0. News - Self-Quarantine / Self-Shielding
1. Majority Willing to Spend More on Nutrition
2. Multivitamins linked to 25 percent of supplement AERs
3. FDA Goes After Bayer…
4. FDA: “H1N1: No Natural Remedy Claims!”
5. Webinar Series Archives
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0. Blog News –
Insider Information: Google Search gives special attention to web pages that have videos embedded in the page; it is easy to embed YouTube videos in web pages (see the example in the HFUSA link in item 5 below).
Follow me on Twitter - www. twitter.com/healthfreedomus
Self-Quarantine / Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
[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.]
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1. Majority Willing to Spend More on Nutrition
www. nutraingredients-usa.com/Consumer-Trends/Nutrition-vs-Cost-Survey-outlines-consumer-priorities/?c=gbrnO2ewSG2cMQI1pLFtsQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
By Lorraine Heller, 17-Jun-2009
Over half of Americans are willing to spend more on healthier versions of food, but price remains a barrier for some, according to a new online survey.
Commissioned by the United Soybean Board and conducted by an independent research firm, the survey found that most people who do not opt for healthier food are still interested in nutrition but cannot deal with the heftier price tag.
Consumer Attitudes about Nutrition 2009 has a strong focus on the nutritional benefits of soy – presented as a “budget-friendly” health food – but it also reveals some useful general statistics about consumer shopping behavior.
The latest study, which is the 16th annual report of its kind, includes 1,009 random online surveys conducted in January 2009, selected to provide a sample representative of the US population…
The survey findings, released yesterday, reveal that 54 percent of Americans will spend more on healthier products. Of those that do not opt for the healthier versions, the majority (52 percent) say the obstacle is financial, suggesting that a lack of interest in nutrition is not always the case.
Some 87 percent of respondents said they were concerned about the nutritional content of the food they eat. In addition, 88 percent said they consider nutrition important when purchasing foods at the grocery store.
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2. Multivitamins linked to 25 percent of supplement AERs
www. nutraingredients-usa.com/Regulation/Multivitamins-linked-to-25-percent-of-supplement-AERs/?c=gbrnO2ewSG31nsFv6bi6DQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
By Lorraine Heller, 16-Jun-2009
“Multivitamins and minerals were the subject of one quarter of Adverse Event Reports (AERs) filed with FDA in the first six months of last year, but this does not mean that this product category is problematic, says the American Herbal Products Association (AHPA).
The trade group analyzed 598 AERs received by the US Food and Drug Administration (FDA) between January 1 and June 30 2008, which highlighted potential adverse health effects of dietary supplement products.
However, although 25 per cent of these were for mainstream multivitamins and minerals, the findings must not be misinterpreted as identifying this as the most dangerous class of products, said Michael McGuffin, director AHPA.
‘This is not a cause and effect reporting system, it’s an association system. So although a large part of the AERs are linked to multivitamins, this does not mean that they are dangerous. It simply reflects usage patterns, and the most used dietary supplements are multivitamins,’ McGuffin told NutraIngredients-USA.com.
The AER reports were obtained by AHPA via Freedom of Information (FOI) requests with FDA. AHPA revealed its analysis of these reports at the recent SupplySide East trade show in Secaucus, New Jersey.
A number of supplement brands or products were repeatedly flagged up in the AERs. The most common single product reports were for:
· Total Body Formula (93 reports)
· Bayer One a Day (all formulas) (81 reports)
· Centrum (all formulas) (25 reports)
· Flintstones Vitamins (all formulas) (24 reports)
· Mainstream calcium products (25 reports)
However, McGuffin again cautioned that this does not implicate these brands or products as being dangerous. It reflects the frequency of reporting by a select number of companies, which have put systematic reporting systems in place, he explained.
Out of the 600 AERs reviewed by AHPA, 44 percent were for combination products, 25 percent were for vitamins and minerals, 10 percent were for ‘other primary ingredients’ products, and 5 percent were for herbals.
