Vitamin Lawyer Update eMemo: September 18, 2008
This issue:
0. News & Practice Notes
1. Mining for Leads: Your Customers are Your Best Source
2. Web Ring and Wiki for Advanced Health Care – closer and closer
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog News and Practice Notes; Fee Increase
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Dennis Kuchinich: Defending Our Right to Know – GMOs
vitaminlawyerhealthfreedom.blogspot .com/2008/09/dennis-kuchinich-defending-peoples.html
Weaponized Avian Flu: Current Estimate of Situation.3
Healthfreedomusa .org/index.php?p=965
URGENT! DIETITIANS MONOPOLY BILL IN NJ WILL STOP ALL ALTERNATIVES: vote on 09/25/08. Tell your state and national legislators to oppose all restrictions on Nutritional Free Speech: HealthFreedomUSA .org/index.php?p=1030
salsa.democracyinaction .org/o/568/t/1128/campaign.jsp?campaign_KEY=25929
Vitamin Lawyer.com Consultancy fees are increasing due to continuing dollar value declines. The new basic fee, starting September 1, 2008, will be $325/hr. Prepaid clients will receive the balance of their time at the original rates. Current clients receive the old rate until October 1st. Regular monthly retainer clients will be charged at $275/hr. and will continue to be permitted to use the Vitamin Lawyer Oversight Seal: http:// tinyurl. com/2cfoyb
“The value of the US and European natural (excluding organic) food and drinks market was worth $11.7bn in 2005 and it is expected to reach $19.2bn by 2010.” (from a Nutraingredients .com email)
“Ninety per cent of the 11,000 athletes in attendance at the Games of the 29th Olympiad used dietary supplements of some kind, according to the European Specialist Sports Nutrition Alliance (ESSNA). There was not a single supplement contamination case… So perhaps Beijing marks a turning point for the industry. Just as the Chinese capital’s hosting of the event boosted China’s public image (at least while it was on), so too has the supplements industry been given a lift by its clean Games performance….”
Nutraingredients .com/Industry/Dietary-supplements-win-Olympic-gold/?c=gbrnO2ewSG2xbUKNPtVBZw%3D%3D
“Companies that take advantage of the growing health and wellness market often don't do enough to tell consumers how to benefit from their products, says a brand-growth expert. Consumers are ‘looking for specific solutions that fit within the overall context of their lives’…"
Mediapost .com/publications/?fa=Articles.san&s=89814&Nid=46820&p=925781
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. Mining for Leads: Your Customers are Your Best Source
-----------------------------------------------
http://www.entireweb.com/newsletter/archive/2008/PRINT471.html
Excerpts: Entireweb Newsletter * September 2, 2008 * ISSUE #471
The Most Valuable Source for Leads
“…The Chief Marketing Officer (CMO) Council has just completed a study... The results of the surveys may not surprise you, but the contrasts of the responses provide a shocking insight into the sheer volume of missed opportunities. This is good news for you, because missed opportunities by others can create new opportunities for you…According to the survey results… most valued source of leads is from customer referrals.
54% Customer Referrals
14% E-Mail or Direct Marketing
8% Internet
7% Events
7% Leads from Vendors
3% Third Party Lead Generation Organizations
8% Other
Would you agree that the best leads come from the referrals of satisfied customers? Is it surprising that customer referrals were ranked as four times more powerful and valuable than E-Mail or Direct Marketing campaigns? Customer referrals were ranked nearly seven times more likely to result in sales and new business than leads derived the Internet…
With all of this insight, how did the same channel executives, distributors, resellers, and channel representatives respond to the survey by Chief Marketing Officer Council with regards to tactics for generating new leads in the coming year?
14% Plan to use Direct Marketing and E-mail campaigns
13% Plan to use Sales Brochures and collateral
10% Plan to focus on Tradeshows for lead generation
8% Will use Seminars to generate leads
7% Will rely on Print Advertising
7% Plan to use Public Relations and Article Placement
7% Plan to use the Internet and Online Advertising
6% Will revert to Telemarketing
6% Plan to invest in Internet Search Engine Marketing
5% Plan to engage customers in User Group Gatherings
4% Plan to rely on Yellow Page Advertising
4% Will experiment on the Internet with Blogs and Social Networking
3% Will use Online Directories
3% Will create Webcasts
1% Plan to use Content Syndication
2% Will try something completely different
The results of the survey regarding lead generation tactics for new business acquisition are hardly surprising. Very little has changed in the planning and tactics as conveyed by the survey response, and yet, the contrast in comparison to the most effective and valued leads is staggering. Even though 54% of respondents acknowledged that the most valued leads are based on customer referrals, the first mention of leveraging this goldmine occurs in the 4% of respondents that plan to engage customers in user group gatherings…. The Internet provides an exciting vehicle to be creative, showcase the brand, and communicate to a very large audience. However, is it targeting the most valuable audience by engaging the most valuable leads that come from customer referrals?
