By: Christos Linardakis, Of Counsel 

How Did We Get to FSMA?

Food is about trust, when people consume food, they assume they’re consuming something that nourishes, not damages. However, when safety and quality standards are not maintained in the supply chain, distribution of food can pose serious health risks to the consumers. Recent food outbreaks illustrate this point:

  • The Center for Disease Control (CDC), the U.S. Food and Drug Administration (FDA) and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O26 (STEC O26) infections, which can cause acute kidney failure and/or death. As of November 19, 2015, 45 people infected with the outbreak strain of STEC O26 have been reported from 6 states, some including hospitalization. The evidence available at this time suggests that a common meal item or ingredient served at a well-known chain restaurant in several states is a likely source of this outbreak.
  • The CDC, the U.S. FDA, the U.S. Department of Agriculture Food Safety and Inspection Service, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O157:H7 (STEC O157:H7) infections. As of November 23, 2015, 19 people infected with the outbreak strain of STEC O157:H7 have been reported from 7 states. The majority of illnesses have been reported from the western United States, including some who are experiencing the possibility of kidney failure. Preliminary evidence indicates that a celery and onion diced blend, produced by a domestic farm, and then sold to a “big box” retailer, may have been contaminated with E. coli.

These are only some of the most recent outbreaks that received publicity, and have contributed to the staggering annual number of 48 million diseases, 128,000 hospitalizations, and 3,000 deaths that the CDC estimates happen every year from contaminated food.  While we will never have a no-risk food contamination, most of these diseases, hospitalizations, and deaths, can be prevented with the implementation of the Food Safety Modernization Act (FSMA). The question your company must ask itself is “whether or not you could survive the negative PR on an outbreak associated with your company’s product and supply-chain?” I highly doubt, unless you are one of those nationwide chain restaurants or big box retailers, that you could survive this sort of damaging publicity. Thus, the more reason to ensure you comply with the import/export and distribution requirements under the FSMA.

FSMA enables the Food and Drug Administration (FDA) to regulate the food safety of most suppliers in the United States, at both the local and international level. It was assented into law in early January 2011, following the rising incidents of food-related illness. When ensuring food safety, the FDA coordinates with state and private systems, including the U.S. Department of Agriculture, Department of Homeland Security, Department of Transport, and other federal and state agencies, as well as the industrial sector. In short, FSMA is designed to ensure that the U.S. food supply is safe by shifting the focus of food safety from responding to contamination to prevention.

FDA & U.S. Customs Empowered with more enforcement options

FSMA gives the FDA, and U.S. Customs, more power in carrying out its mandate of ensuring food safety. The three critical areas of the law upon which the FDA’s responsibilities are expanded are based on the new food safety provisions it adds to the FDCA. First, it improves the FDA’s preventive capacity to identify and resolve problems that arise due to food safety. Second, it enhances the ability to detect and respond to food safety issues. Finally, it improves the safety of imported food. It is important to note that FSMA is still not fully in force since not all of its sections have been implemented. Therefore, the FDA is still limited to some extent in delivering its full mandate under the new law. In this regard, the FDA is required to enact regulations and provide guidance on the implementation for the other sections.

What Does FSMA Mean for the Food Industry?

Food facilities including factories, warehouses, or establishments involved in manufacturing, processing, packing, distributors, and importers are required to undertake activities to prevent food contamination. Such activities include identification and analysis of the food safety risks, and implementation of the precautionary measures to mitigate those risks. This rule expands regulation to protect animal food and feed from contaminants. Some preventive controls include product testing, environmental monitoring, and hazard analysis. For an importer, this means ensuring that your overseas suppliers are complying on their end, with the new FDA regulations, prior to your company’s imports, at which point, non-compliance translates to U.S. Customs seizing, and likely, destroying, your food imports.

Regulations and More Regulations

Since January 2013, the FDA has proposed seven fundamental regulations to implement the FSMA. All but the smallest businesses will need to comply with that rule one year after it is released. Those regulations become final by year-end and in 2016:

  1. Preventive Controls for Human Food
  2. Preventive Controls for Animal Food
  3. Produce Safety
  4. Foreign Supplier Verification Program (FSVP)
  5. Third Party Certification
  6. Sanitary Transportation
  7. International Adulteration

Overall, the new regulations incorporate more adaptability, making them more sensible and specific to individual facilities & businesses. This adaptability means the regulations will be applied differently depending on the customer’s business, including products and facilities. However, this adaptability could also lead to gray areas of interpretation leaving many concerned that FDA inspectors will apply the rules inconsistently. Attorneys, or Consultants, should reference each regulation closely in advising how customers can mitigate noncompliance risks.


FSMA imposes significant new requirements designed to prevent the sale and consumption of contaminated food, to respond to incidents of food-borne illness, and to ensure that imported food meets U.S. standards of food safety. Everyone, from the producers to the consumers will be impacted by these new regulations. It requires that food manufacturers, producers, and suppliers be responsible and comply with the production, import, and distribution of food. For importers (and eventually, exporters), this means an in-depth review of your current supply-chain, including overseas suppliers, import data, and internal audits on your imports, will be necessary, in order to identify high risk areas which may lead to noncompliance. As the Commissioner of Food and Drugs noted, the new law “represents a sea of change for food safety in America, bringing a new focus on prevention, and in the coming years, it will have a dramatic and positive effect on the safety of the food supply.”