Sunday, December 5, 2010

12/05/10 - Will Your Business or Professional Practice Continue Next Year?



To: the Vitamin Lawyer Update eMemo List:
 

I just sent the email below to a group of health and food freedom advocates from various organizations who have been cooperating in the struggle to stop S.510, the fake "food safety" bill that threatens all food businesses and health practices, under the guise of "food safety."

You are all invited to the free online webinar about these issues that impact your businesses or professional practices. It is scheduled for Wednesday 12.08 -- See the bottom of this memo.

This is a long and convoluted political story, and I know many of the people on this list are keeping up with it, so I won't repeat the details here.


You can learn more about the issues here:

Food Freedom Talking Points:
http://www.healthfreedomusa.org/?p=6910
Bloomberg Wrong about $.510, Small Farmers and Food Freedom... http://www.healthfreedomusa.org/?p=7527

Ralph

PS - If you are interested in pre-paying for some of my consulting time this month, to be used in the New Year, I can make a very special deal with you... email me for details.
-----------------------------------------------------------------------
To: Health and Food Freedom Advocates and Allies,


Here is what we have for the start of the week on the S.510 saga:

Actions taken through our system on three separate items:

1. New joint Senate/House item (2 days) - 70,000 emails
2. Recent (past 2 weeks) Senate only - 150,000 emails
3. Original Senate item (last month) - 800,000 emails
4. Total of all House/Senate "food safety" emails in the past 1.5 yrs: about 5 million emails!

And this latest from DC:

"Senate Calendar:
Floor Schedule
Monday, Dec 06, 2010
2:00 p.m.: Convene and begin a period of morning business."
------------

House Adjournment of 12.02 states:

"4:06 P.M. -
The Speaker announced that the House do now adjourn.
The next meeting is scheduled for 12:30 p.m. on December 7, 2010."

So, no meeting of House until Tuesday, but the Senate does meet Monday afternoon and could act then to try to get around the Constitutional error they made earlier. They may need a 2/3 majority to suspend the rules to allow that to happen. This maneuver can only happen if a significant number of GOP RINO "want to be retired" Senators side with the "leadership" and against the voters.

I will call Sen. Coburn's office Monday morning and let you all know what I find out.

We still face the fact that the Senate lame-duck leadership is intent on pushing S.510 through to the White House and that all the Democrats and about a dozen GOPers have shown consistent support for this bill.

If you didn't see our last eblast, which listed the possibilities, they are here:
http://salsa.democracyinaction.org/o/568/t/0/blastContent.jsp?email_blast_KEY=1199953 

And this is what Gen. Bert has to say:
"By the end of any battle, both sides are exhausted, but the side that perseveres just a little longer... wins! That is where we are now, and that is why Push Back is more important now than before! We are flooding Congress with a clear message: Kill the Bill! Keep at it! Victory is within our reach.  Keep pressing forward while you recruit your contacts to act with you now"

Ralph Fucetola JD
www.NaturalClinicalTrials.org www.VitaminLawyer.com  www.HealthFreedomPortal.org 

PS - if you haven't seen it before, I urge you to watch the short video from Prof. Udani, who says that you need to get your Clinical Trials done if you want to remain in business!

See his video here:
http://www.nutraingredients-usa.com/Research/The-secrets-of-success-for-clinical-trials/?c=gbrnO2ewSG2WQC7IuHls2Q%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

And our clinical trial project here:
http://www.naturalclinicaltrials.org/ 
“In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,” said Dr Udani.
And, PS#2 ... don't forget the important webinar & meeting Wednesday in DC:

Jim Turner, Esq. is hosting an important meeting this coming Wednesday in Washington, DC. He has been traveling around the US in recent days building support for a major initiative: an alliance of health and food freedom advocates, practitioners of natural modalities, including energy healers, to educate decision makers about Advanced Health Care, what the govt calls "CAM" practices. This initiative is called
H.O.P.E. - Healers of Planet Earth.

