… 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?
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.
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.'"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 -
 the all-important, updated SOPs format for you to "tweak" for your company,
 the critical clauses to include in your Manufacturer’s standard contract form and
 the Structure and Function Claims Notice format.
FOR YOUR COMPANY AND CERTIFY
YOUR COMPLIANCE FOR FDA REGULATION.
WITH 'SOP' IN THE SUBJECT LINE!
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.
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:
Ralph Fucetola JDwww.FundforNaturalSolutions.org
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com
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