Friday, November 23, 2012

11.23.12 - Vitamin Lawyer Certification Program



… Vitamin Lawyer.com Consultancy
Update eMemo –11.23.2012 


COMING -- JANUARY, 2013!
THE VITAMIN LAWYER REGULATORY COMPLIANCE CERTIFICATION PROGRAM!
But you can get a head start on your competitors... read on!


Natural Products Association (NPA) Confirms
That FDA Inspections will Reach ALL Label-Holders!

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

And as we approach the new year and its fiscal cliff, you need this information too: www.FundforNaturalSolutions.org

THE NATURAL PRODUCTS ASSOCIATION TELLS US WHAT
THE "HOT TOPICS" WILL BE THIS COMING YEAR!

"FDA Hot Topic: Developing compliant master manufacturing and batch production records. FDA Hot Topic: Qualifying your suppliers and other vendors and qualifying Certificates of Analyses (COAs) to allow for reduced testing of components. FDA Hot Topic: Conducting material reviews, appropriate handling of customer complaints, adequate documentation of related investigations, and resulting corrective actions. FDA Hot Topic: Establishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid methods, raw materials and finished product testing requirements, and change control..." http://npa.informz.net/NPA/archives/archive_1815037.html

WHAT ARE WE GOING TO DO ABOUT THAT?

I'm going to provide my 40 years experience, saving your company hundreds of thousands of dollars. I have three simple steps to regulatory compliance: 

PROCEDURE - Standard Operating Procedures and Good Manufacturing/Marketing Practices.
CLAIMS - Claims control, definition and substantiation...
                                                and the FDA required S & F Claims Notice.
TRAINING - It's not enough to have procedures says FDA:
               YOU have to train you team and prove they are qualified.

[Name Redacted] Wellness Company CEO “Alice”
“The FDA Agents said they’d be at our company for at least 6 days.
We showed them the SOPs Counsel Ralph prepared for us
and they were gone in about 2 days… no threats!!”

More from NPA:
The Pressure is on: "Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study released last week by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers.  A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.' Plus, another study by the HHS OIG reviewed labels for the required adverse event contact information and found that a shocking '20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.'"
http://npa.informz.net/NPA/archives/archive_1869633.html
Look for the Vitamin Lawyer Regulatory Compliance Certification Program...

Last issue of the Update eMemo told you about the FDA inspection last month of one of the Vitamin Lawyer Consultancy clients. I was on the phone with that client several times a day, over the course of the inspection. They were ready. Are YOU?

Now, the Natural Products Association confirms what I told you. In a special email broadcast, the NPA notified its members, which include all the largest vitamin companies --

FDA is Taking Inspections to the Next Level—Are You Ready?

FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.”

There is no logical alternative to getting ready NOW.

YOUR PAPERS MUST BE IN ORDER.


I can provide you with the formats needed to meet the new standards and guide you to “tweak” and implement them. This includes -
[1] the all-important, updated SOPs format for you to "tweak" for your company,
[2] the critical clauses to include in your Manufacturer’s standard contract form and
[3] the Structure and Function Claims Notice format.
ONCE YOUR PAPERS ARE IN ORDER,
I CAN CONDUCT A TRAINING WEBINAR
FOR YOUR COMPANY 
AND CERTIFY
YOUR COMPLIANCE FOR FDA REGULATION.
(Extra Charge for Webianr.)
eMAIL ME AT; ralph.fucetola@usa.net
WITH 'SOP' IN THE SUBJECT LINE!
TO SET UP YOUR SPECIAL DISCOUNT TIME! 


Vitamin Lawyer Connections
Yes, you do need clinical trials! Further Services You Need!

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 $25,000.

www.NaturalClinicalTrials.net

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!

Special 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.

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

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.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com –
Airing on: www.telostv.com

Follow me on Twitter - www.twitter.com/healthfreedomus

THESE UPDATE MEMOS NOW ARCHIVED AT:
http://vitaminlawyerarchives.blogspot.com/

ralph …

Ralph Fucetola JDwww.FundforNaturalSolutions.org
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com
www.HealthFreedomPortal.org

I had to rebuild my Vitamin Lawyer email list and have taken every precaution
to include only people who I believe want to opt-in. If you did not want to receive this emai,
please just email me at ralph.fucetola@usa.net with "delete from list" in the subject line.
I apologize for any inconvenience.

