0. Blog & News – (sic) “Food Safety” Bill S.510 Delayed
1. FTC Changes Testimonial Rules – Clinical Trials Needed
2. Sneak Preview: New Web Site for Natural Clinical Trials Center
3. Vitamin Lawyer Webinars
-----------------------------------------------------
Blog
& News – The “Food Safety” bill is delayed in the Senate after we
generate about 150,000 emails in a couple days; changes have been made
that meet some natural product industry concerns… but not all. See: www
.healthfreedomusa .org/?p=4014
Sneak Preview: Natural Clinical Trials – www .NaturalClinicalTrials .org – see below!
Our new affiliation site: www .naturalhealthoptions .com
Do
you have an affiliation program? We’d like to list it. If you don’t
have one… 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
$11.95 – 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
Coming soon…
Health
Freedom's volunteer lobbyist in Washington, Maury Silverman of the
American Library for Health is seeking donations for his nonprofit
institute. Donations will be tax deductible, and this is the Giving
Season... Maury will volunteer to be your man in DC and provide you with
useful information... great networker of information that creates
progress (I can attest how useful he's been to our foundation and some
of my clients). Donations: PO Box 7507 - Silver Springs MD 20907
[240-330-3420].
[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. FTC Changes Testimonial Rules – Are your SOPs Ready?
Here
is what the FTC announced last month: “Under the revised Guides,
advertisements that feature a consumer and convey his or her experience
with a product or service as typical when that is not the case will be
required to clearly disclose the results that consumers can generally
expect. In contrast to the 1980 version of the Guides – which allowed
advertisers to describe unusual results in a testimonial as long as they
included a disclaimer such as “results not typical” – the revised
Guides no longer contain this safe harbor.
“Celebrity
endorsers also are addressed in the revised Guides. While the 1980
Guides did not explicitly state that endorsers as well as advertisers
could be liable under the FTC Act for statements they make in an
endorsement, the revised Guides reflect Commission case law and clearly
state that both advertisers and endorsers may be liable for false or
unsubstantiated claims made in an endorsement – or for failure to
disclose material connections between the advertiser and endorsers. The
revised Guides also make it clear that celebrities have a duty to
disclose their relationships with advertisers when making endorsements
outside the context of traditional ads, such as on talk shows or in
social media.”
The
Vitamin Lawyer is available to guide you through the changes in your
advertising practices made necessary by these changes. If you need a
revised SOP for Testimonials, let me know.
Clearly,
if you want to use testimonials that are anything other than general
and bland, you would need to be able to substantiate what typical users
experience. The “gold standard” of substantiation is, with health
products, a double-blind, placebo-controlled third party clinical study
with biomarkers before and after. For some testimonial claims it might
be possible to get by with an after-market randomized survey of your
customers to find out what their typical experiences are. In either
case, the instructions to the people doing the clinical study or the
people doing the market survey are critical. The instructions and
questions you put to the professionals will control the responses you
get. For example, a couple weeks ago I helped a client’s experts rework
their clinical study report language so that it focused on nutrient
benefits, not medical benefits.
One
approach to dealing with the new testimonial rules is to consider what
Disclaimer can be substituted for the former “safe harbor.” I think the
rationale behind Thompson v. Western States Medical Center (535 U.S.
357) applies, “…if the Government did argue that it had an interest in
preventing misleading advertisements, this interest could be satisfied
by the far less restrictive alternative of requiring each compounded
drug to be labeled with a warning that the drug had not undergone FDA
testing and that its risks were unknown….”
Thus,
I believe we can construct usable interim Disclaimers that companies
can use as they transition to substantiated testimonials. Remember, the
law has always been that a testimonial is a claim subject to
substantiation, not proof of your product or service’s typical results.
But
this interim approach is just that: a stop gap. What you need is the
necessary clinical trials, studies and tests to both substantiate your
claims and show what “typical results” are. That’s the bottom line. See
the next article: Natural Clinical Trials.
www .ftc .gov/opa/2009/10/endortest.shtm
-----------------------------------------------------
2. New Web Site for Natural Clinical Trials Center
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.
Natural
Solutions Foundation, founded in 2004, is an international NGO (Non
Governmental Organization) focused on natural solutions. We are active
and registered in several countries and a not for profit 501(c)(3) tax
exempt organization in the United States. The Mission of the Foundation
is to discover, develop, document, demonstrate and disseminate natural
solutions to the issues which threaten our health, food and freedom,
achieving and maintaining a healthy self, community and world.
Natural
Solutions Foundation, since its founding, has pursued a vigorous
program on many fronts, including the development of an advanced
healthcare clinic in the beautiful, bountiful, temperate Highlands of
Chiriqui Province, Panama -- the advanced healthcare Natural Solutions
Wellness Center.
