The Food and Drug Administration is charged with overseeing the safety and effectiveness of food, drugs, and many cosmetics products. As with other consumer goods and motor vehicles, recalls may be necessary when it is determined that a consumable product may pose considerable risk of harm to individuals. In terms of food, drugs, or cosmetics, recalls may proceed under a manufacturer’s own initiative, by FDA request, or by FDA order. There are three classes of recalls in descending order of urgency:
- Class I recalls are cases in which there is a reasonable chance that the use of or exposure to a product will cause serious adverse health consequences or even death.
- Class II recalls are cases in which exposure to a product may cause temporary or reversible adverse health consequences, or where the odds of serious adverse health consequences are not great.
- Class III recalls are situations in which use of or exposure to a product is unlikely to cause adverse health consequences.
Examples of Class I recalls are foods found to contain botulinal toxin, foods with undeclared allergens, or mislabeling a life-saving drug. A drug that is under-strength but not used to treat life-threatening situations is one example of a Class II recall; another is where two units of blood are collected from a donor who has traveled to a country where malaria is endemic. Class III recalls might include container defects such as a lid that does not seal, a product that is off-taste or color, or a retail food that does not have a label in English.
Recalls may happen in three ways. First, a manufacturer or distributor may decide on its own initiative to issue a recall to remove a product from the market. Second, FDA may request a recall. Finally, two things can happen in the rare instances where a firm does not comply with FDA request. In certain circumstances the FDA has statutory authority to order a recall; in other cases the FDA must seek legal action under the Food, Drug, and Cosmetic Act. The FDA can prescribe a recall only when a medical device, human tissue products, or infant formula pose a risk to human health. Legal remedies available to FDA include seizure of the available product, an injunction against the manufacturer, and/or a court request for recall of the product.
A market withdrawal is a less drastic step than a recall. A market withdrawal is voluntary on the part of a manufacturer, and occurs when a product has a minor violation that would not otherwise be subject to FDA legal action. In these cases, a firm will remove its product from the market or otherwise correct the problem. For example, a product will be removed from the market if there is evidence that its packaging has been compromised. This can happen without any manufacturing or distribution problems.
A medical device safety alert is issued in situations involving a medical device that presents an unreasonable risk of substantial harm. These are primarily intended to inform potential users of possible hazards. In some cases, these alerts also are considered recalls.