0. Blogs & News – cGMPs fully effective this June 25th
1. FDA Warning Letters as cGMPs become effective
2. Micronutrients and Aging
3. Natural Clinical Trials Center
4. Archived Vitamin Lawyer Webinars
5. Vitamin Lawyer connections…
-----------------------------------------------------
0. Blogs & News –
It
is time for you to make sure your Standard Operating Procedures (SOPs)
are in order! The full panoply of current Good Manufacturing (and
Marketing!) Procedures (cGMPs) go into effect for all Dietary Supplement
companies of no matter what size this June. http:// tinyurl
.com/2eu6yj
Report from DC: A brief YouTube video…
RF on Health Freedom Actions needed now:
www .youtube .com/naturalsolutions#p/f/0/UoZ-j0_8v1s
--------------------------------
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.]
-----------------------------------------------------
- FDA Warning Letters
www .functionalingredientsmag. com/article/NorthSouth-America/fda-inspectors-hone-in-on-gmp-documentation.aspx
May 25, 2010 - FDA inspectors hone in on GMP documentation
By Hank Schultz
“As
D-day approaches for the final round of GMP compliance, a preliminary
review of what inspectors have found so far gives small-tier companies
an insight of what to expect.
Paper.
Inspectors are going to want to see lots of it, in the form of master
manufacturing plans, standard operating procedures, and records of all
sorts.
‘FDA
takes a risk-approached approach. What are the areas of risk right now
for FDA? Let's look at (contamination), and that the products are made
as they are written up to be made, and that there aren't accidental
overages that could potentially raise a red flag,’ said Daniel
Fabricant, scientific affairs vice president for the Natural Products
Association.
‘White mounds of paper,’ Fabricant said. ‘If you don't write it down, it didn't happen.’
On
June 25, the third and final phase of tougher GMP rules goes into
effect. Those companies with 20 or fewer employees must be in full
compliance with the Food and Drug Administration guidelines…
FDA
officials began inspections of larger-sized companies in 2008, and the
number of inspections is increasing every year. The agency completed 12
inspections in fiscal year 2008, 28 in fiscal year 2009, and is doing
many more now…
"Quite
honestly, some of the smaller and medium firms are not there yet,’ said
Carl Reynolds, senior advisor in the Division of Dietary Supplement
Programs at FDA's Center for Food Safety and Applied Nutrition….
[About SOPs] ‘How do you control that document?’ Caplette said. ‘Is there a revision number? Is there a date to it?’ …
‘Whatever
your documentation is, it is finite. It has beginning, a middle and an
end,’ said Michael McGuffin, CEO of the American Herbal Products
Association. ‘Whatever (the documentation requirements are), you can get
there. Once you're there, it's more of a headache than an obstacle.’
The
FDA generates documents of its own in the inspection process, including
a 483 letter detailing the shortfalls they found. Companies can expect
to get one of these.
‘It's
very, very rare for an inspectors to come into a facility and spent six
to ten days there and say, 'Gee, that was perfect,'’ McGuffin said.
‘We
don't see the fact that companies are likely to receive a 483
[deficiency notice] as evidence of failure. The failure would be if you
can't fix what's on the 483,’ he said. …
-----------------------------------------------------
2. Micronutrients and Aging
Bruce Ames: Vitamin insufficiency boosting age-related diseases
www .nutraingredients. com/content/view/print/276676
In
an exclusive interview with Stephen Daniells, Professor Bruce Ames from
the University of California, Berkeley explains why his “triage theory”
could have enormous implications for human health.
For
many, Professor Ames needs no introduction. In the 1970s, he invented
the Ames Test, a simple and inexpensive assay to check the mutagenicity
of compounds. Since then he has dedicated his research to understanding
the biochemistry of ageing, with a focus on mitochondria, the power
plants of our cells, as well as how micronutrients may prevent disease,
malnutrition, and obesity.
So,
when the native New Yorker with over 450 scientific publications tells
you his triage theory is “the most important thing I have ever worked
on”, you sit up and listen.
Evolutionary mechanisms
Triage
– from the French word trier meaning to sort, separate, or select –
works on the battlefield by military doctors prioritising treatments
depending on the probable survival of the wounded.
