Patented Medicine, Herbal Remedies, and FDA approval

The majority of people think that we live in an advanced democratic human rights-granted world of equal opportunities painted by the mainstream media governmental propaganda. Let me ask this. If they (people that own big pharma, banks, and other industries) actually researched and spend hundreds of millions of dollars to create medications that actually cured people, how would they continue to profit off our illnesses?

Or would they just treat symptoms and lie? And actually, so much more than just lying. They murder people, destroy people, and waged war against anything that threatens them. Anything that they cannot control is a threat. Both in the form of nature or in the form of technology that cannot be patented or technology that can be patented but is not very profitable because it cures disease instead of treating the symptoms. These people know exactly what the game is and what they are doing.

Anything that comes from nature cannot be patented. There are not interested in that. Everybody can grow a plant. That is a direct threat to industry interest. If there is a cure for some disease in the form of lifestyle changes, there are not interested in that. If there is some medicinal herb that works it must be destroyed. If it cannot be destroyed, then it has to be forbidden by law.

You translate that into the real world of FDA approval, and we get no interest in research into not patented medicine and no interest in research of conventional patented medicine that will really help people in the long run. And of course, the destruction of all things that exist already and has been proven to help. The way they do that is by the FDA.

People don’t realize that the FDA regulations it is illegal to use anything in existence unless it has been tested. You see the catch-22. Nothing from nature will ever be proven to be effective or safe because there is no one that is going to do the research that has the money to do the test. After all, there is no patent at the end of the test and no profit. They have control over you, and they do not like you. FDA does not do any testing of the drugs or supplements. It is relayed solely on submission from the drug companies when it makes its approval. In retrospect, it is designed to protect the industry, and it is a conflict of interest. It also has one more benefit for the industry. There is concern that the FDA has the power now to remove from the marketplace all of the new dietary ingredients that were introduced after October 1994. This includes a big chunk of supplements that are on the market.

People can go and buy potent herbal extras or other supplements and they can regulate their diet and lifestyle and get off the prescribed medicine, so the new law was passed in 1994. The FDA requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the FDA about these ingredients. Information requirement is to include information that is the basis on which the manufacturer or distributor has concluded that new dietary ingredients will reasonably be expected to be safe.

What the safe actually means? In the first decade of the new dietary ingredients guidelines, the FDA took a conservative view of what dietary ingredient was. They will say that if it was in the food supply and if you can show that it is in the food supply then they will allow you to sell it and not require you to make a scientific submission. In the ’90s FDA under pressure from the industry took a more restrictive approach by expanding the definition of a dietary ingredient and starting to keep more things out of the market and increasingly trying to regulate even the old supplements. The public reported purpose of the guidelines was to promote public safety for consumers. In reality, it had other intended purposes. Most of the supplement companies today were not present in 94. Of those that existed hardly any had records. What FDA is saying now is that your product is approved but only if you can scientifically prove it is safe because being on FDA published list before 94 is no proof anymore.

So you have to do the studies, and that seems fine if you are not familiar with the already mentioned catch-22. And of course, when the industry does their studies, they have billions to spend to alter the result in the desired way. We can only remember stories about Aspartame and MSG approval. This would be a topic for separate articles.

So today FDA basically requires a sort of preapproval from the companies and represents a sort of economic barrier for entry and results in the loss of small supplement manufacturers and the creation of a small number of big supplement companies that can be purchased by the big pharma and controlled.

It costs somewhere between $150,000 to about $1.3 million for one NDI (New Dietary Ingredient) submission. It is also made clear that approval of NDI is valid only for the company that submitted it and cannot be transferred to any other company, even if it is the same ingredient. They require every company that sells the same product to submit a new dietary ingredient submission. As a result, there are now even fewer supplements available, and they are even more expensive. The supplements that are pushed are the ones that are useless or dangerous but are in the industry’s interest to promote, like protein powders and bodybuilding chemicals. However, if you want to buy, for example, curcumin extract as support for cancer treatment, it will be more expensive than it should be. There were even attempts to force curcumin to be a prescribed pharmaceutical drug, but they failed.

