Thursday, December 10, 2009

12/10/09 - New FDA Liquid DS Guidance / Clinical Trial Meetings

0.  Blog & News – Holiday Message from Dr Rima and Gen Bert
1.  New FDA Dietary Supplement Guidance
2.  Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars

Blog & News – Rare opportunity to meet with Gen. Stubblebine and Dr. Laibow in the NYC metro area after New Year’s Day.

Private meetings with Dr. Laibow and Dr. Goodman and myself for Natural Clinical Trials are available on Monday, January 4th, in person or electronically. Please contact me at for details if your company is interested in discussing Clinical Tests, Studies and Trials.

For the Weekend Intensive (January 2nd and 3rd) see:
www .healthfreedomusa .org/?p=4183

Dr Laibow and Gen Stubblebine have a Holiday video message for you:  www .healthfreedomusa .org/?p=4157

Health Freedom's citizen lobbyist in Washington, Maury Silverman of the American Library for Health is seeking donations for his nonprofit institute. Donations will be tax deductible, and this is the Giving Season... Maury will volunteer to be your man in DC and provide you with useful information... great networker of information that creates progress (I can attest how useful he's been to our foundation and some of my clients). Donations: PO Box 7507 - Silver Springs MD 20907 [240-330-3420].

[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. New FDA Liquid Dietary Supplement Guidance

www .fda .gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm

This draft guidance is open for comments for 60 days. Thereafter FDA will finalize it and published it as an official guidance document in the Federal Register.

The draft version does suggest that FDA continues to ratchet-up the regulation of nutritional products. FDA says its purpose is: “to assist dietary supplement and beverage manufacturers and distributors in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement.” Since liquid DS products are becoming more popular, as I’ve been telling my clients for the past several years, this guidance will have a significant impact on the continuing development of the industry.

The key issue covered by the guidance is, “…factors that can be used to identify liquid products that are excluded from being dietary supplements because they are represented as conventional foods.” Thus the regulatory intent is to limit what products can be sold as dietary supplements.

That you intend to market a liquid DS may not matter to the FDA: “Beverages are conventional foods under the FFDCA.  Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement.  Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising.  For example, the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food.”

This what the FDA considers in making a determination as to what category the product fits: “name, packaging, serving size, and recommended conditions of use, as well as other representations…”

And this clause may be a key to the FDA’s position: “because of the use promoted in the claim, the product may no longer be consumed as a food -- primarily for taste, aroma, or nutritive value -- but rather as a drug for some other physiological effect.”

And what is the effect of being a beverage and not a DS? “…beverages and other conventional foods are required to bear nutrition information in the form of Nutrition Facts rather than Supplement Facts, and all ingredients in a beverage and other conventional food must be declared in the ingredient statement by their common and usual names, in descending order of predominance.  In addition, a beverage or other conventional food should not be labeled with the FDA disclaimer that is required on dietary supplement labels that bear structure/function claims…”

Bottom line: ALL liquid dietary supplement products should disclaim any intent to be a conventional beverage, or should conform to conventional food rules and not be presented as a DS product.

YES, the Vitamin Lawyer Consultancy is available to help you construct a proper disclaimer.


2.  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.

Dr. Laibow, Dr. Goodman and I are available for in-person or virtual conferences on Monday, January 4, 2010 to discuss Clinical Tests, Studies and Trials. Please email me ASAP if you have an interest in reserving time.


3. 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).


Natural Clinical Trials – www .NaturalClinicalTrials .org

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
$11.95 – 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: Correction and Prevention Analysis
Coming soon…

Ralph Fucetola JD
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) with “Unsubscribe” in the subject line.

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