fdaclearedI left a career as a food scientist and quality control supervisor in 2010. When I entered the tea industry in 2012 I was confident in my ability to navigate USA food regulations and food safety while working directly with tea producers in foreign countries to import and distribute their teas. Much has changed in this time and much more will affect our tea supply within the next few years. On January 4, 2011, in an attempt to further secure the United States food supply, President Obama signed into law the Food Safety Modernization Act (FSMA). This would be the most stringent addition to FDA regulations in the past 70 years.

The FDA took the following five years to develop the regulations that would be enforced with this law, and on September 19, 2016, compliance became necessary for large food companies defined as having more than 500 employees. Tea is probably one of the least regulated industries by the FDA but tea companies in the US will be wise to stay on top of these regulations because these new regulations have put new restrictions on foreign imports and all companies big and small will need to comply by March 18, 2019. As of now, very few tea producers will be in compliance with these new regulations, so much work is necessary.

The five main components of FSMA are preventative controls, inspection and compliance, imported food safety, response, and enhanced partnerships.

fdaPreventative controls mean that tea businesses in the United States will need to have programs in place, such as Good Manufacturing Practices and Hazard Analysis Critical Control Points. Large businesses that are required to comply from September 19, 2016, more than likely already have these programs in place but it is smaller companies that will need to comply by September 19, 2017 (less than 500 employees) or September 19, 2018 (less than $1M in annual sales). Implementing these programs will not put great stress on your operation but a consultant may be required to document and implement these programs.

Inspection and compliance involve more inspections by the FDA to US food facilities. These inspections are risk-based which means that tea facilities will be low on the priority list. This does not mean that tea companies are off the hook. The FDA has the right to inspect at any time and will if they find any reason for threat.

Imported food safety is probably one of the most important sections of the new regulation that will affect the tea industry. The majority of tea consumed in the US originates from other countries. For the most part, the importation and food safety of these products have been beyond the bandwidth of FDA inspections. As of May 30, 2017, large food companies will not only need to trace their food imports to the farm but will also need to verify that the producers of these products in foreign countries have the same preventative controls mentioned above as well as a third-party audit conducted by an FDA-accredited auditor. Smaller tea companies with less than 500 employees will need to be compliant March 19, 2018, and very small companies with less than $1M annual revenue will need to be compliant on March 18, 2019.

Response involves full documentation and traceability of food supplies. This is a program that companies should proactively be doing to prevent the harm of their customers and the potential loss of product on the market due to a full recall. This basically means that if a supplier contacts a food company about a potential contamination of a lot that food company should be able to trace all their products and locations that contain part of the contaminated lot. Without a full traceability program, all products would need to be recalled rather than just a limited amount.

Enhanced partnerships are the FDA’s intention to utilize international networks to facilitate the implementation of these regulations. This includes the accreditation of third party auditors that will facilitate food safety audits at food producers in foreign countries. Compliance with these third party audits will not be begin until May 30, 2017.

The first compliance date for FSMA is September 19, 2016. While no food companies have been shut down by the FDA for being out of compliance the FDA has released a statement that they will guide companies to compliance through education. As other compliance dates approach the FDA will become stricter on the rules. Rules that require documentation are the easiest to regulate, which means the FDA will be able to easily regulate the foreign supplier verification process.

Reading these rules makes it seem like the FDA is further protecting large food companies that have the resources to remain in compliance. Small farmers are at risk of being out of compliance, which is why the FDA has provided exceptions for small farmers that distribute their products within a 275-mile radius. What about tea farmers that need to distribute their products 5,000 miles? These farmers will not be able to afford a third party audit and do not have the knowledge or resources to implement the necessary preventative controls. Even the largest tea estates in India and traditional tea factories in China are not in compliance and will need to invest thousands of dollars retrofitting their facilities to get into compliance. This is the threat to Specialty Tea in the USA.

As an experienced food scientist and activist for small farmers, I have started to turn the wheels of providing consulting and auditing services for tea growers in Tealet’s network. Our company is small, and we do not need to be in compliance until March 2019, so I will use this time to learn the laws and develop a game plan to keep these small growers in compliance so they can continue to share their tea with tea lovers in the United States.