1. Join me in Panama in August: the Dr. Rima Institute is Opening!
2. Survey Shows Customers Distrust Nutrient Advertisements!
3. SPECIAL: Private Vitamin Lawyer Ad Copy Webinar!
4. Natural Clinical Trials Center
5. Vitamin Lawyer connections…
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0. Blogs & News –
Recent issues of this Memo have covered such topics as Trademark “Fair Use”, CCDS (Company Core Data Sheets), Trends in FDA Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding “expiration” dates and “best if used by” dates.
General Bert’s Open Letter to Codex:
www .healthfreedomusa. org/?p=5900
See the special message below from Dr. Rima about the Institute Grand Opening! Come join me on a tour of the Valley of the Moon!
Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net
This from FDA News .com:
“The regulatory environment in the U.S. and Western Europe is largely responsible for a decline in the number of physicians who are willing to participate in clinical trials in those regions, according to a recent survey.
Seventy percent of U.S. and Western European physicians participating in the survey, conducted by the Association of Clinical Research Organizations and the Academy of Pharmaceutical Physicians and Investigators, said the current regulatory environment — including medical liability, conflict-of-interest rules and disclosure requirements — is making clinical trials difficult to manage.
Over the past decade, the number of physicians participating in clinical research has decreased in the U.S. and Western Europe, while double-digit increases have been seen in Asia, Central/Eastern Europe and Latin America. The number of active clinical investigators in the U.S. has declined 3.5 percent since 2001, according to the Center for Information and Study on Clinical Research Participation.”
Dr. Rima is one physician who is willing to work with your companies (and with Natural Clinical Trial’s professional staff) to design and implement meaningful clinical trials, conducted in Panama among populations that can be designated to match US consumers. See further information below.
[Please note: URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
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1. Join Me in Panama for the Grand Opening of the Dr. Rima Institute!
I’ll be traveling from NJ to the beautiful, bountiful, temperate Highlands of Panama from August 3 through August 13 to celebrate the Grand Opening of the Dr. Rima Institute! You can learn more about the Institute at www .DrRima .net
If you’d like to join me, you are invited! Please call me as soon as possible at 973.300.4594 to discuss arrangements.
Here is what Dr. Rima just posted on one of our forums about the event:
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I am so happy to report that although Gen. Bert and I had to be at the Codex Commission meeting in Europe, work on the Dr. Rima Institute at the Natural Solutions Center in Panama continues on track and on time for the Grand Opening event of August 7 – 8, 2010. A number of guests will be attending, including the provincial governor. Our co-trustee Ralph Fucetola JD will be leading a group from the United States to attend, inspect the properties and view the 120 acre Phase III parcel that we see as the future home for the Valley of the Moon Eco Community.
To prepare for these events we have scheduled several conference calls:
Two 1 hour Conference Calls: Number for both calls is the same: Please make note of new number: 661-673-8600, PIN: 125038#
Wed. 9 PM Eastern for people who are interested in providing clinical or other services and/or leading seminars.
Thurs. 9 PM Eastern for people who want to make sure that they can acquire a Beneficial interest Certificate (BIC). We are getting ready to move to Phase III (permanent home) even as we progress with Phase II and the remaining BICs are limited. The participation cost currently is $75,000, but this amount is expected to double when the Phase III parcel is contracted. Remember, a BIC gives you four rights and an opportunity:
1. The right to simple interest at least at the Banco Nacional de Panama prime rate;
2. The right to build and own a home on the Community trust land;
3. The right to buy from Community Enterprises at co-op rates;
4. The right to participate in Community Governance; and
5. The opportunity to develop of Joint Venture Community Enterprise with the Foundation.
Yes, IRA, 401, trust, church and similar funds are certainly welcomed as well!
This week is an important one as we plan for the full function of the Natural Solutions Center. Gen. Bert and I will leave Geneva, where we have been attending the Codex meeting this past week, and where we spent this weekend in meetings with a special colleague, healer, inventer and supporter of our work to see in what ways we can mutually move the important work that his organization and ours engages in.
