How to Initiate and Execute an FDA Recall

A pantry staple, granola bars and granola cereals faced a nationwide product recall just before the holidays by the Quaker Oats Company due to potential contamination with Salmonella, a high-risk bacteria that can cause fatal infections in vulnerable populations such as children, the elderly, and those with weakened immune systems. The recall affected Quaker Chewy Chocolate Chip, Peanut Butter Chocolate Chip and Variety Pack Granola Bars and other flavors. The recall also affected Quaker Puffed Granola Apple Cinnamon Cereal, Honey Almonds & Oats cereal, and others.

The nationwide recall thrust into the spotlight an issue that we see all too often: potentially violative product that needs to be removed quickly to protect consumers, that needs to be executed in coordination with FDA, and that in parallel minimizes business and reputation damage.

Recalls present a tricky balance of interests to say the least. However, with a developed recall strategy, businesses can prepare and execute a recall, be it a food, cosmetic, drug, or device product, with the least amount of shakeup. As the New Year kicks off, we’ll discuss further some recall basics and how to best prepare for a recall so that you are “recall ready” and can minimize the potential impact on your customers and business.

 

Back to the Basics

A recall is a voluntary or mandated action to remove or correct products in the market that are in violation of FDA’s laws, e.g. a product is misbranded or adulterated. Recalls are classified into three classes: Class I, Class II, or Class III. Class I recalls carry the greatest risk of presenting a serious, adverse health consequence whereas Class III recalls present relatively lower risk of causing or contributing to adverse health consequences. There are also other methods to effectively remove products that involve minor or no violations, and that have not penetrated the marketplace.

In many cases, recalls are initiated by the firm that has primary responsibility for the manufacture and marketing of the product to be recalled. In some cases, firms must conduct recalls in a manner specified by FDA (e.g. recent infant formula recalls that presented a risk to human health). And still in other cases, FDA may order a firm to conduct a recall.

In all cases, the first step in determining how to address a potential recall issue is to identify and investigate the issue. This allows a business to direct classification of the recall and the overall approach that the Company and the FDA will take. Having a written Recall Plan will also help minimize delays that are created by uncertainty as to appropriate actions to take when a decision to initiate a recall is made. This includes identifying the appropriate scope and depth of the recall. The Recall Plan will also likely minimize the disruptive effect a recall can have on your business, and may also reduce the amount of time a violative product is on the market. The manner in which you notify FDA, consumers and the public must also be done compliantly and effectively, involving records of monitoring and effectiveness checks.

As the New Year kicks off, we recommend businesses review the following to ensure “Recall Readiness”:

• Confirm you have a Written Recall Plan in place.
• Identify appropriate personnel and assign recall-related responsibilities to designated employees.
• Establish a recall communications plan for FDA, direct accounts, press releases.
• Identify any reporting requirements associated with your products (e.g. Reportable Food Registry, FDA Report for the Correction or Removal of Medical Devices).
• Use adequate product coding to track and trace products.
• Maintain distribution records.
• Maintain monitoring records and effectiveness checks.
• Confirm terms of insurance coverage for recall costs, including direct losses of product and indirect losses from business disruption.
• Identify a close group of internal counsel, outside regulatory counsel, and other parties as part of your Recall Team to provide critical advice early in the decision-making recall process to help reduce the impact on your customers and business, including potentially, a justified decision not to recall. We recommend keeping the recall team to top management and key counsel to maintain confidentiality.

 

Whether you have experienced a recall, or think you are excused from recall and reporting obligations, we strongly recommend (re)confirming your recall and reporting requirements based on your supply chain activities, ensuring you have a Recall Plan in place, and conducting mock recalls to (1) avoid your Company from being the next recall; and/or (2) to execute a recall as efficiently as possible with minimal business disruption and maintaining consumer confidence. This applies significantly to cosmetics and personal care products where FDA has new, and significant expansion of its authority to monitor, track and recall cosmetic products.

 

For more questions on FDA recalls, including information and support in drafting recall plans, and preparing and successfully executing FDA recalls, please contact us at info@garg-law.com.