Health Watch By Steve Mullenix

The North Jefferson News



In recent weeks we have seen and heard a lot on the news about the peanut recalls.

Sometimes the media adds to the apprehension of the recall. Recalls are not something that a company does without due cause, as they can cost companies hundreds of thousands of dollars or put the company out of business. Recalls can be due to something as simple as a labeling issue or in the case of the recent peanut recall, result in consumer deaths.



What is a recall?

A food recall includes any corrective action by a company needed to protect consumers from potentially adverse effects of a contaminated, adulterated or misbranded product.

A recall is a voluntary action, and the recall decision is made by the company management. If the company does not initiate a recall, the government agency responsible for the particular product category may request that the company do so. Recalls are conducted by the industry in cooperation with federal and state agencies.

Manufacturers strive to prevent a recall. Employing Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) plans are vital to preventing a recall. Even the best managed businesses can make occasional mistakes. It is important to be ready for a recall well before a problem occurs.

Management must be part of an effective recall plan and team. The company management should not rely on product liability insurance in the event of a recall. Liability insurance might cover a portion of the losses due to recall, but it will not cover the expense of product retrieval and most importantly, liability insurance will not help the company regain customer trust.

Despite the undesirable nature of a recall event, it is in the best interest of the manufacturing company to complete the recall quickly. Because the manufacturer is responsible for all of the costs involved in this process, it is critical to have a plan to cover recall expenses, to expedite the process without creating negative public opinion, and to prevent down time. When crisis hits, it is too late to work on the recall plan. Preplanning is vital to mitigate a crisis. Generally, recall events should be included in the Crisis Management and Emergency Contingency Program for a company.

Factors prompting a recall include, but are not limited to unsafe, contaminated, or mislabeled products, nonconformities to manufacturer’s specifications, and missing allergen or other hazard warnings.



Purpose of a recall

The basis of the recall depends on the company’s safety policies, ethical procedures, regulatory requirements, and financial constraints. A recall not only protects the consumer, but the company as well.

A swift and smooth recall will not only protect the companies’ reputation, but can prevent future consumer concerns regarding the companies’ products. When there is a recall, the goal should be:

• Protect consumer health

• Comply with existing rules and regulations

• Minimize the cost of the recall to the consumer as well as company

• Regain or improve the company’s reputation

Even though a recall is the responsibility of the company, a government agency can step in and force a recall if they feel the company’s response is not appropriate for the concern. Two government agencies, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture Food Safety and Inspection Agency (USDA, FSIS), share the responsibility for overseeing most recalls. Either of these agencies can mandate a company initiate a recall.

There are different classes of recalls. Recalls are evaluated based on the potential seriousness to consumer safety.

• CLASS I Recall — The most severe classification in which there is a serious potential for serious injury or death.

• CLASS II Recall — A less severe classification where there is a lesser potential for injury of death, but there is still the potential for an adverse effect with irreversible consequences.

• CLASS III Recall — The least severe classification where there is an unlikely potential (but still a chance) for adverse health consequences.

• MARKET WITHDRAWAL — This type of recall occurs when a product has a minor violation that would not be subject to FDA legal action. An example of this type of recall would be when a product is withdrawn due to product tampering, without evidence of manufacturing or distribution problems.

• MEDICAL ADVICE SAFETY ALERT — This type of call is issued when a medical device may present an unreasonable risk of substantial harm. In some cases, these notifications can be considered a recall as well.

It is the ultimate responsibility of the manufacturer to remove the product from circulation before damage or injury occurs. It is the manufacturer’s responsibility to notify the Office of Public and Science, or inform the nearest FDA, or USDA, FSIS office of the product concern. Failure to do so can result in very stiff fines and future regulatory expense.

Recalls may be directed to the “wholesale level,” “retail level” or to the “consumer level.” Yes, a consumer may actually be called to bring in his medication for a replacement if the recall warrants it. However, due to the strict manufacturing regulations of the United States, most problems are identified before a product is distributed that far down the pipeline. In other words, most pharmaceutical related recalls are corrected before the consumer has access to the product.

Consumers can rest easy at night knowing that there is a chain of responsibility for quality and efficacy of products, whether they are food, drug, or device related.

Steve Mullenix (R.Ph) co-owns The Pharmacy in Mount Olive with his wife, Sherry Mullenix (J.D., R.N.). They can be reached at 631-1201.