Discover Why FDA Is Not What You Think!

Healthy or Poison?

FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

Check out the FDA link for more information.

After reading the FDA Mission statement, it appears pretty straight forward that this organization is all about protecting us, the American Public, from all the bad stuff that can present itself in our food, drugs, and medicines. All kinds of products need oversight. Against unscrupulous companies that we clearly know are more interested in profits over consumer safety and health.

Most are familiar with the idea of what happens when the fox is in the henhouse. So see if this makes sense for a drug company wanting to submit a new product for approval. FDA has to do due diligence and have said product tested. That process includes inspecting, assuring it is safe for human consumption among other listed procedures.

So if FDA allows companies to submit their own reviews of products and accepts that as evidence of due diligence, the fox is loose! So guess what? That is a common practice of the FDA. So much for a government entity protecting the public safety. Here is a more in depth report on just what the relation is between the FDA and BIG PHARMA. It’s going to sound like some Fiction Thriller. Shadow oligarchs, entrenched fortunes of historical families long known and suspected of exercising financial control in many areas. It’s all there. Just hard to believe we are under such control and not know it.

Some other actions, or inactions of the FDA are the following;

  • approves after product already in marketplace
  • does not “approve’ rather only inspects
  • does not develop or test before approval
  • FDA experts only review the results of laboratory, animal, and human clinical testing done by manufacturers
  • an approval simply means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

So drugs are one of the big areas where FDA is supposed to perform due diligence. Antibiotics, pain relievers, mood altering medications, anything made by BIG PHARMA. Right? Wait a minute. Is everything made by the Pharmaceutical Giants? The simple answer is “no.” So what else does FDA approve beside the biggie, which is drugs?

Take compounded drugs. What is a compounded drug. FDA defines it in this way. “In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.

Ok, so a drug specifically tailored for an individual. Done under what would appear to be a sanitary, clean, pristine environment. Supervised or done by licensed, trained individuals. So why are compounded drugs not FDA approved?

Here’s another. FDA doesn’t approve tobacco products. So are these tobaccos clean of pesticides, herbicides, chemical fertilizers, things known to pose as much danger to humans as the tobacco itself? Who knows!

Now here is something that raises eyebrows. FDA experts review the results of appropriate tests done by companies for food products. The FDA does not do the tests. It’s a review of those done by food companies. Here’s another bunch of “foxes” and the hen house is empty. Basically any food company can present any food product and a test they have done for approval by the FDA. Sound too simple? Maybe even risky? Knowing that, how much faith and trust would you have in any product approved by the FDA?

FDA also has a voluntary notification process under which a food manufacturer may submit a conclusion that the use of an ingredient is GRAS, or generally recognized as safe. Again, not the FDA but the “fox” is saying, “just trust us!” Remember that old saying about “give ‘em an inch and they’ll take a mile?” Given that sort of flexibility, what do you think happens.

How many recalls have been issued for salmonella, and other food borne bacterias? Where was the oversight to protect the public from those BEFORE it got into the marketplace? Are you beginning to see a trend? Stuff that is harmful to human consumption, at ALL levels, gets into the marketplace unchecked by the very government organization charged with protecting us from malfeasance. Yet there it is hiding in plain sight.

The FDA does not approve animal foods but does approve food additives in animal foods. Where does that make sense? So you could have rotten horse carcass in dog food with additives to make it look, smell, and probably taste good to your dog. What are the chances of some infection or other abnormality happening to Man’s Best Friend?

Did you know that FDA does not approve cosmetics? All those creams, powders, lotions, touted to be so great for helping women to stay young, beautiful, with soft, elastic skin. With this exposure how safe will women feel about their cosmetics?

FDA doesn’t approve medical foods like what? PediaSure? Ensure? Glucerna? (According to Wikipedia) The term medical food, is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

Here are some specific examples;

  •     Axona (caprylic triglyceride) – Alzheimer’s disease
  •     Banatrol Plus (banana flakes/Bimuno, galacto-oligosaccharide – diarrhea
  •     Deplin (l-methylfolate) – depression
  •     Fosteum (genistein aglycone/citrated zinc

bisglycinate/cholecalciferol) –       osteopenia and osteoporosis

  •     Limbrel (flavocoxid) – osteoarthritis
  •     Metanx (L-methylfolate calcium/pyridoxal

5′-phosphate/methylcobalamin) – diabetic neuropathy

  •     Theramine (l-arginine, 5-htp, histidine, l-glutamine) – myalgia

(end Wikipedia)

So these labeled “medical foods” used for things like depression and diarrhea, are not approved by FDA. Yet they are out there in the marketplace. To be recommended, supposedly by medical practitioners, for the various ailments noted for each. What could go wrong? Somehow, the idea that these are called “medical foods” formulated for specific issues with no oversight should cause some raised eyebrows.

Here’s somewhat of a disclaimer: (also found on Wikipedia) Medical foods are not required to undergo premarket review or approval by FDA. Additionally, they are exempted from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990

Here’s one that seems to be at odds with itself. FDA doesn’t approve infant formula. But manufacturers of infant formula are subject to FDA’s regulatory oversight? FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. For what reason if they don’t approve the formula?

Sounds like it’s more about charging the fees for all the so called supervision, but no stamp of approval. And this is what new parents, unaware of all the avoidance by the FDA, feed the new babies. On top of that, there is no approval of the food label or Nutrition Facts panel. By the way, that’s on all foods! Sure makes you wonder if there is really any food in the jar? Or if you really want to eat it.

FDA doesn’t approve dietary supplements. It is stated that dietary supplement manufacturers and distributors are not required to obtain approval from FDA before marketing their supplements. However, before a firm markets a dietary supplement, the firm is responsible for ensuring that;

  • The products it manufactures or distributes are safe
  • Any claims made about the products are not false or misleading
  • The products comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations in all other respects

So these companies and products are not approved by the FDA, but must adhere to specific regulations. A disclaimer must be included with dietary supplements stating *These statements have not been evaluated by the Food and Drug Administration.These products are not intended to diagnose, treat, cure or prevent any disease. *

Although supplements, like Omega3 fish oil,  are not considered “food,” they still fall under the FDA. However, the Center for Food Safety and Applied Nutrition have oversight of these products. It should be interesting to note that if a supplement applies for approval by the FDA, and is received, it then becomes a drug! Do you note an oxymoron there?

If you’ve read this far what is going through your mind? Is there anything you can trust? Our food chain has really suffered with chemicals, pesticides, herbicides, that have suggested alterations to our health. then there are ultra hybrids such as dwarf wheat, and GMO’s we have to contend with. Worse yet we don’t even know when we are consuming such things as neither are required to be present on food labels.

When you start researching the internet about the FDA, BIG FOOD, it’s links to BIG PHARMA, millions of links show up on the topic. We are in a war and don’t even know it!

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Alan Written by:

Alan is retired and resides in Quito, Ecuador. Writing is a passion which has resulted in two eBooks thus far, with more in the works. Married 47 years with four sons and 13 grandchildren, provides potential grist for the mill! Alan is a charter "Boomer", a Viet Nam veteran, committed to roasting his own coffee and writes about whatever pops into his mind. He loves to build and ride recumbent bikes, play racquetball, writes almost daily, travels Ecuador, and talks to anything that does not move fast enough! The twinkle in his eye is a combination of the sun, and an active sense of humor. His desire to encourage others to write is being answered through his articles on the Internet.