Food Safety Modernization Act’s Impact Will Go Beyond Food
By Howard Aughinbaugh
The recently enacted Food Safety Modernization Act (FSMA) is designed to improve the safety of the United States food supply in the wake of a string of high-profile food recalls in recent years. An important consideration, however, is how the expanded powers given to the Food and Drug Administration (FDA) by the new legislation will have an impact beyond food processing. This latest example of expanding regulation reinforces the need for careful compliance in a wide range of industries, not just food.
The pharmaceutical industry in particular will be impacted by the FDA’s expanded enforcement authority. Beyond simply expanding the jurisdiction of the pharmaceutical industry’s primary regulator (which could have further implications down the road), there are a number of ingredients used in drugs that can also be considered foods. These will require the pharmaceutical industry to carefully observe the new regulations for food safety.
For example, a wide range of agricultural products used by medicated feed manufacturers can be treated as foods by regulators, as can sugars and starches used in the production of drugs. Simply because these ingredients are being imported by a pharmaceutical company does not mean that the FDA will not regulate and inspect them as foods as well as drugs.
It is critically important for pharmaceutical manufacturers to prepare for these rule changes and take careful steps to ensure compliance with the FSMA. Simply claiming that your company is not a food manufacturer will not be a sufficient defense if the FDA launches an investigation under its new FSMA powers. And with regulation to protect consumer safety continuing to expand, bare minimum compliance will not be enough to keep you out of trouble.
In fact, taking additional steps beyond basic compliance to establish industry leadership in drug safety can go a long way toward not only protecting your company from regulatory scrutiny, but also to safeguard its reputation in the eyes of the public. Keep in mind that in today’s regulatory landscape, there is no such thing as being too compliant.
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