Thursday, December 17, 2009

12/17/09 - H1N1 Spurs Vitamin Sales / Clinical Trial Meetings / CAPA Outline

 
0.  Blog & News – Opportunity to Meet Gen Bert & Dr Rima; CAPA
1.  H1N1 Spurs Vitamin Sales
2.  Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars
Addendum: CAPA Outline
-----------------------------------------------------

Blog & News – Rare opportunity to meet with Gen. Stubblebine and Dr. Laibow in the NYC metro area after New Year’s Day. Kevin Trudeau, Dr. Coldwell, others to attend…

For the Weekend Intensive (January 2nd and 3rd) see
2010 Health Freedom USA War Council
www. healthfreedomusa .org/?p=4183

Private meetings with Dr. Laibow and Dr. Goodman and myself for Natural Clinical Trials are available on Monday, January 4th, in person or electronically. Please contact me at ralph.fucetola@usa.net for details if your company is interested in discussing Clinical Tests, Studies and Trials.

Dr Laibow and Gen Stubblebine have a Holiday video message for you:  www .healthfreedomusa .org/?p=4157

---------------

CAPA SOPs– Corrective and Preventative Actions Standard Operating Procedures

CAPA is an essential element in cGMP SOPs. Outline below; let me know if you need a formal SOP. As my Holiday Gift to my client base, I’ve included, at the bottom of this eblast, my CAPA notes for the CAPA SOP and webinar being planned.

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------------

1. H1N1 Fuels Supplement Sales Around the Globe, NBJ Research Shows

Nutritionbusinessjournal .com/nutrition-industry/news/H1N1-supplement-sales-nutrition-business/

“December 15, 2009 - Total global nutrition industry sales increased 8% to $270 billion in 2008, and sales are expected to rise another 6% to 10% this year, According to Nutrition Business Journal estimates. On the supplement front, the outbreak of the fear-provoking H1N1 flu pandemic, which surfaced in Mexico in April 2009 and touched nearly every country in the world by August, is helping to lift sales all over the globe.

The rapid spread of H1N1—which has already infected an estimated 1.3 billion people worldwide—is causing a spike in immune-support supplements around the world, as people scramble for anything that could help keep the virus at bay. “In recent months, global health concerns, including H1N1, have resulted in a high demand for general health and immunity products,” said Richard Henfrey, director of people and strategy at Australian supplement company Blackmores, whose sales are up more than 12% this year. Similar comments were made by nutrition industry executives from South Korea to Germany to the Philippines to South Africa...”

-----------------------------------------------------

2.  Natural Clinical Trials Center

Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

Dr. Laibow, Dr. Goodman and I are available for in-person or virtual conferences on Monday, January 4, 2010 to discuss Clinical Tests, Studies and Trials. Please email me ASAP if you have an interest in reserving time.

------------------------------------------------

3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

----------------------------------------------

Natural Clinical Trials – www .NaturalClinicalTrials .org

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

Current SOP Project: CAPA: Correction and Prevention Analysis
Do you need a CAPA SOP? See attached outline, below.

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

-----------------------------------

Corrective and Preventive Action
CAPA notes

Main Headings of the CAPA SOP

Discovery of the Deviation
Documentation of the Event
Immediate Corrective Action
Investigation of the Primary Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation

1. How to Discover a Deviation from SOPs

a. By External and Internal Audits
b. By Observation by Staff
    While performing a task
    While inspecting or testing
    While process and equipment monitoring
    While reviewing records

c. By Review of Change Controls

d. From Complaints, adverse events, product returns or recalls

e. Due to notification by a customer or client

2. Documenting the Deviation

What was the deviation
Who was involved
When did event occur
Where did event occur
How was deviation discovered
How frequently does the process occur
What immediate corrective action taken

