Tuesday, June 16, 2015

Personal Importation / Antioxidant Claims / Cosmetic Dossiers...

June 16, 2015

Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List: Personal Importation  / Antioxidant Claims / Cosmetic Dossiers...

But first: With Rima Laibow MD, Jim Turner JD and Larry Becraft JD's help I just filed a formal Petition with FDA regarding Informed Consent. Read and support here:


[1] Personal Importation... wrote about that years ago here: http://www.lifespirit.org/perimport.html

Recently prepared a Certification Format for personal importation. That format is at the bottom of this email.

[2] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status...

So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware.

Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]:

"(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..."

Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around?

Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation:

"Supports Normal Antioxidant Function" -- SNAF.

Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help.

[3] If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products.

And... if so... have you considered marketing your natural cosmetic products in the European Union? The EU Cosmetic Dossier requirements are similar to the FDA's Section 740 safety dossier requirements.

These are special rules that easily let you do just that!

Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party Cosmetic Dossier services for you.

What is that?

Take a look at the short slide presentation here:


You will be pleasantly surprised.

[3] And remember that my full SOP Training Webinar System is available for your use: www.SOPcertification.com. Does your manufacturing facility need a Virtual Audit? More about that here: www.RegulatoryComplianceNetwork.com.

If you need me, you know how to reach me... 973.300.4594



Petition for Regulatory Discretion
Certification of Personal Importation Pursuant to
FDA RPM Ch. 9-71, Coverage of Personal Importation

[Name], [Address], [Phone], [eMail], as though sworn under Oath, states:

1.     I am a resident of [State] and a United States citizen.
2.     I was diagnosed by [Name], MD with [Medical Condition], Stage [#]. My treating physician is [Name], MD.
3.     I have researched my options and have made the Informed Consent decision to engage in a course of therapy with [Name], a remedy not available in the United States.
4.     I have personally ordered a 90 day supply of same for my personal use.
5.     The remedy is intended for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means, and it is not considered to represent an unreasonable risk.
6.     I am a person who has made my own arrangements for obtaining an unapproved drug from foreign sources.
7.     To the best of my knowledge this remedy has not been commercially promoted in the United States.
8.     I therefore request that FDA exercise discretion and permit this personal importation, Order No. ________________________.

I certify that the above statements made by me are true to the best of my knowledge and belief. I am aware I am subject to punishment as for perjury if any are willfully false.



[The Certification to be included by the Shipper in the shipment.]
Prepared by: Ralph Fucetola JD - www.vitaminconsultancy.com