I have had the privilege to hear Consumer Product Safety Commission (CPSC) Chairman Inez Tenenbaum speak on a number of occasions over the last six months. Most recently, I was in the audience during her keynote address on the first day of the Defense Research Institute’s (DRI) Annual Product Liability Conference.

Each time I’ve heard the Chairman speak, her messages have been consistent. While she doesn’t always speak specifically about the recall process and recall regulations, there are several major product liability themes that come up over and over again in her speeches, including:

• The CPSC is an agency on the rise.
• The CPSC will be fair, but firm.
• The CPSC’s mission is to protect the safety of the American consumer.
• The Chairman is personally focused on protecting our most vulnerable citizens – babies and children.
• The Consumer Product Safety Improvement Act (CPSIA) gave the CPSC new powers and new authority. Under her leadership, the agency will have no fear in using them.
• Moving forward, the CPSC will be creative in enforcement activities.

Elaborating on enforcement, the Chairman cited a $2 million fine levied against Daiso Holding USA earlier this year. While the size of the fine was substantial, the real news was that the CPSC, working in cooperation with the Department of Justice, obtained an injunction against Daiso that prohibits them from importing, selling, or distributing children’s products or toys in the United States, unless the company satisfies a number of specific requirements. 

Also discussing the CPSC’s goals and authority during the Product Liability Conference was Stephen G. Morrison, a partner at Nelson Mullins Riley & Scharborough LLP.  Morrison gave a plenary address on the second day of the conference titled “Staying in Step with CPSIA: A How-To Guide in Handling Reportable Incidents and Addressing Consumer-Reported Incidents in the CPSC’s Database.”

Morrison began his address by acknowledging the Chairman’s remarks and sharing with the audience his past working relationship with her. His description of her validated my own perceptions. Chairman Tenenbaum is a focused individual with a track record of accomplishing what she sets out to do, and she has articulated a clearly defined mission for her agency.  

While Morrison shared with the hundreds of attorneys in the room details about the specific steps companies and their counsel should consider regarding reporting obligations, the reporting process, and the data necessary to substantiate a report, he made clear that the overall theme of his speech was transparency.

Morrison explained that there is an increasing need for transparency in all that we do, particularly when communicating with regulatory agencies and consumers. After all, social media and electronic communication make the global exchange of information almost instantaneous. Additionally, Congressional oversight and proposed regulatory changes in Washington seem focused on making sure that regulatory agencies manage their affairs in a transparent manner.

Morrison encouraged the audience that companies must be transparent in reporting incidents to the agency in order to establish trust and create a better working relationship moving forward.

While there is no perfect process, there is sound judgment and action. Once a determination has been made that a reportable incident has occurred, the right thing to do is report it and let in the light. Chances are the road to recovery will be smoother if you act in a transparent manner.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

A feature article on the front page of a recent edition of The Washington Post pointed out that while there are more and more recalls being announced, consumers appear to be paying less and less attention to them.  The problem? A phenomenon now referred to as “recall fatigue.”

The Consumer Product Safety Commission (CPSC), a small but very important federal agency, regulates some 15,000 consumer products used in and around the home and is involved with approximately 500 recalls a year.  The agency spends a lot of time and energy uncovering defective or non-compliant products that shouldn’t be sold or used by consumers.  These recalls help to reduce the risk to the life and health of consumers including, but not limited to, vulnerable children and senior citizens.  But if the public doesn’t pay attention to the risks of recalled products, then what’s the point of a recall in the first place?     

The CPSC is currently struggling to administer new provisions of the Consumer Product Safety Improvement Act signed into law on August 14, 2008.  The agency has had its budget and staff increased, but the requirements of the new law are numerous and difficult to administer.  The Commission and the industries that are required to meet these new regulations will eventually learn how to import and sell products that are in compliance with the standards and regulations set forth. 

The more difficult problem is avoiding the manufacture, distribution and sale of products that are unregulated by the CPSC but are defective and pose a hazard to consumers.  When any product is recalled and very few people pay attention, or are not even informed of the risk, fewer defective products are removed from commerce and homes leaving both consumers and the manufacturer vulnerable.  Put yourself in the shoes of a mother whose child has been seriously injured or even killed because of a recalled product that she either ignored or of which she was unaware. 

