In a previous blog, we discussed the evolution occurring within the dietary supplement regulatory environment post-NY Attorney General. While the botanical identity testing methods used in the NY AG case are important to consider and discuss, these testing outcomes are not the end-all-be-all when it comes to quality assurance.

We can all agree that reestablishing consumer trust is of the utmost importance right now. To that end, we believe that supply chain traceability is the next great frontier for our industry to embrace as a whole. Traceability within the supply chain preempts botanical identity issues by documenting how individual ingredients were grown, harvested and processed.


The Food Safety Modernization Act


On the federal level, the Food Safety Modernization Act (FSMA) and its ongoing updates to rules and guidelines are forcing a certain amount of supply chain traceability.

The FSMA of 2011 was signed into law to promote safety within the U.S. food supply by shifting regulatory focus away from simply responding to contamination situations, and into proactively preventing them. FSMA is a step in the right direction for avoiding foodborne illness, yet this act and other rules have put a renewed burden on food-based ingredient suppliers.

The new FSMA rules fall into three categories (click here to read more):

  • Prevention Controls for Human Food
  • Foreign Supplier Verification for Importers / Supply Chain Program
  • Accredited Third Party Certification


It is important to note that some of the new human food safety rules may not apply to dietary supplement finished goods, which are already covered by cGMPs. (Read more about this line in the regulatory sandbox here.)

Still, a brand should thoughtfully consider the FSMA and develop partnerships with suppliers to assure that the law is carried out with integrity. While monitoring your supply chain for adherence to FSMA rules may sound like a lot of work, it’s worth it. Product recalls and negative press are always bad for business.


How Should the Dietary Supplement Industry Prepare?


There are a number of questions that dietary supplement brands should consider:

  • Can we verify the safety of our raw materials?
  • Where could safety be compromised?
  • In what ways could consumers get sick?
  • How can we prevent these potential issues?
  • Is our brand prepared for a recall situation?
  • Do we have any of this written down formally?


The time has come to establish and document traceability at every point along the supply chain. If our end goal is to re-establish consumer confidence, every stakeholder within the supply chain must be equally committed to the cause.

What will this new era of full traceability look like? Authentic partnerships, developing new standards and a system of internal checks and balances to assure that guidelines are carried out every day—from the growers and processors to brokers and manufacturers on through to a brand’s internal operations team.


How to Improve Traceability Within Your Supply Chain


There are several key elements to establishing traceability:

  • Learn as much as possible about each stage that yours raw materials go through, From Field To Formula®.
  • Partner with suppliers, foreign and domestic, to develop compliance checklists based on the FSMA guidelines. Has each supplier initiated hazard analysis protocols for implementing and monitoring risk-based preventative controls?
  • Get to know the Foreign Supplier Verification Program requirements. Follow this link to access helpful PPT presentations from a recent public meeting on the topic (scroll to the bottom of the page).
  • Establish a supplier qualification program if you don’t already have one. As part of your supplier program:
    • Develop quality expectations. Establish clear definitions of what quality is to you and your brand.
    • Establish written supply agreements. Are there specific COA items and/or spec tolerances that you want to see for each batch of raw or processed material? Clearly spell out your expectations and take the time to minimize gray area proactively. This supply agreement also serves as your letter of guarantee, allowing your company to reject material that does not meet quality standards.
    • Perform audits. Pick someone at your company to develop supplier audits and carry them out regularly.


Establishing a traceable supply chain requires commitment, patience and strong communication, as well as full cooperation between suppliers and internal departments.


At RFI, we take our motto, “From Field to Formula®” very seriously. Not only are we committed to developing long-term relationships with our partners, we take an active role in the entire supply chain and dedicate a great deal of time and resources to assuring traceability.


Click here to learn more about our commitment to quality and supply chain traceability at RFI.



Written by admin