Prof
Ames’ theory works in much the same way: By appreciating that natural
selection favours short-term survival over the long-term, Prof Ames’
hypothesised that our short-term survival is achieved by prioritising
the allocation of scarce micronutrients. In other words, to stop us
falling over from a lack of iron in the heart, for example, iron is
pulled from non-essential sources.
The triage theory is a way of “measuring the insidious damage going on over time”, he said.
The
theory was first proposed in 2006 (PNAS, Vol. 103, Pages 17589-94) to
explain why age-related diseases like heart disease, cancer, and
dementia may be unintended consequences of mechanisms developed during
evolution to protect against episodic vitamin/mineral shortages.
“If
this hypothesis is correct, micronutrient deficiencies that trigger the
triage response would accelerate cancer, aging, and neural decay but
would leave critical metabolic functions, such as ATP production,
intact,” explained Prof Ames in the Proceedings of the National Academy
of Sciences...
While
the finances may be the lacking, scientific support is not. Working
with the “very good” Joyce McCann, PhD, Prof Ames recently applied his
theory to vitamin K. Writing in the American Journal of Clinical
Nutrition (Vol. 90, pp. 889-907), they reported that five of the 16
known vitamin K-dependent proteins are required for coagulation had
critical functions, meaning that animals genetically manipulated to have
inactive forms did not survive.
On
the other hand, another five proteins were found to be less critical,
and the animals survived through weaning. However, a lack of these less
critical vitamin K-dependent proteins, inadequate intakes of vitamin K1
from the diet, or vitamin K deficiency were all associated with
age-related conditions, including weaker bones and hardening of the
arteries, which increased the risk of cardiovascular disease. An
increase in the incidence of spontaneous cancer was also observed...
Triage theory has cleared every hurdle it has come up against, but that doesn’t surprise Prof Ames.
“My triage theory makes sense,” he said. “And it is almost certainly going to be right.”
-----------------------------------------------------
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. The Natural
Solutions Center in Volcan, Panama is expected to be opened by the end
of May, so Clinical Trials can begin shortly thereafter. 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: 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).
----------------------------------------------
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
------------------------------------------------
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.
0. Blogs & News – Gov’t says: NO RIGHT TO FOOD ACCESS
1. Health Freedom of Speech Bills
2. IRS – New Nonprofit Reporting – the easy way…
3. Natural Clinical Trials Center
4. Archived Vitamin Lawyer Webinars
5. Vitamin Lawyer connections…
-----------------------------------------------------
0. Blogs & News –
This from a recent Federal Govt Brief, in a raw milk case:
[File this under: why we need a Freedom of Health Speech and Conscience Amendment]
“There is No Generalized Right to Bodily and Physical Health.
“Plaintiffs’
assertion of a “fundamental right to their own bodily and physical
health, which includes what foods they do and do not choose to consume
for themselves and their families” is similarly unavailing because
plaintiffs do not have a fundamental right to obtain any food they
wish…; see also Cowan v. United States, 5 F. Supp. 2d 1235, 1242 (N.D.
Okla.1998) (rejecting a claim that the plaintiff had the fundamental
“right to take whatever treatment he wishes due to his terminal
condition regardless of whether the FDA approves the treatment”).
Finally, even if such a right did exist, it would not render FDA’s
regulations unconstitutional because prohibiting the interstate sale and
distribution of unpasteurized milk [sic] promotes ‘bodily and physical
health.’”
--------------------------------
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. Health Freedom of Speech Bills
Foods
or dietary supplements that may be of benefit for health conditions
are, according to the FDA, unapproved "drugs." Representatives Jason
Chaffetz (R-UT) and Jared Polis (D-CO) the co-chairs of the Dietary
Supplement Caucus, have introduced the Free Speech about Science Act -- H.R. 4913.
This bill would ensure our basic Free Speech in health matter, end
censorship and, according to observers, "enable the natural health
products community to share peer-reviewed scientific findings about
natural health products with the public..."
We
have long urged support for Representative Ron Paul’s bills - HR 3394,
the Freedom of Health Speech Act, and HR 3395, the Health Freedom Act.