The agency, its critics, and Congressional oversight committees are struggling with ways to deal with “recall fatigue”.  Recalls that don’t properly emphasize the potential risk posed to consumers are likely to be ignored. However, recalls that pose a severe risk to consumers, make it easy to obtain a remedy, and are communicated through the proper recall communication channels where consumers would be looking to help ensure that the violative product is removed from homes.

Some of the best ways for a recalling company to reach consumers is by e-mail, direct mail or telephone.  Research shows that consumers are more likely to respond to a recall if notified directly.  It is hard to understand why retailers are unable to contact consumers directly in this high-tech world.  As the Washington Post article points out, Costco utilizes its members’club card information to contact customers directly by phone and follow up with a letter. In some cases, this results in 90 percent of Costco’s customers returning the recalled product to its stores. Even if a retailer does not employ a club card, shouldn’t  they be able to reach consumers who purchased the recalled product through the use of credit card information?  I believe they use this information for marketing purposes so why not use it to prevent injuries?

An ineffective recall can negatively impact the recalling company’s reputation and brand.  Moreover, there are product liability implications if the recalling company does not conduct an effective recall, particularly when a user never knew of the recall and was ultimately injured by the product.  Plaintiffs’ attorneys will use an inadequate recall as a basis for their argument for punitive damages, resulting in a larger award for the defendant or increased settlement amount.

Moving forward, we can expect the agency to monitor recall effectiveness more closely. And when the risk is high and the return rate is low, the agency will likely require you to issue an additional notice. It is important to think now about your recall communications and recall plan to ensure that your recall is done right the first time.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Understanding the rapidly changing regulatory environment, safety regulations and industry standards that govern not only whether your company needs to undertake a recall, but also whether your recall process and recall management plans are effective is critical to your success as a manufacturer or retailer. You must be sure that your recall management team is familiar with current regulations, industry standards and your duties and responsibilities once a product is sold and on store shelves. If a recall is necessary, how it goes will directly influence your company’s reputation and financial situation.

In order to help your company keep abreast of current information about your responsibilities once your product hits the market, ExpertRECALL is hosting two Product Safety and Recall Seminars – one aimed at manufacturers and retailers of products regulated by the Consumer Product Safety Commission (CPSC) and the other focusing on issues of concern to manufacturers of products regulated by the Food and Drug Administration (FDA).

Both seminars will offer the latest information about your responsibilities as a manufacturer or retailer and the requirements you will face in a recall. The CPSC-focused Product Safety and Recall Seminar will be held in Los Angeles on Tuesday, August 10, 2010. The FDA-focused Product Safety and Recall Seminar will be held in San Diego CA on Thursday, August 12, 2010.

While no two recalls are ever exactly the same, and the regulatory environment is constantly changing, there are best practices to consider when managing the recall process. During the seminar, our recall experts will discuss recall preparedness and execution and explain in detail the recall lifecycle. The seminar will also offer legal and regulatory insight from attorneys with the law firm Bowman & Brooke LLP. The attorneys will speak in depth about your responsibilities for post-sale monitoring, reporting, and recalls, as well as the intricacies of defending recall litigation.

Speakers will highlight best practices associated with protecting your company from the legal and economic risks associated with product safety, product liability and recalls and help you understand the new regulations your company faces, or may soon face, when conducting post-sale risk assessments, monitoring, reporting and ultimately recalls.

Additional information about the CPSC-focused seminar and registration is available here. Additional information about the FDA-focused seminar and registration is available here.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

The Council for Responsible Nutrition (CRN) announced this month the addition of five new voting members, including ExpertRECALL. CRN is an association of dietary supplement manufacturers and ingredient suppliers, including dozens of major brands across the country. Member companies comply with both state and federal regulations as well as additional voluntary guidelines for manufacturing and marketing dietary supplements.

ExpertRECALL regularly works with over-the-counter drug manufacturers, distributers, and retailers to promote safety and maintain regulatory compliance. Our recall prevention and preparation programs help companies minimize risk and effectively streamline any necessary product withdrawals or recalls.

