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.
Monday, May 10, 2010
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: 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.
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.
Tuesday, February 16, 2010
02/16/10 - FDA Warning Letters; Product Expiration Dates
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.
Wednesday, February 3, 2010
02/03/10 - Top Ten Web Trends for 2010
0. Blog & News – CAPA
1. Top Ten Web Trends for 2010
2. Natural Clinical Trials Center
3. New Webinar on Copy Writing Planned
4. Archived Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News –
Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net
Dr Rima writes Forbes on Vaccination:
www .healthfreedomusa .org/?p=4568
Dr Rima Reports on Panama Eco Project:
www .healthfreedomusa .org/?p=4554
CAPA SOPs–
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
[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. From EntireWeb.com: “It's never been harder to keep up with the latest web trends - with the expansion onto mobile platforms, the growth of social media and the need for start ups to be aware of new SEO techniques.” Here are some excerpts:
… Constructing a mobile website, creating social media campaigns and selling online are just some of the challenges businesses will face during 2010. Here are top online trends for the next 12 months.Mobile web
Every web-savvy business knows smartphone use is on the rise. But few are actively developing for mobiles by creating websites specifically used for handheld devices.
As more and more mobile users flock to gadgets with larger touchscreens and internet browsers, such as the iPhone or Google Nexus One, the mobile space will become bigger and SMEs need to get on board. If your website isn't accessible through a smartphone or app, users will give up and go somewhere else - losing you traffic and potential sales.
Ovum analyst Nathan Burley says the number of people taking up smartphones instead of traditional handsets will require businesses to develop mobile websites.
"In our view there are two big trends that will occur in 2010. That is mobile broadband and the adoption of smartphones, and the impact of those two things on the industry. This is changing the way people access the internet, and that is in mobile." …SEO
Using search engine algorithms in order to get your site on "page one" has been a tactic used by online businesses for years. But SEO experts say the process of getting a website known will become even harder in 2010 with the rise of personalised and real-time search.
Social network Twitter sparked a trend when it designed the first popular real-time search engine. When users search for a term, the site would update that search with new "tweets" as they were being made.
Google has recently introduced a real-time search function of its own, complete with indexed tweets, while Microsoft Bing has made a deal to show tweets in search results. …
Social Media
Facebook and Twitter were the standout social networks from 2009, and their popularity will surge in 2010 with both introducing new features, including paid accounts for business.
But businesses need to pay attention to the trends on these sites. Creating a social media strategy is no longer optional, it is vital to the health of a company and its ability to tap into an online user-base. …Online retail
More and more Australian businesses are selling online, but compared to the US we have a lot of catching up to do. Online spending has grown from 1% to 3% of overall spending over the last 10 years, compared to the American equivalent of 7%. …Advertising
The internet advertising industry continued to grow in 2009 and will do the same in 2010, but the next 12 months is expected to see the ongoing development of mobile advertising.
Last year the Interactive Advertising Bureau forecast the online ad market to pass $2 billion by next month, representing a 27% increase from 2008. While the downturn forced spending down in 2009, it's safe to assume that figure will rise in 2010. …
Reputation management
Most businesses are at least operating a website, but even those rejecting the online space need to be aware of how fast rumours and allegations can fly in the digital age. Several companies have had their reputations tarnished within hours from the activities of either rogue employees, or a botched advertising campaign.
Griffin says businesses need to control their reputation by monitoring what people are saying about them.
… "Auditing, monitoring and analysing social media platforms along with risk mitigation strategies will become standard fare for those companies looking to protect and enhance their brand on social media platforms." …Marketing
While mobile advertising may be taking awhile to heat up, many businesses are developing new and interesting mobile marketing campaigns to draw people into their stores.
Google has developed a system whereby users take a picture of a barcode with their mobile phone and use the search engine to find information. Closer to home, Hoyts Cinemas currently runs a promotion where movie goers with Bluetooth activated on their handsets sometimes receive discount offers via text messages when they walk into a lobby. …
Thomas also says a number of companies will begin to commission mobile apps, especially on the iPhone, purely for marketing purposes. Whether this will gain them revenue or purely open their brand to a new audience, the mobile apps market will become part of an online business's marketing strategy in 2010.Content
The growth of the internet has allowed businesses to publish content of their own, including blogs, pictures and even videos. King says SMEs should think about creating some sort of content on YouTube or similar sites such as a tutorial, and see a fan base grow. …Open Source
Once upon a time, businesses wouldn't trust open-source programs in favour of branded, more trustworthy software solutions. But now open-source has given SMEs a way of operating high-end programs without substantial costs. …Cloud computing
Two years ago "cloud computing" was viewed by many businesses as a buzzword with no particular meaning, used by tech-heads who didn't quite know what they were talking about.
Now, using cloud services has become an essential for businesses. Whether they are backing up their data or using a piece of software hosted on external servers, cloud computing is now a part of everyday operations for many SMEs. …
"Using cloud resources does not eliminate the costs of IT solutions, but does rearrange some and reduce others. In addition, consuming cloud services enterprises will increasingly act as cloud providers and deliver application, information or business process services to customers and business partners."
Author: Patrick Stafford – SmartCompany .com.au
www .entireweb .com/newsletter/archive/2010/PRINT597.html
-----------------------------------------------------
2. 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.
------------------------------------------------
3. 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.
--------------------------------------------------------------
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).
