Comments to FDA at Regulations.gov -- Pre-DSHEA Ingredients List

Filed 26 September 2017
Filing Receipt No. 1k1-8yw3-kmm1

In Re: Development of a List of           }
Pre-DSHEA Dietary Ingredients         }
Docket FDA-2017-N-4625 

Ralph Fucetola JD states as though under Oath:

1         1. This Statement is submitted as a Regulations.gov Comment to FDA docket 2017-N-4625 in advance of the Noticed Public Meeting of October 3, 2017.

2     I am a retired Attorney-at-Law and hold a Juris Doctor Degree. I practiced law from 1971 through 2006 in New Jersey and am a Notary Public.

3     In determining regulatory standards for producing a List of Pre-Dietary Supplement Health and Education Act (DSHEA) Dietary Ingredients (herein, the Pre-DSHEA List), the Food and Drug Administration should, among other factors, consider the relationship of the ingredient to the normal structure and function of the body.

4     Any substance or compound that was part of the food chain on the DSHEA “grandfather” date in 1994 (and not thereafter chemically changed) should be included by reference in any Pre-DSHEA List as such substances or compounds are “grandfathered” by the explicit terms of the Statute.

5     Such substances or compounds, at a minimum, should include all substances found naturally in mammalian, including human, bodies, including compounds produced by such bodies.

6     An example of a substance or compound actually produced by mammalian, including human, bodies and therefore part of the food chain to be considered “grandfathered” and part of any Pre-DSHEA List is Cannabidiol, or CBD.

7.     This substance or compound is also found in the hemp plant and other sources. It is not an intoxicant. It is a human neurotransmitter and a normal part of the cannabidiol neurotransmitter system in the human body.

8.     In 1995, while I was in practice as an Attorney-at-Law I was retained by the Life Extension Foundation to represent two of its members who had been arrested in New Jersey when importing DHEA (dehydroepiandrosterone) a hormone which is a normal part of the human body.

9.     It was believed by the New Jersey authorities that the DEA (Drug Enforcement Administration) had “scheduled” DHEA as a controlled substance. That belief was false. No such “scheduling” had occurred or could occur. Eventually the charges were dropped and an order was signed determining that DHEA was a normal part of the human body, not declared “contraband” by government authority. A copy of the Order closing the cases is posted here: http://www.lifespirit.org/dheaorder.JPG

10. It is my professional opinion that a substance or compound, native to mammalian, including human, bodies, and not being an intoxicant, is a Pre-DSHEA Dietary Ingredient and should be included in any such Pre-DSHEA List.

11. It is my professional opinion that Cannabidiol (CBD) is such a substance or compound.

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

26 September 2017

Ralph Fucetola JD                                                                                                 

FDA GETS IT WRONG AGAIN:CANNABIDIOL IS GRANDFATHERED UNDER DSHEA

Protecting the DSHEA Status of CBDs
Educate Decision Makers Here:
http://tinyurl.com/NaturalRemedyFreedom
The Declaration
http://drrimatruthreports.com/declaration-of-freedom-for-natural-remedies/

On February 10, 2016 FDA sent warning letters to certain CBD companies. The letters made two essential points:

1. Certain claims made by the companies were “treatment of disease” claims and cannot be made without prior government prescription drug approval.
2. CBD is not, based on “available evidence” grandfathered under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The agency claims authority under the 2010 (sic) Food Safety Modernization Act which allows the agency to ban any food that is being studied for medical use. However, that Act includes a specific clause exempting DSHEA products from this enhanced power. 

Natural Solutions Foundation led the effort to keep that clause in the law, and, although it took millions of emails, we succeeded.

Regarding #1 above, in my opinion is it always possible to revise claim language to avoid “treating disease.” Nutrients support normal function and structure, they do not “treat disease.”

During 2014 we directly confronted the FDA on a similar issue arising from the use of Nano Silver to support normal cell membrane integrity during the ebola scare. If a virus cannot penetrate a living cell there is no disease.

FDA originally said we were claiming to “treat ebola” with Nano Silver. After several letters back and forth, the agency did not object to the carefully structured support of normal cell membrane integrity claim. 

The FDA warning letter also addressed the CBDs that Natural Solutions makes available, implying that certain claims were not DSHEA claims, but made no mention of the nutrient not being "grandfathered." 

With regard to #2 above, the FDA is playing a trick: no one has provided FDA with evidence that CBD is grandfathered under DSHEA, therefore the agency says it is not grandfathered, thereby removing CBDs from the protection of the savings clause in the 2010 act.

