The Food and Drug Administration does not permit any seller of pinhole glasses to claim they are useful for anything other than as sunglasses. Thus, by saying we cannot mention other possible uses, the FDA is ITSELF saying there are other uses it doesn't want you to know about. Of course, they cannot stop people or websites from discussing pinhole use, provided they do not sell the product. At least we still have THAT amount of free speech rights left in this country.

And if you find THAT hard to believe, we are not even allowed to tell you the name of the charitable, nonprofit organization that brings you this website. To do so would, according to the FDA, IMPLY that pinholes might be used to further the goals of that organization, goals that are not restricted to selling sunglasses. And we cannot refer you for information to any website which discusses pinhole use, even if we have no direct affiliation with the site, and even if the information there can be backed up with scientific research.

Here is a fictional example of what this censorship means. If we knew of a way that pinholes could save 100,000 people from blindness every year, we could not tell you about it. We could not provide you with scientific evidence so you could make your own decisions. The FDA would find a way to shut us down! They would say that this is a "medical use" of pinholes, and we cannot make such claims without getting a special 510(k) license that could cost a fortune and would probably never be granted. The optical industry and the eye doctors are behind this situation, and they are only motivated by GREED. They don't care if you live, die or go blind. And through their lobbying efforts, they exert tremendous influence on our regulatory agencies.

As an example of its twisted logic, the FDA classifies such things as myopia (nearsightedness), hyperopia (farsightedness), astigmatism, and presbyopia (loss of lens flexibility as we age) as "diseases," even though all textbooks and eye doctors refer to them as "refractive errors." Even that term is too harsh and misleading, since some of these things are quite normal. The correct term is "refractive status." For example, infants are normally born farsighted, with eyes shorter than ideal. That is not nature's "error." That is nature's plan. That farsightedness diminishes as the child grows, and the eyes move closer to their ideal length, neither nearsighted nor farsighted. According to the FDA, these children have diseased eyes. And presbyopia is a natural thing that happens to just about everyone. So a person who has myopic astigmatism plus presbyopia has three different diseases! Why does the FDA take this position? Because it can then more easily classify as "medical devices" anything that might give relief to these conditions, even temporarily.

Actually, the FDA does not even have to resort to that extreme. Just about anything that affects the body in any way comes under their domain, even such things as wooden tongue depressors! The fact is that pinholes have never harmed anyone, and there should be no restrictions on their sale. There is no more reason to "regulate" pinholes than binoculars, magnifying glasses or drugstore reading glasses. These are sold freely to anyone of any age.

To see a website that has been created by the optical industry and which details just how they put pressure on the National Eye Institute, see Click on "About the Alliance" at the top and then "Member Organizations" at the bottom to see all the companies that are directing the work of the NEI for their own profit. They call themselves the National Alliance for Eye and Vision Research and state that they are "serving as friends of the National Eye Institute." Nearly every profit-oriented organization in the optical business world is listed. The only thing they serve is their self-interest. They have even established their office at 1801 Rockville Pike, Rockville, MD 20852, very close to the NEI office in Bethesda, MD. Their interest is maximum profits, not public health. This organization, and others, put pressure on the FDA and other agencies, as well as the NEI.

Fortunately, we don't need to discuss the possible uses of pinholes. Information is available about them all over the Internet. Unfortunately, while you would find accurate information here if we were allowed to present it, searching the Internet can cause you to find INACCURATE information and unsubstantiated claims. The FDA could end all of this nonsense, and end our criticism of the agency, if it would do the right thing and declare harmless pinhole glasses free from any restrictions on their importation or sale.

Doctors routinely prescribe dangerous drugs for purposes not approved by the FDA, called "off-label prescribing." And the patient doesn't even have to be told about it! People have been harmed and killed by this practice. Also, drug companies routinely give financial kickbacks to doctors for prescribing their drugs. Again, the patient suffers, financially and medically. The FDA permits all of these practices. But we cannot even TELL you about "off-label" pinhole uses. Does this make sense? Of course, the American Medical Association and the drug companies have gigantic lobbying groups in Washington and pinhole sellers do not.

However, on December 3, 2012, it was decided that drug company representatives can now freely advise doctors on how to prescribe drugs for unapproved uses. This decision from New York's Court of Appeals for the Second Circuit in Manhattan contradicts many years of rulings that resulted in drug companies having to pay billions of dollars in settlements and penalties to the federal government for what had previously been considered violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In the past, unless FDA gave its blessing to a particular food or drug, there was no such thing as free speech concerning its health benefits.

But this now appears to have changed, at least for Big Pharma, which will be free to invent new uses for existing drugs, and market them for such uses without having to gain FDA approval. Although doctors have long been free to prescribe drugs for off-label purposes, drug representatives have been prohibited from engaging in this practice since the FDA considered it to be "misbranding" and "false advertising."

The ruling sets a new precedent for what defines free speech for the supplement industry as well. According to the health freedom advocacy group Alliance for Natural Health - USA (ANH-USA), the decision cuts both ways. If pharmaceutical companies can now legally allow their representatives to market drugs for off-label purposes in the name of free speech, then there is no legitimate reason why supplement companies cannot do the same thing with their products in the name of free speech. This means cherry growers, for instance, would now have the freedom to print the health benefits of cherries on product packaging. And supplement manufacturers would be allowed to talk about the health benefits of their products with holistic practitioners and health food stores.

The federal government cannot have it both ways when it comes to freedom of speech. Either everyone's freedom of speech is now recognized, or nobody's freedom of speech is recognized. It remains to be seen whether or not the new ruling, if it stands, will be selectively enforced to the benefit of drug companies, or universally enforced to the benefit of everyone.

And it should now be legal for those who sell pinhole glasses to discuss their various uses. This argument will be used if the FDA again tries to destroy the pinhole business.

For a detailed analysis of the above decision by the law firm Emord and Associates, see Caronia Decision.

The eye doctors and optical industry have been exerting their political influence for decades, trying to keep pinholes out of public knowledge. It is because of their advertising clout that pinholes are never mentioned in the mass media. Here is a little history lesson to illustrate what we mean:

The FDA and pinhole glasses - 1992
The FDA and pinhole glasses - 2012

If you want to strike a small blow at the optical industry, buy your sunglasses here and not from an optical store!