The majority (almost 60 percent) of reports had been submitted by companies, while just under a third (30 percent) were submitted by consumers. Around 10 percent were sent in by health professionals.
The majority of cases (73 percent) were female consumers, and 54 percent of reports were for people aged between 50 and 79. Again, this reflects supplement usage, said McGuffin.”
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3. FDA Goes After Bayer…
www. nutraingredients-usa.com/Regulation/Bayer-faces-lawsuit-for-selenium-cancer-prevention-ads/?c=gbrnO2ewSG1kWGM7CmFI8w%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
Bayer faces lawsuit for selenium cancer prevention ads
By Lorraine Heller, 18-Jun-2009
“Bayer Healthcare could face a lawsuit in the United States for advertising that its One A Day vitamins could reduce prostate cancer due to their selenium content.
Consumer advocacy Center for Science in the Public Interest (CSPI) today notified Bayer that it will sue the company unless it ceases the ad claims.
Advertisements and labels for Bayer’s One A Day Men’s 50+ Advantage and One A Day Men’s Health Formula multivitamins claim that “emerging research” suggests selenium may reduce the risk of prostate cancer.
However, according to CSPI, such claims are deceptive and are not backed by sufficient science.
The group also filed a complaint today with the Federal Trade Commission (FTC) today, urging them to put a stop to the claims and to require Bayer to run a corrective advertising campaign since its ads have “for so long reinforced the false notion that selenium prevents prostate cancer”.
Selenium is the only mineral that can carry an FDA-approved qualified health claim for general cancer reduction incidence.
The claim reads: ‘Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.’”
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4. FDA: “H1N1: No Natural Remedy Claims!”
www. naturalnews.com/026473_the_FDA_H1N1_natural_products.html
Natural News: Mike Adams
June 18, 2009
“ In an effort to censor any online text that might inform consumers of the ability of natural products to protect consumers from H1N1 influenza A, the FDA is now sending out a round of warning letters, threatening to "take enforcement action... such as seizure or injunction for violations of the FFDC Act without further notice."
"Firms that fail to take correction action," the FDA warns, "may also be referred to the FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws."
The message is crystal clear: No product may be described as protecting against or preventing H1N1 infections unless it is approved by the FDA. And which products has the FDA approved? Tamiflu (the anti-viral drug that most people will never have access to), and soon the new H1N1 vaccine that's being manufactured at a cost of one billion dollars (paid to Big Pharma by the taxpayers). This vaccine, of course, will be utterly useless because H1N1 will undoubtedly mutate between now and the time the vaccine is ready, rendering the vaccine useless.”
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5. Natural Solutions Vital Connection Archived Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past, including these:
A. 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
B. 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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"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!
C. 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.
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Friday, June 12, 2009
06/12/09 - “Pandemic” Level Now 6!
0. News - “PANDEMIC” LEVEL 6
1. Webinar – Sustainable IRAs – June 13, 2009 – Noon EDT
2. Webinar Series Archives
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0. Blog News –
Yesterday: “Pandemic” Level 6 Declared! Are you prepared?
http:// www. healthfreedomusa. org/?p=2830
Follow me on Twitter - www.twitter.com/healthfreedomus
http:// vitaminlawyerhealthfreedom.blogspot .com/2009/06/nj-adopts-fake-hemp-reform-no-gain-for.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. Sustainable IRA
Saturday June 13, 2009 - 10 AM MT (NOON - EDT): Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees will 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). Sunday Webinar, Noon Eastern Time.
Remember: Webinars are lectures you can either participate in when they are given live OR you can “audit the class” at a later time on-line.
-----------------------------------------------
2. Natural Solutions Vital Connection Archived Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past, including these:
A. CAM Advanced Healthcare Practitioner SOPs
Date: 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
B. Bringing New Natural Products to Market
Date: 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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
1. Webinar – Sustainable IRAs – June 13, 2009 – Noon EDT
2. Webinar Series Archives
------------------------------------------------------
0. Blog News –
Yesterday: “Pandemic” Level 6 Declared! Are you prepared?
http:// www. healthfreedomusa. org/?p=2830
Follow me on Twitter - www.twitter.com/healthfreedomus
http:// vitaminlawyerhealthfreedom.blogspot .com/2009/06/nj-adopts-fake-hemp-reform-no-gain-for.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
-----------------------------------------------
1. Sustainable IRA
Saturday June 13, 2009 - 10 AM MT (NOON - EDT): Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees will 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). Sunday Webinar, Noon Eastern Time.