This objection is easily handled. There are three grandfather clauses in DSHEA --

1. Sold to supplement the diet before June 1994;

2. Part of the food supply and not chemically changed since June 1994;

3. Previously approved as a drug, but sold as a food prior to being approved as a drug (and prior to June 1994).

Since humans and other mammals make CBDs as part of their neurotransmitter systems, CBD has in fact been part of the food supply and while being extracted is not chemically changed.

Furthermore, the government may not make a normal bodily substance into contraband. When I was in practice, in 1995, I won that issue when I won the DHEA Cases, keeping that nutrient available. See: How I Protected DHEA.

THE FIRST STEP IS TO ASSERT OUR RIGHT!

And here is one important step to do just that:
 

Declaration of Freedom to
Choose Natural Remedies

[Please Print and Post at Your Local Health Food Store.]

READ MORE HERE:

http://drrimatruthreports.com/?p=27844

DSHEA & Nutrients Under Increasing FDA Attack!

DSHEA & NUTRIENTS STILL UNDER ATTACK!
http://tinyurl.com/nofoodcontrol *

Updated Foundation Counsel's Blog Report:
http://vitaminlawyerhealthfreedom.blogspot.com/2011/04/free-speech-about-science-act-hr-1364.html

Last week Natural Solutions Foundation's Health and Food Freedom Action eAlert reported on the Nutraingredients USA article that warned us about a new threat to Health and Food Freedom in Congress: the Durbin Dietary Supplement Labeling Bill - http://tinyurl.com/6bpuz7x

According to the article: "The bill would... require manufacturers to register dietary supplement products [with] the FDA, require labels to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. The bill also calls for labels to display the batch number, something already adopted as standard"

The article quotes leading dietary supplement lawyer Jonathan Emord, calling the bill a “classic example of regulatory overkill.... The FDA has full regulatory power to prevent the sale of adulterated and misbranded foods and dietary supplements... By introducing new powers when old ones are more than sufficient, [Durbin] invites abuses, including more burden and cost on an industry that is already overwhelmed by the burden and cost of the GMPs and, now, the [sic] Food Safety Modernization Act...”

POWER IS THE GOAL: "Sen Durbin said that his goal “is to take the decision about how a product will be regulated out of the hands of the manufacturer and put it in the hands of the FDA where it belongs."

For More About Our Analysis of the Attacks on Nutrients please see Foundation President, Gen. Bert Stubblebine's First Risk Assessment, updated: Threats to Health and Food Freedom - http://www.healthfreedomusa.org/?p=9145

Subsequent to this disturbing report, we learned of a new FDA dietary supplement regulation under the new Food Control Law, the infamous S.510 of the 111th Congress.

As Natural News reports: "...nearly all vitamin and supplement ingredients could soon be banned under the FDA's new NDI [New Dietary Ingredient] rules because very few supplement ingredients can be conclusively shown to have been widely used BEFORE [the "grandfathering" date of] 1994... Through this clever trick with NDI rules, the FDA can now position itself as the gatekeeper for all supplement approvals. Far from merely being a requirement to "notify" the FDA of the use of new ingredients, NDI rules essentially subject supplements to approval from the FDA.

Learn more:http://www.naturalnews.com/032912_FDA_dietary_supplements.html#ixzz1RNe6SrP4

Similarly, the Natural Products Association has this to say:

We believe the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to DSHEA should remain on the market. The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. That was not the intent of DSHEA. These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.

http://www.npainfo.org/index.php?src=news&srctype=detail&category=pressreleases2011&refno=330

Our Action Item has been updated to help educate decision makers about the new NDI rule as well as Sen. Durbin's bill: please contact your congress-critters daily about this the other health and food freedom issues that matter!

Updated Action item:
http://tinyurl.com/nofoodcontrol
Here is Dr. Ron Paul about Push Back:



And while you are at it... Please support Dr. Ron Paul's Raw Milk Interstate Commerce Freedom Bill, HR.1830: http://tinyurl.com/rawmilkfreedom - hear him about that here: http://youtu.be/sAQdjjXCN6A
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* The draft of the "Educate Decision Makers" email reads as follows (you can modify it):

To the White House, Speaker Boehner, Chairman Kingston & Congress:

DO NOT FUND THE FOOD CONTROL LAW AND ADDED FDA FOOD & NDI REGULATIONS! REJECT FDA HUNDRED MILLION DOLLAR "USER FEE" INCREASE: IT IS JUST ANOTHER TAX ON FOOD!