…So, how do you encourage and empower customers to grow this incredible pipeline of valued referrals? You ask them, of course. However, before you make such a bold request, your customers must know that you are fully engaged and obligated to their aspirations. When customers are assured that you are a trusted advocate, committed to customer satisfaction, they have the confidence to share referrals and recommendations. Once customer confidence is established and the relationship is mutually rewarding, then it is just a matter of creating the appropriate opportunity for referrals to occur. This can be as simple as asking for referrals… by engaging individuals in group gathering or discussions, leveraging the Internet or Advertising, or by collecting a powerful collage of testimonials… Actively and effectively mining the most valuable source for leads will give you an advantage over 95% of your competition.”
John Mehrmann is author of The Trusted Advocate: Accelerate Success with Authenticity and Integrity.
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care Update
-----------------------------------------------
It is certainly the “Doldrums of Summer…” -- there were some continuing “glitches” since the last updates, but we now expect the Web Ring sign-up page to go live during late September. Below is a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature. I will also be sending a special Vitamin Lawyer Update eMemo in the next week or so which will have many more details about the Web Ring. Please watch for it.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!
Here is what one Web Ring company says about the benefits:
“WebRing offers a unique and effective means of searching, locating and navigating between web sites with similar themes. WebRing allows web site owners to group their sites together into ring communities, and provides a navigation tool that links web sites together called a NavBar. Linked sites not only eliminate the necessity of repetitive searches, but the NavBar also accumulates hits from all of the sites so that a hit to one site is a hit to all sites. Additionally, the NavBar acts as a link so your web site is linked to every other site in the community. So now your site is benefiting from higher search engine results because it has more hits and more links.”
If you are ready to sign-up, the beta form is here:
healthcare-aware .com/subscribe/go.php?r=1&i=l0
-----------------------------------------------
3. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM” practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients. The SOP has been amended to include the latest regulations regarding accepting credit cards for payments.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service. The SOP is being revised to reflect the new Data Security requirement of “a written policy for protecting the security of your customer…”
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Thursday, September 18, 2008
Friday, August 29, 2008
08/29/08 - Credit Card Data Security Rules
Vitamin Lawyer Update eMemo: August 29, 2008
This issue:
0. News & Practice Notes; Fee Rate Increase
1. New Data Security Rules for Credit Cards Processing
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog News and Practice Notes
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Internet Abuzz: Avian Flu Weaponized?
www .healthfreedomusa. org/index.php?p=846
Practice Note: Data Security Rules Upgraded
I’ve worked with G. P. Nehra, Esq. regarding nutrient MLM issues and consider him a leading attorney in that world. The report from his office, below, is being shared with his permission. The five specific legal requirements coming into effect on 11.01.08 are being integrated into the Standard Operating Procedures Manual format maintained by the Vitamin Lawyer.com Consultancy. Regular retainer clients will automatically receive the updates. Others should email me with “SOP Update” in the subject line; there is a ½ hour fee for this service.
Vitamin Lawyer.com Consultancy fees are increasing due to continuing dollar value declines. The new basic fee, starting September 1, 2008, will be $325/hr. Prepaid clients will receive the balance of their time at the original rates. Regular monthly retainer clients will be charged at $275/hr. and will continue to be permitted to use the Vitamin Lawyer Oversight Seal: http:// tinyurl. com/2cfoyb
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. New Data Security Rules for Credit Card Processing
-----------------------------------------------
DATA SECURITY COMPLIANCE - 101
From G.P. Nehra Esq -- Prepared by Rick Waak
The Law Firm has had several inquiries about the announced November 1 effective date for compliance with new tighter data security requirements… [under] the Fair and Accurate Credit Transactions Act…
…[B]ecause of the way the rules affect the payment card industry, their impact covers a much broader segment, virtually all of the commercial world. … The biggest merchant account customers have long since been complying with the strictures of this Industry program as a condition of their using their payment card merchant accounts. Now it is time for smaller merchant users …
WHAT DOES THIS MEAN FOR YOU?
If you have or want to have a merchant account which enables you to accept and process payments from your customers or distributors by credit or debit card, you will need to do the following:
1. Establish a written policy for protecting the security of your customer (and employee) account data. The policy must include designation of employees responsible for carrying out the internal monitoring and security check procedures.
2. Determine what your merchant level will be. (based on number of expected transactions, i.e., Level 4 is 0-20,000 , Level 3 is 20,000-1 million, etc.). By accessing the web site at www. pcicomplianceguide .org you can get information and a chart to help make this determination, as well as other guidance that will tell you way more than you ever wanted to know about complying with the Payment Card Industry Data Security System.
3. Select and contract with an Approved Scanning Vendor (ASV). ASVs are industry certified contractors who conduct electronic scans of your data handling systems…
4. Download and complete periodically (as specified for your merchant level) a PCI DSS Self-Assessment Questionnaire.
5. Have the ASV conduct periodic (again, based upon your merchant level) network security scans.
The PCI compliance website, your ASV, your telecommunications vendor, and your merchant banks will all be able to help and advise you.
© Gerald P. Nehra 2008 - Permission to reproduce with attribution - www. mlmatty. com
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care Update
-----------------------------------------------
It is certainly the “Doldrums of Summer…” -- there were some continuing “glitches” since the last updates, but we now expect the Web Ring sign-up page to go live during early September. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!