Remember: Webinars are lectures you can either participate in when they are given live OR you can “audit the class” at a later time on-line.
-----------------------------------------------
2. Natural Solutions Vital Connection Archived Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past, including these:
A. CAM Advanced Healthcare Practitioner SOPs
Date: 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
B. Bringing New Natural Products to Market
Date: 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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Wednesday, May 20, 2009
05/20/09 - GMPs effective next month…
0. News - Vitamin Lawyer on Twitter!
1. Guest Message on GMPs
2. Webinar Series Archives
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0. Blog News –
Follow me on Twitter - www.twitter.com/healthfreedomus
http://vitaminlawyerhealthfreedom.blogspot.com/2009/05/health-freedom-and-torture.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. GMPs coming to you…
By: Jeffrey S. Bliss
jsb@tampabay.rr.com
“The GMP Final Rule for Dietary Supplements is in full force. The next upcoming compliance dates are June 10th thru the 25th, 2009. Is your company ready to meet the obligations of the rule?
Can you show the FDA that every product you carry is made according to GMP requirements?
As a distributor and holder of dietary supplements, you are fully responsible for what you do in-house as well as for anything that is done on your behalf by manufacturers, packagers and labelers. Given that you have the ultimate responsibility for showing your products comply with GMP rules, what are the steps you need to take to ensure you're ready for an FDA inspection?
Think about the below.
The need to establish written specifications for each product
How to demonstrate your products comply with those specifications
The functions of quality control personnel
Requirements for ID testing of dietary ingredients and finished products
And Much More!
The bigger the company you are, the quicker the FDA will notice you. Much of what will transpire from all this is that those who are operating in an un-ethical manner will find it very hard to continue to do business. It is highly recommended that you have the right people on your side in your efforts to establish, grow, and continue your business.”
Vitamin Lawyer Comment: Jeff Bliss has a good point there. The Vitamin Lawyer SOP (Standard Operating Procedures) focuses on your company’s marketing and claims. Jeff’s focuses on the GMPs… you need both!
-----------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.
A. CAM Advanced Healthcare Practitioner SOPs
Date: 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
B. Bringing New Natural Products to Market
Date: 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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
1. Guest Message on GMPs
2. Webinar Series Archives
------------------------------------------------------
0. Blog News –
Follow me on Twitter - www.twitter.com/healthfreedomus
http://vitaminlawyerhealthfreedom.blogspot.com/2009/05/health-freedom-and-torture.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
-----------------------------------------------
1. GMPs coming to you…
By: Jeffrey S. Bliss
jsb@tampabay.rr.com
“The GMP Final Rule for Dietary Supplements is in full force. The next upcoming compliance dates are June 10th thru the 25th, 2009. Is your company ready to meet the obligations of the rule?
Can you show the FDA that every product you carry is made according to GMP requirements?
As a distributor and holder of dietary supplements, you are fully responsible for what you do in-house as well as for anything that is done on your behalf by manufacturers, packagers and labelers. Given that you have the ultimate responsibility for showing your products comply with GMP rules, what are the steps you need to take to ensure you're ready for an FDA inspection?
Think about the below.
The need to establish written specifications for each product
How to demonstrate your products comply with those specifications
The functions of quality control personnel
Requirements for ID testing of dietary ingredients and finished products
And Much More!
The bigger the company you are, the quicker the FDA will notice you. Much of what will transpire from all this is that those who are operating in an un-ethical manner will find it very hard to continue to do business. It is highly recommended that you have the right people on your side in your efforts to establish, grow, and continue your business.”