DO NOT SUPPORT Sen Durbin's "Dietary Supplement Labeling Act" which would require pre-market registration of these nutrient food products.

I am a concerned organic gardener, family farmer, rancher and/or consumer... I am concerned about food safety and I am concerned about protecting my access to local and natural food production and distribution; that is, Food Freedom.

I am very concerned that the FDA will implement the 2010 Food Safety Modernization Act in ways that will harm these important interests. This is not a "food safety" law; it is a Federal power-grab food control law!

The new Congress ought to re-consider its controversial provisions, such as section 104 that may allow secret regulations, in violation of the pledge of transparency.

Further concerns include the convoluted procedure for local food production exemptions and the "road map" the new law provides for rapid "HARMonization" of our food freedoms with international Codex Alimentarius restrictions.

I urge the White House to be very closely involved in the writing of the regulations under the new law, to ensure the protection of these interests and to make sure all interest groups are heard and considered by the regulators.

To my Congressperson and to Chairman Kingston & Speaker Boehner - please help the White House avoid the worst aspects of the food control bill.

DO NOT FUND ITS PROVISIONS. We are especially concerned with the provision for thousands of new FDA food control inspections. No provision of this bill should be funded by the new Congress. DE-FUND FOOD CONTROL!

I also oppose what Health Freedom USA has called Sen. Leahy's "Criminalization of Food and Speech" bill, which claims to "increase criminal penalties for certain knowing and intentional violations relating to food..." but applies only to SPEECH -- this bill has reared its ugly head again, as S.216.

Do not increase FDA authority; oppose the Durbin Dietary Supplement Labeling Act.

I agree with Rep Jack Kingston:

"I think we will [not fund the food control law]. We have a lot of concerns about the necessity of putting 18,000 food police on the streets and the kitchens of America. The trend in food safety has been very, very favorable. I'm not sure that this kind of investment is going to give any returns that justify it."

Food Freedom is an important issue to me and I will pay attention to what the White House and FDA do with any new power granted by Congress. But what would be best would be for Congress to REDUCE the Power of the FDA!

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Send you message here: http://tinyurl.com/nofoodcontrol

McCain/Dorgan Bill Dies; Its Evil Intent Remains

If you've been following the saga of the so-called "Dietary Supplement Safety Act" or DSSA, S.3002, which would have sacrificed our dietary supplement freedoms for the false "safety" promise of Codex Alimentarius restrictions, died, as it should have, just a month and a day after it was submitted on February 4, 2010.

Huge Push Back from the often fractious Health Freedom Movement (led by HealthFreedomUSA.org's 390,000 emails to decision makers over a couple weeks) showed Senators McCain and Dorgan the error of their proposal... or did it?

We've reported on the developments in this matter several times on this blog and on the HealthFreedomUSA.org blog. We warned that DSSA, by substituting a Codex-compliant "Accepted Ingredient List" promulgated by the bureaucracy for the current law, DSHEA (Dietary Supplement Health and Education Act of 1994) and its determination that dietary supplements are foods and as such are generally considered safe if used as directed, would, like the allowed ingredient list now in effect in the EU, take up to 80% of dietary ingredients off the market... exactly as is happening in Europe now.

WE SAID "NO!" TO NEW WORLD ORDER RESTRICTIONS ON OUR LIBERTY! YOU ALL PUSHED BACK SO HARD THAT THE GLOBALIST PLAN FAILED.

But, they haven't given up. Earlier today the senators let "the other shoe drop" and in a letter to Senators Hartkin and Hatch, asked that the HARMonization language be inserted into the other fake "safety" bill before the Senate, S.510 which would force the industrialization of what's left of natural, family and community food production. A very bad bill by itself; an even worse bill with DSSA added!

Here is what the senators want, with my comments in [brackets]:

* requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services; [Food companies already have to register and dietary supplement facilities, as food facilities, already register under food security laws; this authority superfluous.]

* giving FDA mandatory recall authority if a dietary supplement is adulterated or misbranded; [Already in the law; just a year ago FDA banned a form of Vit B6 under its already existing Section 301(11) authority; another superfluous grant of power to an agency that Dr Ron Paul says "abuses power..."]

* requiring FDA commissioner to publish new dietary ingredient guidelines; [This is the heart of the attack on dietary supplements; it refers to the authority McCain and Dorgan wanted to give FDA to establish the Codex-style approved ingredient list, gutting DSHEA.]

