Thursday, July 8, 2010

07/08/10 - Your Products “Core Data Sheet”

0.  Blogs & News
1.  The Company Core Data Sheet - CCDS
2.  SPECIAL: Private Vitamin Lawyer Ad Copy Webinar!
3.  Natural Clinical Trials Center
4.  Archived Vitamin Lawyer Webinars
5.  Vitamin Lawyer connections…

0. Blogs & News –

Recent issues of this Memo have covered such topics as Trends in FDA Warning Letters; the new FTC testimonial Rule, final cGMP June 2010 effective date and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Dr. Rima’s video reports from the Codex Commission meeting happening right now…
www .healthfreedomusa .org/?p=5821

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

www .DrRima .net -- Dr. Rima Recommends: new web site with information regarding the Dr. Rima Institute Wellness Center that is expected to open in Panama at the end of June.

And the latest from the Vitamin Wars: Is President Obama’s New “Preventative Health” Executive Order just another effort to impose Codex?
www. healthfreedomusa .org/?p=5604

[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. Your Product “Company Core Data Sheet”

The CCDS is your prime reference document for each product you market. It is one of the central documents employees, regulators and resellers rely regarding the labeling and management of the product.

I’ve always recommended to clients that they have a Standard Operating Procedures (SOPs) document that, ideally, is detailed enough so that the company proprietor can, for example, go on vacation secure in the knowledge that much of the information any employee might need is readily available. The CCDS is part of that system, and included in the Product Substantiation Notebook that I recommend as part of the SOPs.

The PSN includes a section for each product, with copies of the CCDS, the product label, the product sales sheet, a copy of the Structure and Function Claims Notice(s) filed with the FDA, and substantiation notes including peer reviewed journal article abstracts and professional reports (such as clinical trial results). The CCDS is a summary sheet for each product.

My SOPs information page: http:// tinyurl .com/2eu6yj

What does a CCDS usually include? Benefits claims; serving sized and requirements; directions for use; concerns of special consumer populations; packaging and storage requirements and limitations; safety information (including allergen and other warnings, disclosures and disclaimers.

Companies should update each CCDS to reflect the product's evolution. New benefit claims, serving and direction changes, changes in handling procedures, safety concerns: all should be added in on a regular basis.

Points to consider:

   * How frequently should a CCDS to be updated?
   * How early in the product development process do you need to formalize the CCDS?
   * At what point should safety issues (allergens, for example) be addressed in the CCDS
   * If only one country's regulators require a labeling change, must the CCDS reflect same?
   * Who in the company should approve updates and revisions to the CCDS?
   * What provision should be included in the SOPs describing creating and maintaining CCDS?

The CCDS is part of the larger issue of SOPs… are your papers in order?


2.  New Vitamin Lawyer Ad Copy Webinar – Private for Your Company, via Internet…

I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.

Webinar covers:

DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources

Sample: Slide #4

“Dietary Supplement products are governed by a complex of statutes and regulations.  The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA).  This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA).  DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.
In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”


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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