Ralph Fucetola JD
The Vitamin Lawyer.com 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
Ralph.Fucetola@usa.net - www.VitaminLawyer.com
Attorney at Law in NJ – 1973 - 2006 – All Rights Reserved.
Monday, February 22, 2010
Saturday, February 13, 2010
Fake food and supplement "safety" bills and the future of healthcare.
03/07/10 Push Back Update: Has McCain withdrawn his support from S.3002? See: http://www.healthfreedomusa.org/?p=4767
-------------
The Federal authorities' program last year to purchase ($6.4 billion worth) of swine flu" vaccines, then to approve the use of those vaccines (by the FDA) and then to recommend their use (by the CDC) and then to distribute the vaccines, collapsed in the face of public refusal to believe there was a real pandemic, despite an unbelievable presidential declaration of national emergency. Perhaps even more important was public refusal to voluntarily accept the unsafety-tested, uninsurable flu vaccines.
Just so, the current plan to subject us to yet more control over our health and food choices by giving that failed agency, the FDA, yet more power to abuse, power over all foods and that class of foods known as "dietary supplements," has suddenly come to the fore.
Two bills are wending their way through Congress to enable the FDA's bureaucrats to tighten their incompetent grip on what choices people are allowed1. One of these claims to be a "food safety" bill, S 510 with Sen Tom Harkin as a chief sponsor, and the other is the so-called "Dietary Supplement Safety" bill, S 3002, chiefly sponsored by Sen John McCain.
Yes, these bills would give FDA even more power to abuse. It was Dr. Ron Paul who accused the agency of being a power abuser in 2007 and nothing has changed to negate that judgment.
The govt owned, approved, recommended and distributed vaccine program collapsed in the face of 2.8 million messages to state legislators and members of Congress demanding respect for our right to reject vaccination. The fake safety bills are stalled in the Senate, facing now over a million messages to Congress and decision makers. In just the past few days well over another hundred thousand messages have gone out.
The future of health care in America will not be decided by final congressional approval of some version or other of national health care, since there will not be enough resources available to fund that system. Rather, programs of nationalized food and natural product control, such as the Swine Flu Vaccine program, or programs of national regulation, such as the false "safety" bills will be the vehicle through which nationalized health control will be imposed.
We already see this with a peculiar clause in the last FDA enabling act to pass Congress, the Kennedy bill of 2007. That bill included Section 301(11) which gives FDA authority to ban the interstate commerce in any food ever studied for medical use. Now why would a govt agency need such a power? What business of govt is it what foods we can trade? Whose interests would such anti-market power serve? Well, let's see how FDA (ab)used that new power Sen Kennedy provided it. Last year FDA banned the interstate trade of a certain form of vitamin B6 because a drug company had studied it for medical use but decided not to use it, and asked FDA to ban it... why? For competitive advantage. For monopoly privilege. This is how FDA (ab)uses its power.
This is a good indication of what FDA would do with the additional authority the McCain and Harkin bills would give it.
Up until a week ago we had thought the "food safety" bill was safely bottled up in the Senate HELP committee where it has languished since its official "mark-up" prior to being brought to the flood of the Senate for a vote. Why was it stuck there? Because over 150,000 messages went to the Senate and president over the weekend before the "mark-up" meeting and even Sen. Harkin had to admit (it's on the taping of the November 18th meeting on the HELP committee web site) that the people were concerned. And he announced that the Dietary Supplement Health and Education Act of 1994 (DSHEA) which had been passed by a unanimous Congress and which allowed the
development of the vibrant, high potency dietary supplement market in the USA, was still the law of the land. No congressional intent to change that.
Until last week, that is. Then John McCain showed us that he is on the side of the power abusers. His bill would in effect "HARMonize" our Dietary Supplement freedoms with EU/Codex international restrictions.
Unless, of course, there is enough public push back, as we know "Push Back Works!" And that push back has started. A week ago this past Thursday (on February 4, 2010) McCain announced the filing of S 3002. Emails were quickly exchanged among health freedom advocates. The next evening we had our first eblast out, to several hundred thousand Natural Solutions foundation supporters and they began to forward the message to millions of others. At the same time freedom advocates such as Citizens for Health were also reaching out with the same message to the Senate: "Do NOT cosponsor S 3002!" Such advanced healthcare luminaries as Gary Null put the link to our Action Item on their websites and thousands more sent messages to Congress.
