A century ago, milk wagons clattered down city streets every morning.

Toledo's Michael J. Owens had not yet perfected the automatic bottle-making machine, and glass bottles were precious. Customers brought pails and pitchers for the driver to fill.

One particular milk wagon horse named Jim, who worked the streets of St. Louis, whinnied his way into a landmark in medical history being observed this year.

It's the 100th anniversary of the first major federal law to regulate medical products. The 1906 Federal Food Drug and Cosmetic Act usually gets that credit. However, the U.S. Congress enacted the Biologics Control Act in 1902.

Few people know what biologics are, let alone their role in safeguarding human health. The agency created a century ago now regulates not just traditional biologics, but cutting-edge stuff like gene therapy.

How did things go from Jim to gene?

Horse owners pocketed a few extra dollars by selling their animals' blood to local firms that made diphtheria antitoxin.

Now rare thanks to childhood vaccination, diphtheria then was a serious infectious disease. Diphtheria bacteria cause illness by producing a toxic protein material. Kids with diphtheria then were treated with “antitoxin” made from horse blood.

Antitoxins still are used to treat diphtheria, botulism food poisoning, and some poisonous snake and spider bites.

Horses or other animals are injected with small amounts of diphtheria bacteria, for instance. Their immune systems make disease-fighting antibodies, which are exacted and purified. When injected into a patient, the antibodies (the antitoxin) attack and neutralize the toxin.

Doctors used a crude extract of horse blood in those days, and there were no federal safeguards for its production.

In 1901, more than a dozen St. Louis kids treated with diphtheria antitoxin died - not from diphtheria, but from tetanus. The tragedy's cause became clear when Jim died from tetanus, then a common animal disease. The kids got tetanus from Jim's blood.

A similar episode in Camden, N.J., led Congress to enact the Biologics Control Act.

Biologics are medical products from living sources.

They include vaccines; blood and blood products; allergy patch tests and extracts; tests to detect HIV and hepatitis; gene therapy products; cells and tissues for transplantation, and new treatments for cancers, arthritis, and other diseases

The 1902 law charted a new course in federal public health policy. It underpinned a whole new generation of later consumer protection laws for foods, drugs, cosmetics, and other products.

It required producers to get an annual license for the manufacture and sale of vaccines, serum, and antitoxins.

Factories had to undergo inspections, and licenses could be revoked or suspended when necessary. Production had to be supervised by a qualified scientist. Products had to be labeled with the product name, expiration date, and manufacturer's address and license number.

Congress also created an agency to implement the law, which now is the U. S. Food and Drug Administration's Center for Biologics Evaluation and Research.

First Published November 1, 2002, 7:17 p.m.