* mandating that FDA notify DEA when a new product contains a synthetic anabolic steroid. [More window dressing; dietary supplements do not contain drugs -- they contain food ingredients and there are no foods that are "synthetic anabolic steroids" so this is another meaningless provision.]

Clearly we were right when we called S.3002 a stalking horse for S.510. They wanted to see how we'd react. And we did. Now they're back to Plan A. Shove Codex in through S.510.

This is something we simply cannot allow to happen. Therefore, we need to drown the Senate in emails. Please go to our Action Item and send the updated message to your Senators.

Time to Push Back again! Time to turn Push Back into Take Down!

http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714


Not yet time to celebrate. We can't have Health Freedom without Food Freedom! And we know that the promise of gaining alleged "safety" by giving up freedom never results in more safety and always results in less freedom!

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

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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.

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

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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

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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

Health Freedom Allowed by DSHEA

I was asked to explain what Dietary Supplement regulation was like before the FDA's iniatives this year.

I think the best way to answer this is to note, first, such regulation is not primarily about the ingredients; it is about claims. Any dietary ingredient on the market before mid June, 1994 is allowed on the market; as is any new dietary ingredient approved by the FDA.

Prior to 1994, when the Dietary Supplement Health and Education Act (DSHEA) was adopted, no claims could be made regarding dietary supplements.

DSHEA allowed certain types of claims; limited or forbid others.

1. Allowed: General Wellness Claims ("take vitamin C and feel good") and claims about Classical Deficiency Diseases ("take 60 mg vitamin C daily and avoid scurvy").

2. Allowed: Normal Structure and Function Claims (which characterize the relationship between a nutrient and the normal function or structure of the body). A 30 day post-marketing notice of claims is required. This type of claim is the typical DS product claim.

3. Allowed only after FDA approval: Health Claims (which characterize the relationship between a nutrient and a health condition). The FDA approved so few health claims that Durk Pearson and Sandy Shaw sued the FDA. In 2000 they won (Pearson v Shalala) thereby forcing the FDA to consider "conditional" or "qualified" health claims where there was not necessarily "Significant Scientific Agreement." The SSA standard, which is mentioned in DSHEA for health claims, is high than the standard commercial substantiation standard of 'Competent and Reliable Scientific Evidence.' The Court basically held that the CRSE standard would apply for such conditional or qualified claims. This is similar to Traditional Use Claims that have to disclose the limits on CRSE for such uses.

In 2004 FDA had stated, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'."

4. Not Allowed: Medical claims (prevent, mitigate, treat, cure) are never allowed for dietary ingredients... as such claims would make the ingredients "drugs" -- even where there is SSA about the claim. This is contrary to the 2002 Supreme Court case of Thompson v Western States that held, "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."

That's where we were by the mid 2000's.

Then, this year, FDA came out with a series of regulatory initiatives: the anti-CAM draft guidance and the Health Claims draft guidance (as well as the Good Manufacturing Process regulations and, shortly, the regulations for the new Adverse Events Reporting law).

The draft guidances, especially, would change the playing field by creating a new category of "CAM Products" (without Congressional approval) and by reimposing the SSA standard on all health related claims, contrary to the FDA's 2004 statement and the intent of Congress in adopting DSHEA that Dietary Supplements should be regulated as foods, not drugs.

Natural Solutions Foundation Analysis - Summer of Decisions: Health Freedom 2007

Natural Solutions Foundation Analysis
Summer of Decisions: Health Freedom 2007

A series of international and US government actions at the end of 2006 and beginning of 2007 have put Health Freedom of Choice -- with regards to Organic Standards, Nutrients, Traditional Remedies and Leading Edge Alternatives -- in greater jeopardy than any time since the adoption of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Thus, the Summer of 2007 has become a Summer of Decision for health freedom activists.

Codex Alimentarius is the least known, the most impactful and potentially the most dangerous threat to health and health freedom. Most threats to health freedom are local (e.g., a State goes on a rampage against physicians practicing drug free medicine), national (e.g., the US FDA decides to articulate the law inaccurately setting the stage for draconian "enforcement" of a regulatory structure which deems all health aides to be untested drugs, like cherries if used for arthritis, or untested devices, like hot rocks to sooth painful muscles). Codex, because it is a UN project
which sets standards and guidelines controlling the international trade of all foods and nutrients, not only determines what is available internationally (with all the market pressure that implies) but also becomes the domestic law for those countries which, like the United States, have decided to "Harmonize" with Codex standards and guidelines. The US announced its intention to do just that on October 11, 1995 in the Federal Register when it stated that it would give preference to international standards over US regulation and, as it has turned out, US law as well.

