compelling almost all Americans to buy a specific product – health insurance – the bill violates the Fifth Amendment protections for individual liberty,” he said.

“That constriction on freedom of choice forces those who wish to rely on unconventional care, including nutrition, to expend thousands of dollars annually on conventional care coverage they may not want or need. The consequence will be to discourage the choice of alternative care, including supplementation, in favor of conventional care covered by insurance.” ”

www .foodnavigator .com/content/view/print/283408

In related news, the Food Safety Bill wending its way through the Senate has apparently had new language added to it, allegedly to protect DSHEA products from enhanced FDA authority. We are very skeptical about such changes and remain opposed to this bill, S.510, as well:

www .healthfreedomusa .org/?p=5144


3.  Natural Clinical Trials Center

Update: NCT now has a relationship with a National University that is very interested
in "breaking into" the nutrient clinical study market -- this is an
opportunity to benefit from a university-level study at modest price.
Obviously, the cost will be greater than the cost of a private clinical study
at Dr. Rima's clinic, but, with our special relationship, we can keep the
costs down to a reasonable and affordable level. And, of course, you will have
the assurance that the professionals at NCT are keeping close watch on the
protocol and progress of the university study.

Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.


4. Archived 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).


5. Vitamin Lawyer Connections…

Do you Skype? If so, free is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site: www .naturalhealthoptions .net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus


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

Current SOP Project: CAPA
Corrective and Preventative Actions Standard Operating Procedures

CAPA is an essential element in cGMP SOPs.
Outline below; let me know if you need a formal SOP.

Main Headings of the CAPA SOP

Discovery of the Deviation
Documentation of the Event
Immediate Corrective Action
Investigation of the Primary Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation


Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) with “Unsubscribe” in the subject line.