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. 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org
Wednesday, November 25, 2009
Wednesday, October 28, 2009
10/28/09 - Making Claims in a Changing Regulatory Market
0. Blog & News – "Stop the Shot" Litigation
1. Making Claims in a Changing Regulatory Market
2. FTC Changes Testimonial Rules – Are Your SOPs Ready?
3. Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News – EU Approves Plant Sterol Claims
www. foodnavigator. com/content/view/print/265330
Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have one…
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
$11.95 – 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
Coming soon…
Dr Laibow and Gen Stubblebine on the way to Codex Meeting in Germany
Support their trip with a MONEY BOMB!
www. healthfreedomusa. org/?p=3686
[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. Making Claims in a Changing Regulatory Market
A recent emailing from Nutraingredients gives us useful insight about the current regulatory market:
“Making substantiated claims in a changing regulatory environment
There are many challenges facing companies due to regulations, with stricter health claim regulation looking set to make the marketing environment stricter in Europe than in North America. Increasingly the biggest issue facing marketers is how to overcome the lack of trust most consumer have in products...
77%, of European consumers do not believe that manufacturers' health and nutrition claims are trustworthy and this acts as a strong inhibitor to future growth, subsequently product claims need to be more specific and clearer for consumers to understand. A crucial mistake to avoid is offering too many claims for one product, progressively manufacturers need to assess whether they offer more "positive" than "negative" nutrition in their portfolios.”
It's time to review all your claims... can you substantiate them? Are you ready to obtain appropriate Clinical Studies of your product -- not just rely upon published literature about your ingredients... that's no longer sufficient!
Both the FDA's cGMPs with the emerging requirement for Clinical Trials of the actual product and the FTC's revision of the testimonial rules to, in essence, require you to do the clinical testing needed to establish what the "typical results" of your product might be before advertising with testimonials, leads to a growing understanding that clinical testing is becoming a necessity to remain in business.
The problem I've found is that it is very difficult to find competent third parties to conduct such tests. The market is beginning to respond and if you are interested in having clinical trials of your products, please contact me with "CLINICAL TRIAL" in the subject line.
-----------------------------------------------------
2. FTC Changes Testimonial Rules – Are your SOPs Ready?
Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.
“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”
The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.
Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.
My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”
Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.
www .ftc .gov/opa/2009/10/endortest.shtm
------------------------------------------------
3. 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org
1. Making Claims in a Changing Regulatory Market
2. FTC Changes Testimonial Rules – Are Your SOPs Ready?
3. Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News – EU Approves Plant Sterol Claims
www. foodnavigator. com/content/view/print/265330
Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have one…
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
$11.95 – 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
Coming soon…
Dr Laibow and Gen Stubblebine on the way to Codex Meeting in Germany
Support their trip with a MONEY BOMB!
www. healthfreedomusa. org/?p=3686
[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. Making Claims in a Changing Regulatory Market
A recent emailing from Nutraingredients gives us useful insight about the current regulatory market:
“Making substantiated claims in a changing regulatory environment
There are many challenges facing companies due to regulations, with stricter health claim regulation looking set to make the marketing environment stricter in Europe than in North America. Increasingly the biggest issue facing marketers is how to overcome the lack of trust most consumer have in products...
77%, of European consumers do not believe that manufacturers' health and nutrition claims are trustworthy and this acts as a strong inhibitor to future growth, subsequently product claims need to be more specific and clearer for consumers to understand. A crucial mistake to avoid is offering too many claims for one product, progressively manufacturers need to assess whether they offer more "positive" than "negative" nutrition in their portfolios.”
It's time to review all your claims... can you substantiate them? Are you ready to obtain appropriate Clinical Studies of your product -- not just rely upon published literature about your ingredients... that's no longer sufficient!
Both the FDA's cGMPs with the emerging requirement for Clinical Trials of the actual product and the FTC's revision of the testimonial rules to, in essence, require you to do the clinical testing needed to establish what the "typical results" of your product might be before advertising with testimonials, leads to a growing understanding that clinical testing is becoming a necessity to remain in business.
The problem I've found is that it is very difficult to find competent third parties to conduct such tests. The market is beginning to respond and if you are interested in having clinical trials of your products, please contact me with "CLINICAL TRIAL" in the subject line.
-----------------------------------------------------
2. FTC Changes Testimonial Rules – Are your SOPs Ready?
Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.
“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”
The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.
Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.
My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”
Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.
www .ftc .gov/opa/2009/10/endortest.shtm
------------------------------------------------
3. 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org
Thursday, October 8, 2009
10/08/09 - FTC Changes Testimonial Rules – Are Your SOPs in Order?
