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…
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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.
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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.]
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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.
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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
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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.
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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: 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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5. Vitamin Lawyer Connections…
Do
you Skype? If so, free Skype.com 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
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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
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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) usa.net with “Unsubscribe” in the subject line.
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