Tuesday, February 16, 2010

02/16/10 - FDA Warning Letters; Product Expiration Dates

1.  FDA Warning Letter Trends
2.  Product Expiration Dates
3.  Natural Clinical Trials Center
4.  New Webinar on Copy Writing Planned
5.  Archived Vitamin Lawyer Webinars

Blog & News –

You’ve heard about the “Stop the Shot” lawsuit aimed at de-licensing the H1N1 and other “seasonal” flu vaccines. We were in Court in DC in November, and New York backed off its health care workers’ mandate, leaving us without legal "standing" to challenge the vaccine licenses. Then we were heading back to Court in December, but New Jersey backed off its licensed child care mandate… As the Judge said, “Your clients are winning…” but we still did not have “standing” to challenge the FDA’s illegal approvals of the flu vaccines!

The November Case: Lawyers Video Report
www .healthfreedomusa .org/?p=3933

The NJ Case: www .healthfreedomusa .org/?p=3970

WELL, WE ARE READY TO GO BACK TO COURT – with new mandated clients -- however, this time we are not “telegraphing our punches” by announcing our clients in advance! Last night I emailed the 13 documents, two of them over 30 pages each, which will make up the initial filing, to our lawyers in DC who will actually file the case.

IT’S TIME TO FUND THE “STOP THE SHOT” LITIGATION. I don’t think I need to dwell on the importance of “putting down” Big Pharma’s vaccine gambit to the natural products industry.

The H1N1 vaccines is the perfect example of Obamacare in action: the govt bought $6.4 billion of vaccines, then the govt (FDA) approved the vaccines (we say, “Illegally!”) then the govt (CDC) recommended the vaccines and then the govt (HHS) distributed them… all without following their own drug approval rules.

This type of litigation is expensive. So far it’s been mostly done with volunteer work, but now the lawyers in DC need some funding to cover the cost of their associate who is actually doing the leg work. We also need to cover the filing fees. Natural Solutions covered the filing fees in November. Our ally Gary Null is covering his lawyer’s costs. WE NEED YOUR HELP TO COVER THE DC LAWYERS.

IF YOU ARE WILLING TO DONATE FOR THIS PURPOSE, please call me or email me immediately. We need to talk. Even donations as little as $100 will help; a couple $1,000 donations would go a long way. But, the total cost of this case could be a hundred grand or more.

‘Nough said. Anyone out there willing to make this happen? I promise you, it will be money well invested. 973.300.4594

Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net

Dr. Rima Recommends: new web site
www .DrRima .net

More Madness from DC: McCain attacks Dietary Supplements
While Harkin attacks Foods… all under the guise of “safety…”
www .healthfreedomusa .org/?p=4683

And this on the Vitamin Lawyer blog:
vitaminlawyerhealthfreedom.blogspot .com/2010/02/fake-food-and-supplement-safety-bills.html

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]

1. An Analysis of Warning Letter Trends [from: FDA News]

“With the FDA issuing warning letters at the rate of one-and-a-half per day in 2009 — a 23% increase over 2008 — now isn't the time to face the FDA unprepared!

“FDA [News]… has analyzed data from FDA warning letters to better understand what problems the FDA most often cites. [We] found FDA inspectors focusing on the following six themes in their inspections:

# International Harmonization
# Supplier Management
# Postapproval Controls
# Records Controls
# Swifter Enforcement …

“Manufacturing and Quality. Production record review and quality laboratory controls topped the list of citations addressed by warning letters, but five other key areas were also cited in more than 25 percent of quality-related warning letters.

“Advertising and Marketing. FDA more than doubled the number of advertising-related warning letters it produced last year, and the agency is promising there will be no letup in the intensity of its enforcement.

“Clinical Trials. Clinical trial regulations were the subject of more than 20 warning letters in 2009. Investigators were cited for inadequate informed consent and failing to take case histories; IRBs were cited for failing to document their actions and maintain adequate policies; and sponsors were faulted for failure to fulfill general responsibilities and stop out-of-compliance investigators.”
2. Product Expiration Dates

As you may be aware from previous issues of the Vitamin Lawyer Update eMemo, the FDA does NOT require dietary supplement manufacturers to put an “expiration” or “best used by” date on product packaging. It does require, however, if you do so, you must have “competent and reliable” substantiation for that date! With the cGMP requirement that your manufacturer keep product samples from each batch, over time, you may develop such substantiation.

But what to do in the mean time? I suggest you remove any such dating from bottles. One client decided to sell “expired” product at discount and asked for my suggestion for a FAQ on the subject. Here is what I suggested:

“Some of our customers have asked us about "expiration dates" on dietary supplement bottles.  It was traditional in the vitamin industry to include "expiration" or "best to use by" dates on bottles, since dietary supplements are foods and food product packing often has expiration dates.

“The Food and Drug Administration (FDA) does NOT require such dating for dietary supplements, and, under the FDA's revised "Good Manufacturing Procedures" such dating is NOT permitted unless there is some good, scientific reason to have an expiration date. We are therefore removing unnecessary dating on our products to conform to current practices.

“Some of our product labels still contain such dating and where the dating has "expired" but without any indication of actual need for such dating, we are offering the products at discount. Should you receive a product with an "expired" date and do not want to use the product, please return it within 30 days of receipt for a full refund.”


3.  Natural Clinical Trials Center

Check out the Videos and PPT Webinar on the Site!

www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.


4.  New Natural Solutions Webinar Planned – Coming this March

“Writing Lawful Natural Products Ad Copy”
Details will be posted at:

www .NaturalHealthOptions .net
www .NaturalClinicalTrials org

If you want to reserve space for this Webinar, please email me at ralph.fucetola (at) usa.net and put “Webinar” in the Subject line. The expected price for the 2 hour event is $99.

5. Archived Natural Solutions Vital Connection Webinars with the Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).


Our new affiliation site: www .naturalhealthoptions .com
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. powerpicturesinc. net/store.html

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

The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj

Current SOP Project: CAPA
Corrective and Preventative Actions Standard Operating Procedures

CAPA is an essential element in cGMP SOPs.
Outline below; let me know if you need a formal SOP.

Main Headings of the CAPA SOP

Discovery of the Deviation
Documentation of the Event
Immediate Corrective Action
Investigation of the Primary Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation

Current Webinar Project: Writing Lawful Ad Copy (March)

Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

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