Dr. Ron Paul's Campaign for Liberty also featured the link generating more viral action, while the people following www.Twitter.com/HealthFreedomUS continued to grow.
The Action Item is:
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?
campaign_KEY=26714
Our analysis of these bills, and how their seemingly "safety" language is just a guise for monopolistic intent, is linked from the Action Item page.
We, the trustees of Natural Solutions Foundation are so very pleased to see the health freedom movement responding together in this way. We see this issue becoming the touchstone for the future of real health care reform -- changes we can believe in, namely, no more "business as usual" with the biggest of the bigs, Big Agribiz, Big Pharma, Big Finance and Big Govt finally being excluded from the control over our food and freedom they so crave.
We have begun the transpartisan process of taking back our health and food freedom. And that is a very good thing.
----
1. This is the same agency that regularly approves dangerous drugs that must be taken off the market or greatly restricted; half the drugs so approved are shown later to have caused more harm than any potential benefit.
-------------
The Federal authorities' program last year to purchase ($6.4 billion worth) of swine flu" vaccines, then to approve the use of those vaccines (by the FDA) and then to recommend their use (by the CDC) and then to distribute the vaccines, collapsed in the face of public refusal to believe there was a real pandemic, despite an unbelievable presidential declaration of national emergency. Perhaps even more important was public refusal to voluntarily accept the unsafety-tested, uninsurable flu vaccines.
Just so, the current plan to subject us to yet more control over our health and food choices by giving that failed agency, the FDA, yet more power to abuse, power over all foods and that class of foods known as "dietary supplements," has suddenly come to the fore.
Two bills are wending their way through Congress to enable the FDA's bureaucrats to tighten their incompetent grip on what choices people are allowed1. One of these claims to be a "food safety" bill, S 510 with Sen Tom Harkin as a chief sponsor, and the other is the so-called "Dietary Supplement Safety" bill, S 3002, chiefly sponsored by Sen John McCain.
Yes, these bills would give FDA even more power to abuse. It was Dr. Ron Paul who accused the agency of being a power abuser in 2007 and nothing has changed to negate that judgment.
The govt owned, approved, recommended and distributed vaccine program collapsed in the face of 2.8 million messages to state legislators and members of Congress demanding respect for our right to reject vaccination. The fake safety bills are stalled in the Senate, facing now over a million messages to Congress and decision makers. In just the past few days well over another hundred thousand messages have gone out.
The future of health care in America will not be decided by final congressional approval of some version or other of national health care, since there will not be enough resources available to fund that system. Rather, programs of nationalized food and natural product control, such as the Swine Flu Vaccine program, or programs of national regulation, such as the false "safety" bills will be the vehicle through which nationalized health control will be imposed.
We already see this with a peculiar clause in the last FDA enabling act to pass Congress, the Kennedy bill of 2007. That bill included Section 301(11) which gives FDA authority to ban the interstate commerce in any food ever studied for medical use. Now why would a govt agency need such a power? What business of govt is it what foods we can trade? Whose interests would such anti-market power serve? Well, let's see how FDA (ab)used that new power Sen Kennedy provided it. Last year FDA banned the interstate trade of a certain form of vitamin B6 because a drug company had studied it for medical use but decided not to use it, and asked FDA to ban it... why? For competitive advantage. For monopoly privilege. This is how FDA (ab)uses its power.
This is a good indication of what FDA would do with the additional authority the McCain and Harkin bills would give it.
Up until a week ago we had thought the "food safety" bill was safely bottled up in the Senate HELP committee where it has languished since its official "mark-up" prior to being brought to the flood of the Senate for a vote. Why was it stuck there? Because over 150,000 messages went to the Senate and president over the weekend before the "mark-up" meeting and even Sen. Harkin had to admit (it's on the taping of the November 18th meeting on the HELP committee web site) that the people were concerned. And he announced that the Dietary Supplement Health and Education Act of 1994 (DSHEA) which had been passed by a unanimous Congress and which allowed the
development of the vibrant, high potency dietary supplement market in the USA, was still the law of the land. No congressional intent to change that.