This new partnership will provide CRN member companies access to ExpertRECALL’s industry-leading planning and execution services, such as recall readiness checks, notification, product processing and retrieval. ExpertRECALL will help companies across the dietary supplement industry maintain regulatory compliance and protect their brands.

We look forward to this new partnership and are excited to work with CRN and its member companies.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

It has become increasingly complicated in recent years to adhere to industry standards and federal regulations throughout the manufacturing, distribution and or sales process. Lawmakers and regulators alike are taking a keen interest in protecting consumers when it comes to food safety, product safety and recalls. It is essential that your recall management team understands what it means to be in recall compliance. In order to be sure that your company is ready to comply with new and ever-changing recall regulations, it is critical to have a recall plan in place.

But the increase regulatory scrutiny from lawmakers and regulators is not unprovoked. In fact, massive recalls across a number of industries have sparked increased scrutiny and sweeping changes to industry standards and recall regulations. This makes it even more important that your company is in tune these new changes as they happen.

I had the opportunity to speak briefly about recall readiness at the National Association of Manufacturer’s Consumer Product Safety Commission (CPSC) Coalition meeting this week. The Coalition is comprised of several trade associations, manufacturers, and other players concerned about new regulations being put in place by the CPSC after passage of the Consumer Product Safety Improvement Act in 2008.

While ensuring your products are safe before they enter the marketplace is critical to consumer safety, it is only half the battle. When it comes to recalls, it’s not a matter of if, but when. And once you undertake a recall, your recall effectiveness and recall compliance are critical to the four goals of every recall: protecting the consumer, protecting your brand, minimizing the impact, and mitigating the risk.

During the NAM meeting, I spoke specifically about trends across industries when it comes to tighter recall regulations, as well as the increased public concern about safe products. We also discussed the importance of communication and documentation throughout the recall lifecycle. Communication and documentation are critical to your success during a recall. Effective recall communication improves consumer response rates. Proper recall documentation proves to regulators that you have managed an effective recall.

Regulators are also taking it up a notch and building in the option of pursuing criminal penalties against manufacturers, retailers or corporate executives for failed or ineffective recalls. Not only is liability and recall risk increasing for manufacturers, retailers and the companies with which you do business, liability is also migrating all the way to your corporate executives, board of directors and the people who make critical business decisions.

It is essential for you to do whatever is necessary to update your recall plan, test it, and review your recall procedures to prepare yourself for a successful recall.

Remember: when it comes to recalls, it’s not a matter of if, it is only a matter of when.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

In an effort to make the federal government more responsive and accessible to U.S. citizens, the government has made available to consumers a handful of mobile applications, including a recall application that gives consumers instant access to recall announcements and recall history.

This new mobile app makes USA.gov more user-friendly, giving consumers easy access to government services and information from most smart phones and other mobile devices. Just another reason why now more than ever it is critical for manufacturers and retailers to understand the impact on their business, including areas of recall management, recall effectiveness and recall compliance.

So how does the recall application work? Simply go to www.USA.gov, choose Product Recalls under the Mobile Apps section of the homepage. Then click on the mobile web button which will direct you to Recalls.gov. The mobile application provides recent recall information on consumer products, motor vehicles, boats, food, medicine, cosmetics and environmental products. 

The product recalls application compiles all current recall information from the U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), the U.S. Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the National Highway Transportation Safety Administration (NHTSA).

Manufacturers and retailers must understand that trying to determine if an exact product has been recalled from a mobile device may be a challenge for some consumers. So having recall information available to consumers on the recall application could impact your entire brand more than you would like. Additionally, bar code scanning technology will soon be available with consumer’s mobile devices to allow a consumer to take a photo of a bar code from their mobile device and find out instantly if the product has been recalled.

The mobile application will enable consumers to have recall information at their fingertips and, most importantly, at the point of purchase. This may influence a consumer to change their purchase decision at the last minute when they use their mobile device to check for a particular manufacturer’s track record on recalled products. More expensive items may be in more danger since consumers are more likely to make the extra effort to research a brand name at the point of purchase before investing in the high-ticket item.