Vitamin Lawyer Comment: Jeff Bliss has a good point there. The Vitamin Lawyer SOP (Standard Operating Procedures) focuses on your company’s marketing and claims. Jeff’s focuses on the GMPs… you need both!
-----------------------------------------------
2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.
A. CAM Advanced Healthcare Practitioner SOPs
Date: 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
B. Bringing New Natural Products to Market
Date: 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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Friday, May 1, 2009
05/01/09 - Supplement Shelf Life; Device Attacks; Webinars
0. News - “Pandemic” Panic…
1. Supplement Shelf Life
2. FDA Plans to Review Pre-’76 Devices
3. Webinar Series Archives and Plans – May 6th and 9th
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0. Blog News – Weaponized Virus; Weaponized Vaccines
Pandemic Alert: Proactive Protection Steps
www .healthfreedomusa.org/?p=2581
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. Supplement Shelf Life
Recently several clients asked me about dietary supplement product shelf-life (and ''best used by'') requirements. The general rule regarding dietary supplements (unlike drugs) is that you do not have to specify a shelf-life unless clinical studies have been done that show a limit on the shelf-life.
If you do state a shelf-life, however, you have to be able to substantiate the claimed shelf-life. Some lawyers advise that having a specific shelf-life limits exposure to consumer claims for use beyond the specified period. I'm not aware of any cases in which that actually became an issue.
The CGMPs "Requires records associated with the manufacture, packaging, labeling, or holding of a dietary supplement to be kept for 1 year beyond the shelf life dating (when such dating is used, such as expiration dating, shelf life dating, or ''best if used by'' dating), or if shelf life dating is not used, for 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records." Final Sec. 111.605
And this comment: "Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data."
http://www.cfsan.fda.gov/~lrd/fr07625a.html
Excerpts from the FDA comments on “shelf-life” are reproduced below.
-----------------
“In the preamble to the 2003 CGMP Proposal (68 FR 12157 at 12203), we stated that we had considered whether to propose requirements for expiration dating, shelf life dating, or ''best if used by'' dating (referred to in this preamble as shelf life or expiration dating). We recognized that there are current and generally available methods to determine the expiration date of some dietary ingredients, such as vitamin C. However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients, especially botanical dietary ingredients…
The preamble to the 2003 CGMP Proposal emphasized that, if you use an expiration date on a product, you should have data to support that date (68 FR 12157 at 12204). We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates…
(Comment 200) Several comments agree with our decision not to require expiration dating on labels for dietary supplements at this time, because of the wide range of products and the need for additional data. Most of these comments state, however, that manufacturers should be allowed to include a ''best if used by'' date. One comment suggests addressing the issue in a separate rulemaking. Other comments support an expiration date because consumers and retailers expect one, and some markets require one. Some comments state that the expiration date or
statement of product shelf life will help ensure that the product meets its label claims and potency…
(Response) These comments do not provide data or information that would reduce the uncertainty about the feasibility of conducting tests to support an expiration date and, thus, do not persuade us to alter our position not to require that you establish an expiration date for your product. Indeed, the comments generally concur with that position. Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data.”
------------------------------------------------
2. FDA Plans to Review Pre-’76 Devices
“FDA to Review Medical Devices Marketed Prior to 1976
“The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.
“These 25 device types… were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976... The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices are marketed after submission of premarket notifications establishing their substantial equivalence to legally marketed devices that do not require premarket approval…
“’We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency,’ said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. ‘New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.’
“… The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II.”
From: www .fda.gov/bbs/topics/NEWS/2009/NEW01990.html
Please note that none of the 25 devices listed at www .fda.gov/OHRMS/DOCKETS/98fr/E9-8022.htm include any of the popular Advanced Healthcare (CAM) electro-energetic devices.
-----------------------------------------------
3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.
A. CAM Advanced Healthcare Practitioner SOPs
Date: May 6, 2009 [This Webinar is being re-taught for the new webinar platform.]
Time: 8:00 PM EDT (approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Date: May 10, 2009
Time: 8:00 PM EDT (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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar..
