FDA Unveils FSMA Final Rule on Intentional Adulteration

FDA has now released its seventh FSMA rule – on intentional adulteration. Published May 27 in the Federal Register, the rule requires registered food facilities to develop a written food defense plan to address intentional adulteration.

In an approach similar to developing a hazard analysis and critical control point (HACCP) plan, facilities must establish food defense monitoring procedures and corrective actions, including a verification step, personnel training and the maintenance of records.

FDA explains that the goal of the rule is to prevent wide-scale public health threats, rather than acts by disgruntled employees or economically motivated adulteration – which is addressed separately in the preventive controls rules for human and animal foods.

The agency knows companies will be working to comply with the other FSMA rules, so it has extended the compliance dates for the intentional adulteration rule. A business that is not defined as “small” or “very small” and does not qualify for exemptions will have three years to comply. A small business employing fewer than 500 employees will have four years to comply, and a very small business will have five years. FDA estimates that the rule will cover 3,400 firms that operate 9,800 food facilities.

In most cases, limiting access to the food product is the key element of an effective food defense plan. But there are other important considerations, such as the volume of food involved and how rapidly the food product is distributed and consumed.

The agency plans to issue guidance on conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions and verification. It is also encouraging stakeholders to look at the existing voluntary food defense program tools at fda.gov/fooddefense.

I believe the process of complying with the FSMA preventive controls requirements should set a lot of the groundwork for the subsequent compliance with the intentional adulteration rule. The vulnerability assessment, risk management, verification and record keeping will be familiar steps for the “qualified individual” who has already mastered the FSMA preventive controls requirements. In addition, EAS consultants can assist in compliance with this additional FSMA rule.

FSMA and Dietary Supplements

By Charles Breen, EAS Senior Advisor for FSMA Consulting Services

FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event reporting. Exemption from these two elements of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA.

The revised Current Good Manufacturing Practices (CGMPs), largely relocated to Part 117 subpart B, still contain general provisions that apply to DS manufacturers if not otherwise covered by Part 111. For example, if a DS relies on moisture control for product safety, the applicable provision in 110.80 Process Controls is carried over to 117.80.

FSMA directly affects dietary ingredient (DI) manufacturers. Only finished DS products are exempted from subparts C and G or Part 117. Facilities making DI’s must comply with not only the revised CGMPs, but must also implement preventive controls and a supply-chain program. This may assist DS manufacturers to assure that dietary ingredients they buy are really what they receive.

The Foreign Supplier Verification Program (FSVP) places new requirements upon importers of finished DS and DI products. Which requirements apply depend on a number of factors, including whether the import is a finished product or an ingredient/component. Briefly:

  • Importers who establish and verify compliance with specifications for dietary supplement components and packaging, which are required under Part 111 Current Good Manufacturing Practices (CGMP) regulation, do not need to comply with most of the standard FSVP requirements.
  • Likewise, importers whose customer is required to establish such specifications and verify that they are met do not need to comply with most of the standard FSVP requirements. The importer is, however, required to obtain written assurance that its customer is complying with those requirements.
  • Importers of other dietary supplements, including finished products, who do notestablish and verify compliance with specifications, are required to comply with most of the standard FSVP requirements (except for hazard analysis). Their verification activities would focus on compliance with the Part 111 dietary supplement CGMP regulations.

In many respects, the very flexibility of FSVP makes it difficult to understand what FDA wants in a particular situation. FDA knows it has a responsibility to provide guidance well in advance of any enforcement activity.

FSMA also affects DS manufactures in a few other ways. FSMA’s primary goal is preventing food safety problems. An FDA prevention through enforcement mindset appears to extend to DS and DI products, using both FSMA and the tools available under the Dietary Supplement Health Education Act. For example:

  • June 2013. FSMA administrative detention authority was used by FDA to detain approximately $8 million worth at retail of USPlabs’ OxyElite Pro and Jack3d for containing DMAA, an unsafe ingredient. USPlabs voluntarily destroyed the detained products.
  • Nov 2015. USPlabs was indicted by the US Department of Justice on criminal charges related to DS manufacturing.
  • Nov 2015. DoJ announced it, and state authorities, were pursuing over 100 civil and criminal investigations of makers and marketers of DS.

The current DS enforcement push is at least partially due to a long history of continued failures by some DS manufacturers to comply with Part 111 requirements. FDA is not going to rely on FSMA education among DS firms as it is for other food facilities.

Simultaneously, FDA knows of many firms, including DS manufacturers, which do comply with applicable regulations. FDA wants to publicly recognize compliance and offer incentives for doing so. Less frequent and shorter inspections for compliant firms are under consideration.