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Beta-Alanine FSMA/FSVP

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Posted 21 February 2018 - 12:09 AM

Can someone provide me with insight on FSMA & FSVP? My company is a distributor of beta-Alanine and from what I've interpreted from the Regulations, I informed my supplier of beta-Alanine from Japan that they would have to comply with FSMA requirements for a Foreign Supplier Verification Program.




Here's the comment back from the Japanese Supplier:



"Dietary Supplements do not fall under FSMA regulation. However food ingredients used in the production of Dietary Supplements do fall under FSMA. So various foodstuff and food used for dietary supplement fall under 

FSMA. B-Alanine is not food itself (except for GRAS approved B-Alanine) and hence we think B-Alanine used for sports nutrition does not fall under FSMA."



Are they correct in this comment?? Help would be greatly appreciated.


Thank you



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Posted 21 February 2018 - 04:37 PM

DS.1 Is a manufacturer of dietary supplements exempt from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule?

Dietary supplements are “food” as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In general, a foreign or domestic facility that manufactures, processes, packs, or holds human food for consumption in the United States has to register with FDA under section 415 of the FD&C Act and is subject to the requirements related to preventive controls of the Current Good Manufacturing PracticeHazard Analysis, and Risk-Based Preventive Controls for Human Food rule, unless subject to an exemption. An exemption for dietary supplements is provided in 21 CFR section 117.5(e) which states that subparts C (hazard analysis and preventive controls requirements) and G (supply-chain program requirements) of 21 CFR part 117 do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with the requirements of 21 CFR part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and section 761 of the FD&C Act (21 USC section 379aa-1) (Serious Adverse Event Reporting for Dietary Supplements).

Source: https://www.fda.gov/...559.htm#Dietary Supplements



There is also a flowchart that state's they're subject to modified requriements here.


They are still required to meet the requirements for importing substances under part 111 that have not changed.

Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

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