Monday, February 22, 2010

Are "Rife Devices" Grandfathered?

Ralph Fucetola JD
The Vitamin Consultancy

February 21, 2010

Declaration of Ralph Fucetola JD

Ralph Fucetola JD declares under penalty of perjury pursuant to 28 U.S.C. 1746 that the following information is true to best of my knowledge and belief and that if called to testify in this matter I could testify competently to these facts.

The following is my research opinion review of the United States vs James Folsom and the matters that should be considered in sentencing or re-sentencing.

The first serious question that must be asked if a fair and reasonable sentence is to be imposed in this case is, ‘Is there a hidden motive why the FDA denies the existence of any predicate Rife type device?’ That is, a Rife device that will qualify frequency devices for “significantly equivalent frequency device” status under the “grandfather clause” of the May 28, 1976 Congressional – Cosmetic, Food and Drug (Devices) Act (1976 CCFD Act)?

From my review of the trial information, it appears that the primary FDA Agent testifying for the Government’s case during the Folsom trial denied that such a device exists. Interestingly, while this denial was/is going on, and as a corner-stone of the Prosecution’s “closing rebuttal” was trial photo Exhibit # 600 revealing such a predicate – 1976 ‘grandfather clause’ device. The Prosecutor certainly did not know what was revealed in that photo, a photo that appears to have been taken April 2, 2003 showing the interior of Folsom’s storage unit with all the property and devices, including the “predicate” one, that were seized during the FDA raid against his business and property. That predicate device is now apparently located at the FDA’s Headquarters evidence room, San Clemente, California. And, significantly the FDA clearly implies no such device exists.

The record shows the Prosecution, under Court Order, in 2008, as part of “pre-trial discovery,” to allow Folsom and his attorney (at the time) complete access to all evidence, and very specifically that evidence held at FDA Headquarters, San Clemente. “Partial” access and discovery was made in the summer of 2008, however, no discovery access to the devices, device components, accessories, manuals, documents, etc., that were shown in the trial photo Exhibit # 600 was made available by the Government/FDA at this evidence room. This access and discovery was denied, even after “court admonishments” toward the Prosecutor because of the intentional “delays and obstructions” that blocked partial and complete discovery. This appears from the record.

I further note that frequency programs and device technology (offered by another), was “grandfather clause” FDA 510 (k) accepted in June 2007, as a TENS device for “pain and muscular relaxation.” The Scanar device, developed from the Russian space program and the Scio devices, both providing the elements of the Rife frequencies, were FDA 510 (k) approved/accepted as “bio feedback devices. Restrictions do apply (similar to those experienced by the Food Supplement industry) in the marketing of these devices and what can be stated to the customer as regards frequencies as they relate to specific conditions and body functions. What is essential is a Disclaimer that there is no intent to “treat disease” but rather that the devices my offer therapies that may benefit.

Such devices, in general, including the Folsom device, do not require 510(k) approval. Generally, devices “intended for human use…” must be registered, with certain exceptions, stated in the statute:

(l) Exemption from reporting requirements - A report under subsection (k) of this section is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) of this section or is within a type that has been classified into class I under section 360c of this title. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.

Furthermore, the statute provides a definition of Class I devices:

(A) Class I, General Controls… (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and (II) does not present a potential unreasonable risk of illness or injury…

It is my understanding that the Folsom device is not “for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and… does not present a potential unreasonable risk of illness or injury…” The intent of the device is provision of pre-diagnostic evaluation for self-education and research purposes, to achieve and maintain a status of wellness, not to prevent impairment of human health, nor does such a device present any potential risk of illness or injury; it is the equivalent of a battery-powered, micro-amp device. It is not intended to “treat” disease but rather to provide the body with biologically compatible energy or to provide a therapy that may benefit.

The importance for having official Government/FDA acknowledgement for the existence of a “predicate” device will allow for Rife type device FDA “acceptance” under Sec. 360 of the 1976 CCFD Act -“grandfather” clause (for “medical device” or complete “exemption”). Meaning for a “Rife type device” to receive FDA acceptance under the 1976 CCFD Act “grandfather” clause there would be no requirement for the multi-million dollar expenses and time consumption for “double-blind” studies, etc., only the pharmaceutical companies can afford. This cost is only one of the many impediments and restrictions preventing pharmaceutical industry competition. This is the reason also no manufacturer within the Rife industry can afford or comply with the normal FDA 510 (k) requirements – it is impossible and therefore the “underground” element to get a low cost alternative health care modality out to the American people. There is no “level playing field” in existence between “Complementary and Alternative Therapies,” vs. “Allopathic/ Pharmaceutical Medicine.” It simply does not exist.

