Sharks with Lasers: Dr. Evil’s FDA Regulatory Concern

Dr. Evil had one simple request, “And that is to have sharks with frickin’ laser beams attached to their heads!” However, complying with endangered species laws prevented this and he had to settle for ill tempered mutated sea bass (until the third movie). Alas, I wonder if Number Two remember the FDA regulatory compliance issue.

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Black Sea Bass looks a little intimidating. Source, NOAA.
Putting aside the potential food regulatory concerns, FDA regulates these ill tempered mutated sea bass because of their “laser.”

Laser, which is actually an acronym (Light Amplification by the Stimulated Emission of Radiation), are regulated by FDA under the Radiation Control for Health and Safety Act of 1968. Under this law, FDA regulates “electronic products” and can establish performance standards and various reporting requirements. While this law has nothing to do with food, drugs, cosmetics, or medical devices (sometimes a product is both a medical device and an electronic product), it is embedded into the middle of the Food, Drug, and Cosmetic Act in Sections 531 through 542.

“Lasers” are one of the most regulated electronic products. In this category, FDA established four (really five) different classes, which each have different warning and  safety requirements. Looking at a laser pointer or CD player (hey some of us still use them) and you’ll see these warnings. Depending on the product, you may see one that looks like this.

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Given that the lasers on Dr. Evil’s sea bass (and later sharks) can kill people, I strongly suspect that they are the highest risk laser (Class IV). For this laser class, there are various design controls and numerous warnings. I also suspect that Dr. Evil’s sea bass (and later sharks) fail to comply with all these requirements. While he can petition FDA for an exemption, I suspect FDA will not grant it. By failing to comply with these requirements, Dr. Evil is looking at possible enforcement action from FDA in federal district court.

However, if he’s willing to hold the world ransom for 1 million dollars, I suspect non-compliance  with this law and its maximum penalty of $300,000 is a lower concern of his.

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