Here is what one Web Ring company says about the benefits:
“WebRing offers a unique and effective means of searching, locating and navigating between web sites with similar themes. WebRing allows web site owners to group their sites together into ring communities, and provides a navigation tool that links web sites together called a NavBar. Linked sites not only eliminate the necessity of repetitive searches, but the NavBar also accumulates hits from all of the sites so that a hit to one site is a hit to all sites. Additionally, the NavBar acts as a link so your web site is linked to every other site in the community. So now your site is benefiting from higher search engine results because it has more hits and more links.”
-----------------------------------------------
3. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM” practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service. The SOP is being revised to reflect the new Data Security requirement of “a written policy for protecting the security of your customer…”
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
This issue:
0. News & Practice Notes; Fee Rate Increase
1. New Data Security Rules for Credit Cards Processing
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog News and Practice Notes
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Internet Abuzz: Avian Flu Weaponized?
www .healthfreedomusa. org/index.php?p=846
Practice Note: Data Security Rules Upgraded
I’ve worked with G. P. Nehra, Esq. regarding nutrient MLM issues and consider him a leading attorney in that world. The report from his office, below, is being shared with his permission. The five specific legal requirements coming into effect on 11.01.08 are being integrated into the Standard Operating Procedures Manual format maintained by the Vitamin Lawyer.com Consultancy. Regular retainer clients will automatically receive the updates. Others should email me with “SOP Update” in the subject line; there is a ½ hour fee for this service.
Vitamin Lawyer.com Consultancy fees are increasing due to continuing dollar value declines. The new basic fee, starting September 1, 2008, will be $325/hr. Prepaid clients will receive the balance of their time at the original rates. Regular monthly retainer clients will be charged at $275/hr. and will continue to be permitted to use the Vitamin Lawyer Oversight Seal: http:// tinyurl. com/2cfoyb
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. New Data Security Rules for Credit Card Processing
-----------------------------------------------
DATA SECURITY COMPLIANCE - 101
From G.P. Nehra Esq -- Prepared by Rick Waak
The Law Firm has had several inquiries about the announced November 1 effective date for compliance with new tighter data security requirements… [under] the Fair and Accurate Credit Transactions Act…
…[B]ecause of the way the rules affect the payment card industry, their impact covers a much broader segment, virtually all of the commercial world. … The biggest merchant account customers have long since been complying with the strictures of this Industry program as a condition of their using their payment card merchant accounts. Now it is time for smaller merchant users …
WHAT DOES THIS MEAN FOR YOU?
If you have or want to have a merchant account which enables you to accept and process payments from your customers or distributors by credit or debit card, you will need to do the following:
1. Establish a written policy for protecting the security of your customer (and employee) account data. The policy must include designation of employees responsible for carrying out the internal monitoring and security check procedures.
2. Determine what your merchant level will be. (based on number of expected transactions, i.e., Level 4 is 0-20,000 , Level 3 is 20,000-1 million, etc.). By accessing the web site at www. pcicomplianceguide .org you can get information and a chart to help make this determination, as well as other guidance that will tell you way more than you ever wanted to know about complying with the Payment Card Industry Data Security System.
3. Select and contract with an Approved Scanning Vendor (ASV). ASVs are industry certified contractors who conduct electronic scans of your data handling systems…
4. Download and complete periodically (as specified for your merchant level) a PCI DSS Self-Assessment Questionnaire.
5. Have the ASV conduct periodic (again, based upon your merchant level) network security scans.
The PCI compliance website, your ASV, your telecommunications vendor, and your merchant banks will all be able to help and advise you.
© Gerald P. Nehra 2008 - Permission to reproduce with attribution - www. mlmatty. com
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care Update
-----------------------------------------------
It is certainly the “Doldrums of Summer…” -- there were some continuing “glitches” since the last updates, but we now expect the Web Ring sign-up page to go live during early September. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!
Here is what one Web Ring company says about the benefits:
“WebRing offers a unique and effective means of searching, locating and navigating between web sites with similar themes. WebRing allows web site owners to group their sites together into ring communities, and provides a navigation tool that links web sites together called a NavBar. Linked sites not only eliminate the necessity of repetitive searches, but the NavBar also accumulates hits from all of the sites so that a hit to one site is a hit to all sites. Additionally, the NavBar acts as a link so your web site is linked to every other site in the community. So now your site is benefiting from higher search engine results because it has more hits and more links.”
-----------------------------------------------
3. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM” practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service. The SOP is being revised to reflect the new Data Security requirement of “a written policy for protecting the security of your customer…”
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Tuesday, August 12, 2008
08/12/08 - EU, Codex: Health Claims Substantiation
Vitamin Lawyer Update eMemo: August 12, 2008
This issue:
0. News & Practice Notes:
1. Codex and EU: Health Claims Substantiation
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News and Practice Notes
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Weaponized Avian Flu Current Intelligence Estimate
http://www .healthfreedomusa .org/?p=755
Practice Note: How Not to Make Claims
I was recently asked to consult in a case where there might be an indictment for selling an “unapproved drug.” The product is a mix of a half dozen herbs with tea, a combination traditionally used to support normal immune function in case of influenza. The problem is: the product was advertised by an “off shore” distributor as “effective treatment for Avian Flu…” The US manufacturer made no such claims, but an off shore distributor did. Although the label was affixed off shore, the authorities want to impute the claim to the US entity, since the product was sold to Americans. This is another case where much trouble could have been avoided had the distributor structured the claims with attention to US permitted language in the first place. The US manufacturer never intended a “drug” use, but now needs to demonstrate that fact. Having your paperwork in order, including clear Standard Operating Procedures, good sales and purchase Records, can go a long way to demonstrating your legal intent.