Manufacturers that are managing a recall will want to close it out faster so it doesn’t cause a decrease in sales of other non-recalled products with the same brand name. Manufacturers going through the recall process will also need to pay close attention to this mobile application and find ways to insure consumers that other products they manufacture are safe to buy.

Manufacturers also need to integrate social media efforts into this new mobile application.  Look to your Consumer Affairs department for ways they may already be using social media so that you can be proactive and use these increasingly popular platforms to inform consumers that your products are safe to purchase.
 
Manufacturers and retailers will also need to do a better job of making sure recalled products are pulled off the shelf within hours of a product recall notification. This new mobile application will enable consumers, reporters, attorneys and special interest groups to easily check for recalled products that are still on the shelf. You don’t want to have any more negative press than you may already have.  It may be time to re-evaluate your current recall notification processes and in store effectiveness checks to test the speed and accuracy of your recall system. After all, just one report about a recalled product on store shelves from a consumer using the mobile application could devastate your attempts to close out the recall and convince regulators of your recall compliance.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

It seems like almost every week there is a food recall or alert that calls attention to the food safety issues facing our country. Over the past few months, we’ve discussed several food safety reports on this blog, including Deloitte LLP’s 2010 Consumer Food Safety Survey and a report by former Food and Drug Administration (FDA) economist Robert L. Scharff that discussed the cost of foodborne illness to the United States. Now a new report is out that makes a number of food safety recommendations for the FDA, including mandatory food recalls and increased effectiveness for food recall communications.

The report, issued by the Institute of Medicine (IOM) and the National Research Council, echoes industry and government concerns about the food supply and found that the FDA currently isn’t equipped to handle food safety problems.

The report was produced in response to a request from Congress to examine the gaps in the current food safety system and identify the tools needed to improve food safety.  The IOM report outlined several steps the FDA should take to mitigate food safety risks and meet its food safety responsibilities. But the IOM recommendations are hardly earth-shattering. In fact, several of the recommendations are already mentioned in some form in the FDA Food Safety Modernization Act pending before Congress – including strengthening the FDA’s authority to regulate the food industry and order mandatory food recalls.

For starters, the report puts a facelift on a recurring idea in Washington to create a centralized food safety authority. While in the past there has been discussion about creating an entire new agency to regulate the food industry, the IOM recommends establishing a data center independent of the agencies. This center would be tasked with collecting and quickly analyzing information in order to identify and respond to potential food safety risks. This center, coupled with the recurring recommendation that the FDA have authority to issue mandatory recalls, could put food manufacturers at increased recall risk.

One of the most significant recommendations in the report focused on food recalls. The IOM found that the FDA must communicate more clearly with health care professionals and consumers during foodborne illness outbreaks and food recalls. As manufacturers and retailers who have been through the recall process know all too well, ineffective recall communication can lead to decreased consumer response and a drawn out recall process – both putting consumers at increased risk.

While there is a keen awareness among consumers about recent food recalls, there is also an illusion that they are invulnerable to the risks. According to the report, there is a general lack of knowledge and understanding among American consumers about how the food recall process actually works.

While we wait to see what impact this report, and any others will have on you as manufacturers and retailers, take the recommendations to heart and do what you can to adopt them in your recall procedures. After all, your brand will be on the line when you face a recall.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

It has been more than two months since the BP oil spill, and it would be hard to find anyone for whom the spill and its ugly aftermath has not given rise to some thought about crisis management, from both a personal and a business perspective.

Amid all the analysis and criticism surrounding the spill, two primary elements continue to drive the discussion: crisis and the environment. Both are fundamental – whether recovering from an oil spill or managing a product recall.

Watching and reading about the spill, you may be thankful you aren’t a part of the catastrophe or the disaster response. You may be wondering what you would have done if your company had been involved. Even if your organization has nothing to do with deep water oil drilling, you may well be looking at the disaster from a broader crisis management perspective.

I recently had the privilege of attending an AdvaMed board meeting and sharing a few words with my fellow attendees. The association is made up of medical technology experts and is committed to providing healthcare providers with the tools they need to diagnose and treat patients. As an association, AdvaMed certainly understands crisis.