Codex is a mechanism for moving the entire world rapidly towards an industrialized, nutrient poor diet. Under Codex, dangerous, expensive and health-damaging changes in the global food supply are being implemented. Organic standards are being degraded, permitted heavy metal residue levels are being increased, Codex permits astonishingly high levels of dangerous industrial drugs, chemicals, pesticides, toxic veterinary drugs and other poisons in the food supply. Maximum Residue Levels (MRLs) for many pesticides are being removed so that there is no upper limit whatsoever to the amounts of these systemic poisons which can be introduced into foods (and into the bodies and environments of the farmer, his family and his land). Others are being increased dramatically. Organic standards are being lowered, so pure, unadulterated food can be expected to vanish globally, since the terminology will be maintained but the reality will be degraded beyond recognition to meet the needs of industrial farming. At the same time, high potency (dose) nutrients are being prohibited since they are treated as if they were toxins (severely limited, unlike most true toxins) and "assessed" by "Risk Assessment" to be present at no more than, for vitamins and minerals, for example, 115% of the amount found in untreated foods. High potency nutrients will become unavailable in any country which "HARMonizes" with Codex" (eg., the US) or adopts Codex texts as its domestic laws (most of the developing world).

In effect, Codex standards and guidelines mandate unparalleled levels of toxicity plus global under-nutrition, the very same condition to which the World Health Organization (WHO), one of Codex's parent organizations (Food and Agriculture Organization, or FAO, is the other) attributes the global epidemic of non-communicable diseases of under nutrition: cancers, cardiovascular diseases, stroke, diabetes and obesity. These diseases are the principle killers in the developed world (after "properly" used pharmaceuticals) and are rapidly becoming the principle killers in the developing world as well. These preventable diseases are also major profit centers for industries that depend on illness for their profits: the pharmaceutical and medical industries.

At this year's Codex Alimentarius Commission (CAC) meeting (FAO Headquarters, Rome, July 2-7, 2007) the procedure has been radically altered. In previous years, standards and Guidelines proposed by the various Codex Committees and regional associations were discussed (at least to some extent) by the national delegates to the annual CAC. Unjust, dangerous, unwise or unhealthy Codex texts were opposed by countries whose self interest or public health was harmed by the text under consideration. If the standard or Guideline was not approved or needed to be revised, it would either be killed or sent back to Committee for revision, often along with specific instructions to that body. When ready, the text would return to CAC for further consideration, advancement to another level of acceptance or rejection.

That has changed dramatically. I have written that the anticipated date for implementation and globalization of total control of the world's food trade appeared to be dramatically off track. Things were not moving very rapidly despite the near-desperate efforts of Committee chairpersons like the German Rolf Grossklaus, MD, of the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU) and the Canadian Ellen Mackenzie, Ph.D. of the Codex Committee for Food Labeling, to rush decisions, curtail discussion and gallop through their view of the agenda at a dizzying pace. Of course, pro-health options like the WHO's Global Strategy on Diet, Physical Activity and Nutrition (mandated for implementation by Codex by both WHO and FAO) somehow never seemed to garner adequate time for meaningful discussion leaving implementation strategies in the dust and in the dark.

This year at CAC not only has the Natural Solutions Foundation been prevented from mingling, eating or talking with the Codex Delegates (by security guards on several occasions!), but the delegates have been prevented from discussion of the standards and Guidelines they are advancing! It is strikingly reminiscent of the US Senate being handed sealed copies of the Patriot Act weeks after 9/11, assured that their security clearances were not high enough to read the law but being instructed to vote on it anyway. If you recall, 99 US Senators did. Robert Bryd of Virginia was the sole member of the Senate to refuse to buy that pig in that poke, and Dr. Ron Paul of Texas one of the very few in the House to vote "No" to protect the republic whose founding we celebrate this week.

At CAC, the Chair now urges members to adopt whatever texts have been brought forward, whether they agree with them or vehemently disagree. Texts and amendments to them are presented "en bloc" for approval en mass without a single word of discussion, if the Chair can bully the delegates into it. When delegates try to overcome this de facto gag rule, either they are told that they are getting in the way of the good work of the CAC (shame) or that they are making it impossible for the CAC to complete its work (guilt).

