What does FDA do when violations are discovered?

Within the United States, compliance with the Federal Food, Drug, and Cosmetic Act is secured through periodic inspections of facilities and products, analyses of samples, educational activities, and legal proceedings. When violations are discovered, there are many regulatory procedures available. Adulterated or misbranded products may be voluntarily destroyed or recalled from the market by the shipper, or may be seized by U.S. Marshals on orders obtained by the Food and Drug Administration from Federal district courts. Persons or firms responsible for violations may be prosecuted in the Federal courts and, if found guilty, may be fined and/or imprisoned. Continued violations may be prohibited by Federal court injunctions. Violation of an injunction is punishable as contempt of court. Civil money penalties may be pursued for certain specific violations. Any or all types of regulatory procedures may be employed, depending on the circumstances.

When FDA investigators (Consumer Safety Officers) observe conditions or practices which may result in violations, they usually leave a written report of their observations with management. Manufacturers, by correcting these conditions or practices promptly, may bring their operations into compliance. Investigators may also make suggestions regarding other types of compliance problems, but they are not experts in all of the technical fields regulated by the Agency. FDA investigators will also report any voluntary corrective action they witness during an inspection, or which management may bring to their attention. Product recalls have become a major means of consumer protection under the law. The Food and Drug Administration prefers, when possible, to promote compliance by means other than going into court.

Recall of a violative product from the market, by the manufacturer, is generally the fastest and most effective way to protect the public. A recall may be voluntarily initiated by the manufacturer or shipper of the product, or at the request of FDA. In situations involving imminent hazards to health associated with the use of a device, FDA may order the recall of a device and/or the notification to users of the device about hazards associated with its continued use. Additionally, device manufacturers are required to report to FDA actions undertaken to remove or correct violative products in commerce which present a risk. The first step, when a product needs to be recalled, is for the manufacturer or distributor to get in touch with the nearest FDA field office. ( Addresses of the major field offices are listed at the end of this publication.) Accurate and complete production and shipping records are vital to the success of a product recall. Products should be code labeled to identify the date and place of manufacture.

It is recommended that all manufacturers develop plans which can be put into effect if a recall emergency arises. Guidelines on FDA recall procedure and industry responsibilities are provided by the Code of Federal Regulations (21 CFR 7). Special provisions on recalls of biologic products, medical devices and infant formulas are in the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

While cooperation in a recall may make court proceedings unnecessary to remove the product from the market, it does not relieve a person or firm from liability for violations.

Seizure is a civil court action against goods to remove them from the channels of commerce. After seizure, the goods may not be altered, used or moved, except by permission of the court.The owner or claimant of the seized merchandise is usually given about 30 days by the court to decide on a course of action. The claimant may: do nothing, in which case the goods will be disposed of by the court; decide to contest the Government's charges by filing a claim and answering the charges and the case will be scheduled for trial; or consent to condemnation of the goods, while requesting permission of the court to bring the goods into compliance with the law. To bring the goods into compliance, the owner of the goods is required to provide a bond (money deposit) to assure that the orders of the court will be carried out, and must pay for FDA supervision of any compliance procedure.

Regulations issued by FDA are an important part of enforcing the Federal Food, Drug, and Cosmetic Act. Especially important are such regulations as:

• Current Good Manufacturing Practice Regulations, which set requirements for sanitation, inspection of raw materials and finished products, and other quality controls.

• New Drug Regulations, which tell drug companies what they must do to get FDA to approve the marketing of a new drug and to assure its continued safety and effectiveness.

• FDA Food Standards, which set specifications for many foods.