1. FTC Changes Testimonial Rules – Are Your SOPs Ready?
2. Vitamin Lawyer Webinars
-----------------------------------------------------
Blog & News – “Stop the Shot” Case being filed today…
Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have one…
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
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter. com/healthfreedomus
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
“Stop the Shot” Litigation filed today in DC District Court!
www .healthfreedomusa. org/?p=3617
(Case should be filed today; link should be active late today.)
[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. FTC Changes Testimonial Rules – Are your SOPs Ready?
Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.
“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”
The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.
Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.
My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”
Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.
www .ftc .gov/opa/2009/10/endortest.shtm
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org
Thursday, September 3, 2009
09/03/09 - Are Bar Codes Required?
1. Are Bar Codes Required for Dietary Supplements?
2. Vitamin Lawyer Webinars
-----------------------------------------------------
- Blog & News – Book Review Published on Mises.org
My Summer Reading: Hyperinflation in Weimar Germany
http://mises.org/story/3661
NEW VITAMIN LAWYER VIDEO – 45 Minute Interview
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter. com/healthfreedomus
Gary Null PhD, Rima Laibow MD and Tedd Koren DC lead Citizens Petition to STAY the SHOT gets FDA Docket Number
www. healthfreedomusa. org/?p=3429
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
[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. Are Bar Codes Required for Dietary Supplements?
Our starting point is that at least 1/3 to 1/2 of all dietary supplement bottles on the store shelves include bar codes. Certain distributers and major retailers may require them.
Whether bar codes are required, however, depends on the terms of the FDA's Good Manufacturing Practices for Dietary Supplements (cGMPs) which became finally effective for all vitamin companies, including small entities, in June 2009, having been promulgated during June 2007.
cGMPs - http://edocket.access.gpo.gov/2007/07-3039.htm
Here are some key definitions from the cGMPs:
The cGMPs apply to "...a person who manufactures, packages, labels, or holds dietary supplements."
"Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time period according to a single manufacturing record during the same cycle
of manufacture."
"Batch number, lot number, or control number means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined."
"Lot means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition."
Here is what the cGMPs say about labels and packaging:
Subpart D 111.80: The Company shall maintain “(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with Sec. 111.70(g), and as applicable, Sec. 111.70(a).”
Subpart F Sec 111.155 - Before using a label, the responsible person at the Company shall (in accordance with Subpart D, Sect. 111.75: (f)(2): “at a minimum, conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met” -- (g): “ You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label” -- and (h)(1) “You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods.”
(e) Subpart D 111.80: The Company shall maintain “(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with Sec. 111.70(g), and as applicable, Sec. 111.70(a).”
Without some system such as bar coding, I fail to see how a company can met the cGMP requirements as to tracking. In the event of a recall, being unable to specify the lot and batch will force a total recall, instead of a limited recall.
Therefore, although the FDA does not require bar coding by specific regulation, it is highly advisable that you use bar coding and that the system you employ is sufficiently robust as to be able to not only identify the product run, but also any batch or lot subdivisions. You also need the coding to be able to maintain representative samples of each lot. Modern practices, driven by traceability regulations, are tantamount to requiring bar coding.
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .cohttp://www.healthfreedomusa.org/?p=507m
Monday, August 17, 2009
08/17/09 - Vitamin Co. Court Victory over FTC!
1. Standard Operating Procedures
2. Vitamin Lawyer Webinars
------------------------------------------------------
- Blog & News – New Vitamin Lawyer Video
NEW VITAMIN LAWYER VIDEO – 45 Minute Interview
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Three Weeks to Save Health Freedom Campaign:
www. healthfreedomusa. org/?p=3209
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
Late breaking news: NJ vitamin company LaneLabs prevails in FTC motion case: “‘This is not a case of a company making claims out of thin air,’ stated the opinion. The court highlighted the fact that LaneLabs had hired a compliance officer and had also sought expert advice to interpret the scientific evidence it used to back its claims. ‘LaneLabs found a product and obtained scientific evidence that the product is efficacious. LaneLabs then consulted experts who opined that the research supporting the product and the product itself were good,’”
Clearly, SOPs and Substantiation are really important! Read all about it on my blog:
vitaminlawyerhealthfreedom.blogspot. com/2009/08/dietary-supplement-court-victory-in-nj.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.]
-----------------------------------------------
- Are Your Papers in Order – SOPs
As the LaneLabs court victory shows, YOUR PAPERS MUST BE IN ORDER! The Vitamin Lawyer’s Standard Operating Procedures (SOPs) format for natural products distributors has been updated to reflect recent increased FDA and FTC oversight of the industry. One new SOP has been added, regarding Change Controls (documenting when and how you adopt and change SOPs is also an SOP!) and several have been extensively updates, including new sections in Quality Controls regarding claims and substantiation. An outline for your Compliance Note Book is included.
