Guerrilla 101: Small Change to FDA Law Makes All the Difference

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Guerrilla 101: Small Change to FDA Law Makes All the Difference

Post Number:#1  Post by ofonorow » Wed Jul 05, 2017 6:11 am

Do you live in the USA and want to change the world? Or at least help us get the monkey off our backs - and many other backs who sell nutritional products that compete with drugs?

We asked our attorneys, Emord and Associates, to draft a change in the FDA law that would focus the FDA on regulating drugs - not vitamins - just because a vitamin makes a "disease claim."

The changes are only about 3 pages. You can help by explaining the problem to your representative (i.e., that the FDA is using government resources to attack vitamin C) and asking your congressman or senator to draft the change as an amendment, introduce it in Congress, and/or support it. :D


https://vitamincfoundation.org/pdfs/2017-6-22-NEWFDALAW.pdf

Hi Owen,

Attached is our recommendation for amending the federal Food, Drug, and Cosmetic Act so that food and dietary supplement products will not be regulated as drugs even if they make disease claims.

If you find a Congressman or Congresswoman to introduce it, his or her legislative staff will format it for introduction as an amendment.



We have been told that passing this is impossible, or it is at least a waste of time to try, because such a change would turn the powerful Big Pharma lobbyists into a snarling pack of wolves.

The only way to fight Big Pharma is with the help of a lot of people.
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#2  Post by Johnwen » Wed Jul 05, 2017 11:03 am

The US Code is like a spider web or the internet if you will! To lock in on one subject you must follow the golden road around to get the full scope of the intent of what your reading. In this case ;

(FYI this § is what is known as a silcrow or better known as a section sign! On Windows push and HOLD “ALT’ KEY then punch in 0167 and let go! And you get a §)

21 US CODE Chapter 9 Subchapter IV §350

Authority and limitations of Secretary; applicability

(1) Except as provided in paragraph (2)—

(A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;

(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;

(C) the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural— (i) vitamin, (ii) mineral, or (iii) other ingredient of food, within a food to which this section applies.

(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women.
For purposes of this subparagraph,[1] the term “children” means individuals who are under the age of twelve years.


As you can see this section throws the wrench in making any claims that these FOODS can fix anything! However If it’s claimed anywhere else, say the Inet they can point the finger at the seller for promoting this idea by selling the FOOD mentioned some where else. Or you could say “Guilt by association!” Even though the seller had no knowledge of anyone else’s health claims. So the safe route is to label the product with a disclaimer which would disavow their knowledge of other’s claims.

So my advice when reading these codes is to follow the path and read and see if what your trying to say or point your trying to get across isn’t really a law somewhere else.
You think the Internet is a web? Wait till you get into the US CODES!!!
Or try reading the 142 page Health care bill in the Senate and following all the laws referenced in it then try applying it to the referenced laws! Then you’ll realize why each senator has so many aides working for them!

Good Luck!
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Re: Small Change to FDA Law Changes the World

Post Number:#3  Post by ofonorow » Wed Jul 05, 2017 11:48 am

I appreciate the feedback. This isn't my wording, this is the wording of experienced FDA attorneys. We asked them how to take vitamin C (or any food) out of the realm of FDA drug enforcement merely because of a health claim. This is there answer.


Combined with what you seem to have found, it then becomes almost ironclad.
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#4  Post by davea0511 » Wed Jul 12, 2017 9:57 am

Owen, I was really sorry to hear about the FDA's letter.

You are absolutely correct that the vitamin c foundation needs to have a new mission, and that is to actively campaign, not just complain, against the egregious tax-funded favoritism and bias that controls (and holds hostage) healthcare in the US.

I applaud your efforts, and I wish you the best of luck in deregulating the treatment of foods as drugs. I'll help you campaign wherever possible. In fact I'm doing something similar and perhaps we can work together.

I have recently have started a new non-profit called DASH - Detanglement Alliance to Save Healthcare, for this very purpose (to campaign to detangle corporate interests from healthcare policy). I have thrown together a website showing the objective with a preliminary set of initiatives that *any* science advocate, health advocate, and good-society advocate should quickly embrace (presuming they are on the up and up):

http://joinTheDASH.org

All of the 22 initiatives listed there are beneficial to the cause of promoting non-proprietary treatments which are often unfairly relegated to the trash heap by the FDA. In particular to this situation, you’ll want to look at initiatives #11 (Better detail and follow up for inconclusive results) and #17 (FDA watchdog-action will trigger a treatment investigation).