This new bill joins them to offer the possibility of a real turn-around
in US law; finally supporting the intent of the Dietary Supplement
Health and Education Act of 1994 (DSHEA) that we have broad freedom to
use food for heatlh and fully rejecting the FDA's discredited public
policy of "HARMonizing" especially with international restrictions on
our rights.
Action Item: salsa.democracyinaction .org/o/568/p/dia/action/public/?action_KEY=3729
.-----------------------------------------------------
2. IRS to Begin Revoking Tax Exemptions May 17 for Failure to File
www .njnonprofits. org/CheckIRSRevocation.html
“Thousands
of … nonprofit organizations - including as many as 5,600 public
charities [in NJ] - could be in danger of losing their tax exemptions if
they don't submit required information filings to the IRS by May 17th. …
Under the federal Pension Protection Act of 2006, exempt organizations
that fail to file required Form 990 annual information returns (or, in
the case of
small organizations, the Form
990-N e-postcard) for three consecutive years will have their tax
exemptions automatically revoked by the IRS effective on the filing due
date of the third year. The Form 990 or e-postcard is required to be
filed annually by the 15th day of the 5th month following the end of an
organization's fiscal year.
The
first round of revocations will begin May 17, 2010. If tax exemption is
revoked, the only way to reinstate it will be to reapply (at a fee of
as much as $850). You can save your tax-exempt status by filing!
If
you are running a nonprofit, consider form 990 N (for nonprofits with
expected gross receipts under $25,000 (I assume in average since
inception). This new rule does not apply to religious bodies which are
exempt from filing form 990.
Here is where form 990 N can be filed on line: www .irs. gov/charities/article/0,,id=169250,00.html
This is what information is required:
1. Employer identification number (EIN).
2. Tax year
3. Legal name and mailing address
4. Any other names the organization uses
5. Name and address of a principal officer
6. Web site address if the organization has one
7. Confirmation that the organization’s annual gross receipts are
normally $25,000 or less
8. If applicable, a statement that the organization has terminated or is
terminating (going out of business)
-----------------------------------------------------
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. The Natural
Solutions Center in Volcan, Panama is expected to be opened by the end
of May, so Clinical Trials can begin shortly thereafter. 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: 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).
----------------------------------------------
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
------------------------------------------------
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.
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: 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).
----------------------------------------------
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
--------------------------------
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) usa.net with “Unsubscribe” in the subject line.
0. Blog & News – URGENT FUNDING NEEDED
1. FDA Warning Letter Trends
2. Product Expiration Dates
3. Natural Clinical Trials Center
4. New Webinar on Copy Writing Planned
5. Archived Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News –
URGENT FUNDING NEEDED
You’ve
heard about the “Stop the Shot” lawsuit aimed at de-licensing the H1N1
and other “seasonal” flu vaccines. We were in Court in DC in November,
and New York backed off its health care workers’ mandate, leaving us
without legal "standing" to challenge the vaccine licenses. Then we were
heading back to Court in December, but New Jersey backed off its
licensed child care mandate… As the Judge said, “Your clients are
winning…” but we still did not have “standing” to challenge the FDA’s
illegal approvals of the flu vaccines!
The November Case: Lawyers Video Report
www .healthfreedomusa .org/?p=3933
The NJ Case: www .healthfreedomusa .org/?p=3970
WELL,
WE ARE READY TO GO BACK TO COURT – with new mandated clients --
however, this time we are not “telegraphing our punches” by announcing
our clients in advance! Last night I emailed the 13 documents, two of
them over 30 pages each, which will make up the initial filing, to our
lawyers in DC who will actually file the case.
IT’S
TIME TO FUND THE “STOP THE SHOT” LITIGATION. I don’t think I need to
dwell on the importance of “putting down” Big Pharma’s vaccine gambit to
the natural products industry.
The H1N1 vaccines is the perfect example of Obamacare in action: the
govt bought $6.4 billion of vaccines, then the govt (FDA) approved the
vaccines (we say, “Illegally!”) then the govt (CDC) recommended the
vaccines and then the govt (HHS) distributed them… all without following
their own drug approval rules.
This
type of litigation is expensive. So far it’s been mostly done with
volunteer work, but now the lawyers in DC need some funding to cover the
cost of their associate who is actually doing the leg work. We also
need to cover the filing fees. Natural Solutions covered the filing fees
in November. Our ally Gary Null is covering his lawyer’s costs. WE NEED
YOUR HELP TO COVER THE DC LAWYERS.
