Is FDA’s Extended Enforcement Discretion Applicable to Your Facility?
On Friday, March 11, FDA issued new guidance on its intent not to enforce certain provisions of five rules of FSMA. Before we discuss what this means, we want to note what it doesn’t mean: FDA is not stating that it’s not enforcing FSMA – as we’ve heard coming from some parts of the industry. Rather, the enforcement discretion notice means that FDA intends to not enforce specific provisions of certain rules “as they currently apply to entities or activities addressed in the guidance” while FDA “take(s) time to consider options, including rulemaking, to address concerns raised by stakeholders.”
Now that we’ve gotten that out of the way, let’s talk about what it does mean. It is understandable that the guidance has been misinterpreted by some, as we, ourselves, found it to be complex and initially difficult to understand. So we brought together our experts to provide some insights.
The first major take-away is that there really isn’t much new; it isn’t much different than FDA’s previous enforcement discretion guidance documents. In fact, the agency itself stated, “In many instances, this guidance builds upon previously announced enforcement policies.” But there are some things that are new. Following is TAG’s interpretation of the key points of the new guidance.
- Human & Animal Preventive Controls Rules: Co-manufacturer Supplier Approval Program. The new guidance extends FDA’s enforcement discretion policy for supply-chain program requirements for co-manufacturers, i.e., receiving facilities that are contract manufacturers of human and animal foods, which was originally described in a November 2017 guidance. Essentially if a co-manufacturer of a branded product is using ingredients that have had the supply chain approval of the brand, the co-manufacturer does not need to have its own separate supply chain program for those ingredients. FDA bases this on the understanding that there are business complexities that prevent co-manufacturers from knowing the details of upstream suppliers. With supplier approval programs being contractual with brand owners, co-manufacturers don’t always have access to suppliers or even know who the suppliers of those ingredients are. Therefore, the burden is on the brand to conduct these approvals. Although the regulation does not specifically state this, the guidance provides for FDA’s enforcement discretion “when a receiving facility that is a contract manufacturer/processor is not in compliance with certain supply-chain program requirements for food manufactured for a brand owner.” However, even given that the brand owner conducts supplier approval activities, the co-manufacturer must describe these activities in its food safety plan and conduct any necessary supplier approval activities not conducted by the brand owner.
- Foreign Supplier Verification Program (FSVP) for Co-manufacturers. Similarly, a co-manufacturer does not need to implement an FSVP for food manufactured for the brand owner by a contract manufacturer/processor for which the brand has an FSVP in place. (See previous section for detail.) It is essential that facilities understand that this does not mean that FDA is not focusing on or enforcing FSVP overall. In fact, the reverse seems to be true – TAG has been seeing an increase in the number of 483s and warning letters for noncompliance with FSVP requirements.
- Intentional Adulteration (IA) for Farms. FDA does not intend to enforce the IA regulation for facilities under the preexisting farm-activity related enforcement policy established in a January 2018 FSMA guidance. The new guidance clarifies the continuation of this nonenforcement while FDA considers and issues rulemaking that could change the definition of “farm.” Depending on the finalization of that definition, FDA would determine if and how IA provisions apply to these entities.
- Intentional adulteration Rule (IA) Food Defense Plan Reanalysis. Additionally, the new guidance states that FDA does not intend to enforce the IA requirement for reanalysis in certain circumstances, such as for a single failure that is addressed through the implementation of corrective action procedures. This means that a facility would not have to conduct a full reanalysis of the Food Defense Plan (as required by the rule) if the improper implementation of mitigation strategies is addressed through actions that correct the deficiency and reduce the likelihood that it will happen again. FDA does, however, intend to enforce the requirement to conduct a reanalysis when the FDP as a whole is not properly implemented.
While much of the new guidance is reiteration or extension of previous enforcement policy guidance, it is important for facilities to have an understanding of how FDA is applying its enforcement discretion, — to ensure a complete understanding of where such discretion is not being applied. Enforcement discretion for certain aspects of a provision of FSMA does not mean that you don’t need to be compliant with the rest of the provision or with FSMA as a whole.
We see this as particularly critical in relation to FSVP. To follow FDA’s example of reiterating previous guidance, we reiterate that FDA is closely monitoring and enforcing FSVP, and we recommend that you ensure your programs are complete and up to date.
If you need any assistance with compliance or training, give TAG a call. We can help.