Saturday, September 3, 2011

09/03/11 - Vitamin Lawyer Update eMemo - 9.3.2011

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...

[0] FDA Ratchets-up Company Inspections
[1] Compounding Pharmacy Purchase: An Opportunity for You...
[2] Yes, You do Need Clinical Trials…
[3] New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from us!

FDA Ratchets-up Company Inspections

From FDA yesterday: “The recent trend of increasing FDA inspections and warning letters is continuing this year, as the agency has already issued 874 letters in fiscal 2011, compared with 673 last year. From fiscal 2005 to fiscal 2009, the number of warning letters issued per year hovered in the high 400s.  
With increased staffing, the agency has doubled the number of establishment inspection reports reviewed, from 215 in 2006 to 416 in 2011...
“As heightened inspections — and warnings — become the "new normal," it's vital to know what's triggering citations …
To paraphrase FDA News: Exactly what [does] Commissioner Hamburg mean by "get tough" enforcement?

Are you ready for an FDA inspection? Call me if you are not sure!


Opportunity Knocks... knock, knock...
Private and Confidential …
Based upon information received under a Non-Disclosure Agreement from the Foundation to the company selling the Pharmacy, we have ascertained certain important information which may have significant potential for your business despite the current hostile climate of the US regulatory authorities to nutrients and wellness products, which we summarize here. This general information memorandum is not an offering. The Compounding Pharmacy is one of only two in the region, and has a certified clean room, again, one of only two in the region. The Trustees of the Natural Solutions Foundation have determined that purchasing the Compounding Pharmacy is within, and consistent with, the purposes and principles of the Foundation.
The Business Plan for this project is available upon execution of a Non-Disclosure Agreement. The Foundation anticipates a significant opening into the world nutrient and wellness product market, due to our world-wide footprint, allowing us to expanded to markets in growing economies around the world, where governments are more friendly to natural remedies and products. This project is intended to further the Mission of the Foundation.
As a Foundation trustee I am advising the Foundation to move ahead expeditiously. Therefore, this private note to you all, giving you an opportunity to participate prior to reaching out to the general supporter base as private expressive association. For those Advanced Health Care Practitioners and Leading-Edge Natural Product innovators, this is a significant opportunity, as the investors will have a priority opportunity to have the Compounding Pharmacy manufacture nutrients, remedies and other products especially for your order. The minimum investment is $100,000. This investment will be credited to the NSF Green Fund and therefore the risk will be spread among the projects of the Fund. See:
The Compounding Pharmacy entity (“the Pharmacy”) has three significant assets, in the three licenses it hold from the local government. These  licenses allow the Pharmacy:
1. To engage in the business of international export and import of pharmaceuticals.
2. To engage in the business of compound pharmacy manufacturing and sales.
3. To engage in the business of operating a retail pharmacy.

Coupled with a new Free Trade Zone law, which lets anyone have a Free Trade Zone business with a minimum of 2 hectaria* and a qualifying financial investment which the purchase of the Pharmacy would meet, the NSF Green Fund and Natural Solutions Foundation believes that the potential is strongest in three areas:
"1. Providing compounded IV nutrient and chelation intravenous infusions (“drips”) ready made and pre-compounded to US and other physicians who use these materials in their practices. It is getting more and more difficult, especially for US and EU doctors, to obtain these nutrients and remedies and the overhead cost of doing so, mixing and stocking them, is a significant impediment to physicians using these options. Rima E. Laibow, MD, a well-known nutritional and environmental practitioner, has written an extensive Continuing Medical Education course for physicians who can then be expected to take this route for their patients, creating a knowledgeable and licensed ready market for these products and others she, and the Foundation, suggest and/or endorse.
2. Compounding hard to find medicine combinations for the international market either for individual use at the prescription of the physician (as permitted by law in virtually every country) and for specialized “compassionate use” by patients using non-approved compounds under the direction of a physician when the substances are permitted in another country. This is also permitted under the law of virtually every country. The physician will be able to source the desired materials for the patient from the Pharmacy.
3. Compounding the nutrient and chelation drips for physicians both in their own offices and in Medical Tourism contexts such as that of the Natural Solutions Center in Volcan.
4. The licenses of the Pharmacy open the door to distribution and sales in the rest of Central and South America. There is only one other certified equivalent Clean Room in Central America and the potential demand for its manufacturing capacities could be very brisk, with resultant profits generated through its use.
Transportation and cargo movement in the area is outstanding. Import/export trade is well developed and world-wide distribution and shipping are a significant asset of the region.  In addition, favorable regulatory conditions make this an ideal setting for the approval of compounds, nutrients and products.  This approval then carries weight in the rest of the available market.
The Pharmacy will employ regulatory specialists to deal with national and international approvals to aid in the development of international markets for our investors and clients.
The asking price for the Pharmacy is $5,000,000.
The Pro Forma Statement shows continual company growth. Most recent gross sales: $1,059,000 for 2010.
The founding physician has indicated that he intends to continue at the Pharmacy after its sale in a managerial capacity. Another factor to note is that the principle and Dr. Rima are working together on a number of continuing education courses for doctors, the first of which is training in chelation therapy, under the imprimatur of Johns Hopkins University School of Medicine.
The Pharmacy includes one of only two licensed Class 100 Clean Rooms in Central America, the Pharmacy facility and the sister Pharmacy Company in Hong Kong.
The Foundation's NSF Green Fund seeks participants for the purchase, operation and development of the Compounding Pharmacy.
Please contact me at for a copy of the Non Disclosure Agreement so that we can initiate a dialogue about your participation in this unusual and highly interesting investment opportunity. Phone: 973-300-4594, Skype: "vitaminlawyer"
Ralph Fucetola JD
The Vitamin Consultancy
*1 hectar = 2.45 acres

Yes, you do need clinical trials!
Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!
The Red Letter warnings I sent you in recent months from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared.
HHS Secretary Sibelius admitted that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats!
What do you need to survive an FDA inspection? I’ve told you several times!
  1. Standard Operating Procedures – in place and up-to-date -from $500. The SOP document not only satisfies FDA, but also helps you organize your business!
  2. Product Substantiation Notebook – in place and up-to-date –from $500 plus your research time; this Notebook is a MUST if you get inspected! Part of the Notebook includes copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. The cost for these notices is from $340.
  3. Copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! My webinar on these issues is inexpensive. $99 for the archived CAM Webinar; a private copywriter webinar just for your company copywriters will cost above $500 (the webinar includes an eBook specially written for your company).
  4. A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $35,000.
WHAT SHOULD YOU DO? Contact me NOW!  973.300.4594
The longer you put off addressing any of the above issues,
the more at-risk is your company!

Archived Cautions for CAM Wellness Practices
"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."

NCT Clinical Trials Center
The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. The cost of a basic 12-person, one month Clinical Trial with a formal Report signed-off by credentialed professionals is about $40,000.
Prof. Udani on Clinical Trials - 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 from Expo West here:
NCT Web Site:
Important Videos on the above web site:
Meet Drs. Laibow and Goodman.
• 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.
“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.
New EU Cosmetics Dossier Service from NCT:

Vitamin Lawyer Connections…
Notice of Fee Increase: New rates: $340 standard and $285 discounted.
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f so, free is one of the easiest ways to contact me, no matter where I may be.

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Ralph Fucetola JD
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