Those few delegates who try to clarify the irregularities of the process or the dangers of the standards or Guidelines are told that they are getting in the way. Since Codex refuses to define "consensus" and the Chair's agenda is set before the meeting, the Chair does whatever the Chair had intended to do in the first place. An example: today new standards were authorized for a whole group of dangerous industrial chemicals (Pesticides) whose MRLs were simply evaporated by the Chairman's administrative fiat. This means that there is no upper limit to the amount of these metabolic poisons which may be incorporated into your food.

At least one country understands what is happening. China routinely "intervenes" with one simple comment: It is China's position that this matter is within its national competence. The Chinese delegates apparently understand the Codex Two Step Process.

Critical health freedom choices this summer mean making sure that your country does not harmonize with Codex Alimentarius and that your national scientists and legislators follow the Codex Two Step Process to make pro-health choices where Codex makes pro-industry ones and to protect your right to clean, unadulterated and healthy food. If you are a United States citizen, that also means signing the Natural Solutions Foundation Citizens Petition to force the US Government to comply with US law, rather than Codex standards and Guidelines with reference to vitamins and minerals.

In the last days of the past year the President signed the Adverse Event Reporting Act that requires supplement sellers to report reactions to their products; we view this law as potentially beneficial to consumers. At the same time the Food and Drug Administration - the FDA - issued a draft "CAM" Guidance (complementary and alternative modalities) that Congressman Ron Paul, MD, called "an abuse of FDA power..." This is an attempt to grab power over our remedies traditionally overseen by state law, by an agency that has show itself unable to effectively implement its confused and contradictory authority over foods and drugs.

The FDA issued the draft Guidance on December 26th, but did not bother to give the public notice until February 26, 2007. Then the public had its turn to comment. Nearly two hundred thousand people did so, telling the FDA to leave our alternatives alone. This same grassroots movement has swelled the ranks of NSF supporters. We've joined Dr. Paul in condemning this blatant power grab and have called for meaningful reorganization of the FDA. The FDA needs to focus on its core mission of protecting the public from dangerous, side-effect causing, prescription drugs that, these days, have much more in common with chemical toxins than natural materials. To do that, the agency's food jurisdiction should be shifted to the US Agriculture Department or other existing agencies.

Every Federal agency, however, is capable of causing great harm to the public and the USDA is no exception. Early June, the Department approved the addition of 38 more non-organic source materials to products that can continue to mislead us by pretending to be truly organic. This continues a general and disturbing trend to dilute organic standards. The NSF supports strong organic standards and supports the disclosure of conditions, such as irradiation and genetic modification, that allow the public to make informed choices.

Late in June the FDA, 14 years after being instructed to do so by Congress, finally issued what are called "Good Manufacturing Practices" regulations to the dietary supplement industry. This 467 page document has capacity to reduce consumer access to high potency nutrients and admits that many small companies will be driven out of business as a result. We are very concerned about this increase in regulation. Just previously, the US Senate adopted the FDA “Revitalization” bill which would "solve" the problem of FDA failures by granting it more power to abuse. When the public rose up against that bill, it was amended to protect dietary supplements from its new powers. But the House must now consider it, as HR.1561, which ought to be further amended to further protect natural remedies. We note that Dr. Paul has introduced the Health Freedom Protection Act, HR.2117 that would do just that. Our Representatives need to hear from the public so they support our freedoms with Dr. Paul instead of the new restrictions proposed by Sen. Kennedy. So far, NSF supporters have generated over 87,000 messages to the House supporting HR.2117 or asking to amend HR.1561.

At the same time, various regional and international agencies continue to threaten market access to wholesome foods, natural remedies and dietary supplements. As always, the FDA's announced intent to "HARMonize" our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat. Codex Alimentarius - the world food code - still remains too much a creature of big governments and big commercial interests, although a nascent alliance of health-friendly countries, inspired by information from NSF, is making inroads and this alliance recently protected healthy babies from being exposed to fluoride in their formulas.

This is an especially exciting time for the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawful and correctly used prescription drugs.

The wise people who wrote the Declaration of Independence told us, "But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security..."

It is now time for people concerned with natural solutions to our health care crises to declare our independence from the failures of the bureaucratic system and to demand new freedoms to offset and correct the old failures of the regulators.

Ralph Fucetola, JD
Trustee
Natural Solutions Foundation
http://www.vitaminlawyer.com/

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation

http://www.healthfreedomusa.org/
http://www.globalhealthfreedom.org/

Citizens Petition: www.healthfreedomusa.org/index.php?page_id=184

HR. 2117: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754


HR. 1561:

http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344