Until last week, that is. Then John McCain showed us that he is on the side of the power abusers. His bill would in effect "HARMonize" our Dietary Supplement freedoms with EU/Codex international restrictions.
Unless, of course, there is enough public push back, as we know "Push Back Works!" And that push back has started. A week ago this past Thursday (on February 4, 2010) McCain announced the filing of S 3002. Emails were quickly exchanged among health freedom advocates. The next evening we had our first eblast out, to several hundred thousand Natural Solutions foundation supporters and they began to forward the message to millions of others. At the same time freedom advocates such as Citizens for Health were also reaching out with the same message to the Senate: "Do NOT cosponsor S 3002!" Such advanced healthcare luminaries as Gary Null put the link to our Action Item on their websites and thousands more sent messages to Congress.
Dr. Ron Paul's Campaign for Liberty also featured the link generating more viral action, while the people following www.Twitter.com/HealthFreedomUS continued to grow.
The Action Item is:
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?
campaign_KEY=26714
Our analysis of these bills, and how their seemingly "safety" language is just a guise for monopolistic intent, is linked from the Action Item page.
We, the trustees of Natural Solutions Foundation are so very pleased to see the health freedom movement responding together in this way. We see this issue becoming the touchstone for the future of real health care reform -- changes we can believe in, namely, no more "business as usual" with the biggest of the bigs, Big Agribiz, Big Pharma, Big Finance and Big Govt finally being excluded from the control over our food and freedom they so crave.
We have begun the transpartisan process of taking back our health and food freedom. And that is a very good thing.
----
1. This is the same agency that regularly approves dangerous drugs that must be taken off the market or greatly restricted; half the drugs so approved are shown later to have caused more harm than any potential benefit.
Wednesday, February 3, 2010
McCain Bill Poses Threat to DSHEA and Health Freedom
Update: Action Item to Protest McCain Bill
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
---------
I re-post in full today's media release from the Natural Products Association regarding new threats to health freedom.
It was Constitutionalist Dr. Ron Paul (R-Texas) who described the FDA's behavior as "an abuse of power..." and now failed presidential candidate McCain, a "RINO" (Republican In Name Only) lets us know where he stands: on the side of the power abusers.
The "Accepted Dietary Ingredient List" is especially troubling since such a code provision moves us away from our Common Law Right to access the foods we choose to a Civil Law (Codex Alimentarius) regulation of what we may choose. Under the Common Law what is not explicitly forbidden is allowed; under the Code, whatever is not permitted is forbidden. This "lawyer's distinction" is of the greatest significance in preserving our Liberty.
We will post an Action Item at Heatlh Freedom USA opposing the McCain bill when it is formally introduced. See: http://www.healthfreedomusa.org/?p=4608
The terms of this bill further the Globalist Eugenicide Agenda in that it seeks to treat dietary supplements, which are foods and therefore ought to be deemed safe if used as directed, as though they were toxins (while, of course, the agency treats the real dangers - GMOs, food additives, dangerous drugs, vaccines and industrial toxins as though they were perfectly safe). rf
-----------------
February 3, 2010: New Legislation Poses Threat to DSHEA
At a press conference held earlier today, Sen. John McCain (R-Ariz.) announced that he would be introducing legislation that would amend the Dietary Supplement Health and Education Act (DSHEA) to give the U.S. Food and Drug Administration (FDA) additional powers over retailers and suppliers in the dietary supplements industry. The Natural Products Association is reviewing McCain's bill, which is cosponsored by Sen. Byron Dorgan (D-N.D.), and offers this initial analysis regarding the impact of the legislation on the industry.
NPA will work aggressively to address this threat to the industry. The association will continue to keep its members informed and let them know how they can help protect their businesses.
Brief description of the provisions of the
Dietary Supplement Safety Act of 2010
New Requirements from Suppliers to Retailers
Suppliers and retailers regardless of size all along the chain of commerce are required to "obtain adequate written evidence" from the seller that the product is registered as required. That evidence must be retained in a file available for inspection.
Adverse Event Reporting (AER)
Requires reporting of all adverse events, not just serious adverse events. In addition, a compilation of non-serious AERs must be submitted annually, and records must be maintained for three years.
"Accepted Dietary Ingredients" List
Mandates creation by the Secretary of a list of "Accepted Dietary Ingredients" to replace the current "in commerce pre-DSHEA" test.
