Medical Inventions & America’s Favorite Mind-Altering Substance

Medical Patents Broker Inc.
By Kenneth Pearce, President

Caffeine, caffeine, caffeine! Nothing else comes close.

A. America’s Favorite Drug and Medical Inventions

For most of human existence, the ones who like coffee first had to acquire a taste for a bitter “liquid pill.” In the last few decades, we increased coffee consumption by disguising the bitter pill with other ingredients. Today’s liquid caffeine may cost several dollars. About 25 years ago, on a cold day in Manhattan, just before Thanksgiving, I dashed into a café and drank a cup of coffee. It was three dollars, but it tasted the same as most other stale coffees, bitter and bad.

1. The Hospital Urn

Hospitals are early risers. Gallons of coffee, or a tea bag for a single cup. Coffee was better at 4:00 AM than any other time of the day. Still, it was not good, but we drank it. Most docs, nurses, pharmacists, and technicians needed a fix to get the day started. Hospitals generate lots of medical patents.

2. The Lab Coffeemaker

When the coffee first dripped into the pot, it tasted good, but after it sat for a few minutes, it tasted a bit nasty. My boss did not show up until about 9:30 AM. He would toss the left-over coffee from the night before and pour a cup from the pot that had been waiting for over an hour into his mug. Never saw him wash his mug. A few years later, he was a Vice President of an international pharmaceutical company.

3. The Magnificent Machine That Makes One Cup

At MPB, each person can make a cup to their taste. I have a 14-ounce decaf black. Since the Board wants me to monitor costs, one cup costs about 69 cents. Seems like this machine increases productivity because everybody gets to have control of making their coffee or tea their way.

B. How the FDA Regulates Caffeine:

Coffee, tea, and other natural products containing caffeine are designated foods. It’s liquid food—no forks or knives, just spoons and straws, please.

1. Food Facility Registration & Imports

Since a vast majority of coffee beans and tea leaves are grown outside the United States, foreign farms and processing facilities must navigate strict import rules.

Facility Registration: Any facility that manufactures, processes, packs, or holds coffee or tea for consumption in the U.S. must register with the FDA.

FSMA (Food Safety Modernization Act): Importers must verify that their foreign suppliers use preventive safety controls equivalent to U.S. standards to prevent contamination (like mold or dangerous mycotoxins).

2. Chemical Safety & Defect Action Levels

The FDA monitors green and roasted coffee beans for physical and chemical defects.

The "Defect Action Level": The FDA actually has established limits for what it considers natural or unavoidable defects. For green coffee beans, they track the percentage of beans that are insect-damaged, moldy, or contaminated by foreign matter.

Pesticide Residues: The FDA, alongside the EPA, monitors imported beans to ensure pesticide residues do not exceed strictly enforced tolerance levels.

3. The Caffeine Conundrum (GRAS Status)

Caffeine is a naturally occurring substance in coffee and tea, which changes how the FDA treats it compared to energy drinks or sodas where caffeine is an additive.

Generally Recognized as Safe (GRAS): Caffeine naturally found in coffee beans and tea leaves is considered GRAS under long-standing historical use.

Added Caffeine: If a manufacturer adds extra synthetic caffeine to a coffee drink to give it an extra kick, that added caffeine faces much stricter scrutiny regarding safe usage levels. FDA approval is required before selling this type of product.

4. Labeling & Decaffeination Rules

Like other foods, for coffee and tea packaged for retail sale, the FDA enforces strict compliance statements on the container.

Standard Labeling: The container must feature a statement of identity (e.g., "Ground Coffee"), net quantity, a nutrition facts panel (if ingredients like sugar or milk are added), and allergen declarations.

The "Decaf" Standard: For coffee to be labeled "Decaffeinated," the FDA looks to trade standards requiring that at least 97% of the original caffeine content has been removed.

Chemical Residues in Decaf: Many decaffeination processes use chemical solvents like methylene chloride to strip the caffeine. The FDA strictly regulates the residual amounts of these solvents allowed in the final product—limiting methylene chloride to a maximum of 10 parts per million (0.001%) for safety precautions.

The President’s Viewpoint

The evidence indicates that Americans love their caffeine. The United States grants more medical patents than any other country. Is there a correlation between coffee and tea in the workplace and increased productivity?

From what I have witnessed, the answer is an overwhelming yes.

About 50 years ago, I decided no more sugar – only black coffee. Today it’s decaf. Like medical inventions, the subsequent invention can be almost the same, better than or worse than the original. Do you prefer the 100 percent caffeinated or the 3 percent version of your mind-altering substance?