3. Immediate Corrective Action Taken

a. Products: isolated, sampled, discarded

b. Equipment: removed and replaced

c. Processes: suspend process

4. Investigation

a. Circumstances at time of deviation

  How and why deviation occurred
  Determine if other products, processes involved
  Determine staff involved
  Gather data to develop corrective action

b. Interview: staff, customers, suppliers

c. Review: policies, procedures, forms

d. Review: Training, equipment, soft/hardware

5. Primary Cause Analysis

To discover the primary (root) cause
To reduce risks or recurrence
To improve operations: policies, procedures, forms
To maintain compliance with SOPs and QC

a. Conclusions should be based on systematic review of documented evidence.

b. Problems may have more than one primary cause. All known casual links need
to be established. Performance improvement recommendations should be based
on the primary cause analysis.

b. PCA answers:

How did the deviation occur?
Why did the deviation occur?

c. PCA also seeks to understand:
Physical, organizational or process factors in place to detect deviations
[where were the factors; what was their level of effectiveness; what
factors failed]

6. Corrective Action

a. A plan of action that will eliminate or reduce the primary cause of the
deviation, failure or breakdown.
Implementation through:

b. SOPs
Process changes (including materials and procedures)
Training and retraining
Use of automation or new equipment

c. Corrective action is limited to changing the primary cause through the
above noted implementation strategies.

7. Effectiveness Evaluation

Effectiveness evaluation aims at documenting that the corrective action was
implemented as planned and that the corrective action is effective in the
reduction or prevention of recurring deviation, failure or breakdown.

a. The EE verifies:

That corrective action was properly implemented
The data source for the EE
When the EE was performed
Success criteria
Whether the CA met the success criteria

b. Document omissions, corrections, completion and recurrence of original deviation

c. EE is the responsibility of Operations Management to be accomplished within
a reasonable period after the implementation of the CA.

d. QA should perform a post CA audit to determine overall effectiveness.
e. If the EE shows a failure to correct the deviation, the CAPA process must
be restarted with a new Primary Cause Analysis.

f. Consider:

i. Possible undiscovered other or multiple (independent) primary causes
ii. Significant undiscovered contributing factors

CAPA SUMMARY

Define deviation, failure or breakdown
Gather data
Identify causal relationships
Identify which causes if changed with prevent recurrence
Identify effective potential solutions to prevent recurrence
Implement Corrective Action
Evaluate Effectiveness

Thursday, December 10, 2009

12/10/09 - New FDA Liquid DS Guidance / Clinical Trial Meetings



0.  Blog & News – Holiday Message from Dr Rima and Gen Bert
1.  New FDA Dietary Supplement Guidance
2.  Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars
-----------------------------------------------------

Blog & News – Rare opportunity to meet with Gen. Stubblebine and Dr. Laibow in the NYC metro area after New Year’s Day.

Private meetings with Dr. Laibow and Dr. Goodman and myself for Natural Clinical Trials are available on Monday, January 4th, in person or electronically. Please contact me at ralph.fucetola@usa.net for details if your company is interested in discussing Clinical Tests, Studies and Trials.

For the Weekend Intensive (January 2nd and 3rd) see:
www .healthfreedomusa .org/?p=4183

Dr Laibow and Gen Stubblebine have a Holiday video message for you:  www .healthfreedomusa .org/?p=4157

-------------------
Health Freedom's citizen lobbyist in Washington, Maury Silverman of the American Library for Health is seeking donations for his nonprofit institute. Donations will be tax deductible, and this is the Giving Season... Maury will volunteer to be your man in DC and provide you with useful information... great networker of information that creates progress (I can attest how useful he's been to our foundation and some of my clients). Donations: PO Box 7507 - Silver Springs MD 20907 [240-330-3420].

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------------

1. New FDA Liquid Dietary Supplement Guidance

www .fda .gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm

This draft guidance is open for comments for 60 days. Thereafter FDA will finalize it and published it as an official guidance document in the Federal Register.

