EAS Senior Directors Allen Sayler and Tara Couch, Ph.D. discussed importing challenges of dietary supplements, particularly in light of the Foreign Supplier Verification Program in Food Safety Magazine. Dietary supplement firms must comply with GMPs set forth in 21 CFR 111 Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients which are also subject to FSMA and FSVP.
“When the 1994 Dietary Supplement Health and Education Act (DSHEA) created a legal class of foods, called “dietary supplements,” it carved out many unique regulatory requirements and exemptions. Since the passing of the Food Safety Modernization Act (FSMA) in 2011, dietary supplement firms have the added confusing task of identifying which FSMA rules apply, and what impact, if any, this has to their current dietary supplement quality system designed to meet 21 CFR 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients.
“The For example, CGMP and Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food (HARPC) requirements for foods are dictated in 21 C.F.R. 117, but firms that are in compliance with dietary supplement CGMPs in 21 C.F.R. 111 are exempt from Subparts C – HARPC and Subpart G – Supply Chain Program of 21 C.F.R. 117. In addition, since both 21 C.F.R. 111 and 21 C.F.R. 117 define the CGMP requirements for the sourcing, manufacturing, packaging, holding, and distribution of foods, a dietary supplement firm that is in compliance with 21 C.F.R. 111 will already have a quality system in place to address the 21 C.F.R. 117 requirements as well. It is also very important to note that 21 C.F.R. 111 has very rigorous and specific quality and testing requirements for raw materials, in-process materials, packaging components and labels, and finished products; detailed requirements for manufacturing, packaging, and labeling operations; and extensive responsibilities that must be conducted by a quality unit….” Read more in Food Safety Magazine.