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Export products Recall procedures

The officers and employees of a food manufacturing company have a legal responsibility to ensure that their products are safe, sanitary and accurately labeled.

If you discover, or even suspect, a problem with the food product you are manufacturing, distributing or selling, you have certain duties—both legal and ethical—to do whatever you can to correct the problem.  But exactly what do you have to do, and who requires it?  

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A recall is, until otherwise determined by law, a voluntary action. Recalls are procedures used to identify and recover potentially adulterated, misbranded, and/or hazardous foods in order to prevent potential food safety problems or economic fraud. The recall procedures outlined in this text are based on traditional industry practices that have proven to be effective for all foods, in all levels of commerce. Preventing purposeful contamination of food is the ultimate goal, but from the experience gained from years of observing “natural” occurrences of food contamination, prevention is far from 100% achievable. Thus, assuming that total prevention is not possible, containment of an event becomes a worthy goal.

The ability to remove products from the marketplace quickly and effectively has always been vital to businesses, large and small, which grow, pack, process, and distribute foods. So, businesses have to be prepared for the possibility of recalls, and enhance their ability to conduct rapid and effective removal of foods from the marketplace.

Manufacturers  have 2 possible type  of products removal :

1) A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity. Recalls are costly to a company because they often entail replacing the recalled product or paying for damage caused by use, although possibly less costly than consequential costs caused by damage to brand name and reduced trust in the manufacturer.

Most often, a business first learns of a threat or problem from a local, state, or federal government agency, so it is very important that the affected business have the right group of people trained and available to understand the nature of the threat, whether suspected or real, and then to assist in the most critical decision the business will make—whether or not to embark on a product recall.

In situations involving “naturally occurring” contamination, a company’s decision to remove or correct suspect product will be considered a recall only if:

·       - The regulatory authority considers the marketed product to be in violation of its food laws

·       - The regulatory authority concludes that the violation is serious enough to warrant legal action unless a voluntary correction or removal is undertaken by the company.

2) Not a Recall but … Product withdrawal. The act of removing a product from distribution when it violates federal or state law in a minor or technical way (not posing a health-related risk) ,or when it doesn’t meet the manufacturer’s own specifications or quality standards. It does not include products that have been contaminated or adulterated.

In a withdrawal, you can notify your consignees (usually wholesale distributors and retailers) to remove certain products from distribution, and to replace them with new stock that you provide. You can have your own sales force or sales brokers perform the removal and replacement duties.

What is the regulatory basis for food product recalls or withdrawals ?        

In general, while recalls are voluntary, it is usually in the best interest of a food facility and its owners or managers to fully cooperate and initiate a recall when requested. Federal agencies can, and probably will, take more stringent actions, when a product poses a significant risk to human health, if the manufacturer or distributor is unwilling to launch a voluntary recall, or if the agency decides the company’s voluntary action is ineffective.

• Recall is a voluntary action.

• Recall is an alternative to FDA (or FSIS) initiated court action, and a recall may be undertaken with or without a request by the agency.

• The agency appoints a Health Hazard Evaluation Committee to evaluate the potential danger presented by any product being considered for recall. The committee looks at things like whether any disease, injury or death has already occurred, and what documentation there is to associate these occurrences with the product.

• The committee looks at the label directions on the product, and decides whether “any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard.” In short, was it used correctly, or misused? Mislabeled

• Was it a product malfunction? In the case of a food, adulteration? In the case of a drug or cosmetic, an incorrect formulation? A quality issue, like contamination? Badly designed? All possible problems are taken into account.

• The committee assesses the problem’s potential impact on various segments of the population (such as high-risk individuals: children, senior citizens, immuno-compromised consumers, etc.); the “degree of seriousness” of the health hazard; and its actual likelihood of occurrence.

• The committee also considers the short-term and long-term consequences of the potential hazard.

When can a recall be requested ?         

The Commissioner of Food and Drugs (or his/her designee, usually an FDA Regional Office) may request a recall when an agency determines: 

Why does a company voluntarily recall  or withdraw a product?         Recalling the product allows the company to destroy, replace, and/or alter the problem product. In addition to protecting consumer health, the company must demonstrate they have corrected the problem and are complying with existing rules and regulations. The company also needs to minimize the cost of the recall, while regaining and improving the company’s reputation for future sales and business.

General steps to a product recall:       

 A product recall usually involves the following steps, which may differ according to local laws:

Who pays ? The manufacturer is responsible for all of the costs involved in this process. Most companies carry product recall insurance to assist with the costs of the recall. It depends on what your ability is to self-insure. Recall insurance is extremely expensive, so the company’s got to make a decision whether they’re going to self-insure, or rely on a second party to insure them. By self-insure, I mean set money aside to use in case of this type of problem.