Tuesday, June 24, 2008

06/24/08 - FDA "Cancer Cure" Warning Letters

 
Vitamin Lawyer Update Memo: June 24, 2008

This issue:

0. Blog and Important News Notes
1. FDA Warning Letters – “Cancer Cures”
2. 97% of Nutrient and Health Claims Rejected in Europe!
3. Pharma Lobby Spends a Billion in a Decade…
4. Professional Practice Record Keeping SOP Available
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0. VL Blog and News Notes

Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org

The Valley of the Moon Eco Community – For those of you who are considering investing, retiring or relocating off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation.

Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. FDA Warning Letters – “Cancer Cures”

“The US Food and Drug Administration sent warning letters to 23 American companies and two foreign individuals for allegedly marketing a range of products fraudulently claimed to prevent and cure cancer… it had also warned North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, all sold under various names on the internet… contain[ing] ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.”

FDA says the following claims are “fraudulent:”
• "Treats all forms of cancer"
• "Causes cancer cells to commit suicide!"
• "80% more effective than the world's number one cancer drug"
• "Skin cancers disappear"
• "Target cancer cells while leaving healthy cells alone"
• "Shrinks malignant tumors"
• "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"

functionalingredientsmag. com/fimag/articleDisplay.asp?strArticleId=1771&strSite=FFNSite
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2. 97% of Nutrient and Health Claims Rejected in Europe
“23-Jun-2008 - The European Commission has culled its gargantuan nutrition and health claims list from more than 40,000 to 1500 as the health claims process moves closer to fruition in January, 2010. … [Some claims] were deemed inappropriate for want of supporting data or were making claims about foods or food supplements that were not legally available in the EU… The nutrition and health claims regulation was enacted last year and seeks to harmonize claims across the … EU's 27 member states…”

foodnavigator. com/news/ng.asp?n=86073&c=gbrnO2ewSG3%2BoFrFccmRkw%3D%3D
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3. Pharma Lobby Spends a Billion in a Decade…

Investigative report on the Public Integrity web site says Big Pharma spent more in 2007 ($186,000,000 – right, that’s nearly two hundred million dollars!) than in any previous year, but the past ten year total is approaching a billion dollars… all to convince Congress that this industry’s often dangerous products are… good for us?

publicintegrity. org/rx/report.aspx?aid=985
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4. Professional Practice SOPs

The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

Friday, June 6, 2008

06/06/08 - Weight Control Supplements Attacked

 
Vitamin Lawyer Update Memo: June 6, 2008

This issue:
1. US and Japan Forming Health Food Alliance
2. Weight Control Dietary Supplements Under Attack
3. Professional Practice Record Keeping SOP Available
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Blog Update: NY to Mandate Forced Vaccine Pharma Profits
http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org

And for those of you who are considering relocating some or all of your activities off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this planned zero emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability.

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]

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1. US and Japan forming health food alliance

06-Jun-2008 (by Neil Merrett – “Two leading US nutrition groups are teaming up with a Japanese counterpart to combine their knowledge in a bid to meet both the domestic and international challenges facing the industry. … The Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the National Nutritional Foods Association of Japan (NNFA-J) yesterday agreed to work together to better deal with regulatory and research issues… ‘Emerging research is increasingly supporting the safety and benefits of supplements for maintaining good health and reducing the risk of chronic diseases," he stated. "Regulatory approaches in both countries should likewise reflect good science to help consumers make healthy decisions.’”

www. nutraingredients-usa. com/news/ng.asp?n=85762&c=gbrnO2ewSG3bTjEYx%2BWZAA%3D%3D

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2. Weight Control Dietary Supplements Under Attack

Dietary Supplements that support normal weight have been under increasing attack by both government and special interests. Even well-known weight loss brands such as TrimSpa® are failing (its parent company recently filed for bankruptcy).

Recently it seems that GlaxoSmithKline (GSK) will stop at nothing to rub out the competition when it comes to weight loss supplements. (No matter what your opinion is on weight loss supplements, this issue affects the vitamin industry as a whole.) GSK has petitioned FDA to classify all over-the-counter weight loss supplements as unapproved “drugs.” This means that mere overweight would be classified as a “disease” (as “obesity” is currently classified).

Furthermore, GSK hopes to remove any weight loss claims from dietary supplements. It should be noted that there is currently only one over-the-counter weight loss product with FDA approval: GSK’s alli®.

If FDA starts reclassifying normal conditions of life as “diseases” to protect the Pharmaceutical Industry, we may well see more dietary supplements threatened.
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3. Professional Practice SOPs

The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

Contains the following topics:

1. Maintaining copies of all paid invoices
2. Maintaining regular back-up copies of client database.
3. Maintaining copies product ordered for resale records
4. Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com