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U.S. Department of Health and Human Services

Safety

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What Happens When a Problem is Reported?

The Food and Drug Administration welcomes reports from consumers alerting the agency to problems with products regulated by FDA. These reports help FDA ensure that products on the market are safe and properly manufactured, labeled and stored.

Every report is important to FDA. In each case, the information the consumer furnishes is evaluated to determine how serious the problem is and what follow-up is needed.

When reviewing the information from these reports, FDA considers these factors:

  • Is an illness or injury involved? If so, what is the health hazard?
  • Is the illness possibly an allergic reaction--to a food or a drug (such as penicillin)--or, in the case of drugs, is it a reaction already known to occur with that product?
  • Is the problem life-threatening?
  • Is the product likely to be associated with the problem?
  • Is the problem likely to be widespread or is this an isolated case?
  • Is more information needed about the problem or the product?
  • Is the product or problem within the jurisdiction of FDA or is it the responsibility of another federal agency or local or state government?

Depending on the seriousness of the problem, FDA will either investigate it immediately or will cover it during the next inspection of the facility responsible for the product.

 

Serious Illness, Injury or Death

Top priority is given to products that have caused or may cause a serious illness, injury, or a life-threatening situation. Swollen cans of various food products, an unexpected drug reaction, a serious medical device defect, or, in some cases, even mislabeling of a product would be in this category.

In cases where FDA determines that the problem with the product could be a health hazard, an FDA investigator may visit the consumer to get in-depth information about the problem and the product. A sample of the product may be collected. In most cases, FDA will collect only unopened or intact products for laboratory analysis in case the sample becomes evidence in a legal case.

The investigator may visit retailers, wholesalers, or the manufacturer of the product in question to find out if there have been other complaints. Many times product samples from the same lot and code will be collected for laboratory analysis. The investigation may involve several FDA districts, depending on where the consumer report was taken and where the manufacturer is located. If the investigation reveals that the illness, injury or death was caused by using the product and the problem with the product is widespread, a recall could be initiated to remove the product from the market. To prevent additional illness or injuries, FDA could issue a press release advising consumers not to use the product or to return it to the store.

 

Other Problems

Not all product problems pose a risk of illness, injury or death. For example, pieces of stems in a box of raisins or too few capsules in a bottle of aspirin are not health hazards, but would still be of concern to FDA.

Many times a consumer gives such complete information to FDA that the cause of the problem can be pinpointed with no need for a follow-up visit to the consumer. An investigator still may visit retail stores, wholesalers or the manufacturer to collect samples for laboratory analysis.

In all cases, information from the consumer's report is sent to the FDA district in which the manufacturer is located, to be used as background information to identify possible problem areas that need to be looked at the next time the company is inspected.

 

National Tracking Systems

Consumer product reports serve as an important alert system for FDA. Tracking systems for consumer reports are maintained in FDA's national headquarters. Reports from across the nation are forwarded to the appropriate headquarters offices whenever the problem involves a baby food, drug reaction, or any illness, injury, or life-threatening situation related to an FDA-regulated product.

More than 21 cents of every dollar spent by consumers goes for products FDA regulates. This amounts to more than $1.4 trillion a year. FDA is responsible for overseeing more than 90,000 U.S. facilities where food, drugs, and other products are manufactured, processed or stored. FDA routinely collects samples from manufacturers, producers, supermarkets, drugstores, importers, and other sources to check quality, safety and labeling. But FDA cannot be everywhere at all times. Therefore, consumer product reports are an important part of FDA's monitoring system and help ensure that the products the agency regulates are safe, properly manufactured and stored, and correctly labeled.