Imports of FDA-Regulated Products on the Rise – How Does FDA Plan to Crack Down?

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Mike Rozembajgier
06-21-2012

Last year, 25 million U.S. Food and Drug Administration (FDA)-regulated products were imported into the nation. These products accounted for 20 to 25 percent of all U.S. consumer spending.

As consumers continuously demand global products, the ability to guarantee the safety and quality of these imports becomes essential to public safety.  And, it is  FDA’s responsibility to do just that. The agency must ensure that imported food, medical products and other goods it regulates meet the same standards as those products manufactured in the U.S.

How does FDA plan to keep up with this ever-increasing formidable task?

It recently released a Global Engagement Report that lays out its plan to protect U.S. consumers from coming into contact with potentially hazardous imported food and medical products. The report outlines a number of strategies FDA will utilize including risk-based monitoring and inspection, building strong partnerships with counterparts abroad and strengthening its regulatory capacity.

All of the strategies listed within the report point to one common goal – for FDA to transform from a domestic agency operating in a globalized economy to a global agency that is wholly prepared for the regulatory pressures that come along with increased globalization.

FDA currently has seven international offices in strategic locations around the world. However, for the agency to reach its goal within the next ten years to become a global regulatory body, it is imperative that outreach to other nations’ governments and industry organizations continue. Building meaningful relationships with international partners will lead to the creation of a global safety net that will not only benefit the U.S., but the rest of the world.

Maintaining progress is not just the responsibility of the government, but also those businesses that make up the food and pharmaceutical industries. They too should look for ways in which they could better ensure the safety and quality of their products, imported or not. By remaining ahead of the regulatory game, companies will not have to question whether or not they are in compliance when any future rules are set by FDA.

Are you surprised to see the types of tactics FDA is planning to implement in an effort to ensure the safety of imported products? What steps does your company take to learn of new laws and regulations that could affect your industry? Your comments are welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

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