Remembering the “Quote of the Week” from my last eMemo, the new Commissioner of Food and Drugs said, “Now is a good time to reassess whether you have … [a compliance] effort in place.”
Standard Operating Procedures are a primary part of that compliance effort.
If I have already provided you with your SOPs, please email me (with SOP) in the subject line and I will forward you the revised format.
If you don’t already have your SOPs in order, WHY NOT? My standard fee for customizing the format for you is one hour.
And here is a teaser: Compliance Note Book outline:
(1) A copy of the product label
(2) Copy of the Notice(s) of Structure and Function Claims
(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters
Do you need your SOPs? Please email me with “New SOP” in the subject line.
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .cohttp://www.healthfreedomusa.org/?p=507m
Monday, August 10, 2009
08/10/09 - FDA Promises More Enforcement
0. Blog &News
1. Comments on Stronger FDA Enforcement
2. Vitamin Lawyer Webinars
------------------------------------------------------
NEW VITAMIN LAWYER VIDEO – 45 Minute Interview
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Three Weeks to Save Health Freedom Campaign:
www. healthfreedomusa. org/?p=3209
Quote of the Week from the Commissioner of Food and Drugs - “Now is a good time to reassess whether you have … [a compliance] effort in place.”
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
[Please note: all URLs in this memo are "broken" with spaces inserted after the www. to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------
1. Comments on Stronger FDA Enforcement
Margaret Hamburg, M.D.
Commissioner of Food and Drugs
“…a strong FDA enforces the law.
Every company with products or activities under FDA’s jurisdiction has a duty
to comply with the law… to meet the standards that the FDA has set to protect
the public. I have been impressed by the commitment to compliance that many
companies have made – both in terms of their corporate culture and their
investment in compliance systems.
Our goal is for all companies to make and implement such a commitment in order
to prevent harm to the American people. We have a responsibility to clearly
articulate and explain our rules and regulations, but a key part of the strategy
to support private sector compliance is effective enforcement against violations
of the law.
Effective enforcement has many clear benefits to public health.
It enables FDA to intercept unsafe or fraudulent products promptly… and
prevent additional harm.
By holding violators accountable, enforcement deters others who would put the
public at risk or prey upon vulnerable consumers.
Visible and clearly explained enforcement actions inform members of the public
about potential dangers.
And enforcement helps industry too – by maintaining a level playing field for
safe products. Making sure that offenders are held legally accountable prevents
companies from having to choose between doing the right thing and staying
competitive…
The solution is a commitment to compliance backed by a strong compliance
program. Now is a good time to reassess whether you have such an effort in
place.”
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
1. Comments on Stronger FDA Enforcement
2. Vitamin Lawyer Webinars
------------------------------------------------------
- Blog &News – New Vitamin Lawyer Video
NEW VITAMIN LAWYER VIDEO – 45 Minute Interview
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html
Follow me on Twitter - www. twitter.com/healthfreedomus
Three Weeks to Save Health Freedom Campaign:
www. healthfreedomusa. org/?p=3209
Quote of the Week from the Commissioner of Food and Drugs - “Now is a good time to reassess whether you have … [a compliance] effort in place.”
The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
[Please note: all URLs in this memo are "broken" with spaces inserted after the www. to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------
1. Comments on Stronger FDA Enforcement
Margaret Hamburg, M.D.
Commissioner of Food and Drugs
“…a strong FDA enforces the law.
Every company with products or activities under FDA’s jurisdiction has a duty
to comply with the law… to meet the standards that the FDA has set to protect
the public. I have been impressed by the commitment to compliance that many
companies have made – both in terms of their corporate culture and their
investment in compliance systems.
Our goal is for all companies to make and implement such a commitment in order
to prevent harm to the American people. We have a responsibility to clearly
articulate and explain our rules and regulations, but a key part of the strategy
to support private sector compliance is effective enforcement against violations
of the law.
Effective enforcement has many clear benefits to public health.
It enables FDA to intercept unsafe or fraudulent products promptly… and
prevent additional harm.
By holding violators accountable, enforcement deters others who would put the
public at risk or prey upon vulnerable consumers.
Visible and clearly explained enforcement actions inform members of the public
about potential dangers.
And enforcement helps industry too – by maintaining a level playing field for
safe products. Making sure that offenders are held legally accountable prevents
companies from having to choose between doing the right thing and staying
competitive…
The solution is a commitment to compliance backed by a strong compliance
program. Now is a good time to reassess whether you have such an effort in
place.”
------------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Setting up a Student Account at VCU is free and relatively easy:
www. VitalConnectionUniversity. com
[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009: This webinar is Archived. –
(approximately 2 hours)
A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.
Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169
[2] CAM Advanced Healthcare Practitioner SOPs
Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
Direct sign-up: 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).
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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