Thursday, May 27, 2010

05/27/10 - FDA Warning Letters; cGMPs effective next month…

0.  Blogs & NewscGMPs fully effective this June 25th
1.  FDA Warning Letters as cGMPs become effective
2.  Micronutrients and Aging
3.  Natural Clinical Trials Center
4.  Archived Vitamin Lawyer Webinars
5.  Vitamin Lawyer connections…

0. Blogs & News –
It is time for you to make sure your Standard Operating Procedures (SOPs) are in order! The full panoply of current Good Manufacturing (and Marketing!) Procedures (cGMPs) go into effect for all Dietary Supplement companies of no matter what size this June. http://  tinyurl  .com/2eu6yj

Report from DC: A brief YouTube video…
RF on Health Freedom Actions needed now:
www .youtube .com/naturalsolutions#p/f/0/UoZ-j0_8v1s

Recent issues of this Memo have covered such topics as Recent Trends in FDA Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding “expiration” dates and “best if used by” dates.

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

Dr. Rima Recommends: new web site with information regarding the Wellness Center that Dr. Rima E. Laibow MD is opening in Panama at the end of May: www .DrRima .net – I will be in Panama for the Grand Opening (the Provincial Governor is cutting the ribbon) for the event. If anyone wants to travel to Panama for a week and see the Valley of the Moon, a small party of interested people will be joining me for the trip; please let me know if you are interested ASAP

[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. FDA Warning Letters

www .functionalingredientsmag. com/article/NorthSouth-America/fda-inspectors-hone-in-on-gmp-documentation.aspx

May 25, 2010 - FDA inspectors hone in on GMP documentation
By Hank Schultz

“As D-day approaches for the final round of GMP compliance, a preliminary review of what inspectors have found so far gives small-tier companies an insight of what to expect.

Paper. Inspectors are going to want to see lots of it, in the form of master manufacturing plans, standard operating procedures, and records of all sorts.

‘FDA takes a risk-approached approach. What are the areas of risk right now for FDA? Let's look at (contamination), and that the products are made as they are written up to be made, and that there aren't accidental overages that could potentially raise a red flag,’ said Daniel Fabricant, scientific affairs vice president for the Natural Products Association.

‘White mounds of paper,’ Fabricant said. ‘If you don't write it down, it didn't happen.’

On June 25, the third and final phase of tougher GMP rules goes into effect. Those companies with 20 or fewer employees must be in full compliance with the Food and Drug Administration guidelines…

FDA officials began inspections of larger-sized companies in 2008, and the number of inspections is increasing every year. The agency completed 12 inspections in fiscal year 2008, 28 in fiscal year 2009, and is doing many more now…

"Quite honestly, some of the smaller and medium firms are not there yet,’ said Carl Reynolds, senior advisor in the Division of Dietary Supplement Programs at FDA's Center for Food Safety and Applied Nutrition….

[About SOPs] ‘How do you control that document?’ Caplette said. ‘Is there a revision number? Is there a date to it?’ …

‘Whatever your documentation is, it is finite. It has beginning, a middle and an end,’ said Michael McGuffin, CEO of the American Herbal Products Association. ‘Whatever (the documentation requirements are), you can get there. Once you're there, it's more of a headache than an obstacle.’

The FDA generates documents of its own in the inspection process, including a 483 letter detailing the shortfalls they found. Companies can expect to get one of these.

‘It's very, very rare for an inspectors to come into a facility and spent six to ten days there and say, 'Gee, that was perfect,'’ McGuffin said.

‘We don't see the fact that companies are likely to receive a 483 [deficiency notice] as evidence of failure. The failure would be if you can't fix what's on the 483,’ he said. …


2.  Micronutrients and Aging

Bruce Ames: Vitamin insufficiency boosting age-related diseases
www .nutraingredients. com/content/view/print/276676

In an exclusive interview with Stephen Daniells, Professor Bruce Ames from the University of California, Berkeley explains why his “triage theory” could have enormous implications for human health.

For many, Professor Ames needs no introduction. In the 1970s, he invented the Ames Test, a simple and inexpensive assay to check the mutagenicity of compounds. Since then he has dedicated his research to understanding the biochemistry of ageing, with a focus on mitochondria, the power plants of our cells, as well as how micronutrients may prevent disease, malnutrition, and obesity.

So, when the native New Yorker with over 450 scientific publications tells you his triage theory is “the most important thing I have ever worked on”, you sit up and listen.

Evolutionary mechanisms

Triage – from the French word trier meaning to sort, separate, or select – works on the battlefield by military doctors prioritising treatments depending on the probable survival of the wounded.

Prof Ames’ theory works in much the same way: By appreciating that natural selection favours short-term survival over the long-term, Prof Ames’ hypothesised that our short-term survival is achieved by prioritising the allocation of scarce micronutrients. In other words, to stop us falling over from a lack of iron in the heart, for example, iron is pulled from non-essential sources.

The triage theory is a way of “measuring the insidious damage going on over time”, he said.

The theory was first proposed in 2006 (PNAS, Vol. 103, Pages 17589-94) to explain why age-related diseases like heart disease, cancer, and dementia may be unintended consequences of mechanisms developed during evolution to protect against episodic vitamin/mineral shortages.

“If this hypothesis is correct, micronutrient deficiencies that trigger the triage response would accelerate cancer, aging, and neural decay but would leave critical metabolic functions, such as ATP production, intact,” explained Prof Ames in the Proceedings of the National Academy of Sciences...

While the finances may be the lacking, scientific support is not. Working with the “very good” Joyce McCann, PhD, Prof Ames recently applied his theory to vitamin K. Writing in the American Journal of Clinical Nutrition (Vol. 90, pp. 889-907), they reported that five of the 16 known vitamin K-dependent proteins are required for coagulation had critical functions, meaning that animals genetically manipulated to have inactive forms did not survive.

On the other hand, another five proteins were found to be less critical, and the animals survived through weaning. However, a lack of these less critical vitamin K-dependent proteins, inadequate intakes of vitamin K1 from the diet, or vitamin K deficiency were all associated with age-related conditions, including weaker bones and hardening of the arteries, which increased the risk of cardiovascular disease. An increase in the incidence of spontaneous cancer was also observed...

Triage theory has cleared every hurdle it has come up against, but that doesn’t surprise Prof Ames.

“My triage theory makes sense,” he said. “And it is almost certainly going to be right.”

3.  Natural Clinical Trials Center

Update: NCT now has a relationship with a National University that is very interested
in "breaking into" the nutrient clinical study market -- this is an opportunity to benefit from a university-level study at modest price. Obviously, the cost will be greater than the cost of a private clinical study at Dr. Rima's clinic, but, with our special relationship, we can keep the
costs down to a reasonable and affordable level. And, of course, you will have the assurance that the professionals at NCT are keeping close watch on the protocol and progress of the university study. The Natural Solutions Center in Volcan, Panama is expected to be opened by the end of May, so Clinical Trials can begin shortly thereafter. 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. 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:

[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).


5. Vitamin Lawyer Connections…

Do you Skype? If so, free 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. powerpicturesinc. net/store.html

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


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

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

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