THE FDA AND PINHOLE GLASSES - 2012
In 1999, the nonprofit organization, CENSORED BY THE FDA, decided to challenge the FDA's attack on pinhole glasses because with the Internet growing rapidly, pinholes could be bought from many sources overseas. The optical industry could not keep them from public knowledge any longer. Thus, pinholeglasses.org was created. For the next 12 years, four different male FDA Commissioners stood up to pressure from the optical industry and did not interfere with the sale of these harmless devices. These were Henney in 1999, McClellan in 2002, Crawford in 2005, and von Eschenbach in 2006. Then Obama appointed Margaret Hamburg to head the FDA in 2009 and a new attack on pinhole glasses was launched in 2012. Then, in 2016, Obama appointed Robert Califf as the new head of the FDA. It remains to be seen if there will be any changes in the way this agency treats the public it is supposed to serve.
It is impossible to determine exactly who is responsible for this attack on pinholes, but it could well have been initiated by someone several levels down from the top in the FDA who wanted to show off his importance and justify his salary. And the optical industry could have lured him with the promise of a high-paying job when he leaves the FDA. This kind of bribery is routine in our government. But this would not have happened if it were not for the overall anti-consumer policies of the FDA.
In March of 2012, our order of 4800 pinhole glasses from China was blocked by the FDA at the UPS hub in Louisville, KY. We were informed by the FDA Compliance Officer in Cincinnati that an FDA "Alert" had been issued. We found out that the alert was several years old and had been issued against a South African company that was mailing pinholes to its US customers and making claims about pinhole use that the FDA didn't like. The company was no longer in business and the alert din't pertain to any other company anyway. When this was pointed out to the Officer, he found other stupid reasons to ban the import. We ordered an emergency shipment of 2400 pinholes which were then stopped at the Fedex hub in Anchorage, Alaska. Equally stupid reasons were given. The pinholes would not be admitted until they were "in compliance" with FDA regulations. But, they gave no indication of how that could be done.
It was obvious at this point that word had gone out from top FDA officials to Port of Entry customs agents to be on the lookout for boxes of eyeglasses destined for the nonprofit organization, CENSORED, and to open the boxes to see if they contained pinholes. If so, they were to sound the alarm by contacting the local Compliance Officer. So, another attack on pinholes had begun.
We took our protests to Jeff Shuren, head of the FDA's Center for Devices and Radiological Health (CDRH) and to his boss, FDA Commissioner Margaret Hamburg. We never got a reply from them. They remained in seclusion and let their underlings fabricate all kinds of lies to try to get rid of us. They said we had made ridiculous health claims such as "pinholes can prevent cataracts" and "pinholes can prevent macular degeneration", which we would never think of doing. Did Hamburg wake up one day and think, "Let's get those harmful pinholes off the market once and for all?" Obviously not. The optical industry had again exerted its influence and the FDA folded to their pressure.
The result was that all 7200 pinholes in both shipments were destroyed. All the effort made by Chinese workers to produce these useful devices was wasted. The work and fuel used by the airline to bring them here was wasted. And we lost tens of thousands of dollars. Of course, this didn't bother the bureaucrats at the CDRH. After wasting two months trying to get some sensible information out of these people, further money had to be spent to hire an attorney in June, 2012 to deal with the FDA. All this wasted money could no longer be used to further our charitable goal of assisting children in need. It was just a sickening waste of money and a lot of headaches for everyone.
Only after the expenditure of considerable money for legal fees were we able to get the FDA to stop lying and abide by its own regulations. We found out that if we claimed that pinholes were useful only as sunglasses, and nothing else, we could once again import and sell them. So why didn't the FDA contact us with this request in the beginning so we could change the website wording? We could have done this in one day. But that was not the FDA's agenda. They wanted to ban the sale of pinholes completely and also strike a blow at our nonprofit organization which is critical of the optical industry in general. They could kill two birds with one stone, so to speak.
There are numerous Internet sources of pinhole glasses where false statements are made, such as "Use pinholes 15 minutes per day and improve your vision" or "Improve your vision by exercising your eyes with pinholes." Why didn't the FDA go after these companies? Instead, they tried to shut US down because the optical industry does not like we say elsewhere about how they exploit the public.
It was in February, 1998 that the law was changed to allow pinholes to be sold freely as sunglasses only. No other uses can be discussed by anyone who wishes to sell them. To see the convoluted regulations the FDA has come up with just to regulate sunglasses, go to Sunglass Regulations,
No other country in the world bans pinhole sales. Pinholes have been around for decades. See www.google.com/patents/US1959915 for the 5/22/1934 patent by C. C. Guthrie on pinhole glasses. The Google page was created by using Optical Character Recognition and contains many errors. The actual patent can be seen at the www.uspto.gov website. By granting the patent, the US government accepted the term "lensless spectacles." Legally and scientifically, these are not lenses at all but "opaque perforated discs." A lens is a transparent substance upon which you can grind a refractive power. Pinholes are not medical devices. They are no different than looking through holes punched in a piece of paper or through binoculars. And an earlier pinhole patent No. 564,518 was granted on 7/21/1896 to Franz Heilborn of Breslau, Germany.
