Pharmaceutical companies in the U.S. might have thought that because the recently enacted Food Safety Modernization Act (FSMA) enhances food authorities at FDA, that Pharmaceutical manufacturers or importers have escaped unscathed. But this is an unsafe and incorrect assumption. Food is food in FDA’s mind. And at the border FDA tends to think of imported articles in ways to enhance agency power, not to restrict it. So even though the FSMA was passed with a view to increasing food safety, there are areas of concern Pharma companies should watch out for or find themselves quite surprised.

For instance:

• Imported agricultural products, flavorings, minerals, vitamins, and food additives for use in animal health will probably be treated as foods at the border even if they are being used by medicated feed manufacturers.
• Many sugars and starches and other food ingredients are used as drug excipients (such as binders and fillers) in the manufacture of drug products.
• Some pharma companies have run into problems importing placebos, which are technically foods and drugs.

Assuming FDA does not mean to reach these kinds of articles just because they are imported by a pharmaceutical company is like assuming FDA will not treat a dietary ingredient as a bulk drug just because it is imported by a dietary supplement company. Ooops. That would be a mistake.

Be prepared; Be compliant … FDAImports.com.

Share