While this week and last, the signal issue has been a Georgia-based peanut contamination with salmonella, this is only the latest in a series of contamination issues straddling half the globe and thousands of products. In this particular case, the manufacturer, Peanut Corp., knowingly shipped tainted peanuts that initially tested positive for salmonella after retesting and getting a negative result. Apparently, the FDA has asked the Justice Department to launch a criminal investigation into the plant and its operations.
As the new Obama administration introduces its financial stimulus package, yet again many eyes focus on the currently ‘leaderless’ FDA and its ability to act, and perhaps more importantly, its ability to act quickly. While the focus continues to also be on international activities, the entire FDA operation is and will be under scrutiny. President Obama in fact, commented directly, "I think that the FDA has not been able to catch some of these things as quickly as I expect them to." Expected to be a high priority on the legislative agenda, food safety legislation is imminent and almost certainly will further beef up FDA budgets. Exposed national issues compound the challenges facing the agency – it’s a lot easier to point fingers at practices abroad and throw a net over the borders than it is to overhaul national systems at the same time as policing imports from around the world. The current issue also illustrates that the problems run deeper than many assumed, and while it’s important for us, as an industry, to keep perspective, (and keep relative ‘safety’ numbers quite visible) with ourselves already earmarked as a potential target in the new administration (those in the Waxman camp have been vocal adversaries), it’s also critical that at this time especially, we be beyond reproach for quality and safety practices.
So where will the proverbial ‘rubber hit the road’ for us?
This June marks the implementation date of GMPs for mid-size supplement companies. Word on the street suggests that many of these companies are just now realizing the investment and changes they must make to operations and procedures in order to comply. In fact, in at least a couple cases, core facility changes that should ideally have been made long ago are just now beginning, ironically, in a very credit-strapped environment. The urge to take shortcuts has probably never been higher, the same for the risks inherent in doing so.
With a series of recent recalls and warnings related to ‘supplements containing drug actives’, the potential for a spate of adverse events leading to unwanted scrutiny is certainly higher than ideal. I was interviewed a couple weeks ago by a consumer magazine looking for an industry perspective or response to the recent FDA warnings about weight loss products, and believe, in the course of the hour long interview, I was able to explain a bit about industry dynamics and the concept of ‘outliers’. The dialogue underscored, again, the inadequacy of the separation between industry at its best and these outliers.
The concept of ‘garbage in garbage out’ applies to data management, but as we are coming to know all too well, is an issue for all consumer products, including the food and related product sector of which we are a part. Those manufacturers who read into the supplement GMP regulations a ‘free pass’ on ingredients will ultimately discover their mistake. I hear that demand for analytical services, even for verification of raw material Certificates of Analyses is on the rise, a piece of news I can only interpret as positive.
As speed of response becomes increasingly more important, perhaps another area of potential concern may be the definition and subsequent actions related to the detection of a ‘signal event’. Adverse event reporting rules documentation refers to this concept and if the threshold for determining a signal event is lowered, as it almost certainly will be, the categories of products we supply may be caught in the crossfire.
While we focus on creating and maintaining successful businesses in the ‘new normal’ environment, we cannot ignore the ‘noise’ around us. While Washington likely will take some time to get to the ‘supplements issue’, there are triggers and relationships we need to be aware of as we focus activities and take care of current business. This may also be our chance to take some measures, as an industry and as individual operations, to prevent being not a casualty of the economy, but perhaps even more unfortunate, a casualty of poor management.