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:

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  

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

"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…  

• 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 is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

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

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Ralph Fucetola JD

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