Saturday, October 29, 2011

10/29/11 - Vitamin Lawyer Update eMemo - 10.29.2011

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

[1] Dr. Rima & Gen. Bert & I will be in L.A. & Houston Next Week
[2] Substantiating Product Claims through Patents & Other Methods
[3] Yes, You do Need Clinical Trials…

New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from us!

Please take a look at:

THIS JUST IN, LAST NIGHT... A Warning from Europe...
From a emailing today:  “Martin Last, the chairman of the UK Health Food Manufacturer’s Association (HFMA) reports that US companies need to get up to speed with the European Union’s Health Claim changes or face missed opportunities and BIG hits on existing trade.  During a natural health trade show interview in Las Vegas today, Last said that he came to the show to present to the American supplement manufacturers information on what’s really happening in Europe, particularly regarding the health claims of supplement promotion and advertising... We are now reaching the point now where the EU Directive’s drug-biased negative opinion regarding natural supplements will be incorporated into the new health claim laws and there is not much time left...”

[1] I'll be joining Dr. Rima & Gen. Bert at next week's meetings ...
Here's Your Chance to Meet With
Dr. Rima & Gen. Bert - In Person!
Join the Natural Solutions Foundation Trustees For Very Special Meetings in California and Texas, November 4-8, 2011.
The Fund for Natural Solutions, a tipping point program, is designed to provide your portfolio with a safe haven while putting your money to work for what YOU believe: clean, sustainable, empowering and profitable projects! As a qualified investor, we invite you to schedule a private meeting with us. Our first intended purchase is a Compounding Pharmacy that will position us for rapid positive growth.
The Fund's Form D was filed with SEC on October 20th and the Fund is now open for business! The Private Placement Memorandum is now available, upon request.
Strictly Limited Schedule so Reservations are Required: Make Your Reservations NOW!
Call 973-300-4594 for appointment or email us with "FUND" in the subject line.
Los Angeles November 4, 2011
- Hilton Woodland Hills/Los Angeles

Houston November 7, 8, 2011
- Woodlands Resort and Conference Center
Purpose: This is a Rare Opportunity for a Personal Meeting with all Foundation Trustees to Answer Your Questions and Get the Details You Need. Qualified Investors Are Invited to Meet With Foundation Trustees to Discuss their Participation in the Fund For Natural Solutions,

[2]  Substantiating Product Claims Through Patents & Other Methods
I thought I would give you all a hint about a new webinar I am putting together. This webinar will about the various methods available to substantiate claims about your natural, nutritional, cosmetic or other products...
This from a recent journal article:
“...where the Patent Office accepts certain research as cogent on a particular issue, that legal conclusion can be binding not only on the Patent Office, but also, thanks to a 1940 Supreme court case (Sunshine Anthracite Coal Co. v. Adkins), on the FTC.”

[3] 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."

Vitamin Lawyer Connections…
Notice of Fee Increase: 2011 Rates: $340 standard and $285 discounted.
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:
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.
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Ralph Fucetola JD
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