Friday, March 16, 2007

03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked


1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online Outlines Available
3. Health Freedom Site Attacked


Say your company needs a "DSHEA compliance" letter from The Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.

Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).

The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:

"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."

Here is access to the FDA guidance: Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.



SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents -

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at:



The websites of the Natural Solutions Foundation - and – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at:

Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”

As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.

Ralph Fucetola JD

* The Foundation can receive donations through PayPal, however.
You can PayPal to and the donation will go directly to the Foundation.

Also, do see Nutricide, now on YouTube at:

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