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. Codex and EU: Health Claims Substantiation
-----------------------------------------------
Nutraingredients .com/Regulation/IADSA-keeps-pressure-on-Codex-over-science-for-health-claims/?c=gbrnO2ewSG3cp4pUuVpXUw%3D%3D
“August 11, 2008 (By Stephen Daniells) The International Alliance of Dietary/Food Supplement Associations (IADSA) is keeping up pressure on changing how health clams are substantiated by Codex. te science to substantiate health claims should bring together all studies, and putting too much emphasis on clinical trials is “not practical” …Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition (CRN) and IADSA - “Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials. These studies are, of course, important, but they provide only one source of information. All sources of scientific data have inherent limitations, hence the need to focus on the totality of the available data and weighing of the evidence.”
Codex agreed at the end of 2007 that its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation. And the calls for a wider consideration of the overall science by IADSA will keep up the pressure on Codex ahead of a review and redraft by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in November 2008. …
In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalized… The text, as it currently stands, states that short-term human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation…
“The scientific evidence to support the diet and health relationships for dietary guidelines and health claims for fruits and vegetables, and for whole grain cereals, are based mainly on human observational studies, not clinical interventions,” said Richardson. Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use. The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.”
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care Update
-----------------------------------------------
There were some “glitches” since the last update, but we now expect the Web Ring sign-up page to go live this coming weekend. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!
-----------------------------------------------
3. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
This issue:
0. News & Practice Notes:
1. Codex and EU: Health Claims Substantiation
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News and Practice Notes
Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Weaponized Avian Flu Current Intelligence Estimate
http://www .healthfreedomusa .org/?p=755
Practice Note: How Not to Make Claims
I was recently asked to consult in a case where there might be an indictment for selling an “unapproved drug.” The product is a mix of a half dozen herbs with tea, a combination traditionally used to support normal immune function in case of influenza. The problem is: the product was advertised by an “off shore” distributor as “effective treatment for Avian Flu…” The US manufacturer made no such claims, but an off shore distributor did. Although the label was affixed off shore, the authorities want to impute the claim to the US entity, since the product was sold to Americans. This is another case where much trouble could have been avoided had the distributor structured the claims with attention to US permitted language in the first place. The US manufacturer never intended a “drug” use, but now needs to demonstrate that fact. Having your paperwork in order, including clear Standard Operating Procedures, good sales and purchase Records, can go a long way to demonstrating your legal intent.
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. Codex and EU: Health Claims Substantiation
-----------------------------------------------
Nutraingredients .com/Regulation/IADSA-keeps-pressure-on-Codex-over-science-for-health-claims/?c=gbrnO2ewSG3cp4pUuVpXUw%3D%3D
“August 11, 2008 (By Stephen Daniells) The International Alliance of Dietary/Food Supplement Associations (IADSA) is keeping up pressure on changing how health clams are substantiated by Codex. te science to substantiate health claims should bring together all studies, and putting too much emphasis on clinical trials is “not practical” …Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition (CRN) and IADSA - “Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials. These studies are, of course, important, but they provide only one source of information. All sources of scientific data have inherent limitations, hence the need to focus on the totality of the available data and weighing of the evidence.”
Codex agreed at the end of 2007 that its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation. And the calls for a wider consideration of the overall science by IADSA will keep up the pressure on Codex ahead of a review and redraft by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in November 2008. …
In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalized… The text, as it currently stands, states that short-term human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation…
“The scientific evidence to support the diet and health relationships for dietary guidelines and health claims for fruits and vegetables, and for whole grain cereals, are based mainly on human observational studies, not clinical interventions,” said Richardson. Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use. The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.”
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care Update
-----------------------------------------------
There were some “glitches” since the last update, but we now expect the Web Ring sign-up page to go live this coming weekend. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!
-----------------------------------------------
3. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Thursday, July 24, 2008
07/24/08 - Using Italics and Bold in Copy Writing
Vitamin Lawyer Update eMemo: July 24, 2008
This issue:
0. News Notes: The Valley of the Moon Eco Community
1. Using Italics and Bold in Copy
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News Notes
Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com
US Takes Over Codex Commission Chair… agency consensus breaking…
Support Health Freedom: join the eAlert Newsletter at: www. HealthFreedomUSA .org
I’ve previously told you about The Valley of the Moon Eco Community, for investing, retiring or relocating off-shore in free and prosperous Panama. Please take a look at www. naturalsolutionsfoundation .org – there you will find links to The Valley of the Moon Eco Community information. Located in the beautiful, bountiful, temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation. Tax deductible donations for this project are gratefully accepted.
