While U.S. product recalls were relatively flat from the second to the third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unregulated categories.
Part of that pressure on regulators is a result of past handling of product safety issues. But there is also a push to get ahead of fast-moving issues regarding cybersecurity, food safety modernization, children’s sleep products and cannabis, where regulation is currently unclear or uncertain.
We’re at a point in time when product offerings are so vast, innovation so rapid, and competition so fierce, that research and science isn’t keeping up. It’s a challenge that nearly every industry is facing.
Given how short-staffed the regulators are, it is impossible for them to keep track of everything. This empowers consumer advocacy organizations like Consumer Reports and Kids in Danger to continue their consumer product safety campaigns and launch new ones. On the drug and medical device side, you have Members of Congress propelling themselves into the debate and states creating their own rules and regulations.
It’s a dangerous mix for any company that finds itself in the middle of it all. Companies and organizations need to be sensitive to the fact that, even where there is no clear regulatory standards or guidance, they may find themselves facing unbearable pressure from consumer groups, Congress, and the news media to announce a recall, change marketing strategies, issue consumer warnings, or even eliminate a product line entirely. How those decisions are made and communicated will ultimately determine the reputational impact on a company.
So that’s the regulatory environment we’re working in, but we know you’re interested in the data. Here are a few highlights.
Consumer products
Consumer product recalls remained steady during the third quarter, and two more deaths were reported in connection with recalled products. Yet, the number of consumer product safety incidents is currently trending to be the lowest in five years.
Pharmaceutical
cGMP deviations continue to plague the industry, causing 25 percent of pharmaceutical recalls and impacting more than 93 percent of all units. As long as the drug supply chain remains so complex, ensuring quality will remain a challenge. The ongoing NDMA issue, which has impacted a significant percentage of two product categories, is a textbook example.
Medical device
Recalls are ongoing even though they are smaller and we hear less about them. Because of their connected nature, the fixes they require can happen almost entirely without doctor or medical organization involvement.
Food and beverage
Undeclared allergens were the most frequent cause of food recalls at both FDA and USDA, but in terms of units or pounds impacted, another different reason took the lead. Foreign material accounted for nearly 50 percent of FDA recalled units, while bacterial contamination caused about 31 percent of USDA recalled pounds.
Automotive
Automotive recalls continue to be the industry with the steadiest recall activity, consistently logging 180-220 recalls every quarter. But what’s worrisome is the ongoing issues related to core safety components of a vehicle, such as airbags, seat belts, and brakes. In fact, service brakes accounted for more than one-third of all recalled units.