Wednesday's meeting room is rapidly filling... so Natural Solutions Foundation has volunteered to host a WebEx online live-casting of the event. If you haven't used Cisco System's WebEx yet, you will find it as easy as Skype, but better connection. I'm training to DC Wednesday morning with my webcam laptop and will broadcast the event as soon as I get set up, so by about 9 AM we should be broadcasting. You will be able to participate and comment. WebEx can host 200 participants.

If you can attend, even for part of the meeting, which will run from about 8:30 AM through noon, please let me know by replying to this email.. The people attending in DC will be spending the afternoon on the Hill and then meeting again for an informal dinner after. When on the Hill, S.510 will be a main focus.

Here are the on line meeting instructions:

-------------------------------------------------------
Meeting information
-------------------------------------------------------
Topic: HOPE - Healers of Planet Earth
Date: Wednesday, December 8, 2010
Time: 8:30 am, Eastern Standard Time (New York, GMT-05:00)
Meeting Number: 738 915 752
Meeting Password: hope

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To start or join the online meeting
-------------------------------------------------------
Go to
https://naturalsolutionsfoundation.webex.com/naturalsolutionsfoundation/j.php?ED=140352562&UID=489018037&PW=NZjA4YzUyNTNj&RT=MiMxMQ%3D%3D

-------------------------------------------------------
For assistance
-------------------------------------------------------
1. Go to
https://naturalsolutionsfoundation.webex.com/naturalsolutionsfoundation/mc
2. On the left navigation bar, click "Support".
Please let me know who can attend from your organization.

Monday, November 1, 2010

11/01/10 - Good Clinical Trial Advice from an Industry CEO – FDA/FTC Enforcement Threats

 
0.  Blogs & News – Planning Trip to Panama in January
1.  Clinical Trial Advice from an Industry CEO at Supply Side West
3.  Cautions for CAM Wellness Practices Webinar Now Archived!
4.  Natural Clinical Trials Center
5.  Vitamin Lawyer connections…
-----------------------------------------------------

0. Blogs & News –

Recent issues of this Memo have covered such topics as recent Claims Surveys, Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule, the FDA Rule regarding “expiration” dates and “best if used by” dates, and the FTC and POM juice claims...

I’ll be leading a group of interested people to the Natural Solutions Center in Panama from January 19 through 27, 2011. We’ll be there to inspect the Natural Clinical Trials facility, enjoy the eternal Spring weather, participate in seminars led by Dr. Robert H. Sorge ND and Nancy Orlen Weber, RN, among others… If you want to join, please email me ASAP.

Election 2010 Food Freedom Talking Points blog: http://www.healthfreedomusa.org/?p=6910

FDA/FTC ENFORCEMENT THREAT UPGRADE
This Headline from Last Week is Worth Repeating:
FDA Seizures Replacing Warning Letters!


10.25.10 -- This today from FDA News: “Last Week, Howard Sklamberg, Director of the Office of Enforcement at FDA said the agency has stopped sending repeat offenders warning letters — instead they are going straight to enforcement! Sklamberg said the agency is targeting seizure of products or sales injunctions as likely punishments.”
A word to the wise: Note that the FDA sees its initial attack as a “punishment” without, of course, the benefit of due process! Now more than ever, “your papers must be in order…”

I can now report that one homeopathic/herbal remedy products firm recently received a joint FDA/FTC warning letter telling them their claims were unsubstantiated medical claims; this new tactic of sending one letter signed by both agencies is a significant increase in enforcement activities; implied in the letter is a threat to “Traditional Use” claims which FTC has historically allowed. For at least a decade, FTC’s position has been:

"Claims based on historical or traditional use should be substantiated by confirming scientific evidence, or should be presented in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose. A number of supplements, particularly botanical products, have a long history of use as traditional medicines in the United States or in other countries to treat certain conditions or symptoms. Several European countries have a separate regulatory approach to these traditional medicines, allowing manufacturers to make certain limited claims about their traditional use for treating certain health conditions. Some countries also require accompanying disclosures about the fact that the product has not been scientifically established to be effective, as well as disclosures about potential adverse effects. At this time there is no separate regulatory process for approval of claims for these traditional medicine products under DSHEA and FDA labeling rules."

