1937 - Elixir of Sulfanilamide, containing the poisonous solvent
diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
1959 - U.S. cranberry crop recalled three weeks before Thanksgiving for FDA tests to check for
aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA on a food product.
1962 -
Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of
Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
(an estimated 10,000 to 20,000 children worldwide were born with birth defects as a direct result of Thalidomide; thanks to Dr. Kelsey at FDA, it was
never legally sold here)
1979 - In the hours following the Three Mile Island nuclear emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and package enough doses of potassium iodide to protect those threatened with thyroid cancer if exposed to radiation. Nearly one quarter of a million bottles-enough for every household in the area-were delivered to Harrisburg, Pennsylvania within 72 hours.
1989 - FDA issues a nationwide recall of all over-the-counter dietary supplements containing 100 milligrams or more of L-Tryptophan, due to a clear link between the consumption of L-tryptophan tablets and its association with a U.S. outbreak of Eosinophilia Myalgia Syndrome (EMS), characterized by fatigue, shortness of breath, and other symptoms. By 1990 the Centers for Disease Control and Prevention confirm over 1,500 cases of EMS, including 38 deaths, and FDA prohibits the importation of l-tryptophan.
1990 - Safe Medical Devices Act is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.
2000 - The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et al., ruled 5-4 that FDA
does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.
2004 - Passage of the Food Allergy Labeling and Consumer Protection Act requires the labeling of any food that contains a protein derived from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat. (mostly from
FDA site)
Some cases there where the system worked ... Now let's look at the negative -- the mean old gubbamint leaving a consumer choice
in lieu of a ban:
1997 - "The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has
asked the manufacturers to voluntarily withdraw both treatments for obesity from the market.
This is the diet control substance commonly known as "fen-phen". It was targeted because of its adverse coronary and pulmonary effects. Tens of thousands of people were injured; one of them is my friend (Foxy knows) afflicted with pulmonary hypertension (PH), the same disease Sunshine suffers from. There is
no cure for it. It's with you "for the duration". Nice, huh?
Had the FDA been more proactive and had a Frances Kelsey to put a skeptical eye on fen-phen, instead of asking for voluntary action after the fact, those tens of thousands might have been spared. But that's what you get when regulation doesn't go far enough.