The FDA spends its time and resources trying to ban pinhole glasses, which have never harmed anyone. In its view, pinhole glasses were such a threat to human health that they alerted their agents at all the ports of entry and had the glasses destroyed. What they SHOULD be doing is banning the really harmful things on the market which have killed and maimed millions, such as:
1. the neurotoxin MSG. To make matters worse, MSG is called by some 25 different names, like autolyzed yeast extract, on food labels to hide its presence from consumers. And there are no limits on the amount that can be put in food. This is criminal, because many consumers are highly allergic to MSG. It is known to trigger migraine headaches and many other health problems.
2. the neurotoxin Aspartame (NutraSweet). Do an Internet search for "aspartame neurotoxin" and you will wonder why this poison is allowed on the market.
3. high fructose corn syrup.
4. cholesterol-lowering statin drugs, which could be replaced by safe Red Yeast Rice. Instead, the FDA has gone to court at least twice in an effort to ban RYR from the market. And it wages a constant war against harmless nutritional supplements.
5. the dozens of drugs that cause permanent tinnitus, like Biaxin.
6. payments by drug companies to doctors for prescribing the company products.
7. adding fluoride, a rat poison, to our drinking water, merely to benefit those industries that need to get rid of this toxic industrial byproduct.
8. the constant flow of unneeded and dangerous drugs that are allowed to flood the marketplace.
9. the advertising of drugs directly to the public, wasting billions of dollars and increasing the use of poisonous drugs as well as their cost. No other country in the world permits this.
10. the routine addition of growth hormones, antibiotics, and animal parts to cattle feed.
11. genetically modified food, which has now been shown to cause horrible cancers in laboratory mice.
12. the term "natural flavoring", which usually means "fake flavoring" and comes from a chemical factory.
13. the fake research provided by drug companies to get their products approved for sale.
14. milk ads claiming that the calcium in milk prevents osteoporosis, when just the opposite is true. The animal protein in milk and other animal products causes calcium to be lost from the body. The process is called "negative calcium balance."
15. the prescription of "minus power" eyeglasses which destroy vision. Yet, the FDA refuses to require a warning to the user when they are prescribed.
16. risky cataract surgery, without first telling the customer that eye drops are now available from Russia that can dissolve cataracts.
17. and on and on...
The FDA doesn't ban these things because they are the products of powerful companies. It prefers to go after the little guy.
The FDA was a scientific agency when it was formed long ago, and it was given the task of protecting the public from harm caused by the greedy business world. Now it is a political organization protecting the business world from anything that would decrease profits. The FDA has truly lost its way. But let's put the blame where it belongs. The FDA does not have a free hand to serve the public. It is controlled by vested interests. Until the public throws the lobbyists out of Washington, this situation will continue.
On July 27, 2012, health freedom attorney Jonathan Emord was interviewed. He has defeated the FDA in court many times in an effort to preserve our freedom to make choices that affect our lives. Here is a small portion of the interview.
Interviewer: What is happening with our liberties today, and especially in the context of these FDA and Department of Agriculture raids on raw milk producers and distribution centers?
Jonathan Emord: It's the tragic but logical consequence of the transformation of our government from a republic to a bureaucratic oligarchy, which has occurred over the last 80 years. And the FDA is all powerful. You have a commissioner of the FDA who rules as if she were a an absolute monarch and she gets to choose what she does with the resources of the agency, and she's largely unaccountable to the courts, the Congress, and the American people. So it's totalitarianism, but it is the characteristic of the modern bureaucratic state. You can be accused and tried and punished all without ever having a true and independent searching review of the charges brought against you. These raids are occurring across the United States, as you reported. They are outrageous, they're horrific, and they are causing great injury to people and to those that rely on the companies that are providing the goods and services, all without any necessity of proving that the products are in fact causing injury.
For the full interview, see Emord Interview
We want to make it clear that any effort by anyone to prevent the legitimate use of these harmless pinhole glasses will be met with the strongest possible resistance, both in the courtroom and in the public forum. Any such attempt will be widely reported on the Internet. We will charge the FDA with criminally conspiring with the eye doctors and the optical industry in order to destroy the pinhole business. No one is going to succeed in suppressing these useful devices any longer. This is an old idea whose time has finally come. Pinhole glasses have been around far longer than prescription eyeglasses and centuries before the FDA started to regulate medical devices. They are, in fact, not medical devices.