The U.S. presents massive opportunities within the food industry, while at the same time posing considerable regulatory barriers for foreign food manufacturers. This is mainly due to the lack of U.S. harmonization with other global frameworks for food safety. Even though a company meets all criteria set out by the European Food Safety Authority (EFSA), there are still several regulatory steps to be aware of when opening up for sales to U.S. consumers.
In addition, the recent implementation of the Food Modernization Act has shifted the FDA’s role from working reactively to preventatively. This new law also places a greater focus on the FDA to evaluate the entire supply chain for food sold in the U.S. This means that every actor along the supply chain, including suppliers and importers, must take on a greater responsibility in ensuring that safety measures are being taken and documented for all food produced for consumption in the U.S.
What regulatory steps do a Swedish company need to be aware of when considering sales to the U.S.?
The various regulations can be broken down into 6 steps:
Step 1-3 may be your partner’s responsibility. If your company process/manufacture, hold or store food for sales in the U.S., you will need to register your facility with the FDA, assign an agent, and ensure your company has an FDA compliant food safety plan in place. However, if you are using a third party for manufacturing or storage, they will need to cover these steps. The chart below can be used to help you understand your level of responsibility.
Our manufacturing facility has a BRC certification and/or ISO 22000 HACCP. Do we really need to create a new food safety plan?
Unfortunately, yes. However, the good news is that if your company already has a HACCP plan in place, you’ve already come a long way in developing your U.S. food safety plan! A traditional HACCP plan tends to cover around 80% of what’s required for an FDA compliant HARPC plan. You can even use your HACCP plan as the foundation when developing your U.S. version. In general, the HARPC plan is more focused on preventative safety measures rather than reactive ones.
We translated our Swedish labels to English – what else is required for U.S. labeling?
Besides the obvious language difference, the U.S. requires measurements to be listed using both the metric and empirical system, food additives to be listed under their common name, and % daily value to be based on serving size (as opposed to 100g), as well as U.S. dietary guidelines, which differ from Europe’s.
We’re only planning on selling our products online – do we still need to meet all regulatory steps outlined?
Yes. The sales channel doesn’t matter; all food produced for consumption in the U.S. must adhere to FDA regulations, regardless is sold online or in a physical store. Even food samples handed out at trade shows must meet FDA requirements if they are consumed in the U.S. In fact, the only exception is food sent to the U.S. for laboratory testing only.
But if we meet all the regulations in the EU, we must be covered for the U.S. market, right?
Overall, it can be argued that the EU has stricter food regulations than the U.S. Despite this, there are many instances for which a specific ingredient is widely used and accepted in Europe, while at the same time being forbidden in the U.S. If you’re thinking about exporting food to the U.S., make sure to always review the approval status of ingredients used. Some companies must adjust their recipe for their U.S. sales; a piece of information that’s much better to receive during the planning phases as opposed to after your product has been launched and must undergo a recall.
Who can help me make sense of all these FDA requirements?
Business Sweden has published an FDA handbook designed for Swedish companies looking to enter the U.S. market. The handbook contains additional information regarding each step described below and can be downloaded here. Business Sweden can also provide tailored regulatory support for your company.