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
1. Supplement Shelf Life
2. FDA Plans to Review Pre-’76 Devices
3. Webinar Series Archives and Plans – May 6th and 9th
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0. Blog News – Weaponized Virus; Weaponized Vaccines
Pandemic Alert: Proactive Protection Steps
www .healthfreedomusa.org/?p=2581
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. Supplement Shelf Life
Recently several clients asked me about dietary supplement product shelf-life (and ''best used by'') requirements. The general rule regarding dietary supplements (unlike drugs) is that you do not have to specify a shelf-life unless clinical studies have been done that show a limit on the shelf-life.
If you do state a shelf-life, however, you have to be able to substantiate the claimed shelf-life. Some lawyers advise that having a specific shelf-life limits exposure to consumer claims for use beyond the specified period. I'm not aware of any cases in which that actually became an issue.
The CGMPs "Requires records associated with the manufacture, packaging, labeling, or holding of a dietary supplement to be kept for 1 year beyond the shelf life dating (when such dating is used, such as expiration dating, shelf life dating, or ''best if used by'' dating), or if shelf life dating is not used, for 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records." Final Sec. 111.605
And this comment: "Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data."
http://www.cfsan.fda.gov/~lrd/fr07625a.html
Excerpts from the FDA comments on “shelf-life” are reproduced below.
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“In the preamble to the 2003 CGMP Proposal (68 FR 12157 at 12203), we stated that we had considered whether to propose requirements for expiration dating, shelf life dating, or ''best if used by'' dating (referred to in this preamble as shelf life or expiration dating). We recognized that there are current and generally available methods to determine the expiration date of some dietary ingredients, such as vitamin C. However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients, especially botanical dietary ingredients…
The preamble to the 2003 CGMP Proposal emphasized that, if you use an expiration date on a product, you should have data to support that date (68 FR 12157 at 12204). We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates…
(Comment 200) Several comments agree with our decision not to require expiration dating on labels for dietary supplements at this time, because of the wide range of products and the need for additional data. Most of these comments state, however, that manufacturers should be allowed to include a ''best if used by'' date. One comment suggests addressing the issue in a separate rulemaking. Other comments support an expiration date because consumers and retailers expect one, and some markets require one. Some comments state that the expiration date or
statement of product shelf life will help ensure that the product meets its label claims and potency…
(Response) These comments do not provide data or information that would reduce the uncertainty about the feasibility of conducting tests to support an expiration date and, thus, do not persuade us to alter our position not to require that you establish an expiration date for your product. Indeed, the comments generally concur with that position. Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ''best if used by'' date) should be supported by data.”
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2. FDA Plans to Review Pre-’76 Devices
“FDA to Review Medical Devices Marketed Prior to 1976
“The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.
“These 25 device types… were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976... The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices are marketed after submission of premarket notifications establishing their substantial equivalence to legally marketed devices that do not require premarket approval…
“’We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency,’ said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. ‘New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.’
“… The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II.”
From: www .fda.gov/bbs/topics/NEWS/2009/NEW01990.html
Please note that none of the 25 devices listed at www .fda.gov/OHRMS/DOCKETS/98fr/E9-8022.htm include any of the popular Advanced Healthcare (CAM) electro-energetic devices.
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3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
Go to www. VitalConnectionUniversity .com
At the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past.
A. CAM Advanced Healthcare Practitioner SOPs
Date: May 6, 2009 [This Webinar is being re-taught for the new webinar platform.]
Time: 8:00 PM EDT (approximately 2 hours)
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
B. Bringing New Natural Products to Market
Date: May 10, 2009
Time: 8:00 PM EDT (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 and a private forum for additional communications.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002
"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!
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). The new webinar system will also include Vital Connection forums specific to the participants in the webinar..