The draft version does suggest that FDA continues to ratchet-up the regulation of nutritional products. FDA says its purpose is: “to assist dietary supplement and beverage manufacturers and distributors in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement.” Since liquid DS products are becoming more popular, as I’ve been telling my clients for the past several years, this guidance will have a significant impact on the continuing development of the industry.

The key issue covered by the guidance is, “…factors that can be used to identify liquid products that are excluded from being dietary supplements because they are represented as conventional foods.” Thus the regulatory intent is to limit what products can be sold as dietary supplements.

That you intend to market a liquid DS may not matter to the FDA: “Beverages are conventional foods under the FFDCA.  Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement.  Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising.  For example, the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food.”

This what the FDA considers in making a determination as to what category the product fits: “name, packaging, serving size, and recommended conditions of use, as well as other representations…”

And this clause may be a key to the FDA’s position: “because of the use promoted in the claim, the product may no longer be consumed as a food -- primarily for taste, aroma, or nutritive value -- but rather as a drug for some other physiological effect.”

And what is the effect of being a beverage and not a DS? “…beverages and other conventional foods are required to bear nutrition information in the form of Nutrition Facts rather than Supplement Facts, and all ingredients in a beverage and other conventional food must be declared in the ingredient statement by their common and usual names, in descending order of predominance.  In addition, a beverage or other conventional food should not be labeled with the FDA disclaimer that is required on dietary supplement labels that bear structure/function claims…”

Bottom line: ALL liquid dietary supplement products should disclaim any intent to be a conventional beverage, or should conform to conventional food rules and not be presented as a DS product.

YES, the Vitamin Lawyer Consultancy is available to help you construct a proper disclaimer.

-----------------------------------------------------

2.  Natural Clinical Trials Center

Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

Dr. Laibow, Dr. Goodman and I are available for in-person or virtual conferences on Monday, January 4, 2010 to discuss Clinical Tests, Studies and Trials. Please email me ASAP if you have an interest in reserving time.

------------------------------------------------

3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

----------------------------------------------

Natural Clinical Trials – www .NaturalClinicalTrials .org

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

Current SOP Project: CAPA: Correction and Prevention Analysis
Coming soon…


Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

Wednesday, November 25, 2009

11/25/09 - Sneak Preview: Natural Clinical Trials

 
0.  Blog & News – (sic) “Food Safety” Bill S.510 Delayed
1.  FTC Changes Testimonial Rules – Clinical Trials Needed
2.  Sneak Preview: New Web Site for Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars
-----------------------------------------------------

Blog & News – The “Food Safety” bill is delayed in the Senate after we generate about 150,000 emails in a couple days; changes have been made that meet some natural product industry concerns… but not all. See: www .healthfreedomusa .org/?p=4014

Sneak Preview: Natural Clinical Trials – www .NaturalClinicalTrials .org – see below!

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it. If you don’t have one… I have Affiliate Program SOPs & Rules …and good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
Current SOP Project: CAPA: Correction and Prevention Analysis
Coming soon…

Health Freedom's volunteer lobbyist in Washington, Maury Silverman of the American Library for Health is seeking donations for his nonprofit institute. Donations will be tax deductible, and this is the Giving Season... Maury will volunteer to be your man in DC and provide you with useful information... great networker of information that creates progress (I can attest how useful he's been to our foundation and some of my clients). Donations: PO Box 7507 - Silver Springs MD 20907 [240-330-3420].

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------------

1. FTC Changes Testimonial Rules – Are your SOPs Ready?

Here is what the FTC announced last month: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.

“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”

The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.

Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.

One approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”

Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.

But this interim approach is just that: a stop gap. What you need is the necessary clinical trials, studies and tests to both substantiate your claims and show what “typical results” are. That’s the bottom line. See the next article: Natural Clinical Trials.

www .ftc .gov/opa/2009/10/endortest.shtm

-----------------------------------------------------

2.  New Web Site for Natural Clinical Trials Center
www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

Natural Solutions Foundation, founded in 2004, is an international NGO (Non Governmental Organization) focused on natural solutions. We are active and registered in several countries and a not for profit 501(c)(3) tax exempt organization in the United States. The Mission of the Foundation is to discover, develop, document, demonstrate and disseminate natural solutions to the issues which threaten our health, food and freedom, achieving and maintaining a healthy self, community and world.