We are also seeking high-yield, short term (6 month) Angel Loans to provide the balance of the purchase funds for the first “finca” (farm) being purchased in the Valley. Panama’s strong banking sector does not provide funds to purchase property, but, once owned, routinely loans 80% of the purchase price of agricultural land at very low interest. Initial participants have contributed the 20% and the land contract is about to be signed, so we are reaching out to all our contacts for the next step. Let me know if you are interested.
Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. When to Use Italics and Bold in Copy
-----------------------------------------------
Entireweb Newsletter * July 24, 2008 * ISSUE #460
“…Roman type is the straightforward, upright type we read everyday in our newspapers, magazines and books, and on our monitors. Italic is the 'handwriting' equivalent of whatever roman font we are reading… Bold type is roman or italic font that has been emphasized by thickening and making it darker than the surrounding text.
The question is: when should we use which version of a particular typeface - roman, italic, or bold? … It is obvious that for most copy the roman version of the chosen font should be used. …
Because the bold version of a font makes text stand out strongly, it is used for highlighting important words, phrases and sections. Thus headlines, decks and subheads set in bold will, along with pull-quotes and other tricks of the typesetter's art, provide the casual scanner with clues as to what your article or story is all about…
Bold however is too strong to be used, except very occasionally, within body text. To set off words from surrounding text is the main function of italics.
…Here's a sort of check-list…
[1] The names of ships and aircraft… This is the oldest when-to-use-italics rule…
[2] The titles of poems...
[3] Foreign words…
[4] The titles of books, newspapers, articles and stories…
[5] Latin phrases used to classify living things...
[6] Where a word is used as an example rather than for its meaning…
[7] For introducing new terms…. This is a neat solution to highlighting words that will probably be explained later.
[8] For the subjects of definitions…
[9] For mathematical symbols…
[10] For emphasis…
[11] To indicate a character's internal reflections in stories…
[12] Using a letter or number as a noun…
Of course, you don't have to follow these when-to-use-italics rules. However most of them are in current use because they do aid reader comprehension….”
Paul D Kennedy paulkpg@yahoo.ie - freelance writer of articles and stories - http:// www. writingservices. eu.
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care
-----------------------------------------------
Yes, it is finally nearly here, after about a year of effort by a team of advanced Internet professionals. The ADVANCED HEALTH WEB RING and the ADVANCED HEALTH WIKI are now in the beta test stage.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). Why do you want to know about these important innovations for nutritional and natural products purveyors, non-medical devices and advanced health care professionals, researchers, students and advocates?
Read Tim Bolen’s analysis of how “the other side took over” the Internet and you will understand why this initiative is so important. See: “The Six Components of the Quackbuster Operation” - http:// www .bolenreport .net/feature_articles/feature_article070.htm – learn how the skeptics, with their distorted views, outrank the best health care practitioners on major search engines.
Then you will understand this opportunity to take back the “high ground” of publicity for advanced health care (sometimes called “Complementary and Alternative Modalities – CAM)… and what this may mean for your company.
Within the next few weeks the Web Ring will be opened for membership. A near future issue of The Vitamin Lawyer Update will give you information on how to join. You will be among the first to have this opportunity. I have been telling a few of my clients, privately, about this important development… now you all know. And you found out first, here on the Vitamin Lawyer Update eMemo!
-----------------------------------------------
3. Codex Approves 35 Food Standards
-----------------------------------------------
The annual Codex Commission meeting just concluded in Geneva adopted 35 new food standards that may impact your businesses. These standards include, for example, sharply reducing the level of gluten allowed in “gluten free” products. You can read more at Nutraingredients.com.
Nutraingredients .com/news/ng.asp?n=86380&c=gbrnO2ewSG0lWhPfglxeag%3D%3D
My intrepid co-trustees of the Natural Solutions Foundation – Gen. Bert Stubblebine and Dr. Rima Laibow – were in Geneva. You can read their comments, and see a series of “as it happened” video reports at: www .healthfreedomusa .org/index.php?p=726
-----------------------------------------------
4. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
This issue:
0. News Notes: The Valley of the Moon Eco Community
1. Using Italics and Bold in Copy
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News Notes
Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com
US Takes Over Codex Commission Chair… agency consensus breaking…
Support Health Freedom: join the eAlert Newsletter at: www. HealthFreedomUSA .org
I’ve previously told you about The Valley of the Moon Eco Community, for investing, retiring or relocating off-shore in free and prosperous Panama. Please take a look at www. naturalsolutionsfoundation .org – there you will find links to The Valley of the Moon Eco Community information. Located in the beautiful, bountiful, temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation. Tax deductible donations for this project are gratefully accepted.
We are also seeking high-yield, short term (6 month) Angel Loans to provide the balance of the purchase funds for the first “finca” (farm) being purchased in the Valley. Panama’s strong banking sector does not provide funds to purchase property, but, once owned, routinely loans 80% of the purchase price of agricultural land at very low interest. Initial participants have contributed the 20% and the land contract is about to be signed, so we are reaching out to all our contacts for the next step. Let me know if you are interested.
Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!
[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
-----------------------------------------------
1. When to Use Italics and Bold in Copy
-----------------------------------------------
Entireweb Newsletter * July 24, 2008 * ISSUE #460
“…Roman type is the straightforward, upright type we read everyday in our newspapers, magazines and books, and on our monitors. Italic is the 'handwriting' equivalent of whatever roman font we are reading… Bold type is roman or italic font that has been emphasized by thickening and making it darker than the surrounding text.
The question is: when should we use which version of a particular typeface - roman, italic, or bold? … It is obvious that for most copy the roman version of the chosen font should be used. …
Because the bold version of a font makes text stand out strongly, it is used for highlighting important words, phrases and sections. Thus headlines, decks and subheads set in bold will, along with pull-quotes and other tricks of the typesetter's art, provide the casual scanner with clues as to what your article or story is all about…
Bold however is too strong to be used, except very occasionally, within body text. To set off words from surrounding text is the main function of italics.
…Here's a sort of check-list…
[1] The names of ships and aircraft… This is the oldest when-to-use-italics rule…
[2] The titles of poems...
[3] Foreign words…
[4] The titles of books, newspapers, articles and stories…
[5] Latin phrases used to classify living things...
[6] Where a word is used as an example rather than for its meaning…
[7] For introducing new terms…. This is a neat solution to highlighting words that will probably be explained later.
[8] For the subjects of definitions…
[9] For mathematical symbols…
[10] For emphasis…
[11] To indicate a character's internal reflections in stories…
[12] Using a letter or number as a noun…
Of course, you don't have to follow these when-to-use-italics rules. However most of them are in current use because they do aid reader comprehension….”
Paul D Kennedy paulkpg@yahoo.ie - freelance writer of articles and stories - http:// www. writingservices. eu.
-----------------------------------------------
2. Web Ring and Wiki for Advanced Health Care
-----------------------------------------------
Yes, it is finally nearly here, after about a year of effort by a team of advanced Internet professionals. The ADVANCED HEALTH WEB RING and the ADVANCED HEALTH WIKI are now in the beta test stage.
You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). Why do you want to know about these important innovations for nutritional and natural products purveyors, non-medical devices and advanced health care professionals, researchers, students and advocates?
Read Tim Bolen’s analysis of how “the other side took over” the Internet and you will understand why this initiative is so important. See: “The Six Components of the Quackbuster Operation” - http:// www .bolenreport .net/feature_articles/feature_article070.htm – learn how the skeptics, with their distorted views, outrank the best health care practitioners on major search engines.
Then you will understand this opportunity to take back the “high ground” of publicity for advanced health care (sometimes called “Complementary and Alternative Modalities – CAM)… and what this may mean for your company.
Within the next few weeks the Web Ring will be opened for membership. A near future issue of The Vitamin Lawyer Update will give you information on how to join. You will be among the first to have this opportunity. I have been telling a few of my clients, privately, about this important development… now you all know. And you found out first, here on the Vitamin Lawyer Update eMemo!
-----------------------------------------------
3. Codex Approves 35 Food Standards
-----------------------------------------------
The annual Codex Commission meeting just concluded in Geneva adopted 35 new food standards that may impact your businesses. These standards include, for example, sharply reducing the level of gluten allowed in “gluten free” products. You can read more at Nutraingredients.com.
Nutraingredients .com/news/ng.asp?n=86380&c=gbrnO2ewSG0lWhPfglxeag%3D%3D
My intrepid co-trustees of the Natural Solutions Foundation – Gen. Bert Stubblebine and Dr. Rima Laibow – were in Geneva. You can read their comments, and see a series of “as it happened” video reports at: www .healthfreedomusa .org/index.php?p=726
-----------------------------------------------
4. Professional Practice SOPs
-----------------------------------------------
The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Tuesday, June 24, 2008
06/24/08 - FDA "Cancer Cure" Warning Letters
Vitamin Lawyer Update Memo: June 24, 2008
This issue:
0. Blog and Important News Notes
1. FDA Warning Letters – “Cancer Cures”
2. 97% of Nutrient and Health Claims Rejected in Europe!
3. Pharma Lobby Spends a Billion in a Decade…
4. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News Notes
Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com
Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org
The Valley of the Moon Eco Community – For those of you who are considering investing, retiring or relocating off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation.
Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. FDA Warning Letters – “Cancer Cures”
“The US Food and Drug Administration sent warning letters to 23 American companies and two foreign individuals for allegedly marketing a range of products fraudulently claimed to prevent and cure cancer… it had also warned North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, all sold under various names on the internet… contain[ing] ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.”
FDA says the following claims are “fraudulent:”
• "Treats all forms of cancer"
• "Causes cancer cells to commit suicide!"
