In claiming that NVI had failed to file a premarket application for a new product, the FDA was ignoring its own regulations. Pinhole glasses are not a new product. They were first formally demonstrated in 1575 by Scheiner. On 5/22/34, Charles C. Guthrie of Pittsburgh, PA obtained US patent no. 1,959,915 for lensless spectacles. Pinhole glasses have clearly been in commercial use since that time. You can see this patent at patent US1959915. Note all the references to pinhole use down the right side of this document. Actually, 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.

In accepting this patent for "lensless spectacles", the government has agreed that, technically and legally, pinhole glasses do not contain lenses, but "opaque perforated discs." A lens, according to the dictionary definition, is a clear substance upon which you can grind a refractive power. Of course, in everyday language, the public uses the term "lenses" because that is simpler. Consequently, The FDA has no legal basis for interfering in the sale of these devices. But, of course, that doesn't stop the lawless FDA.

In the past, people who attempted to sell pinholes have left themselves open to this kind of attack by claiming that pinholes can permanently eliminate all kinds of visual problems. Such claims could not be substantiated. In one case, 14 state attorneys got together to close down one such operation that was advertising that pinholes could improve vision. How often do you hear of that many state attorneys getting together to do anything? The recent case where a lawsuit was brought against the tobacco companies is one of the few instances. That might be understandable since tobacco is an extremely harmful product that was costing the states hundreds of millions of dollars in health care costs. But pinhole glasses are a perfectly harmless device, even if exaggerated claims were being made. Exaggerated claims seem to be the rule in the marketing world. What would create such a massive coordinated attack against a small company selling such a harmless product? Do you smell the presence of the eye doctors and optical companies in the background as we do? Proof is difficult to find, but what other explanation is there? We are certain that if there was a way to make squinting illegal, they would try to do it. Isn't it strange that pinholes are not offered for sale in retail stores, where they could be made available without making any claims at all for them, just like off-the-rack reading glasses? The reason is that any attempt to mass distribute them has been deliberately and massively squashed.

Does your local drug store get raided by armed federal agents for selling products that claim to grow hair on bald heads or for selling toothpaste that claims to prevent decayed teeth? Of course, it doesn't. On the other hand, the federal government spends millions of our dollars to force upon the American public the unbelievable fraud of compulsory fluoridation, SOLELY to benefit industrial interests.

Fortunately, the dictatorial powers of the FDA were considerably diminished by a recent landmark court decision. In the past, the FDA has made it a criminal act to place any information on the label of a dietary supplement that would claim any health benefits for the product, even when such claims could be backed up by research. Some supplement manufacturers took the FDA to court over this and ended the FDA's 20-year-old suppression of dietary supplements. Judge Laurence Silberman of The Washington, D.C. Court of Appeals wrote:

As best we understand the government, its first argument runs along the following lines: that health claims lacking "significant scientific agreement" (which is no more than FDA opinion) are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be mislead. We think this contention is almost frivolous. We reject it.

The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. The FDA's obvious motive was to protect pharmaceutical interests. If the truth about the power of certain nutrients were allowed, millions would give these items a try, and millions would find relief. Consequently, they would neither need nor desire expensive and far more dangerous prescription drugs. In fact, this is precisely the concern the FDA addressed in its Dietary Supplement Task Force Report, when it stated that "the agency should insure that the existence of dietary supplements on the market does not act as a disincentive for drug development."

Similarly, the FDA's obvious motive in conducting armed raids against those who sell pinhole glasses is to protect optical interests. This ruling can and will be used against the FDA's bullies if they are foolish enough to initiate further attacks against pinhole glasses.

We want to make it clear that any effort by anyone to prevent the legitimate use of these harmless devices 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. No one is going to succeed in suppressing these useful devices any longer. This is an old idea whose time has finally come.

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