Are Dietary Ingredient Facilities Subject to Mandatory HACCP Requirements?

By Ricardo Carvajal & Wes Siegner –

As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences.  By way of background, the FSMA requires all food facilities subject to registration under FDC Act § 415 to implement a HACCP-type system (or in the terms of the FSMA, Hazard Analysis and Risk-Based Preventive Controls – but that yields an ugly acronym).  There are exceptions, one of which applies to “any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761” of the FDC Act.  Section 402(g)(2) authorizes FDA to prescribe good manufacturing practices (GMP) for dietary supplements, and § 761 requires serious adverse event reporting for dietary supplements. 

Generally, dietary ingredient suppliers aren’t subject to FDA’s dietary supplement GMP regulation (but they can be under certain circumstances, as discussed in FDA’s recent guidance for small businesses).  Further, the reporting requirement under § 761 applies only to the manufacturer, packer, or distributor of a dietary supplement whose name appears on the label.  Given these circumstances, it appears that the FSMA’s exemption from HACCP for dietary supplement facilities could be interpreted to not apply to dietary ingredient facilities, thereby making these facilities subject to the mandatory HACCP requirement.  This result would seem to make little sense in light of FDA’s conclusion when it issued the final dietary supplement GMP rule that the quality of dietary supplements could be achieved without subjecting all dietary ingredient suppliers to the GMP rule.  Given that the HACCP requirement takes effect 18 months after FSMA’s enactment, and that operation of a facility that doesn’t comply with the HACCP requirement is a prohibited act, affected entities will want a seat at the table when FDA drafts the implementing regulation.