ms CAROLYN SABATINI

Adequate funding for FDA, GMP inspections. Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections. Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections. Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections. Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections. Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections, NDI Guidance finlization, Inclusion of the the multivitamin in SNAP program; general introduction to company, facilities, employees and products.

Adequate funding for FDA, GMP inspections, NDI Guidance finlization, Inclusion of the the multivitamin in SNAP program

*Adequate FDA resources to implement GMP rules for dietary supplements and to provide adequate funds for full inspection of dietary supplement manufacturers. *Discussion about revised NDI Guidance from FDA *Full implementation of DASCA (HR 4771/S2012) *Inclusion of the multivitamin in SNAP legislation in 2018 Agriculture bill. *Support for inclusion of dietary supplements in HSA and FSA accounts. Bill anticipated in 2017.

*Adequate FDA resources to implement GMP rules for dietary supplements and to provide adequate funds for full inspection of dietary supplement manufacturers. *Support for prompt publication of NDI Guidance from FDA *Full implementation of DASCA (HR 4771/S2012) *Inclusion of the multivitamin in SNAP legislation in 2018 *

*Adequate FDA resources to implement GMP rules for dietary supplements and to provide adequate funds for full inspection of dietary supplement manufacturers. *Support for prompt publication of NDI Guidance from FDA *Full implementation of DASCA (HR 4771/S2012) *Inclusion of the multivitamin in SNAP legislation in 2018 *Federal solution to gmo labeling issues for food products

*Adequate FDA resources to implement GMP rules for dietary supplements and to provide adequate funds for full inspection of dietary supplement manufacturers. *Support for prompt publication of NDI Guidance from FDA *Full implementation of DASCA (HR 4771/S2012)

1) Adequate FDA funding to fully enforce DSHEA, inspect dietary supplement manufacturers, take enforcement action against clear violations of law and carryout other required regulatory activities 2) New Dietary Ingredient Guidance - prompt publication of second draft guidance of this document from FDA 3) Full implementation by DEA of HR/4771 and S2012 Designer Anabolic Steroid Control Act 4) Shared information about key nutrient shortfalls based on NHANES data

1) Adequate FDA funding to fully enforce DSHEA, inspect dietary supplement manufacturers, take enforcement action against clear violations of law and carryout other required regulatory activities 2) New Dietary Ingredient Guidance - prompt publication of second draft guidance of this document from FDA 3) Full implementation by DEA of HR/4771 and S2012 Designer Anabolic Steroid Control Act 4) Shared information about key nutrient shortfalls based on NHANES data

1) Adequate FDA funding to fully enforce DSHEA, inspect dietary supplement manufacturers, take enforcement action against clear violations of law and carryout other required regulatory activities 2) New Dietary Ingredient Guidance - prompt publication of second draft guidance of this document from FDA 3) Full implementation by DEA of HR/4771 and S2012 Designer Anabolic Steroid Control Act

1) Adequate FDA funding to fully enforce DSHEA, inspect dietary supplement manufacturers, take enforcement action against clear violations of law and carryout other required regulatory activities 2) New Dietary Ingredient Guidance - prompt publication of second draft guidance of this document from FDA 3) Full implementation by DEA of HR/4771 and S2012 Designer Anabolic Steroid Control Act

HR 4771/S2012 - the Designer Anabolic Steroid Control Act. I met with various members of Congress and staff to discuss Pharmavite support for this proactive measure.

Discussed FDA's NDI guidance document issued 2011 and need to have FDA issue revised draft. Support for both HR 4771 and SB 2012. Support for full enforcement of DSHEA. Dept of Commerce meeting - discuss regulatory hurdles relative to marketing dietary supplement products in China.

Support for HR 4771 and SB 2012 Support for full funding of Military Commissaries Support for prompt publication of FDA's NDI guidance

Support for full continued funding of military commissaries in the US and around the world.

