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OMB MEETING MATERIALS

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STATEMENT OF EXPERTISE & STAFF RECOMMENDATION  Mohamed Koroma Pharmavite  Supplements 

Industry 

USA 

Statement of  Expertise 

As director of Analytical Services at Pharmavite (and in my previous role as  Quality Services and Quality Control manager) I am responsible for the  organization and control of all analytical functions in product research and  development, and analytical method validation. Vitamin B12, SAMe, Vitamin D,  K1 and K2 are part of our product portfolio as single components in various  delivery forms and as part of a complex multi‐vitamin matrix. I have  participated in method optimization and validation to establish fit for purpose  analytical methods for raw materials as well as bulk products and have  participated in external engagements including AOAC and USP. Dr. Koroma has tremendous expertise in method development and dietary  supplements and raw materials, including Vitamin B12 and SAMe.  He is a  participant in several SPDS meetings.  He applied to serve on the SPDS SAMe  and Vitamin B12 ERPs. 

Sr. Staff Review 

Staff  Recommendation 

Recommend for the SPDS SAMe ERP  Recommend for the SPDS Vitamin B12 ERP 

CV for Mohamed Koroma

RECOMMENDATION :  For OMB to approve during meeting or by e‐ballot. 

SPDS GINGER METHODS: 

Name

Affiliation 

Baig, Jameel Brown, Paula

1. 2. 3. 4. 5. 6. 7. 8. 9.

University of Sindh 

British Columbia Institute of Technology 

Bzhelyansky, Anton 

US Pharmacopeia

Cao, Congmei

Herbalife 

Es‐Safi, Nour‐Eddine  Mohammed V – University in Rabat

Johnson, Holly Koerner, Philip Krueger, Dana

American Herbal Products Association 

Co‐Chair 

Phenomenex 

Krueger Food Laboratories 

Rimmer, Catherine Brian Schaneberg

US NIST  Starbucks 

10. 11. 12. 13. 14.

Co‐Chair 

Solyom, Aniko Yang, Jinchuan Young, Kurt Zhang, Yanjun

GAAS Analytical  Waters Corporation  Nutra Manufacturing 

Herbalife 

Brian Schaneberg (Starbucks), chair of the ERP will not attend the meeting. Therefore, the  recommendation is to add Holly Johnson as a co‐chair to the ERP.   Holly is a vetted member of the  ERP.  Therefore, there are no changes in balance of the ERP or in statement of expertise. 

RECOMMENDATION :  For OMB to approve during meeting or by e‐ballot. 

08/09/2018