Trust, but verify. Over the years as both an end-user and then working with suppliers to help certify processes for manufacturing safe and responsibly sourced products, I’ve found the concept of “trust but verify” a critical concept. No matter how long a distributor has worked with a supplier, it should always apply: Having trust in that supplier is no substitute for a need for documentation of processes all along the supply chain.
As the promotional products industry has rushed to provide personal protective equipment (PPE) as a source of financial survival for many suppliers, the results of a recent Wall Street Journal investigation could be chilling. The FDA requires that all foreign manufacturers of medical devices must have a representative with a confirmed address in the U.S., with a live person available during business hours. These agents are intended to serve as a point of contact between the FDA and Chinese manufacturers to coordinate inspections, recalls or other urgent issues with products. And yet the WSJ investigation found that more than 1,300 Chinese medical suppliers, including 217 N95 mask manufacturers, used false addresses and phone numbers in their registrations with the FDA. The 1,300 Chinese companies with false registrations all listed CCTC Service Inc. as their U.S. agent. According to the WSJ, no company by that name exists in the U.S., according to databases of corporate records. CCTC’s supposed address is a three-bedroom brick house in Wilmington, Del., where both the tenants and landlord say they know nothing about CCTC.
If nothing else, the COVID-19 pandemic exposed the fact that the supply chain for PPE was easily disrupted. The moving target that was the FDA’s rush to respond to the pandemic created regulatory holes in the agency’s emergency-use authorization program. The WSJ findings highlight flaws in that program, including the fact that a listing in the medical device database is commonly cited by sellers of protective masks as proof of legitimacy. That’s just wrong.
In May, the FDA withdrew permission for dozens of manufacturers exporting N95-style masks from China to the U.S., reversing emergency approvals the agency had granted just the month before. “There do appear to be fake N95 masks out there,” Larry Whitney, product safety and compliance expert, and managing partner at Whitney and Whitney Consulting told us. “In the past two months, I have seen Rapid Alert For Non-Food Products (RAPEX) listing dozens of recalls for masks whose filtration levels don’t even come close to the claimed filtration levels.” In one sample, the National Institute for Occupational Safety and Health found that 60 percent of 67 different types of N95 masks imported from China failed to provide adequate protection, offering as low as 24 percent filtration instead of the required 95 percent.
The fact is that the virus continues to spread. Without Federal guidelines, states and municipalities are beginning to move on their own from suggestions to requirements when it comes to wearing a mask in public, and demand for PPE is not going away any time soon. What should you do? The majority of the masks being offered in the promotional products space already are face coverings, not FDA/NIOSH-approved respirators, and that’s a good part of the market to channel your non-medical clients into. The CDC advises the use of cloth face coverings to slow the spread of the virus and keep people who may have the virus and don’t know it from transmitting it to others. The cloth face coverings recommended are not surgical masks or N95 respirators, which are still considered critical supplies that must continue to be reserved for healthcare workers and other medical first responders.
Finally, I’d be remiss if I didn’t mention the end of an era in promotional product safety. The accredited supplier members of the Quality Certification Alliance have voted to wind down the non-profit organization. Industry consolidation continued to drive a reduction in the total number of supplier participants, putting pressure on the ability to maintain and grow the organization. No new applications are being accepted and current members will continue to be supported through August 2020. “QCA drove the appetite for product safety and responsible sourcing with the idea that compliance wasn’t just good business, but it is good for business,” said David Clifton, president of QCA’s Board of Directors.
QCA started in 2008 when a group of 14 suppliers agreed to work together to establish industry standards. As PCNA’s president David Nicholson says, “It was at a time when the industry had no clear standards nor any central organization to promote and drive awareness of compliance issues. QCA has permanently raised the bar on the compliance standards across the industry as well as building supplier, distributor, and end-user awareness of the importance of compliance and brand protection.”
The driving force behind the creation of QCA was Jay Deutsch, co-founder of BDA. “I’m really proud of the work that we accomplished, and the great suppliers that opened their doors to improve and certify their supply chain practices. There are many professional suppliers, working hard to protect both our clients’ brands and our overall industry. Thank you to them.”
The one constant during the 12-year run, and my partner during the four years I served as executive director, was D.E. Fenton. “The fact that QCA, the organization, is winding down doesn’t mean member companies are going to disassemble processes that made them more knowledgeable about their businesses and product,” said the current executive director. “In fact, I expect them to continue to be the innovators in the promotional products industry.” Based on my experience, it’s a very reasonable expectation. Good luck to the more than 100 suppliers, distributors, and end-users that helped QCA leave a legacy of impacting product safety and responsible sourcing for the industry.
Jeff Jacobs has been an expert in building brands and brand stewardship for 40 years, working in commercial television, Hollywood film and home video, publishing, and promotional brand merchandise. He’s a staunch advocate of consumer product safety and has a deep passion and belief regarding the issues surrounding compliance and corporate social responsibility. He retired as executive director of
Quality Certification Alliance, the only non-profit dedicated to helping suppliers provide safe and compliant promotional products. Before that, he was director of brand merchandise for Michelin. Connect with Jeff on
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jeffreypjacobs.com. Email
jacobs.jeffreyp@gmail.com.