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Friday, April 10, 2009
04/10/09 - FTC Substantiation Questions
0. News - Food Safety isn’t…
1. FTC Questions about Substantiation
2. Webinar Series Archives and Plans
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0. VL Blog News – Codex and (sic) “Food Safety Bills” threaten nutrients
875… 425… 759… hike!
vitaminlawyerhealthfreedom.blogspot. com/2009/04/no-harmonization-against-our-health.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. FTC Questions about Substantiation
One of the best ways to learn about how the agencies view the law and their power under it, is to read what they are saying in ongoing litigation. One such case wending its way through the FTC garnered the following claims against the company (the “respondents”) and its claims substantiation:
“Respondents Did Not Possess Substantiation For Such Claims At the Time They Were Made.
“Respondents conducted no scientific testing on any of the … Products
“Respondents have not conducted any double-blind studies on the … Products
“Respondents' have not conducted any controlled studies on any of the … Products
“No person has been involved in the scientific testing, research, substantiation, or clinical trials of the … Products
“Respondents have no documents relating to their policies, procedures, or requirements for evaluating or reviewing each safety, efficacy, or bioavailability representation made for the … Products
“It was not Respondents' practice to obtain scientific studies about any of the components in their Products
“Respondents did not search for scientific studies regarding the components in their Products…”
In effect, the above is a listing of what you need to do if you are attempting to meet the FTC standard – and what the agencies will say you have failed to do if they target your company.
The agency’s complaint counsel also stated what he believes to be the advertising standards the law requires FTC to follow:
“In implementing the "likely to mislead" standard, "the [FTC] examines the overall net impression of an advertisement] and engages in a three-part inquiry: (1) what claims are conveyed in the advertisement; (2) are those claims false or misleading; and (3) are those claims material to prospective consumers." Kraft, 970 F.2d at 314. The FTC may use its own reasoned analysis to determine what claims an advertisement conveys. See Kraft, 970 F.2d at 318 ("[i]n determining what claims are conveyed by a challenged advertisement, the [FTC] relies on ... its own viewing of the ad"); see also FTC v. Colgate-Palmolive Co., 380 U.S. 374, 385 (1965). In determining whether an advertisement conveys a claim, the Commission looks to the overall, net impression created by the advertisement, through the interaction of different elements in the advertisement, rather than focusing on the individual elements in isolation. Stouffer Foods Corp.,118 F.T.C. 746, 799 (1994); Kraft, 114 F.T.C. 40 at 122 (1991); American Home Prods. Corp. v. FTC, 695 F.2d 681, 688 (3d Cir. 1982); FTC Policy Statement on Deception, 103 F.T.C. 174, 179 (1984) (appended to Cliffdale Assocs.) (emphasizing importance of considering "the entire mosaic, rather than each tile separately").
“Features of an advertisement such as a product name, visual images, and the use of testimonials may imply claims. Jacob Siegel v. FTC, 327 U.S. 608, 609 (1946); Kraft, 114 F.T.C. at 322; Thompson Medical, 104 F.T.C. at 793 and 811-12; Porter & Dietsch, Inc. v. FTC, 605 F.2d 294, 301, 303 (7th Cir. 1979).
“To determine how "reasonable consumers" interpret a claim, the Commission considers the target market for the advertisement. When the target market consists of "desperate consumers with terminal illnesses," the FTC has shown particular care in evaluating deceptive acts or practices. FTC v. Travel King, Inc., 86 F.T.C. 715 (1975).
“Advertising claims may be express or implied. Kraft, 970 F.2d at 318. Express claims
directly state the representation at issue, while implied claims make representations
without direct statements. Id. at 318 and 319 n.4; Thompson Medical, 104 F.T.C. at 788-
89. The courts and the FTC have recognized consistently that implied claims fall along a
continuum, from those which are so conspicuous as to be virtually synonymous with
express claims, to those which are barely discernible. See, e.g., Kraft, 970 F.2d at 319; FTC v. Febre, No. 94 C 3625, 1996 WL 396117, at *4 (N.D. 111. July 2, 1996) (magistrate judge recommendation), adopted by 1996 WL 556957 (N.D. m. Sept. 25, 1996), off d, 128 F.3d 530 (7th Cir. 1997); see also Bronson Partners, 564 F. Supp. at 127-28 (an advertisement's statements were "so clear, repetitive, and unambiguous that they constituted] the functional equivalent of express claims")…”
From this language, you can see that you need to be very careful about what you claim “by implication” as well as what you claim in plain language. When I advise clients regarding claims and claims substantiation, I keep in mind the expansive view of its authority that the FTC advocates in cases that reach the stage of litigation. The object is, however, to be careful enough with language that issues such as these never rise to the level of agency concern. That means you need to review each piece of new copy you use to make sure that in context it will not be seen to create an implication of claims that are not “truthful and not misleading.” I’m here to help make that happen.
