Whistleblowers have a thankless job standing up for what they believe is right.
Five years ago, two whistleblowers notified the US Food and Drug Administration about the contamination of disposable baby wipes made by Wisconsin-based Rockline Industries and that the company knew about but failed to stop the distribution of the products. They further wrote that the company had a special “code” they would broadcast should a surprise inspection occur.
Two weeks later, on Nov. 7, 2006, a government inspector paid an unannounced visit and discovered problems that included faulty product testing and poor sanitation, as well as customer complaints about mold and foreign objects such as a dead cockroach and razor blade in the wipes.
Rockline makes wipes for retailers under a variety of different brand names.
After the surprise inspection, Rockline announced a nationwide recall later that month of 20 brands of potentially contaminated baby wipes but said they posed little risk to consumers. Shortly after, FDA test results showed the contaminated wipes were teaming with Burkholderia cepacia, a bacterium that poses a health risk to anyone with a compromised immune system, at levels thousands of times higher than FDA and industry guidelines. Experts said these were high enough to sicken even those with healthy immune systems.
Sad to say, the FDA took no enforcement action.
This was the first shoe dropping. The second one is falling now.
Rockline is currently recalling the same product, again because of contamination. FDA inspectors have returned but again have taken no action.
Lest you think this is limited to one company, it’s not. The disposable baby wipes industry, which supplies products to millions in hospitals and consumers across the country, isn’t being guarded by our nation’s top health watchdog.
According to research by Milwaukee’s Journal Sentinel,
- The FDA hasn’t inspected several thousand drug and device makers in at least five years, and hundreds of plants have not seen an inspector in a decade.
- FDA records show Rockline’s plant in south China and products shipped from there have not been inspected.
By law, this and Rockline’s other plants were to have been inspected every two years.
There are no serious injuries or illnesses that have been definitively linked to the contaminated wipes. But because the status of this situation is unreported, consumers may not make the connection if they were indeed made ill.
This contamination problem hasn’t been limited to a one-time, one-place for Rockline. In 2001, 2006, 2007 and again this year an FDA inspector found problems in their Arkansas plant. Again, however, the agency took no action.
Burkholderia cepacia can, according to company reports, cause toxic shock syndrome. The FDA failed to list this in their reports.
This wasn’t the only bacterium discovered at a Rockline plant. Company records showed a more virulent bacterium, Staph aureus, was found on Rockline wipes twice in 2006. A form of Staph aureus was implicated in the toxic shock syndrome that sickened and killed women through contaminated tampons in the 1970s. Yet FDA records again failed to note this serious health problem.
Disposable wipes labeled as sterile are required to be bacteria-free, are classified as drugs, and are used to treat or prevent diseases. They can have direct contact with wounds, bloodstreams and spinal fluid. Wipes can also be considered devices if they’re included in an injection kit.
Non-sterile wipes aren’t subject to clear bacteria limits but are regulated as a drug if they are anti-bacterial. Baby wipes are regulated as cosmetics and are subject to less oversight. Congress has left the FDA fairly powerless when it comes to regulating baby wipes. It’s like having working garage doors but not being able to use the remote to open them.
Oh, and what about the whistleblowers? The company hunted down the two employees and fired them in 2008. They in turn sued the company in federal court.
The moral of this story?
Consumers somehow need to hold our government agencies accountable – particularly the ones charged with safeguarding our health. Perhaps this is a cause worth taking up on change.org. Any takers out there?