Friday, September 7, 2012

09.05.12 - What Happens When The FDA Inspects: A Case Study


… Vitamin Lawyer.com Consultancy
Update eMemo – 9.05.2012

What Happens When The FDA Inspects: A Case Study
Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
[1] Vitamin Lawyer Update eMemo Archives Updated!
[2] A VITAMIN LAWYER CLIENT WAS JUST INSPECTED BY THE FDA
[3] Yes, You do Need Clinical Trials…
[4] Vitamin Lawyer Connections: All the Links You Need!
--------------------------
[1] Vitamin Lawyer Update eMemo Archive Updated!
            I confess I outsourced finally bringing the Vitamin Lawyer Update eMemo Archives up to date. Over the next couple weeks you will find more of the past memos posted as blogs at: http://vitaminlawyerarchives.blogspot.com/ . Bookmark this page! The entries will be indexed for ease of searching.

[2] What Happened Last Week when a VL Client was Inspected by the FDA


At first, the FDA agents announced the inspection would probably take six days… then the Vitamin Lawyer-drafted SOPs (Standard Operating Procedures) documentation was provided to the agents. Two days later (four days less than predicted) the agents left, more satisfied than not. Just 5 minor Observations were issued, requiring changes in the SOP. This client’s experience will benefit all, as I have now updated the SOPs to cover the observations and to make other changes that will strengthen the process when other Vitamin Lawyer clients are inspected; as all will be, more regularly than in the past.

Observation 1:  To have documented qualifications of contract manufacturers and to institute a process to receive documentation from the manufacturer that each lot is approved prior to release.
Observation 2:  Document a quality control person in charge and to have written procedures for quality control responsibilities.
Observation 3:  Document procedures for holding and distributing operations in the proper environment and organizational procedures to prevent error or contamination.
Observation 4:  Develop an employee training manual and document training of employees.
Observation 5:  Document established procedures and operations to conduct when a product is returned and keeping records of returned products.

These changes are documented in revisions to the Standard Operating Procedures (SOPs). A specific Contract Manufacturing Agreement has also been developed, meeting GMP requirements. Vitamin Lawyer monthly retainer clients will receive the updated SOPs. Any others who have not yet completed their SOPs are reminded that “having one’s papers in order” is more necessary now than ever before.





[3] 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 pastt 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!

[4] 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.
Trailer:
www.youtube.com/watch?v=wWPvzpn0YgA
www.powerpicturesllc.com – Airing on: www.telostv.com
Follow me on Twitter - www.twitter.com/healthfreedomus 
ralph …
Ralph Fucetola JD
Click here to unsubscribe from the Health Freedom Action eAlerts: 
http://www.demaction.org/dia/organizations/healthfreedomusa/unsubscribe.jsp
We respect your right to privacy. View our policy.

Thursday, August 16, 2012

08/16/12 - Daily Value and “Excellent Source” Claims; Your PAD App!


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

[1] Daily Value and “Excellent Source” Claims
[2] Yes, You do Need Clinical Trials…

[3] EU Cosmetics Dossier
[4] Vitamin Lawyer Connections: All the Links You Need!
--------------------------

[1] Daily Value and Excellent Source Claims
 

States FDA in one warning letter: 
 
“Nutrient content claims that use the defined terms “rich in,” “excellent source,” or “high,” (“superb source” is an unauthorized synonym for “excellent source”) may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)].  Such claims may not be made about a nutrient for which there is no established DV…”

 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm239410.htm

 





[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 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.
Trailer:
www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com – Airing on: www.telostv.com
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

Click here to unsubscribe from the Health Freedom Action eAlerts: http://www.demaction.org/dia/organizations/healthfreedomusa/unsubscribe.jsp
We respect your right to privacy. View our policy.