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2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
A. Bringing New Natural Products to Market
Date: To Be Provided (late April or early May)
Time: 8:00 PM EDT (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 and a private forum for additional communications.
The sign-up link will be posted in mid April at: www. healthfreedomusa. org/?page_id=2002
In the meantime, you can email me at ralph.fucetola@usa.net with “Webinar” in the subject line to reserve your place.
"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!
B. CAM Advanced Healthcare Practitioner SOPs
Date: 02/26/09 [This Webinar has been archived and is available to view.]
Time: 8:00 PM EST (approximately 2 hours)
You can see the archived webinar at:
vital-connection. com/ethical-legal-considerations-course-february-26th-2009/
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
All Webinars include useful eBooks of forms and other information that will help you bettr organize.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
Thursday, March 12, 2009
03/12/09 - FDA Enforcement Threat Level Rises…
1. FDA Official’s Comments at Expo West
2. Webinar Series Archives and Plans
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0. VL Blog News
A. Costs of getting a Health Claim approved in the EU now believed to be in excess of $6 million (Euro 5 million) and to take 6 months to two years.
See: nutraingredients. com/Regulation/Health-claim-dossiers-cost-5m-says-DSM/?c=gbrnO2ewSG1X%2FtLolfh2%2FA%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
And here is the current status of Health Claims in the EU:
efsa.europa. eu/EFSA/efsa_locale-1178620753812_article13.htm
B. Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot. com/2009/03/pandemic-risk-alert.html
[Please note: all URLs in this memo are "broken" with spaces inserted before the .com or .org to avoid the memo being treated as "spam" by AOL and other service providers.]
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1. FDA Honcho Promises More Rigid Enforcement of GMPs
FDA’s Brad Williams stated that boosted funding means FDA inspectors may be about to “saturate the field” according to his comments at Expo West. The FDA Dietary Supplements Program Manager spoke with Shane Starling of Nutraingredients-USA.com. The video of their discussion can be seen at:
nutraingredients-usa. com/Industry/FDA-we-will-enforce-GMPs/?c=gbrnO2ewSG1jP7DYIvsGew%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
Bottom line:
“GMPs are a brand new rule… increased inspections last year, more this year… this time next year [when even the smallest companies will have to comply] will have even more inspections … informed by new administration that FDA is about to receive much more money and will be able to saturate the field with inspectors… a large increase in our force out there… largest supplements firms shouldn’t have a problem funding, but some mom and pop operations will be lost… recommends that small firms band together so the new rules don’t break their backs… burden on manufacturer to make sure ingredient suppliers comply. The plan for this rule is that we will enforce it… we want to help people comply…”
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2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
A. Bringing New Natural Products to Market
Date: April 17, 2009
Time: 8:00 PM EDT (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 and a private forum for additional communcations.
The sign-up link will be posted in early April at: www. healthfreedomusa. org/?page_id=2002
In the meantime, you can email me at ralph.fucetola@usa.net with “Webinar” in the subject line to reserve your place.
"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!
B. CAM Advanced Healthcare Practitioner SOPs
Date: 02/26/09 [Archived]
Time: 8:00 PM EST (approximately 2 hours)
You can see the archived webinar at:
vital-connection. com/ethical-legal-considerations-course-february-26th-2009/
You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html
All Webinars include useful eBooks of forms and other information that will help you organize.
----------------------------------------------
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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