• "80% more effective than the world's number one cancer drug"
• "Skin cancers disappear"
• "Target cancer cells while leaving healthy cells alone"
• "Shrinks malignant tumors"
• "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"
functionalingredientsmag. com/fimag/articleDisplay.asp?strArticleId=1771&strSite=FFNSite
------------------------------------------------------
2. 97% of Nutrient and Health Claims Rejected in Europe
“23-Jun-2008 - The European Commission has culled its gargantuan nutrition and health claims list from more than 40,000 to 1500 as the health claims process moves closer to fruition in January, 2010. … [Some claims] were deemed inappropriate for want of supporting data or were making claims about foods or food supplements that were not legally available in the EU… The nutrition and health claims regulation was enacted last year and seeks to harmonize claims across the … EU's 27 member states…”
foodnavigator. com/news/ng.asp?n=86073&c=gbrnO2ewSG3%2BoFrFccmRkw%3D%3D
-----------------------------------------------
3. Pharma Lobby Spends a Billion in a Decade…
Investigative report on the Public Integrity web site says Big Pharma spent more in 2007 ($186,000,000 – right, that’s nearly two hundred million dollars!) than in any previous year, but the past ten year total is approaching a billion dollars… all to convince Congress that this industry’s often dangerous products are… good for us?
publicintegrity. org/rx/report.aspx?aid=985
-----------------------------------------------
4. Professional Practice SOPs
The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
This issue:
0. Blog and Important News Notes
1. FDA Warning Letters – “Cancer Cures”
2. 97% of Nutrient and Health Claims Rejected in Europe!
3. Pharma Lobby Spends a Billion in a Decade…
4. Professional Practice Record Keeping SOP Available
------------------------------------------------------
0. VL Blog and News Notes
Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com
Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org
The Valley of the Moon Eco Community – For those of you who are considering investing, retiring or relocating off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation.
Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. FDA Warning Letters – “Cancer Cures”
“The US Food and Drug Administration sent warning letters to 23 American companies and two foreign individuals for allegedly marketing a range of products fraudulently claimed to prevent and cure cancer… it had also warned North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, all sold under various names on the internet… contain[ing] ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.”
FDA says the following claims are “fraudulent:”
• "Treats all forms of cancer"
• "Causes cancer cells to commit suicide!"
• "80% more effective than the world's number one cancer drug"
• "Skin cancers disappear"
• "Target cancer cells while leaving healthy cells alone"
• "Shrinks malignant tumors"
• "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"
functionalingredientsmag. com/fimag/articleDisplay.asp?strArticleId=1771&strSite=FFNSite
------------------------------------------------------
2. 97% of Nutrient and Health Claims Rejected in Europe
“23-Jun-2008 - The European Commission has culled its gargantuan nutrition and health claims list from more than 40,000 to 1500 as the health claims process moves closer to fruition in January, 2010. … [Some claims] were deemed inappropriate for want of supporting data or were making claims about foods or food supplements that were not legally available in the EU… The nutrition and health claims regulation was enacted last year and seeks to harmonize claims across the … EU's 27 member states…”
foodnavigator. com/news/ng.asp?n=86073&c=gbrnO2ewSG3%2BoFrFccmRkw%3D%3D
-----------------------------------------------
3. Pharma Lobby Spends a Billion in a Decade…
Investigative report on the Public Integrity web site says Big Pharma spent more in 2007 ($186,000,000 – right, that’s nearly two hundred million dollars!) than in any previous year, but the past ten year total is approaching a billion dollars… all to convince Congress that this industry’s often dangerous products are… good for us?
publicintegrity. org/rx/report.aspx?aid=985
-----------------------------------------------
4. Professional Practice SOPs
The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Friday, June 6, 2008
06/06/08 - Weight Control Supplements Attacked
Vitamin Lawyer Update Memo: June 6, 2008
This issue:
1. US and Japan Forming Health Food Alliance
2. Weight Control Dietary Supplements Under Attack
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
Blog Update: NY to Mandate Forced Vaccine Pharma Profits
http:// vitaminlawyerhealthfreedom .blogspot .com
Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org
And for those of you who are considering relocating some or all of your activities off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this planned zero emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability.
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. US and Japan forming health food alliance
06-Jun-2008 (by Neil Merrett – “Two leading US nutrition groups are teaming up with a Japanese counterpart to combine their knowledge in a bid to meet both the domestic and international challenges facing the industry. … The Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the National Nutritional Foods Association of Japan (NNFA-J) yesterday agreed to work together to better deal with regulatory and research issues… ‘Emerging research is increasingly supporting the safety and benefits of supplements for maintaining good health and reducing the risk of chronic diseases," he stated. "Regulatory approaches in both countries should likewise reflect good science to help consumers make healthy decisions.’”
www. nutraingredients-usa. com/news/ng.asp?n=85762&c=gbrnO2ewSG3bTjEYx%2BWZAA%3D%3D
------------------------------------------------------
2. Weight Control Dietary Supplements Under Attack
Dietary Supplements that support normal weight have been under increasing attack by both government and special interests. Even well-known weight loss brands such as TrimSpa® are failing (its parent company recently filed for bankruptcy).
Recently it seems that GlaxoSmithKline (GSK) will stop at nothing to rub out the competition when it comes to weight loss supplements. (No matter what your opinion is on weight loss supplements, this issue affects the vitamin industry as a whole.) GSK has petitioned FDA to classify all over-the-counter weight loss supplements as unapproved “drugs.” This means that mere overweight would be classified as a “disease” (as “obesity” is currently classified).