In another incident of which I am aware, an East Coast wellness center had a Federal search warrant served upon it recently, seeking information about an acoustic device that was developed by a world-renowned MD over fifty years ago. The warrant said the feds were investigating whether the device was an unapproved medical device.

The infamous Ear Candling case continues to be stalled in Court. This past February the 15 largest Ear Candle companies (over 90% of the industry) received Cease and Desist letters from FDA saying that Ear Candles (which have been traditionally used for centuries for relaxation and ear comfort) were unapproved medical devices that had no medical use and therefore could never be approved. The approx. ten companies that got together to sue FDA are still in business; the companies that did not join the suit are being harassed and the Judge has been sitting on the govt’s motion to dismiss (for “lack of standing”) for about 5 months.

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

1. Good Advice: "regulators... expect original research on the final product..."
Here is a very interesting video interview about clinical trials from Dr. Jay Udani, CEO of Medicus
http://www.nutraingredients-usa.com/Research/The-secrets-of-success-for-clinical-trials/?c=gbrnO2ewSG2WQC7IuHls2Q%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily  

Dispatches from SupplySide West - Interview with Dr Jay Udani - CEO, Medicus Research
By Stephen Daniells, 27-Oct-2010, duration 05:12

"Increasing regulatory pressure around the globe is focusing attention on supporting the efficacy of ingredients and products. Dr Jay Udani, CEO of Medicus Research, gave us his 5 secrets for clinical trials success.
At the recent SupplySide West show in Las Vegas, Dr Udani – also an associate clinical professor at UCLA – explained that companies can no longer piggy-back on the science of others, and must undertake clinical trials now.
“In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,” said Dr Udani.
Dr Udani explained that success is defined as successfully supporting the claims in the market place, and he then explains how to achieve this success with clinical trials. "
My notes from the video on the 5 Secrets for Clinical Trial Success:
1. Why – because of the regulatory requirement to substantiate your claims to support your marketing.
2. Who – the population of who is being tested; the wrong population can get the product labeled as a "drug."
3. What – the serving and dose level: dose escalation study; or test the highest safe, available serving.
4. Where – Phenotype expression - overseas subject similar to US population with similar nutrient needs.
5. How – How do you select endpoints related to mechanism of action that are not also
disease endpoints.
Important factors include primary and secondary endpoints and the development path. Use "adaptive design methodology" designed to run small pilot studies, perform interim analysis, then run "true power calculations" to see how many subjects are required to see true statistical distinctions between groups. Companies may find that they can account for their clinical trials as part of their R&D budget, with the usual tax credits for such research and development.
The final word from Dr. Udani: "you can't afford not to do it if you intend to be in business in two to three years..."
------------------------------------------------------

2.  Cautions for CAM Wellness Practices Webinar Now Archived

http://www.naturalhealthoptions.net/LifeSpiritWebinars.php

"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?

Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?

Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.

I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"

This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."
-----------------------------------------------------

3.  Natural Clinical Trials Center

The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. Check out the Videos and PPT Webinar on the Site!  I am leading an inspection tour to Panama in January (see above) and you are invited to see the NCT facility…

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 Center Staff.

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

4. Vitamin Lawyer Connections…

Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site: www.naturalhealthoptions.net
Do you have an affiliation program? We’d like to list it.

If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

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

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

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

Ralph Fucetola JD
www.NaturalHealthOptions.net
www.vitaminlawyer.com
http://vitaminlawyerarchives.blogspot.com
http://vitaminlawyerhealthfreedom.blogspot.com
www.HealthFreedomPortal.org

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

Monday, October 25, 2010

10/25/10 - FDA Says: Seizures Replacing Warning Letters

 
0.  Blogs & News – Planning Trip to Panama in January
1.  New Treaty to Protect Intellectual Property
3.  Cautions for CAM Wellness Practices Webinar Now Archived!
4.  Natural Clinical Trials Center Inspection Tour in January
5.  Vitamin Lawyer connections…
-----------------------------------------------------

0. Blogs & News –

Recent issues of this Memo have covered such topics as recent Claims Surveys, Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule, the FDA Rule regarding “expiration” dates and “best if used by” dates, and the FTC and POM juice claims...

