Regulatory compliance has become increasingly crucial to running a tea business. Tea companies nationwide have seen an increase in FDA onsite facility audits. The Food Safety Modernization Act (FSMA), which has modified or added new laws to the manufacturing of food (which tea is classified) is nearing the end of its implementation cycle. But the hard part is yet to come. With the grace periods coming to an end, FDA auditors are cracking down on companies to ensure compliance with all of the new regulations. If your company is not ready and in compliance, you can expect a citation from the FDA auditor. Most citations give you a 15-day window to comply unless there are gross negligence or major food safety issues that could harm the general public.
The FDA has been increasing its checks on the Foreign Supplier Verification Program (FSVP). There have been more than 31 citations in 2020 (at the time of publication of this article in October 2020), accounting for seven percent of the warning letters that the FDA has issued. As a comparison, only five were issued in all last year. Violations we cited are for one of two reasons:
1. Violations for not developing an FSVP
2. Violations for incomplete FSVP
Other citations were issued for not having a Preventative Control Qualified Individual (PCQI) either on staff or as a hired consultant. A PCQI is responsible for writing, monitoring and verifying all FDA and FSMA standard operating procedures (SOPs) and forms. One of the main items missing was a hazard analysis with preventative controls to mitigate the hazard. This is different than having a Hazard Analysis Critical Control Point (HACCP) plan in place.
USDA organic certification has also been an issue in 2020. With the new organic flavoring law that went into effect on Dec. 27, 2019, many companies have struggled with complying and have had to drop many teas from the certification. All flavorings used must now be certified organic. The struggle is finding certified organic flavoring with the same aroma and taste in both quality and strength that is affordable and does not drive down the cost of goods (COGS). It can be done with most flavoring, but it takes a lot of time and effort and the right partners.
For 2021, new laws are being voted on again in the coming weeks. These new laws, if approved, will, directly and indirectly, affect tea businesses. If you are importing organic products to the USA, additional paperwork and regulations will need to be followed to import and sell as organic certified. If a local agency or state government organically certifies your company, you may find your audits to be more in-depth and more complex, similar to national brands like QAI, CCOF, QCS, Oregon Tilth, etc. More emphasis is being put on surprise organic inspections of at least five percent of the agency’s customer base. We may see a drop in auditors, as there would be more requirements to be and continue to be an auditor. This could delay audits, renewals and new submissions.
The FDA biennial application renewal has begun. From Oct. 1 to Dec. 31, all FDA registered facilities must renew or the application will be dropped. New for 2020 is the requirements for a Unique Facility Identifier (UFI). The only accepted UFI at the moment is the FDA DUNS. This is the number you had to register to get for your FSVP. Even if you do not import products into the United States, or even plan to, you will need this number to renew your FDA application.
The world of regulatory compliance is ever-changing. New laws are being voted on and adopted. Existing laws are being modified. Even enforcement of the laws change. It is essential to keep up on all these changes to ensure compliance when the auditor walks into your facility.
Scott Svihula has carved out a niche as an expert in the specialty coffee and tea industry over the last 25 years. Svihula started his own tea and coffee consulting business, Hula Consulting, to offer a unique one-stop service approach offering everything a company needs to grow. His customized consulting approach allows companies to capitalize on his skills and knowledge to target specific growth areas. Svihula is also the founder of The Scents of Tea, the first science-based tea aroma training kit. To learn more, visit HulaConsulting.com or ScentsofTea.com.