Currently, without use of the 1976 CCFD Act “grandfather” clause, all manufacturers within the Rife industry, would be required for FDA 510 (k) acceptance, to apply over and over again for each applicable body “health and wellness” or “medical” condition (for hundreds, if not thousands of conditions if each were applied) , for man or animal. The costs and processes would be prohibitive. However, if it can be officially acknowledged and accepted there exists a 1976 “predicate” Rife type device, as the Government/FDA is hiding in San Clemente) then all the above would not be required. A major efficacious low cost “health and wellness” frequency modality would then readily be made – “out in the open and non underground anymore” – available to the American people. And, as the beneficiaries of this technology they would then be the true winners – “not victims anymore.”

Is there a conflict of interest within the FDA regarding Alternative vs. Allopatic/ Pharmacological medicine? June 1996 President Clinton signed an executive order allowing all the “ABC” Governmental agencies to resource their own revenues. It’s well documented of the FDA’s mastered “mining of income” from the pharmaceutical industry. It is even reported from those within the FDA, even by FDA mid-level researcher Dr. David Graham who testified before Congress, that this government agency values the pharmaceutical industry as its’ own “financial fiefdom.”

Besides the Rife industry, past discrediting took place against other “alternative healing modalities.” The Chiropractic industry experienced the same until winning a major court case in 1991. The “food supplement” industry was fending off the unwanted encroachments of the FDA until the supplemental DSHEA Act was brought about as a compromise – sponsored by Senator Orin Hatch in 1994. Acupuncture, recognized in the Orient for thousands of years, was finally accepted by main stream medicine as one of the “healing arts” here in the U.S. in 2001.

There is a regulatory category of product or service in which these various modalities, including Rife technology, clearly fit that excludes them from the practice of medicine and thus from being medical devices or services. That category is what may be termed “therapies that may benefit.”
The Code of Medical Ethics of the American Medical Association has also begun to acknowledge an independent use of the term “therapy” to describe non-medical health care services.

While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to "refer" a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard.

While physicians "prescribe" treatments for disease, therapies that may benefit; may be subject to "referral" thereby further indicating the distinction.  Thus, for example, energetic devices that support normal structure and function, even to support therapeutic outcomes, can be seen to complement licensed medicine, but not to be part of it, or held to its strictures, nor limited in its practice to licensed physicians. This is the essence of the case of Andrews v Ballard (USDC, TX, 498 F Supp 1038, 1980) is cited as a leading authority for the propositions that (1) a decision to obtain (in this case) acupuncture needle therapies from one not licensed as a medical doctor is a constitutional right encompassed by the right of privacy (p.1048) and (2) the provisions of the medical practices act, insofar as they limit the use of acupuncture needles to licensed physicians, are unconstitutional (p.1051, et seq.). This and other cases recognized a Federally protected right to access information about unlicensed products and services.

See also, Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357 where the Court said, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort… We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information… Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning that the [product] had not undergone FDA testing and that its risks were unknown."

Thus, since such therapies are not prescription services, members of the public may choose such services without the permission of their physician and as of right.

In the case of State v Biggs (46 SE Reporter 401, 1903) the North Carolina Supreme Court dealt with a person who was advising people as to diet, and administering massage, baths and physical culture. In the Biggs case, the defendant "advertised himself as a 'nonmedical physician'...[and] held himself out to the public to cure disease by 'a system of drugless healing'..." p.401. That Court held that there could be no "state system of healing" p.402 and while "Those who wish to be treated by practitioners of medicine and surgery had the guaranty that such practitioners had been duly examined...those who had faith in treatment by methods not included in the 'practice of medicine and surgery' as usually understood, had reserved to them the right to practice their faith and be treated, if they chose, by those who openly and avowedly did not use either surgery or drugs in the treatment of diseases..." p.402. Biggs was acquitted.

In the Folsom case, the Jury was not given the opportunity to understand the distinction between the “treatment of disease” which is a predicate for a device to be a “medical device” and “therapies that may benefit” which include such well-known modalities as acupuncture and biofeedback and some lesser know modalities such as energetic devices, including Rife devices.

Under these circumstances, Justice would be best served by considering Jim Folsom’s age and leaving him at home, under such restrictions as might be deemed to protect the public, but not to restrict his private expressive association activities which are beyond the lawful purview of the Federal government..

I declare that the above statements made by me are true and accurate to the best of my knowledge and belief

Very truly yours,
Ralph Fucetola, JD -
Attorney at Law in NJ – 1973 - 2006 – All Rights Reserved.

1 comment:

Anonymous said...

thanks for the article.

-J.D. Grand rapids, Michigan