I’ll be leading a group of interested people to the Natural Solutions Center in Panama from January 19 through 27, 2011. We’ll be there to inspect the Natural Clinical Trials facility, enjoy the eternal Spring weather, participate in seminars led by Dr. Robert H. Sorge ND and Nancy Orlen Weber, RN, among others… If you want to join, please email me ASAP.

Access to the Vitamin Lawyer Webinars and more; videos, major site updates:
www.NaturalHealthOptions.net

Election 2010 Food Freedom Talking Points: http://www.healthfreedomusa.org/?p=6910

FDA Seizures Replacing Warning Letters!

10.25.10 -- This today from FDA News: “ Last Week, Howard Sklamberg, Director of the Office of Enforcement at FDA said the agency has stopped sending repeat offenders warning letters — instead they are going straight to enforcement! Sklamberg said the agency is targeting seizure of products or sales injunctions as likely punishments.”
A word to the wise: Note that the FDA sees its initial attack as a “punishment” without, of course, the benefit of due process! Now more than ever, “your papers must be in order…”

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

1. Anti-counterfeiting Accord Compromises on Food Names
http://www.foodnavigator-usa.com/content/view/print/328817
By Caroline Scott-Thomas, 11-Oct-2010


“Delegates from 37 countries representing more than half the world’s trade have agreed to an international anti-counterfeiting trade pact designed to protect against illegal copies of foods and other products. The nearly finalized text of the anti-counterfeiting trade agreement (ACTA) follows talks in Tokyo earlier this month, which some US food manufacturers had feared could lead to American parmesan cheese, champagne or gorgonzola being seized as illicit goods by border controls… However, the finalized draft released late last week reached a compromise on the issue, referring to tolerance of existing rights in various countries… The agreement is largely intended to crack down on intellectual property (IP) right infringements, particularly in light of digital piracy and trade in counterfeit goods online.

The consolidated text is available online here:  http://trade.ec.europa.eu/doclib/docs/2010/october/tradoc_146699.pdf

From the Agreement:

“Counterfeit trademark goods means any goods, including packaging, bearing without authorization a trademark that is identical to the trademark validly registered in respect of such goods, or that cannot be distinguished in its essential aspects from such a trademark, and that thereby infringes the rights of the owner of the trademark…
“Section 1 - General

“1. Parties shall ensure that enforcement procedures are available under their law so
as to permit effective action against any act of infringement of intellectual property
rights…
“Section 2 – Civil Enforcement

1. Each Party shall make available to right holders civil judicial procedures
concerning the enforcement of any intellectual property right… Each Party shall provide that, in civil judicial proceedings concerning the enforcement of intellectual property rights, its judicial authorities shall have the authority to issue an order against a party to desist from an infringement… declaratory judgments and adequate compensation shall be available… At least with respect to pirated copyright goods and counterfeit trademark goods, each Party shall provide that in civil judicial proceedings, at the right holder’s request, its judicial authorities shall have the authority to order that such goods be destroyed, except in exceptional circumstances, without compensation of any sort…”

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

2.  Cautions for CAM Wellness Practices Webinar Now Archived

http://www.naturalhealthoptions.net/LifeSpiritWebinars.php

"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?

Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?

Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.

I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"

This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."
-----------------------------------------------------

3.  Natural Clinical Trials Center

The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. Check out the Videos and PPT Webinar on the Site!  See Clinical Trial SOPs below. I am leading an inspection tour to Panama in January (see above) and you are invited to see the NCT facility…

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 Center Staff.

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

4. Vitamin Lawyer Connections…

Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site: www.naturalhealthoptions.net
Do you have an affiliation program? We’d like to list it.

If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

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

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

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

Ralph Fucetola JD
www.NaturalHealthOptions.net
www.vitaminlawyer.com
http://vitaminlawyerarchives.blogspot.com
http://vitaminlawyerhealthfreedom.blogspot.com
www.HealthFreedomPortal.org

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