However, the intention is there, and it goes in one direction. If there was any way to ban the turmeric plant and many other plants, they will gladly do it with no hesitation. Because there is not, or it is hard to do, because curcumin does not have any psychoactive properties and it is just a spice, there is nothing that the industry can do. However, then we have these forms of economic manipulation going on. Ingredients that we use to manage our health, from foods to concentrated nutrients sold as dietary supplements, are now being given requirements to prove safety before they can be used. Also, if hard to believe, but they want to ban medicinal foods too. The FDA Food Safety Modernization Act of 2007 (FSMA) gave the FDA unprecedented power over food. It gave the power to ban interstate commerce with any food in existence that has been studied for medicinal use. This act gives the FDA more power and more money to hire agents to run around the countryside of the USA to begin to arrest small organic gardeners and raw dairy farmers and intimidate even people who grow food for themselves in their own yards and gardens.

The idea that you take some plant that is grown for millennia and requires to enforce all kinds of double-blind placebo studies that underline regular drug testing is designed not to protect consumers but to remove the choice and to take responsibility for our own health from us and put it in the hand of industry and its enforcer the government.

And they did it already to the empirics and natural healers at the beginning of the 20th century but did not target individual people. Now they are going to target regular people as well. What are they going to do with this new authority is the same thing that they have done until now. Every product that comes on the market would be assumed to be an unsafe product, any natural herb should be assumed to be dangerous, any other medical treatment not approved by the FDA should be assumed to be dangerous, and every natural remedy, supplement, or anything else if not approved should be assumed to be dangerous and are going to be removed until people manufacturing that product prove that the product is safe. And if a product is already proven to be safe, the approval needs to be done again for every single company. The small farmer who wants to sell medicinal herbs is going to be treated like selling dangerous substances for example like selling poison or cannabis. It started to happen already today, but the intention is to be even more enforceable in the future.

By current law, what an agency can do to small farmers or small companies that did not approve its products is they can come and take everything the farmer or company owns of any value. They can do it without any advance notice, weapons drawn, barging into the business, seizing assets, freezing bank accounts, seizing all the products, and seizing all the material inside the offices, computers, papers, and files before trial or conviction. Charges can be both civil and criminal and can result in incarceration for a lifetime. Even if you don’t get indicted, what they do is ruin someone’s business completely. They did start to do this to some extent to local farmers, especially in regards to raw milk and herbal remedies, but there was some backlash, but that did not stop the intention.

What this is in reality all about is to start to push small businesses out. If you have a small family supplement company can you afford to spend up to 1 million for approval for every product? What would you do most likely is to send your kid to college so that he can get a job at a regular pharmacy and close. It is not logical to conclude that the government forces companies to test one ingredient that has been proven to be safe over and over again just for safety and what is completely out of the scope of logic is to force payment that goes up to more than a million dollars.

The real intention is to economic burden and then remove the small organic farmers and businesses, natural herbal doctors that are outside of the medical line, and all other “threats” with this well-calculated economic warfare.

And this is not just the US it has gone global.

War on plants had been waged by industry monopolists for more than 100 years now, and the final chapter is already written in the UN.

It is called Codex Alimentarius. That is a fancy Latin name for the world food code. The ambiguous title “Codex Alimentarius” is no accident. It was written by the same companies and even in some cases the same individuals, who wrote the Auschwitz concentration camp slogan “Arbeit mach frei” (“Work makes you free”). It was created in 1963s in the UN by the same oligarchy. It is a body that was established by the Food and Agriculture Organization of the United Nations (FAO), and the World Health Organization (WHO). In fact, Codex is the next stage of intention for multi-national corporations razed above national sovereignty and enforced upon the world. The five segments of business that benefit from Codex are Big Bio-Tech, Big Chem, Big Medica, Big Pharma, and Big Agra biz.

References:

Passages selected from a book: Pokimica, Milos. Go Vegan? Review of Science Part 2. Kindle ed., Amazon, 2018.