Monday at 6 AM local time, immediately after we finished the Dr. Rima Reports Internet radio program (9PM to Midnight, Eastern time, but 3 AM to 6 AM Geneva time!) we left to make the plane back to Panama. We will be travelling for about two days, but you can always contact Ralph Fucetola at 973.300.4594 if you have any questions.
On Tuesday we'll be back in the Valley of the Moon and then the real work starts! We have a little over 3 weeks to get the Center decorated and ready for the Grand Opening!
The Natural Solutions Center Grand Opening will take place on August 7 and 8. You are invited!
As I mentioned at the start of this email, we will hold two special Conference Calls:
Wednesday night from 9 PM to 10 PM Eastern for people who are interested in providing clinical services (which means through a Joint Venture with the Foundation and/or leading seminars at the Center and Thursday night 9 PM to 10 PM Eastern for people interested in making sure that they have a BIC - there are a limited number and we will be moving from Phase II to Phase III rapidly.
By the way, if you have an idea for a seminar, please send as much detail as you can to me at releyes[at]gmail.com with a copy to Ralph at ralph.fucetola[at]usa.net and we'll start working on the schedule, etc.
The call number for the special conference calls is 661-673-8600, PIN: 125038#
I hope you will be able to join us on either one or both of those calls and come to the opening. Please, PLEASE RSVP let me know since you know how awful it is to run out of food at a party! Email me at releyes@gmail.com. Please don't forget and just arrive!
Since Ralph is leading a tour to the Valley of the Moon at the same time, if you want to coordinate with him, please call him as soon as possible.
In addition, if you have other questions you want to discuss about providing clinical services, having a JV (to provide services or other collaborations), securing your BIC while they are still available, what types of funds can be used for the BIC, etc., etc., feel free to contact Ralph Fucetola, ralph.fucetola[at]usa.net, Skype "vitaminlawyer", phone 973.300.4594.
For a look at some of the protocols we will offer, please visit www .DrRima .net.
See you soon!
Yours in health and freedom,
Dr. Rima
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2. Survey on Consumer Trust in Vitamin Claims
Here is Lorraine Heller’s July 13, 2010 article:
“The majority of US consumers are mistrustful of claims on dietary supplement products, reveals a survey conducted last month.
The findings come as part of a Thompson Reuters Pulse Healthcare Survey, which collects information about health behaviour, attitudes and product use from over 100,000 US households.
Conducted in the first two weeks of June 2010, the survey found that nearly 60 percent of participants believe that advertising for dietary supplements is untrustworthy.
Advertising reach
Out of the 3,013 participants in the telephone survey, around 63 percent said they had seen, heard or received advertising for nutritional or dietary supplements over the past six months.
Overall, 77 percent of adults earning more than $100,000 said they had been exposed to advertising for these products during the period. This compares to 51 percent of people earning less than $25,000.
A similar trend was noted according to the level of education of respondents: 47 percent of people with high school education or less said they had seen supplement ads in the past six months, compared to 70 percent of those with college degrees.
Influence from advertising
However, despite relatively high levels of exposure to supplement marketing, only 11.5 percent of those who had seen ads said they were influenced by these to purchase the product.
Those who were most influenced were the lower income bracket (18 percent of people earning under $25,000 compared to 9 percent of those earning over $100,000). Younger consumers were also more likely to purchase advertised supplement products (16 percent of people under 35, compared to 10 percent of 35-64 year-olds and 8 percent of over 65 year-olds).
Not trustworthy
Participants were also asked how trustworthy they found claims made by dietary supplement manufacturers.
Overall, almost 60 percent of people said they did not find these to be trustworthy, compared to 10 percent who trusted the claims.
Thompson Reuters said the margin of error of its survey findings is 1.8 percent.”
www .nutraingredients-usa. com/content/view/print/312032
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3. New Vitamin Lawyer Ad Copy Webinar – Private for Your Company, via Internet…
I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.
Webinar covers:
DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources
Sample: Slide #4
“Dietary Supplement products are governed by a complex of statutes and regulations. The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA). This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA). DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.
In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”
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4. Natural Clinical Trials Center
The Natural Solutions Center in Volcan, Panama is opening August 7, 2010, so Clinical Trials can begin shortly thereafter. 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 Center Staff.
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5. 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
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Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.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.
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