Given the current COVID-19 outbreak that has resulted in numerous travel bans and restrictions all over the world, it is important to note FDA’s temporary enforcement suspension of FSVP supplier verification on-site audit requirements for receiving facilities and importers under FSMA, provided other supplier verification methods are used instead.
My colleague Allen Sayler and I recently co-wrote an article on FSVP requirements published in Food Safety Magazine that discusses the FSMA rule for importing dietary supplements.
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.
There are seven major rules that have been issued by the FDA to support the enforcement of FSMA:
- Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food (HARPC)
- Foreign Supplier Verification Program (FSVP) Rule
- Intentional Adulteration Rule
- Product Safety Rule (Fruits and Vegetables)
- Sanitary Transportation Rule
- Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Voluntary Accredited Third-Party Certification Program
The cGMP and HARPC requirements for foods are dictated in 21 CFR 117, but firms that are in compliance with dietary supplement cGMPs in 21 CFR 111 are exempt from Subparts C – HARPC and Subpart G – Supply Chain Program of 21 CFR 117. In addition, since both 21 CFR 111 and 21 CFR 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 CFR 111 will already have a quality system in place to address the 21 CFR 117 requirements as well. It is also very important to note that 21 CFR 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.
Whenever a dietary supplement product or ingredient (raw material) is imported from a foreign supplier, the FSMA Foreign Supplier Verification Program (FSVP) rule applies, and many of the raw materials used for the manufacture of dietary supplements are sourced from foreign suppliers. This is NOT covered under 21 CFR 111. However, a Supplier Qualification Program consistent with 21 CFR 111.75(a)(2)(ii) that incorporates the requirements for FSVP is the optimal way to ensure compliance with this FSMA requirement. This Supplier Qualification Program should be a multi-step process which includes the use of a Supplier Qualification Questionnaire, often referred to as the “Paper” or “Documentation” audit; an on-site facility audit of the supplier; and confirmation testing to ensure that the material meets the quality requirements for identity, purity, strength, composition, and the lack of potential contaminants as dictated on the Raw Material Specification. The extent of testing necessary is dependent on the type of material being qualified as well as the responses on the questionnaire and results of the on-site audit. Periodic requalification of the supplier is also required and is based upon a number of factors such as the frequency of material quality issues.
With the global pandemic of COVID-19, for now, the performance of an on-site facility audit of the supplier may not be physically possible and is certainly, not recommended due to the need to exercise “social distancing” to limit the spread of the virus. The Food and Drug Administration (FDA) has acknowledged this challenge and released the attached Guidance for Industry, Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency.
I hope this information is beneficial, as everyone works to ensure continued compliance to all of the FDA regulatory requirements for dietary supplement finished products while also taking all appropriate and necessary precautions for the health and wellbeing of every employee, the community, the nation, and the World.
Thanks and Take Care,
Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services