It is not a unique perspective to say that food is more complex than drugs when it comes to quality, says Ronald Piervincenzi, Chief Executive of the United States Pharmacopeial Convention.
But there couldn’t be a more opportune time to understand that complexity than now in India, when Maggi noodles is facing the heat for containing excess lead and flavouring item MSG (monosodium glutamate.)
A non-profit scientific organisation, USP sets standards for food, drugs and dietary supplements — quality benchmarks that are enforceable in the US by the regulatory Food and Drug Administration.
For each of these segments, quality standards are an analytical set of tools to measure product quality, says Piervincenzi. “We follow the same processes to create the standards, (but) the industries they affect and the world they live in are very different,” he says, ranging from the “ludicrously fragmented” food industry at one end to expensive biologic therapies at the other.Global strategy
In fact, USP is looking to customise its approach to the different industry segments, in its soon-to-be-unveiled five-year global strategy.
Food includes quality standards for ingredients, food colouring, preservatives and a level of purity in process (raw) material, he says. In medicines, there are quality tests for ingredients, a quality process for bringing those ingredients together, and a quality test for the finished product. The complication with food involves the finished product. “You cannot take that complicated food and do simple testing,” he says.
Almost all packaged foods are a mixture of materials. So quality standards for the bulk ingredients help raise the quality of products, he explains. “But that only gets so far” because even with quality ingredients and a good manufacturing technique, it still may not be a quality food, he adds.
Even with supply chain, food is “infinitely more complicated”. Companies do not completely control the supply chain, nor do they control the inputs to the food supply like farming etc. And this is where environmental concerns on pollutants come in, he explains.No complete check
“Some of that can be tested for…but I don’t think any one player, including regulators, have all the tools they have to do it, it requires a system,” he points out.
KV Surendra Nath, USP head of global sites including India, illustrates this complexity with the example of fish. When USP sets standards for fish, it looks at its source, where the fish is coming from etc. “If you see the monograph for fish oil, you will see all toxic elements are to be tested,” he says.
It’s the whole thing, the end product and the process, adds Piervincenzi, as fish oil involves “concentrating down multiple fish into one”. There may be a contaminant in a fish that is borderline for eating. “But when you concentrate it into fish oil ...you could land up with something that is very toxic. So this can happen in foods as well,” he explains.
While mercury in fish or metal in chocolate are global concerns, in the US, heavy metals are a concern in the manufacturing of medicines too, he says. It becomes important if the raw material has contaminants and impurities.
“It can happen in food but in medicines it becomes a more acute problem. On the other hand, the ability to have a single quality standard for complex foods is even more difficult,” he adds.