Tuesday, July 10, 2012

07/10/12 - FDA UDI- Universal Device ID System Coming

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

[0] FDA Universal Device ID System Coming
[1] FDA Guidance Regarding Adverse Event Reporting

[2] EU Cosmetic Dossiers
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!

[0] FDA “UDFI” Universal Device ID System Coming

From FDA News, July 9, 2012: “The Office of Management and Budget has approved the FDA's long-awaited universal device identifier (UDI) proposed rule, clearing it for release by the FDA. The FDA says the rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program….

“First proposed in the FDA Amendments Act of 2007, each UDI will include a device identifier, which encodes the device model, as well as a production identifier, which includes the device's batch or lot number and expiration date, if any.

“The proposed rule requires the UDI appear on labeling and packaging for almost all devices within one year of the final rule's implementation. They'll then be placed on devices themselves over the next several years... Class I and over-the-counter devices would be exempt. [My emphasis.]

The … requirement for UDIs on packaging is likely to kick in during the first half of 2014.

[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] 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!

[3] 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!

[4] Vitamin Lawyer Connections

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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