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Here is the draft of the Certification in Support of Habeas Corpus

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 and opinions. This Certification is made to support the issuance of a Writ of Habeas Corpus under 28 U.S.C. 2241(a) in that the Petitioner has been convicted and confined in violation of the Constitution and Laws of the United States.

1. I practiced law from 1971 through 2006 in the State of New Jersey; thereafter I have provided professional legal consultation services to the natural products and nonmedical devices industries. I am a Notary Public of the State of New Jersey, Notary No. 2398815.

2. In the course of my practice and consultancy I had occasion to meet James Folsom and to counsel and consult with him regarding the nonmedical device he offered. I provided consulting services and written opinions for the Defendant, and when he was indicted, I provided an expert opinion pre-trial report. I was not called upon to testify at the trial although I was prepared to do so and expected to do so.

3. Upon information and belief, at the time Defendant began to provide the device an Operations Manual that he had not written was available. This was the Manual that had been prepared as part of an Investigative New Device application. I was asked to advise regarding changes needed to update the Manual and make sure that it did not communicate in such a way as to suggest that the device was a medical device.

4. I also provided my opinion that under section 360(c) of the Statute the device, when properly presented with claims that did not include claims to diagnose, prescribe for, treat or cure medical conditions, did not require registration under the Statute. Although in general devices “intended for human use…” were subject to registration, the law and regulations provides exceptions that applied to the device.

5. In addition to that opinion, it was also my opinion that it is possible to qualify devices for “significantly equivalent frequency device” status under the “grandfather clause” of the May 28, 1976 Cosmetic, Food and Drug (Devices) Act (1976 CCFD Act).

6. From my review of the trial information, it appears that the primary FDA Agent testifying for the Government’s case during the 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 just 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, although it does, or at least did exist.

7. 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.

8. I am further aware 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 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 may offer therapies that may benefit. This is the advice I gave the Defendant and he forthwith directed that all suggested changes be made to the Operations Manual to include appropriate Disclaimers.

9. Such devices, in general, including the device herein, 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…

10. It is my understanding that the device herein 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.

11. Government acknowledgement of the existence of a “predicate” device allows FDA “acceptance” under Sec. 360 of the 1976 CCFD Act -“grandfather” clause (for “medical device” or complete “exemption”). Meaning for a 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 device 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.

12. Currently, without use of the 1976 CCFD Act “grandfather” clause, all manufacturers within the device 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 that there exists a 1976 “predicate” device, then the path to regulatory acceptance would be open. A major efficacious low cost “health and wellness” frequency modality would then readily be made – “out in the open and not underground anymore” available to the American people.

13. Besides the device 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 as a result of a leading Federal Court case arising in Texas.

14. There is a regulatory category of product or service in which these various modalities, including device 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” as opposed to “treatment of disease.”

15. 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.

16. 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.

17. 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.

18. In the case involving this Defendant, an old Operations Manual that he did not author was shown to the jury but the revised Manual that he authorized was not, thereby depriving the Public of access to information about unlicensed products and services.

19. 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.”

20. 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. That right is beyond FDA authority to prohibit, based on First Amendment Expressive Association interests.

21. 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 actually “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.

22. In this Defendant’s 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 known modalities such as energetic devices.

23. Under these circumstances, Justice would be best served by considering Jim Folsom’s age and returning him to his 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. Defendant should be released forthwith as he is being punished for acts which could not be criminal under any reasonable interpretation of law. This matter is an exceptional case where the prisoner can show that his remedy is “inadequate or ineffective” and either the conviction should be voided, or he should therefore be permitted to be resentenced and released.