Natural Solutions Foundation, since its founding, has pursued a vigorous program on many fronts, including the development of an advanced healthcare clinic in the beautiful, bountiful, temperate Highlands of Chiriqui Province, Panama -- the advanced healthcare Natural Solutions Wellness Center.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

------------------------------------------------

3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

Wednesday, October 28, 2009

10/28/09 - Making Claims in a Changing Regulatory Market

 
0.  Blog & News – "Stop the Shot" Litigation
1.  Making Claims in a Changing Regulatory Market
2.  FTC Changes Testimonial Rules – Are Your SOPs Ready?
3.  Vitamin Lawyer Webinars
-----------------------------------------------------

Blog & News – EU Approves Plant Sterol Claims
www. foodnavigator. com/content/view/print/265330

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have one…
I have Affiliate Program SOPs & Rules …and good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
Current SOP Project: CAPA: Correction and Prevention Analysis
Coming soon…

Dr Laibow and Gen Stubblebine on the way to Codex Meeting in Germany
Support their trip with a MONEY BOMB!
www. healthfreedomusa. org/?p=3686

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------------

1. Making Claims in a Changing Regulatory Market

A recent emailing from Nutraingredients gives us useful insight about the current regulatory market:

“Making substantiated claims in a changing regulatory environment
There are many challenges facing companies due to regulations, with stricter health claim regulation looking set to make the marketing environment stricter in Europe than in North America. Increasingly the biggest issue facing marketers is how to overcome the lack of trust most consumer have in products...

77%, of European consumers do not believe that manufacturers' health and nutrition claims are trustworthy and this acts as a strong inhibitor to future growth, subsequently product claims need to be more specific and clearer for consumers to understand. A crucial mistake to avoid is offering too many claims for one product, progressively manufacturers need to assess whether they offer more "positive" than "negative" nutrition in their portfolios.”

It's time to review all your claims... can you substantiate them? Are you ready to obtain appropriate Clinical Studies of your product -- not just rely upon published literature about your ingredients... that's no longer sufficient!

Both the FDA's cGMPs with the emerging requirement for Clinical Trials of the actual product and the FTC's revision of the testimonial rules to, in essence, require you to do the clinical testing needed to establish what the "typical results" of your product might be before advertising with testimonials, leads to a growing understanding that clinical testing is becoming a necessity to remain in business.

The problem I've found is that it is very difficult to find competent third parties to conduct such tests. The market is beginning to respond and if you are interested in having clinical trials of your products, please contact me with "CLINICAL TRIAL" in the subject line.

-----------------------------------------------------

2.  FTC Changes Testimonial Rules – Are your SOPs Ready?

Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.

“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”

The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.

Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.

My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”

Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.

www .ftc .gov/opa/2009/10/endortest.shtm

------------------------------------------------


3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

Thursday, October 8, 2009

10/08/09 - FTC Changes Testimonial Rules – Are Your SOPs in Order?

 
0.  Blog & News –
1.  FTC Changes Testimonial Rules – Are Your SOPs Ready?
2.  Vitamin Lawyer Webinars
-----------------------------------------------------

Blog & News – “Stop the Shot” Case being filed today…

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it.
If you don’t have one…
I have Affiliate Program SOPs & Rules …and good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
$11.95 – www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

“Stop the Shot” Litigation filed today  in DC District Court!
www .healthfreedomusa. org/?p=3617

(Case should be filed today; link should be active late today.)

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
-----------------------------------------------------


1.  FTC Changes Testimonial Rules – Are your SOPs Ready?

Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.

“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”

The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.

Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.

My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”

Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.

www .ftc .gov/opa/2009/10/endortest.shtm

------------------------------------------------


2. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org