IF
YOU ARE WILLING TO DONATE FOR THIS PURPOSE, please call me or email me
immediately. We need to talk. Even donations as little as $100 will
help; a couple $1,000 donations would go a long way. But, the total cost
of this case could be a hundred grand or more.
‘Nough said. Anyone out there willing to make this happen? I promise you, it will be money well invested. 973.300.4594
-----
Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net
Dr. Rima Recommends: new web site
www .DrRima .net
More Madness from DC: McCain attacks Dietary Supplements
While Harkin attacks Foods… all under the guise of “safety…”
www .healthfreedomusa .org/?p=4683
And this on the Vitamin Lawyer blog:
vitaminlawyerhealthfreedom.blogspot .com/2010/02/fake-food-and-supplement-safety-bills.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.]
-----------------------------------------------------
1. An Analysis of Warning Letter Trends [from: FDA News]
“With
the FDA issuing warning letters at the rate of one-and-a-half per day
in 2009 — a 23% increase over 2008 — now isn't the time to face the FDA
unprepared!
“FDA
[News]… has analyzed data from FDA warning letters to better understand
what problems the FDA most often cites. [We] found FDA inspectors
focusing on the following six themes in their inspections:
# CAPA
# International Harmonization
# Supplier Management
# Postapproval Controls
# Records Controls
# Swifter Enforcement …
“Manufacturing
and Quality. Production record review and quality laboratory controls
topped the list of citations addressed by warning letters, but five
other key areas were also cited in more than 25 percent of
quality-related warning letters.
“Advertising
and Marketing. FDA more than doubled the number of advertising-related
warning letters it produced last year, and the agency is promising there
will be no letup in the intensity of its enforcement.
“Clinical
Trials. Clinical trial regulations were the subject of more than 20
warning letters in 2009. Investigators were cited for inadequate
informed consent and failing to take case histories; IRBs were cited for
failing to document their actions and maintain adequate policies; and
sponsors were faulted for failure to fulfill general responsibilities
and stop out-of-compliance investigators.”
-----------------------------------------------------
2. Product Expiration Dates
As
you may be aware from previous issues of the Vitamin Lawyer Update
eMemo, the FDA does NOT require dietary supplement manufacturers to put
an “expiration” or “best used by” date on product packaging. It does
require, however, if you do so, you must have “competent and reliable”
substantiation for that date! With the cGMP requirement that your
manufacturer keep product samples from each batch, over time, you may
develop such substantiation.
But
what to do in the mean time? I suggest you remove any such dating from
bottles. One client decided to sell “expired” product at discount and
asked for my suggestion for a FAQ on the subject. Here is what I
suggested:
“Some
of our customers have asked us about "expiration dates" on dietary
supplement bottles. It was traditional in the vitamin industry to
include "expiration" or "best to use by" dates on bottles, since dietary
supplements are foods and food product packing often has expiration
dates.
“The
Food and Drug Administration (FDA) does NOT require such dating for
dietary supplements, and, under the FDA's revised "Good Manufacturing
Procedures" such dating is NOT permitted unless there is some good,
scientific reason to have an expiration date. We are therefore removing
unnecessary dating on our products to conform to current practices.
“Some
of our product labels still contain such dating and where the dating
has "expired" but without any indication of actual need for such dating,
we are offering the products at discount. Should you receive a product
with an "expired" date and do not want to use the product, please return
it within 30 days of receipt for a full refund.”
-----------------------------------------------------
3. Natural Clinical Trials Center
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. New Natural Solutions Webinar Planned – Coming this March
“Writing Lawful Natural Products Ad Copy”
Details will be posted at:
www .NaturalHealthOptions .net
www .NaturalClinicalTrials org
If
you want to reserve space for this Webinar, please email me at
ralph.fucetola (at) usa.net and put “Webinar” in the Subject line. The
expected price for the 2 hour event is $99.
--------------------------------------------------------------
5. 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).
----------------------------------------------
Our new affiliation site: www .naturalhealthoptions .com
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
-----
Current Webinar Project: Writing Lawful Ad Copy (March)
Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives .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.
