In 1937, a Tennessee drug company introduced a new form of sulfa, the first miracle drug of the last century and a precursor to penicillin, especially geared to the pediatric market. The drug, elixir of sulfanilamide, contained a new and untested solvent, diethylene glycol, now known to be very toxic. Over one hundred people died after taking the drug, and the resulting public outcry contributed to the 1938 Food, Drug and Cosmetic Act which is still the basis for guaranteeing drug safety in the United States.
Nearly 70 years later, authorities in Panama unwittingly mixed the same solvent into 260,000 bottles of cold medicine. The solvent was falsely marked as "glycerin", a safe but more expensive solvent used in pharmaceuticals. The deaths exceed a hundred in this case, too, although precise figures will never be established.
Here the two stories diverge. The manufacturer of the toxic substance in the latter case was not a Panamanian firm but a Chinese one, and it is most unlikely that events in Panama would cause the necessary public outcry in China for better food and drug safety. So far the Chinese government's response has been to argue that no criminal laws were broken or that the Chinese drug safety system cannot be applied since the manufacturer was not licensed to produce pharmaceutical products in the first place.
The moral of these two stories might be that we should take great pride in the Food and Drug Administration (FDA) and that excellent 1938 legislation for lives saved. But are the current FDA rules and regulations an adequate firewall against the dangers inherent in global trade of food and pharmaceuticals -- a trade which often consists of products such as chemicals and mixes, with no easily measurable external quality or safety indicators? It was only in 1995, after all, when the FDA let at least one shipment of counterfeit glycerin into the country, only to be spotted by the bulk pharmaceuticals supplier Avatar Corporation.
It is in the context of yet another contamination story, that of melamine and animal fodder from China, that the ability of the FDA to protect the domestic food chain has come under scrutiny. Apparently it is common for Chinese manufacturers to spike animal fodder with melamine, a type of plastic. The practice isn't legal, but it's generally regarded as unlikely to harm animal health .
Or was, at least, until something went wrong late last year. A shipment of wheat gluten with unusually large melamine values was sent to American pet food manufacturers, and many cats and dogs died after consuming food made with the gluten. Nobody knows the exact numbers because nobody keeps the necessary statistics. At first only a few pet food companies responded by recalling their products from the store shelves, then a few more and then a few more joined the recall effort.
Then a rice protein from China was found to be similarly affected. Next, hogs meant for human food consumption were found to have been fed with melamine-tainted fodder. Then chickens. Then fish. American consumers were told that these hogs and chickens and fish were safe to eat. In an attempt to reassure the public, an FDA assistant administrator claimed that "a 132-pound person would have to eat 800 pounds of pork a day" to suffer health effects from the melamine traces in the animals. This is true, assuming that the 132-pound person hasn't already been eating melamine-tainted pork for some years.
Melamine is a common material, found in kitchen countertops and in Melmac dishes made out of melamine resin. Why would it be added to animal fodder? The reason is that melamine scrap, residue left over from plastics manufacturing, registers as nitrogen in tests of protein contents of animal feeds. It is this property of melamine that makes it attractive to manufacturers, who are able to charge more for products with higher protein measurements. As one Chinese animal-feed seller put it, "Melamine will cost you about $1.20 for each protein count per ton whereas real protein costs you about $6, so you can see the difference." In other words, melamine is a cheap but dangerous substitute for protein. You can't tell the difference unless you subject the product to laboratory analyses.
And these analyses were not done very often by the overstretched FDA, which is responsible for the safety of not only imported pharmaceuticals but of all imported foods other than meat, poultry and fish. As a result, 99 percent of such imports are simply waved through without lab testing.
The melamine story is not yet over. But it speaks volumes about China's role in the global markets, and about what happens when a country with unregulated markets becomes the world's largest producer of many foodstuffs. The wheat gluten implicated in the early pet deaths did not come from China by chance; it came from China because the Chinese produce wheat gluten more cheaply than other countries.
This also speaks to the need to regulate markets more carefully. Legislators are currently debating ways to make the FDA better equipped by increasing its power and staff. They are also considering the creation of a new, separate agency to ensure food safety. Even several manufacturers support these steps, because if consumers lose their trust in the safety of our food supply, all sellers will suffer.
Whether the Bush administration is up to these challenges remains to be seen. A recent Washington Post article reports that the administration has opposed new safety rules for foreign foods, and that it views China more as a market for American products than as the source of potentially contaminated products later found in the United States. Add to that conservatives' general anti-regulation beliefs and their faith in unregulated markets, and one begins to have some doubts about reform. But the resumption of high-level trade talks with China this week gives the administration a good opportunity to dispel them by imposing stricter regulations on imports from China.
The administration should also promptly address the problem of the overburdened FDA, the firewall that is supposed to keep all of us safe. And how safe are we right now? Are we any better off than in the era before the passage of the 1938 food safety legislation? To return to the glycerin story, in early May of this year the FDA sent out an advisory which recommends -- but does not require -- that pharmaceutical manufacturers in this country test solvents marked as glycerin for the possible presence of diethylene glycol. Our next major food-safety scandal may be just around the corner.