FDA Enforcement Activities Protect Public

by Food and Drug Administration (FDA)

Many people know the Food and Drug Administration as the federal agency whose scientists approve the safety and effectiveness of drugs and medical devices, safeguard the wholesomeness of the nation's food supply, and ensure the safety of cosmetics. But FDA is also a law enforcement agency whose nearly 1,000 investigators, compliance officers, laboratory personnel, and attorneys work long and hard to make sure that the companies that produce products under the agency's jurisdiction comply with the federal Food, Drug, and Cosmetic (FD&C) Act and other statutes enforced by FDA.

It's a big job, covering merchandise accounting for nearly a quarter of all consumer spending. FDA-regulated goods are produced and distributed by 89,400 establishments, including 48,000 companies that handle food, 15,400 medical device firms, 13,600 companies that handle drugs for human use, and 5,800 firms that make and sell animal drugs and medicated feeds.

During an average year, FDA investigators inspect about 20,000 of these companies in the United States and 400 abroad, review about 1.5 million imported goods, and conduct 100,000 examinations at the wharves. In addition, agency scientists each year analyze 75,000 product samples.

FDA investigators look for violations of more than 20 specific "prohibited acts" in the FD&C Act, ranging from introduction into interstate commerce of unapproved new drugs and drug counterfeiting to adulteration or misbranding of any food, drug, medical device, or cosmetic. Many of these violations are noted during routine inspections or are reported by consumers.

Typically, FDA enforcement annually results in 25,000 import detentions, 8,000 "inspectional observations" of violations, and about 9,000 other measures, ranging from warning letters to voluntary corrections, product recalls, seizures, injunctions, and criminal prosecutions.

Statistics alone, however, do not illustrate the commitment and skill of FDA investigators. FDA routinely refers to the Department of Justice recommendations for criminal investigation or prosecution. The charges filed range from misbranding or adulterating products to conspiracy, counterfeiting, and obstructing justice.

Here are some examples:

Adulterated Fruit Juices

One major criminal case involved Beech-Nut Nutrition Corp. FDA investigators found that the company had for years been substituting colored water for apple juice. A 470-count indictment of the company and some of its officers was filed charging conspiracy, mail fraud, and marketing artificially flavored sugar water as apple juice concentrate with the intention to defraud and mislead, a felony violation of the FD&C Act. The company pleaded guilty to 215 felony violations of the FD&C Act and was sentenced to pay fines and costs totaling almost $2.2 million. The Beech-Nut vice president for operations was tried, convicted and sentenced to a year and a day in jail, and the president of the company to six months of community service. In addition, each had to pay a $100,000 fine. Five companies that supplied raw materials to Beech-Nut entered into plea-bargaining and received lesser sentences.

In a similar case, FDA investigators determined that Bodine's Orange Juice had sold 28 million more pounds of orange juice concentrate than it had purchased and that the firm had bought 35 million pounds of beet sugar more than was needed for the drink products sold during the same period. Faced with the evidence, Edward Boden Sr., Bodine's chief executive officer, pleaded guilty to felony violations and was sentenced to two years' imprisonment, a $250,000 fine, 1,000 hours of community service, and five years' probation. The president and vice president of the company received lesser sentences.

Potatoes in Horseradish

An FDA inspection of Tulkoff's Horseradish Co. revealed that the firm was substituting potatoes for horseradish in its products. Although company officials went to great lengths to cover up the practice, FDA investigators found at the firm large quantities of hidden potatoes, some of which were kept in a secret compartment.

A new analytical method developed by FDA scientists revealed the presence of potato starch in several lots of the company products, all of which were seized. Both the company and two responsible individuals pleaded guilty to adulteration charges and were fined a total of $11,500.

Failure to Report Adverse Drug Reactions

In 1985, FDA investigations revealed that SmithKline Beckman (which was then SmithKline & French) and Eli Lilly and Company had failed to make mandatory reports of significant adverse reactions in people using their products. In the first of these cases, the company pleaded guilty to 14 counts of failure to report adverse reactions and 20 counts of selling in interstate commerce misbranded Selacryn, an antihypertensive prescription drug. the company and three of its employees were sentenced to a total of 1,100 hours of community service. In addition, the corporation agreed to contribute $100,000 to help establish a child-abuse prevention program. Selacryn was withdrawn from the market at FDA's request.

A few months later, Eli Lilly and Co. pleaded guilty to 10 counts of failing to report adverse reactions occurring overseas that were associated with the arthritis drug Oraflex, and to 15 counts of misbranding the drug. The corporation and its former vice president were sentenced to fines of $25,000 and $15,000, respectively. Oraflex was withdrawn from the market.

Contaminated Penicillin

In 1988, FDA and grand jury investigations led to the indictment of two drug companies and their president-owner John Copanos. The charges included conspiring to violate the FD&C Act and defraud FDA, making false statements and falsifying records, concealing test records on contaminated penicillin, and selling penicillin with an unapproved ingredient.

FDA's surveillance had earlier resulted in multiple seizures, an injunction of drug shipments from plants with poor manufacturing conditions, and the revocation of all new drug approvals for injectable drugs issued to the companies. Copanos pleaded guilty to two felony violations and was sentenced to a year and a day in prison and 1,600 hours of community service. He and his companies were fined a total of $630,000.

Unapproved New Drug for Infants

E-Ferol was a high-potency, vitamin E intravenous injection manufactured by Carter Glogau Laboratories exclusively for O'Neal, Jones and Feldman (OJF). OJF sold it to neonatologists and neonatal intensive-care units. E-Ferol, used to treat deterioration of the retina and as a vitamin supplement, was associated with adverse reactions in about 100 premature infants, 40 of whom died.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.