Tuesday, June 19, 2012

06/19/12 - FDA Estimates Regarding Dietary Supplement Companies

Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
[0] FDA Estimates of Size of Dietary Supplement Industry in the USA
[1] FDA Guidance Regarding Adverse Event Reporting
[2] Roehr’s Patented Medical Food & Dietary Supplement Delivery System
[3] Moving Nutrition into the Social Media: NutraSpace and the Fund
[4] Yes, You do Need Clinical Trials…
[5] Vitamin Lawyer Connections: All the Links You Need!

[0] FDA Estimates of Size of Dietary Supplement Industry in the USA

June 14, 2012: “Based on the A.C. Nielsen Sales Scanner Data, FDA estimated that the number of dietary supplement SKUs for which sales of the products are greater than zero is 55,600. Assuming that the flow of new products is 10 percent per year, then approximately 5,560 new dietary supplement products will come on the market each year. FDA also estimates that there are about 1,460 dietary supplement manufacturers, re- packagers, re-labelers, and holders of dietary supplements. Assuming the approximately 5,560 new products are split equally among the firms, then each firm would prepare labels for close to four new products per year (5,560 new products/1,460 firms is approximately 3.8 labels per firm). Thus, the estimated total annual disclosures are 5,560 (1,460 firms × 3.8 labels per year = 5,560).” - http://www.gpo.gov/fdsys/pkg/FR-2012-06-14/pdf/2012-14487.pdf

“All 1,600 dietary supplement manufacturers, packers, or distributors, are subject to serious adverse event mandatory recordkeeping, thus FDA estimates that there are a total of 1,600 record keepers. FDA further estimates that each record keeper will keep approximately 74 records per year, for a total of 118,400 records. The Agency estimates that assembling and filing these records, including any necessary photocopying, will take approximately 30 minutes, or 0.5 hours, per record. Therefore, 118,400 records x 0.50 hours = 59,200 total hours. FDA bases its estimates on its experience with similar adverse event reporting programs.” http://www.gpo.gov/fdsys/pkg/FR-2012-05-29/html/2012-12878.htm

[1] FDA Guidance Regarding Adverse Event Reporting

FDA has issued an updated guidance on adverse event reporting. The Vitamin Lawyer Consultancy includes standard procedures for AER processing in the Standard Operating Procedures (SOPs) document available from this office. Just email ralph.fucetola@usa.net with “SOP” in the subject line to start the process. I estimate an hour to set up your SOPs and a couple hours to fine-tune them to your actual operations.

Guidance Summary: "the guidance recommends that the responsible person keep the following other records:

(1) Communications between the responsible person and the initial reporter
of the adverse event and between the responsible person and any other person(s) who provided information about the adverse event,

(2) the responsible person's serious adverse event report to FDA with attachments,

(3) any new information about the adverse event received by the responsible person,

(4) any reports to FDA of new information related to the serious
adverse event report."


[2] Roehr’s Patented Medical Food & Dietary Supplement Delivery System
Opportunities for Pharmacies, Physicians, Clinics and other Health Care Providers. The patented Bio-G Micro Tab Nutrient Delivery System for Dietary Supplements and Medical Foods. Compounding Pharmacies, Physicians and Nutritionists collaborating for optimal outcomes.
BioG-MicroTabs are tablets compressed with
custom made precision tools “Made in Germany”

   Every BioG-MicroTab is exactly 2 mm

  in diameter and height.    
Every BioG-MicroTab contains an exact 
amount of the active ingredients and has, including 
  exipients, the same weight of 7mg. 

Every BioG-MicroTab complies with the requirements of Ph.Eur and with United States FDA requirements for Dietary Supplements and Medical Foods.
Learn more about this patented microtab delivery system from Germany here:http://biog-microtabs.weebly.com

