50th Anniversary for Regulatory Law

Saturday marks the 50th anniversary of the signing into law of the Food, Drug & Cosmetic Act by President Franklin Delano Roosevelt.

The act is considered landmark legislation for it established the nation’s first substantial safety regulations at a time when questionable medical remedies and tainted food were commonplace.

The act, which superseded a much weaker 1906 law, was also responsible for expanding the role of the U.S. Food and Drug Administration.

To commemorate the occasion the agency has published a listing of health hazards that faced the country in the years immediately prior to 1938.

Harmful pesticide residues, for instance, were frequently found on food. According to FDA records, the apples sold by former business executives on street corners during the Depression were often tainted with high levels of arsenic.

Another instance of the harmful application of chemicals on produce occurred in 1931 when at least six people became seriously ill after consuming greens sprayed by a highly toxic lead-based pesticide. A year later, similarly treated fruit claimed the life of a 4-year-old in Philadelphia. And these were only the reported cases of such pesticide-related illnesses at a time when science was poorly equipped to monitor for chemicals in food.

However, it was the drug industry that was responsible for the worst abuses. Prior to the 1938 legislation, a manufacturer could produce any kind of drug product and sell it without federal approval.

As a result, radioactive water was sold as a cure for cancer. Other companies advertised salt crystals that, when added to drinking water, could purportedly cure diabetes.

The cosmetics industry was not without its problems. A widely available eyelash dye was responsible for one fatality and 18 cases of blindness because the chemical mix actually “corroded the users’ eyeballs,” according to an FDA report.

For five years prior to its passage, the Food, Drug & Cosmetic Act was heatedly debated in Congress. At the time, the legislation was opposed by the three affected industries. The adoption of any such stringent standards, opponents argued, would create further financial hardship for the firms already struggling from a severely depressed economy.

But it was the stock market crash of 1929, which precipitated the Depression, that was ultimately responsible for forcing the federal government to take the regulatory initiative.

“As the Depression got worse, some companies were too often ready to peddle worthless or dangerous drugs and diluted or tainted foods,” an agency history states.

The turning point in the spirited debate, though, occurred in 1937 after 107 deaths were linked to a liquid form of the drug sulfanilamide, which was promoted as an elixir or cure-all. Most of the fatalities were children, creating even greater pressure on Congress to approve the legislation.

Upon passage, the Food, Drug & Cosmetic Act required prior FDA approval for new drugs and medical devices. Warning labels, when necessary, were required and harmful ingredients banned. Food companies were also subjected to greater in-plant scrutiny and product labeling requirements. And cosmetics came under the control of the federal government for the first time.

FDA Commissioner, Frank E. Young, writing in the current issue of FDA Consumer magazine states, “I can think of no law with more practical benefits in our daily lives that the ‘FD&C; Act.’ This law gave FDA the responsibility for ensuring the safety of products commanding a quarter of every dollar we consumers (presently) spend.”

Lower Calories Likely--History aside, the FDA recently expanded the number of product categories in which aspartame, the sugar substitute trademarked as NutraSweet, could be used by food manufacturers.

The agency granted a request by the NutraSweet Co. to use the artificial sweetener in beverages, refrigerated products and frozen foods.

Among those items likely to be sold in low-calorie versions in the near future are yogurts, flavored milks, aseptically packaged fruit juices, ready-to-serve gelatins, fruit-wine beverages and frozen desserts.

Presently, more than 1,250 food products contain NutraSweet, a number expected to increase in light of the recent FDA action.

“We have no projections yet on what the FDA approval will do for aspartame sales . . . It depends on how many companies jump in and launch aspartame-sweetened products. But you will see an increase,” said Thym S. Smith, NutraSweet Co. vice president.

Total sales of the six categories where aspartame will now be permitted as an ingredient is about $6 billion, Smith said.

The Deerfield, Ill.,-based firm generated more than $722 million in 1987 sales of NutraSweet, which is 180 times sweeter than sugar.

On a related front, the FDA is also reviewing a request by the Stroh Brewery Co. to use NutraSweet in malt beverages containing fruit juice, according to Nutrition Week, a publication of the Community Nutrition Institute.

Although the petition is likely to be approved, the agency is currently reviewing the “function and safety of aspartame in malted beverages,” the newsletter reports.

Stroh’s is apparently developing a low-calorie, fruit-flavored malt liquor, but the Detroit-based firm has not disclosed the exact composition of the beverage.