- FDA, Food Regulations, US
On August 31, 2016, Danish-American Business Forum attended an event by DI (Dansk Industri) to learn more about the current topics of food- and drug regulation in the US, namely the political landmark called the Food Safety Modernization Act (FSMA). Minister Counselor Anna de Klauman, who works for the Danish Embassy in Washington, took us on an interesting tour of the new legislation and explained the consequences for Danish companies doing food related business in the US.
“The voice of the consumer matters more and more, to a point where it now influences the legislation“, says Anna de Klauman, Minister Counselor, Food & Agriculture, Embassy of Denmark, Washington DC.
The FSMA and its 7 elements
As the most comprehensive reform of US food safety laws in 70 years, the FSMA is a political landmark. Notably, the focus has shifted from responding to contamination to preventing it. Also, the regulations now include all actors, from the primary farmer to the retail distributor.
The FSMA consists of 7 elements, and applies to the food types that are regulated by the US Food and Drug Administration (FDA), e.g. dairy. USDA regulated products, like meat and poultry, are not influenced by the FSMA.
The 7 elements of the FSMA are:
- Preventive Controls for Human Food
- Preventive Controls for Animal Food
- The Foreign Supplier Verification Program (FSVP)
- Accredited Third Party Certification
- Produce Safety Standards
- The Sanitary Transportation of Human and Animal Food
- The Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
You can read more about the individual elements here.
When will the FSMA affect me?
The elements of the FSMA will gradually be put into force over the next four years. For a tentative time schedule, see below (subject to changes, indicative use only).
General Compliance Period:
Small Business Compliance Period (less than 500 employees )
Very Small Business Compliance Period (business has annual food sales below the applicable limits)
How will the FSMA affect me?
The Danish exporters are in general well equipped, but Anna de Klauman predicts that the relationship between the importer and the exporter will change as a result of the new legislation. For example, the Foreign Supplier Verification Program prescribes that the American importers are now legally responsible for the food safety of the import and must verify this in reference to American standards. This also means that the documentation workload for the Danish exports can get heavier than it is today, as it must now not only live up to the demands of FDA, but also the American importer.
If you want more information on the topic, please feel free to check out and subscribe to Anna de Klauman’s business brief, where you can read about regulations, development and the newest trends in food safety. Find the business brief here.
Take a look at this infographic (shown on the left) to get an overview of other trends in US food legislation!
You can also read more about how to prepare for FDA inspections here.