[3] Moving Nutrition into the Social Media: NutraSpace and the Fund

Introducing NutraSpace Social Network and Search Platform Serving
Health, Nutrition and CAM
This week I am pleased to bring to your attention NutraSpace, a major Internet initiative that could change the face of the nutrition industry on the world wide web.  NutraSpace is an integrated platform serving the health, nutrition, and complementary/ alternative medicine (CAM) marketplace with its own social network, search engine, real-time news aggregation, mobile applications and agent–based digital assistant services.  What Google, Facebook, WebMD and the Drudge Report provide for their users, NutraSpace customizes and tailors to the needs and requirements of the health and wellness space.  CNN has reported that “83% of Internet users have looked online for health information”.   Currently there is no health and wellness Internet search engine other than the NutraSpace search engine which was developed over a five year period.  The NutraSpace team includes the President of the American College of Nutrition and the President of the Certification Board for Nutrition Specialists.  The Chairman of the company is Dr. H. Reginald McDaniel, a medical doctor who has for some 25 years championed the cause of integrative medicine and nutritional supplementation.  
The Company launched its web platform in October 2011 and will be launching Android and iPhone applications with NutraSearch and NutraFlash, its flagship applications, this month.  The Company has raised some $700,000 and is, I understand, currently engaged in another round of financing.  NutraSpace depends on the health and wellness community to make its presence felt in the larger business environment.  After the role played by Facebook and Twitter in the change of governments in the Middle East, no one can underestimate the impact of social media.  Please support NutraSpace in any way you can particularly by spreading the word on the platform and creating your own space on it. For more information on NutraSpace, please contact me or the company itself at rvarghese@nutraspace.com.
As a Trustee of the Natural Solutions Foundation, I am particularly pleased with the NutraSpace technology which we have deployed under an OEM license to create the Free World Network and FreedomFLASH! – health and food freedom’s version of the NutraSpace platform. You can see that implementation of the platform here: www.FreeWorldNetwork.org
The NutraSpace platform provides:
  • NutraSearch, a proprietary search engine for those who wish to crawl the web for information on health in general, specific diseases, natural and nutritional remedies, quality of life improvement;
  • A social network for those who share a common interest in health challenges, preventive health, nutrition and alternative medicine;
  • A digital library of peer-reviewed data on herbs, vitamins, minerals and nutrients addressing various health conditions along with blogs from noted scientists, doctors and researchers;
  • NutraFlash, a news aggregation engine that serves up in near real-time the latest health news from traditional, nutraceutical and social media (including Twitter, Facebook and YouTube);
  • And forthcoming features:
    • The only application of agent technology in the health
    • A nutrition scoring system for foods and beverages
    • Mobile Applications for the Android and Apple iOS platforms (April 2012)

So, what is the bottom line? What is NutraSpace looking for from
Answer: support from the natural products and nutrition industry; support from the Advanced Health Care Practitioners…

How can you do that?
  1. Invest in the our SEC-filed private equity fund, the Fund for Natural Solutions – www.FundforNaturalSolutions.org – the Fund is already an investor in NutraSpace, LLC (ask me for the Private Placement Memorandum; no offer is made except through the PPM).
  2. Help NutraSpace directly (contact Roy and let him know The Vitamin Lawyer sent you!)
  3. Use and promote the use of the NutraSpace and FreeWorldNetwork communities.

Our FreeWorldNetwork focuses on Health & Food Freedom & Justice while the NutraSpace platform focuses on nutritional and health information and communication.
Together, we shall change the world… with passion, perfection and profitability!

I urge you to call is Virtually Local.  Virtually Local, a premier Internet Marketing business, is owned and operated by Lynda Leibowitz.  She is also the author of “Lynda A Leibowitz’s Guide To Marketing Your Business: Harness the Power of the Internet to Boost Your Profits”.*  Visit Virtually Local today or call (973) 498-8497. Direct URL: http://www.virtually-local.com
*Now being sold on Amazon.com

[4] Yes, you do need clinical trials! Further Services You Need!
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. The 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!

New Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from NCT! Please take a look at our new Webinar linked from this web page: http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php.
Announcement: For information about the SEC-filed Fund for Natural Solutions: wwwFundforNaturalSolutions.org (offering only by Private Placement Memorandum, available upon request: just email me at ralph.fucetola@usa.net with “Fund” in the subject line). Our first proposed investment: an off-shore (Panama/Hong Kong) compounding pharmacy. Doing good while doing well… think about the possibilities!

[5] Vitamin Lawyer Connections
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…
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.
www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesinc.net/store.html
Follow me on Twitter - www.twitter.com/healthfreedomus  
ralph …
Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
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