New Dietary Ingredients (NDI)
NDIs are considered adulterated unless there is a history of use or evidence of its safety. Registrants shall maintain a "scientifically reasonable substantiation file" available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market.
Recall Authority
Provides immediate recall authority to the Secretary upon determination that a supplement "would cause serious, adverse health consequences or death, or is adulterated or misbranded." Companies subject to a recall have the right to challenge the order in an "informal hearing" within 10 days. At their own expense, retailers must notify customers of such recalls.
Registration of Dietary Supplement Facilities
Dietary supplement facilities shall register with the Secretary (required information includes name, address of all facilities, trade names, list of supplements, their ingredients, and labels). Registration is annual.
Read the complete bill here:
http://www.npainfo.org/clientuploads/regulatoryLegislative/2010%20Dietary%20Supplement%20Safety%20Bill.pdf
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
---------
I re-post in full today's media release from the Natural Products Association regarding new threats to health freedom.
It was Constitutionalist Dr. Ron Paul (R-Texas) who described the FDA's behavior as "an abuse of power..." and now failed presidential candidate McCain, a "RINO" (Republican In Name Only) lets us know where he stands: on the side of the power abusers.
The "Accepted Dietary Ingredient List" is especially troubling since such a code provision moves us away from our Common Law Right to access the foods we choose to a Civil Law (Codex Alimentarius) regulation of what we may choose. Under the Common Law what is not explicitly forbidden is allowed; under the Code, whatever is not permitted is forbidden. This "lawyer's distinction" is of the greatest significance in preserving our Liberty.
We will post an Action Item at Heatlh Freedom USA opposing the McCain bill when it is formally introduced. See: http://www.healthfreedomusa.org/?p=4608
The terms of this bill further the Globalist Eugenicide Agenda in that it seeks to treat dietary supplements, which are foods and therefore ought to be deemed safe if used as directed, as though they were toxins (while, of course, the agency treats the real dangers - GMOs, food additives, dangerous drugs, vaccines and industrial toxins as though they were perfectly safe). rf
-----------------
February 3, 2010: New Legislation Poses Threat to DSHEA
At a press conference held earlier today, Sen. John McCain (R-Ariz.) announced that he would be introducing legislation that would amend the Dietary Supplement Health and Education Act (DSHEA) to give the U.S. Food and Drug Administration (FDA) additional powers over retailers and suppliers in the dietary supplements industry. The Natural Products Association is reviewing McCain's bill, which is cosponsored by Sen. Byron Dorgan (D-N.D.), and offers this initial analysis regarding the impact of the legislation on the industry.
NPA will work aggressively to address this threat to the industry. The association will continue to keep its members informed and let them know how they can help protect their businesses.
Brief description of the provisions of the
Dietary Supplement Safety Act of 2010
New Requirements from Suppliers to Retailers
Suppliers and retailers regardless of size all along the chain of commerce are required to "obtain adequate written evidence" from the seller that the product is registered as required. That evidence must be retained in a file available for inspection.
Adverse Event Reporting (AER)
Requires reporting of all adverse events, not just serious adverse events. In addition, a compilation of non-serious AERs must be submitted annually, and records must be maintained for three years.
"Accepted Dietary Ingredients" List
Mandates creation by the Secretary of a list of "Accepted Dietary Ingredients" to replace the current "in commerce pre-DSHEA" test.
New Dietary Ingredients (NDI)
NDIs are considered adulterated unless there is a history of use or evidence of its safety. Registrants shall maintain a "scientifically reasonable substantiation file" available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market.
Recall Authority
Provides immediate recall authority to the Secretary upon determination that a supplement "would cause serious, adverse health consequences or death, or is adulterated or misbranded." Companies subject to a recall have the right to challenge the order in an "informal hearing" within 10 days. At their own expense, retailers must notify customers of such recalls.
Registration of Dietary Supplement Facilities
Dietary supplement facilities shall register with the Secretary (required information includes name, address of all facilities, trade names, list of supplements, their ingredients, and labels). Registration is annual.
Read the complete bill here:
http://www.npainfo.org/clientuploads/regulatoryLegislative/2010%20Dietary%20Supplement%20Safety%20Bill.pdf
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