In fact, AdvaMed established the Medical Technology Preparedness Council with the sole purpose of ensuring the healthcare delivery system and the military are fully prepared to respond to crises. The Council reports directly to the AdvaMed Board of Directors, my audience that evening. These industry leaders understand the importance of risk management and effective crisis response. They take crisis management seriously.

When considering a crisis response – whether you are the product manufacturer, a supplier, a retailer or a distributor – a thorough understanding of the entire recall process is critical to success. Preparing for and executing product recalls in an effective and compliant manner is crucial to recovery.

At the same time, you must understand the impact potential on the environment and what you can do to protect it. In fact, developing strategies and execution plans for alternative use, recycling, and depackaging of recalled products should always be a part of your overall recall planning.  When you do what you can to “reduce, reuse and recycle” your recalled product, you not only win points with your customer base but you can also reduce costs.

Are you ready for the next crisis?  Is your recall team in place?  Do you have a plan? When was the last time you tested it?  Have you conducted a recall look-back analysis to identify hidden opportunities?

Are you doing everything you can from a sustainability perspective?  Are you maximizing beneficial reuse and minimizing costs?  Are you capturing all the green points you can and receiving credit you deserve for doing so?  Can you do more? 

These are all good questions to ask … and questions we can help you answer.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

There is no doubt that managing a recall – no matter what the industry – can be a costly and time-consuming process, especially considering the external recall logistics and communications expertise required. With increasingly stringent recall regulations making it next to impossible to handle a recall internally, recall insurance options can help protect manufacturers, wholesalers, retailers, and distributors from the financial and reputational damage that often results from a recall.

As I recently told Fortune, companies facing a product recall are often too busy keeping the business going and making adjustments to prevent future problems to actually manage the recall logistics and recall communications as well as they would like. But they can rest a bit easier if they have invested in advance in a recall insurance program. Recall insurance usually covers the cost of actual product retrieval and the crisis communications support necessary to address the concerns of regulators and consumers.

Just as important, however, is the recall insurance carrier’s focus on recall prevention and preparedness. In many cases, recall insurance companies require companies to prepare a recall plan before writing the coverage.

This requirement shouldn’t be considered a burden. It is a launching point from which to start a larger conversation about recall preparedness and recall prevention. Minimizing the risk of a recall will not only satisfy recall insurance providers, it will also protect your bottom line, your brand reputation, and, most important, the health and safety of your customers.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

We’ve discussed on this blog before the importance of qualifying your product ingredients in order to ensure that they are safe. But occasionally manufacturers still find themselves facing a recall because of a defective ingredient obtained from a supplier.  For example, recent recalls of contaminated black pepper, HVP, and even peanuts eventually led to massive recalls of consumer products that contained these ingredients. Now Kellogg Co. and Procter & Gamble have been forced to manage a recall because of the failure of something that wasn’t even in the final product at all, but just a part of the packaging.

In Kellogg’s case, breakfast cereal was recalled because of complaints about an “uncharacteristic off-flavor and smell” linked to the package liners. In the case of Procter & Gamble, Scope mouthwash was recalled because the child-resistant caps were defective. Keep in mind, in both cases, the core product was perfectly safe. But both products had to be recalled anyway because of defective product packaging.

And these are not the only high-profile recalls that have occurred this year because of packaging, components, or ingredients. To insure quality and avoid recalls, manufacturers need to know and test their supply chain partners. This has become increasingly difficult as supply chains have become more complex, but it is your responsibility as a manufacturer to increase your own testing and standards in order to ensure product and consumer safety.

Don’t be mistaken – product packaging is still considered part of your final product. And be sure to note that consumer concern about foodborne illnesses, overexposure to lead and cadmium, and health risks associated with chemicals, bacteria or harmful substances is steadily increasing. As a manufacturer you must be absolutely certain that everything from the water you use to make a product to the plastic used to carry it is safe for consumers of all ages.

As a manufacturer, you must take the necessary steps to make sure that the ingredients and components used in your products meet all regulatory requirements and manufacturing specifications and that nothing will contaminate them while in transport. Taking these preventative steps could help you avoid a devastating product recall, potential harm to the public and to your brand image, not to mention potentially serious legal and regulatory repercussions.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.