Interestingly (and I hope this will not be a sticking point for you), you will see that the DASH initiatives do not impugn watchdog efforts, but rather make them fair and force the NIH to fairly do the research ASAP when the FDA flexes their muscle, which research will ultimately justify high-value and relatively safe treatments regardless whether they come from big pharma or are food-based or non-proprietary (which, like orthomolecular medicine, receives most of the prejudice from the FDA and from willfully-ignorant members of the medical community). This way we force the FDA and NIH to promote the cause of good non-proprietary treatments, rather than allowing them to paint non-proprietary treatment proponents as the enemy to science (which is false and which perception does more harm to our agenda than anything else).

I do not think impugning watchdog efforts is ever going to be fruitful, and honestly I have concerns whether trying to avoid watchdog efforts is going to play out in our favor, and while I support efforts to separate out treatments based on vitamins from big pharma treatments, I think we need to do more to prevent the FDA from following the agenda to maintain the pharma-empowered status quo and from promoting their willful ignorance into policy that gives pharmaceutical companies a huge advantage at the cost of severe public endangerment. Watchdog efforts can be good, but the way they go about it is bad and needs radical transformation to work from a position of knowledge-based authority regarding non-proprietary treatments (which the FDA currently doesn’t do). When they do their job fairly it will work to our favor, because the science is on our side, and the public suspects that is true ... knows there is collusion at the highest levels, and will support a science-based agenda over an agenda that to many will look like: "let us do whatever the hell we want because it's vitamins". Of course I know that isn't the objective of the legislative changes you're sponsoring, but there is about $900,000,000,000 worth of commerce every year in Big pharma, and those fat cats on the receiving end are extremely motivated to market your objective that way with more influence under the table to your congressmen than any number of petitions will do.

So let me propose that we demand scientific integrity to force our institutions to work in our favor.

When research and policy is done right, treatments and claims like many of those made on your website will be carried through phase 4 testing, and the results known and accepted as scientifically sound. Right now those with the purse strings are doing everything they can to prevent that from happening, and our system allows them to do that ... by using our own tax dollars (about 40 billion per year) to direct NIH research activities and bias FDA rulings against non-proprietary treatments.

Preventing gag orders like the one you received is precisely the result of corporate interests. My approach is different, but I’ve looked at this 100 ways and the DASH approach to force the healthcare system to exercise fair and balanced scientific integrity is the only method that I believe every medical doctor will stand behind. If they aren't on-board nothing will change.

Thanks,
David Austin
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Re: Small Change to FDA Law Changes the World

Post Number:#5  Post by ofonorow » Thu Jul 13, 2017 6:29 am

Wonderful David.

I know when I contacted my contacts who have links to Trump - they will not spend any political effort on changing the law. The feedback is that it would be easier to change the regulations at the FDA - rather than try to change the underlying law. I disagree because changing the law would make an ever lasting change - so long as we have something called the FDA. (Helping the public understand the problem is another issue. If there is no money, then there must be public support.)

It is also a crime that a $27 billion funded National Institutes of Health (last time a checked - a long time ago) makes NO effort to find and/or investigate the real cures for disease. This $27 billion in tax payer money is essentially funneled, one way or the other, into the drug industry.
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#6  Post by ofonorow » Sat Jul 15, 2017 4:09 am

Rereading and thinking about DASH, e.g.

So let me propose that we demand scientific integrity to force our institutions to work in our favor.


One problem is that our current educational system has created a lot of fat, dumb and happy Americans.

And even if your approach is correct, the doctors you have in mind to support it have obvious self interests. (If the truth about Pauling's invention was revealed, most cardiologists would be on the street looking for work.) I am all for scientific integrity, (See Hickey's book TARNISHED GOLD), but those with the $$$$ get to decide what "science" is real science, by virtue of their control over the media and medical journals. Watch dogs over these outlets are a very good idea..

So how do we force our institutions to work in our favor? The idea I had last night is to file a federal law suit to the effect that FDA law violates the general welfare clause.

Current FDA law turns substances with any value into drugs - so that they can then be suppressed. (Vitamin C just happens to be well known, so it is an easier "sell" to our fat, dumb and happy friends. There are more important substances being suppressed.. but that is another story.) Taking the wraps off these developments, permitting free competition, and the world changes the way we want it to, because the power of Big Pharma rapidly diminishes - naturally.

I think I know that the commerce clause to the U. S. Constitution is what empowers the government to form the FDA, and that the general welfare clause has, at times, been restricted to the area of taxation.

However, if a federal law cannot favor one state over another, how can law that favors or protects pharmaceutical interests be constitutional?

I am thinking of filing a federal law suit to the effect that the FDA law, or the portion that classifies all substances as drugs, and then effectively shuts down free speech, is unconstitutional under the general welfare clause and first amendment.

