How Is the Food, Drug, & Cosmetic Act Enforced?
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FDA As Regulator
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In the United States, the Food and Drug Administration (FDA) has regulatory authority over food products, drugs, cosmetics, medical devices, health and beauty products. If the FDA obtains information that an item poses a risk to health, is improperly labeled, tainted or adulterated, the FDA can intervene through its regulatory powers.
Enforcement Action
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If an FDA investigation substantiates a problem, the FDA has several avenues of recourse.
It can work with the United States Department of Justice to obtain an injunction to stop the product from being sold. An injunction is a legal remedy where the court directs the person or entity to cease and desist from a certain type of action.
The FDA in conjunction with the Department of Justice can obtain federal court relief to recall any items in the marketplace that are hazardous.
The FDA may be able to take criminal action, especially where the person or entity refuses to cooperate or comply with a court order.
Finally, the United States Agency of Customs and Border Protection may work in conjunction with the FDA in order to prevent tainted, illegal and/or adulterated products from entering the United States. -
Regulatory Action
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In addition to enforcing United States regulations, the FDA regulates the manufacturing, processing and distribution of food and drug items to ensure that these functions are done properly. For example, the FDA may inspect manufacturers' sites to assess how a product is made and whether the manufacturer follows applicable safety regulations. The FDA also provides guidelines for manufacturing items under its jurisdiction. In the event of a minor infraction, the FDA issues a warning letter. Where a significant, dangerous infraction occurs, the FDA will take appropriate legal action. The FDA has programs that allow for the voluntary reporting of problematic items
Based upon 2008 data contained in an FDA report, the FDA inspected 15,245 locations, refused entry to 17,907 shipments, issued 2,721 recalls, issued 445 warning letters, received 369 convictions and obtained five injunctions and eight seizures.
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