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.