I envision the press release something like TINY VITAMIN C FOUNDATION SUES UNCLE SAM: FDA LAW SUPPRESSING VITAMIN C VIOLATES THE GENERAL WELFARE CLAUSE :)
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#7  Post by Johnwen » Sat Jul 15, 2017 3:04 pm

Owen
I would suggest you Venture into title 21 of the US Code instead of going into the general welfare clause or Amendment 10.
In Title 21 clearer definitions of what constitutes something as a Food or Drug would clear up a lot.
Right now You can go to any foody website and you’ll see their making all kinds of health claims for what this that or the other can do for a person and none of them have to issue a disclaimer.
However if you take a component of these foods that do all these wondrous things and isolate it, you can’t make the same claims without a disclaimer that it don’t do what they say the food can do!

There is where the problem lies, unless they can show that one is in fact different from the other! Notice I said “THEY!”
They should not be treated differently! Let’s just say they are “Discriminating!”

My 2 cents on this subject! :idea:
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Re: Small Change to FDA Law Changes the World

Post Number:#8  Post by ofonorow » Mon Jul 17, 2017 7:12 am

Johnwen wrote:Owen
I would suggest you Venture into title 21 of the US Code instead of going into the general welfare clause or Amendment 1.
In Title 21 clearer definitions of what constitutes something as a Food or Drug would clear up a lot.


Yes, this is exactly where our attorneys suggested new wording. https://vitamincfoundation.org/pdfs/2017-6-22-NEWFDALAW.pdf

El problemo is that without the support of all the fat, dumb and happy Americans who get their news from the Mainstream media, there doesnt seem to be a clear way to overcome the Big Pharma lobby. It would be a "hard sell" because these changes to the law won't engender public support. And even if people understand the concept, Stop the FDA from treating vitamin C as a drug, how do we get the word out.

The idea behind a constitutional court case is that either we only have to convince 8 to 12 people (jurors), or if we make it to the Supreme Court, 5 supreme court justices. More expensive,but more manageable. What is going on is wrong. It is unconstitutional. They could rename the FDA the Federal Death Agency - and it would be a better description of their activities.

So getting the law changed - either by legislation or the courts will be extremely difficult.

Your idea has always seemed to be that the current law is already clear.... That we should be able to work change under the current law?


Right now You can go to any foody website and you’ll see their making all kinds of health claims for what this that or the other can do for a person and none of them have to issue a disclaimer.
However if you take a component of these foods that do all these wondrous things and isolate it, you can’t make the same claims without a disclaimer that it don’t do what they say the food can do!


Your saying "whole foods" are exempt, but extracts or components seem to be attacked? Interesting :D They fear "supplements." (Not sure if this observation does us much good, or would help liberate the "invention" that would rid kids poisoned by the mercury in vaccinations of their Autism - that the FDA has "squashed.")


There is where the problem lies, unless they can show that one is in fact different from the other! Notice I said “THEY!”
They should not be treated differently! Let’s just say they are “Discriminating!”

My 2 cents on this subject! :idea:
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#9  Post by ofonorow » Mon Jul 17, 2017 1:52 pm

Drugs kill people.

What about a basic litmus test for a drug based on some LDL-50 number?

i.e., if the LDL-50 (Level that kills 50% of the laboratory animals) is less than water - disqualified from being treated as a drug period.
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Changes the World

Post Number:#10  Post by ofonorow » Mon Jul 24, 2017 10:40 am

Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”

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Re: Small Change to FDA Law Makes All the Difference

Post Number:#11  Post by ofonorow » Thu Jul 27, 2017 6:23 am

I thought I saw someone elses post for a Vitamin C Petition (If you find it please post) ... can't find it now - but note the last post.

Takes 2 minutes to sign. This small change in the law frees up the market.

There are guerilla style things that can be done in the meantime, with the help of social media and family and friends.

#1, comment on the blogs of the media outlets when they publish the fake news stories damning supplements, eg. something like

This is a good article - if you work for a large drug company and make money when people become chronically ill. Otherwise, the question has to be asked of the author and media source, why would you want to harm the health of your readers? Where is the balance, i.e. the contrast with prescription medications, which are one of the largest, if not the largest cause of death


#2, it turns out the FDA has been unable to control on-line product reviews, so a good tactic is to review vitamin C products... "My dad reversed his heart disease taking vitamin C..."... or even, "I was able to control and reverse my heart disease following Linus Paulings advice"...
Owen R. Fonorow, Orthomolecular Naturopath
My statements have not been evaluated by the Food and Drug Administration. Any product mentioned is not intended to diagnose, treat, cure or prevent any disease.”


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