----------------------------------------------
Natural Clinical Trials – www .NaturalClinicalTrials .org
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: Correction and Prevention Analysis
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.
1. Top Ten Web Trends for 2010
2. Natural Clinical Trials Center
3. New Webinar on Copy Writing Planned
4. Archived Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News –
Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net
Dr Rima writes Forbes on Vaccination:
www .healthfreedomusa .org/?p=4568
Dr Rima Reports on Panama Eco Project:
www .healthfreedomusa .org/?p=4554
CAPA SOPs–
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
[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. From EntireWeb.com: “It's never been harder to keep up with the latest web trends - with the expansion onto mobile platforms, the growth of social media and the need for start ups to be aware of new SEO techniques.” Here are some excerpts:
… Constructing a mobile website, creating social media campaigns and selling online are just some of the challenges businesses will face during 2010. Here are top online trends for the next 12 months.Mobile web
Every web-savvy business knows smartphone use is on the rise. But few are actively developing for mobiles by creating websites specifically used for handheld devices.
As more and more mobile users flock to gadgets with larger touchscreens and internet browsers, such as the iPhone or Google Nexus One, the mobile space will become bigger and SMEs need to get on board. If your website isn't accessible through a smartphone or app, users will give up and go somewhere else - losing you traffic and potential sales.
Ovum analyst Nathan Burley says the number of people taking up smartphones instead of traditional handsets will require businesses to develop mobile websites.
"In our view there are two big trends that will occur in 2010. That is mobile broadband and the adoption of smartphones, and the impact of those two things on the industry. This is changing the way people access the internet, and that is in mobile." …SEO
Using search engine algorithms in order to get your site on "page one" has been a tactic used by online businesses for years. But SEO experts say the process of getting a website known will become even harder in 2010 with the rise of personalised and real-time search.
Social network Twitter sparked a trend when it designed the first popular real-time search engine. When users search for a term, the site would update that search with new "tweets" as they were being made.
Google has recently introduced a real-time search function of its own, complete with indexed tweets, while Microsoft Bing has made a deal to show tweets in search results. …
Social Media
Facebook and Twitter were the standout social networks from 2009, and their popularity will surge in 2010 with both introducing new features, including paid accounts for business.
But businesses need to pay attention to the trends on these sites. Creating a social media strategy is no longer optional, it is vital to the health of a company and its ability to tap into an online user-base. …Online retail
More and more Australian businesses are selling online, but compared to the US we have a lot of catching up to do. Online spending has grown from 1% to 3% of overall spending over the last 10 years, compared to the American equivalent of 7%. …Advertising
The internet advertising industry continued to grow in 2009 and will do the same in 2010, but the next 12 months is expected to see the ongoing development of mobile advertising.
Last year the Interactive Advertising Bureau forecast the online ad market to pass $2 billion by next month, representing a 27% increase from 2008. While the downturn forced spending down in 2009, it's safe to assume that figure will rise in 2010. …
Reputation management
Most businesses are at least operating a website, but even those rejecting the online space need to be aware of how fast rumours and allegations can fly in the digital age. Several companies have had their reputations tarnished within hours from the activities of either rogue employees, or a botched advertising campaign.
Griffin says businesses need to control their reputation by monitoring what people are saying about them.
… "Auditing, monitoring and analysing social media platforms along with risk mitigation strategies will become standard fare for those companies looking to protect and enhance their brand on social media platforms." …Marketing
While mobile advertising may be taking awhile to heat up, many businesses are developing new and interesting mobile marketing campaigns to draw people into their stores.
Google has developed a system whereby users take a picture of a barcode with their mobile phone and use the search engine to find information. Closer to home, Hoyts Cinemas currently runs a promotion where movie goers with Bluetooth activated on their handsets sometimes receive discount offers via text messages when they walk into a lobby. …
Thomas also says a number of companies will begin to commission mobile apps, especially on the iPhone, purely for marketing purposes. Whether this will gain them revenue or purely open their brand to a new audience, the mobile apps market will become part of an online business's marketing strategy in 2010.Content
The growth of the internet has allowed businesses to publish content of their own, including blogs, pictures and even videos. King says SMEs should think about creating some sort of content on YouTube or similar sites such as a tutorial, and see a fan base grow. …Open Source
Once upon a time, businesses wouldn't trust open-source programs in favour of branded, more trustworthy software solutions. But now open-source has given SMEs a way of operating high-end programs without substantial costs. …Cloud computing
Two years ago "cloud computing" was viewed by many businesses as a buzzword with no particular meaning, used by tech-heads who didn't quite know what they were talking about.
Now, using cloud services has become an essential for businesses. Whether they are backing up their data or using a piece of software hosted on external servers, cloud computing is now a part of everyday operations for many SMEs. …
"Using cloud resources does not eliminate the costs of IT solutions, but does rearrange some and reduce others. In addition, consuming cloud services enterprises will increasingly act as cloud providers and deliver application, information or business process services to customers and business partners."
Author: Patrick Stafford – SmartCompany .com.au
www .entireweb .com/newsletter/archive/2010/PRINT597.html
-----------------------------------------------------
2. 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.
------------------------------------------------
3. 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.
--------------------------------------------------------------
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).
----------------------------------------------
Natural Clinical Trials – www .NaturalClinicalTrials .org
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: Correction and Prevention Analysis
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.
Subscribe to:
Posts (Atom)