The issue has been highlighted in recent weeks with the outbreak of cases of hepatitis associated with turmeric supplements that are being sold in Europe. The cause of this outbreak is not yet clear. But what is clear is the risk of such an issue affecting companies in many markets across the globe, including here in the United States.
What does ‘full funding’ for FDA really mean?
It’s a common refrain within the dietary supplement industry that stakeholders support the ‘full funding’ of the Food and Drug Administration. And the dearth of FDA resources is often noted, too, with fewer than 30 full time staff members in Washington DC devoted to the dietary supplement industry. There are many more inspectors in the field, of course, but nowhere near enough.
So what does this ‘full funding’ mantra really mean? To me, it’s sounds like a bit of a cop out. (I know that’s an anachronistic term, but all of these 50-year anniversary stories about the Moon landing have put me in a nostalgic mood).
I say this because it seems to me that suggestions of any sort of fee for service structure for FDA have gone mostly nowhere. And the notion that the agency can charge hefty fees for reinspections of facilities has been met with consternation.
In my view, what stakeholders are really saying is, FDA needs and ought to have a bigger budget. Just don’t you use MY money.
Mismatch between capabilities and responsibilities
As FDA’s budget has mostly languished, the size of the markets it regulates continues to explode. There are thousands of registered food facilities in the US and many, many more overseas. In theory, every one of these is subject to an inspection at any time by FDA.
In practice, only a small fraction of these will be inspected in any one year. FDA is forced to rely on the speeding ticket theory for food safety; i.e., writing up one facility will incentivize others to comply.
So the mismatch between FDA resources and the tasks it supposed to accomplish will likely continue and will likely get worse. What can companies do to protect themselves in this interregnum?
FSMA provides roadmap
One answer is provided by Larisa Pavlick, chief of regulatory and compliance for the United Natural Products Alliance. Pavlick said the hazard control evaluation and foreign supplier verification portions of the Food Safety Modernization Act provide a roadmap for self regulation.
Pavlick is a former FDA inspector herself and has become a go-to resource for the dietary supplement industry on FSMA compliance. She said rather than viewing the FSMA requirements as annoying additional regulatory burdens, they can instead become tools companies can use to reassure themselves, their investors and ultimately their consumers about the safety and security of their supply chains.
“FDA doesn’t have the ability yet to fully investigate all the products that are coming from overseas,” Pavlick said. “You can’t really count on FDA to be your filter on food safety.”
Proactive control of hazards
Take the risk of hepatitis for example. Pavlick said this is rarely the result of animals interacting with crops. It comes from poor hygiene on the part of workers or contaminated water being used at the growing or processing sites.
What FSMA would require, then, is for there to be a detailed hazard evaluation and control plan in place at your supplier. Do workers have adequate restroom facilities, and water and soap to wash their hands? Is someone making sure they are complying with the sanitation requirements? Is the water they use (and the water being used for the crops) treated and is it periodically tested?
What other kinds of contamination risks are present, such as chemical deposition? How are those risks being mitigated?
Testing of raw materials coming from suppliers is of course important and mandatory. But, as they say, you can’t test your way into a quality program. Following the procedures laid out in FSMA can go a long way toward proving a company has a robust safety program, and is proactive rather than reactive in nature, Pavlick said. And showing a record of such compliance puts teeth in the notion of an industry that is stepping up to the plate to regulate itself.