Furthermore, GSK hopes to remove any weight loss claims from dietary supplements. It should be noted that there is currently only one over-the-counter weight loss product with FDA approval: GSK’s alli®.
If FDA starts reclassifying normal conditions of life as “diseases” to protect the Pharmaceutical Industry, we may well see more dietary supplements threatened.
-----------------------------------------------
3. Professional Practice SOPs
The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
Contains the following topics:
1. Maintaining copies of all paid invoices
2. Maintaining regular back-up copies of client database.
3. Maintaining copies product ordered for resale records
4. Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
-----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
This issue:
1. US and Japan Forming Health Food Alliance
2. Weight Control Dietary Supplements Under Attack
3. Professional Practice Record Keeping SOP Available
------------------------------------------------------
Blog Update: NY to Mandate Forced Vaccine Pharma Profits
http:// vitaminlawyerhealthfreedom .blogspot .com
Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org
And for those of you who are considering relocating some or all of your activities off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this planned zero emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability.
[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. US and Japan forming health food alliance
06-Jun-2008 (by Neil Merrett – “Two leading US nutrition groups are teaming up with a Japanese counterpart to combine their knowledge in a bid to meet both the domestic and international challenges facing the industry. … The Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the National Nutritional Foods Association of Japan (NNFA-J) yesterday agreed to work together to better deal with regulatory and research issues… ‘Emerging research is increasingly supporting the safety and benefits of supplements for maintaining good health and reducing the risk of chronic diseases," he stated. "Regulatory approaches in both countries should likewise reflect good science to help consumers make healthy decisions.’”
www. nutraingredients-usa. com/news/ng.asp?n=85762&c=gbrnO2ewSG3bTjEYx%2BWZAA%3D%3D
------------------------------------------------------
2. Weight Control Dietary Supplements Under Attack
Dietary Supplements that support normal weight have been under increasing attack by both government and special interests. Even well-known weight loss brands such as TrimSpa® are failing (its parent company recently filed for bankruptcy).
Recently it seems that GlaxoSmithKline (GSK) will stop at nothing to rub out the competition when it comes to weight loss supplements. (No matter what your opinion is on weight loss supplements, this issue affects the vitamin industry as a whole.) GSK has petitioned FDA to classify all over-the-counter weight loss supplements as unapproved “drugs.” This means that mere overweight would be classified as a “disease” (as “obesity” is currently classified).
Furthermore, GSK hopes to remove any weight loss claims from dietary supplements. It should be noted that there is currently only one over-the-counter weight loss product with FDA approval: GSK’s alli®.
If FDA starts reclassifying normal conditions of life as “diseases” to protect the Pharmaceutical Industry, we may well see more dietary supplements threatened.
-----------------------------------------------
3. Professional Practice SOPs
The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.
Contains the following topics:
1. Maintaining copies of all paid invoices
2. Maintaining regular back-up copies of client database.
3. Maintaining copies product ordered for resale records
4. Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission
If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Friday, April 25, 2008
04/25/08 - FTc and FDA Tactics to Limit Healthcare Free Speech
Vitamin Lawyer Update Memo: April 25, 2008
This issue:
1. FDA to Require Data on Substantiation – Seeks Comments
2. FTC Unapproved Medical Claims Tactic: “Disgorgement”
3. Are Your SOPs in Order? AER SOP Available
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Blog Update: Co-creating the next wave in health freedom
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1. FDA to Require Data on Substantiation – Seeks Comments
FDA is moving to upgrade the enforcement of the Claims Notice requirements by setting up a system to collect data on substantiation (heretofore, you had to have the data “on file” – now FDA seeks to collect that data.
“To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to baguilaz@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title, "Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act." Also include the FDA docket number found in brackets in the heading of this document. [Docket No. FDA-2008-D-00301 - formerly Docket No. 2004D-0466]…
“Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their product's label. Gathering evidence on their product's claim is a one time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act…
“The standard discussed in the draft guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature…
“FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established… FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals…”
fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0030-n.pdf
Please note the new data production requirements are not yet in effect and I will let my list know as this develops further.
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2. FTC Unapproved Medical Claims Tactic: “Disgorgement”
FTC has been pursuing what is usually a criminal law tactic in its civil complaints against nutrient purveyors who make “medical claims” by demanding that the offender “disgorge” all of its gross sales income from such claims to the FTC, for, as stated in a Stipulation of Settlement offered one company earlier this month, “All funds paid pursuant to this Order shall be deposited into a fund administered by the Commission or its agents to be used for equitable relief , including but not limited to restitution, and any attendant expenses for the administration of such equitable relief. In the event that direct redress of consumer injury is wholly or partially impracticable or funds remain after the restitution is completed, the Commission may apply any remaining funds roe such other equitable relief (including consumer information remedies) as it determines…”
Conclusion: if you make unapproved medical claims, ALL the money that comes into your company from those claims will be taken by the government. You need to review and revise any such claims… contact me if you need my help.
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3. Are your Papers in order? AER SOPs
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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