GMP enforcement by FDA Adequate funding for FDA for GMP inspections NDI Guidance from FDA, timing and revisions NHANES and nutrient shortfalls in American diet

GMP Enforcement, Increased FDA funding to inspect dietary supplement manufacturers Introduction of Pharmavite dietary supplement issues to new Congressional staff

GMP enforcement and consequences of reduced funding for FDA inspections Introduction of new staff to Pharmavite and the need for adequate funding for FDA for GMP enforcement

Support for FDA funding to ensure GMP inspections Support for New Dietary Ingredient guidance from FDA which would reflect the intent of DSHEA NHANES data presentation on the nutrient gaps in the American diet and need for braoder approach to nutrition policy

Adequate FDA funding New Dietary Ingredient Guidance Nutrient shortfalls and the need for improved diet

FDA New Dietary Ingredient guidance and its impact on dietary supplement business Introduction of Pharmavite to new staff and the general laws which govern the dietary supplement business Safeguarding FDA funding to ensure adequate inspections for GMP adherance Invitations to join Dietary Supplement Caucus

New Dietary Ingredient regulation from FDA and the negative impact of the rule if not modified Concern over shrinking FDA budget and its impact on GMP compliance Concern about adequacy of GMPs and the impact of Senator Durbin's inquiries on caffeine and supplement labeling Updates on Pharmavite manufacturing expansion

FDA New Dietary Ingredient guidance document and its impact on our dietary supplement business Background on Pharmavite and our dietary supplement business (introduction) Adequate support for FDA to implement DSHEA GMPs Invitation to join Dietary Supplement Caucus

Discussed New Dietary Ingredient guidance document from FDA and its negative impact as written by FDA. Secondary: Introduced new staff to Pharmavite, our company, products, etc.

Nutrient shortfalls in the US population Adequate funding for FDA to carry out GMP inspections NDI Guidelines issued by FDA and the implications for the dietary supplement industry

Nutrient deficiency in the US population Adequate funding for FDA to carry out GMP inspections NDI Guidelines issues by FDA on 7/5/11 and implications for industry Development of Dietary Caucus

Adequate funding for FDA to implement DSHEA and GMP inspections Upcoming NDI Guidance document expected from FDA Dietary Supplement Caucus

Support of adequate funding for FDA to implement DSHEA and inspections of dietary supplement manufacturing facilities under the cGMPs. Introduction of a new version of the Dietary Supplement Full Implementation and Enforcement Act.

Food Safety bill - Support the Senate version of the bill S. 3002

Food Safety bills - Senate and House. Support for moving the Senate bill to a vote. Support for S. 3002 Dietary Supplement Full Enforcement Bill

Food Safety (S.510) and HR 2749 - impact on dietary supplement industry S. 3414 DSHEA Full Implementation and Enforcement Act Section 4206 of Patient Protection and Affordable Care Act which includes "Prevention of Chronic Disease and Improving Public Health: Creating Healthier Communities":

Food safety bill in the Senate (S 510) and House of Representatives (HR2749) - impact on dietary supplement industry S.3002 - discuss impact on dietary supplement industry Support for section 327 of Senate version of the Patient Protection and Affordable care act which proposes Wellness Demonstration projects.

Food safety bill in the Senate and House (S. 510) and potential impact on dietary supplement industry. Support for increase in FDA funding to enforce the Dietary Supplement Health and Education Act. Support for Section 327 of the Senate version of the Health Care Reform bill for a Wellness Demonstration Project.

Food safety bills in the Senate and the House (specific bill S. 510) and their potential impact on the dietary supplement industry. Support for increase for FDA funding to enforce the Dietary Supplement Health and Education act. Support for Section 327 of the Senate version of the Health Care Reform bill for a Wellness Demonstration Project

Food safety issues and its impact on the dietary supplement industry. Support for increased FDA funding to implement the Dietary Supplement Health and Education Act. Support interest in Community Health Centers demonstration project as part of the Senate's health care reform bill.

Food safety issues and its impact on the dietary supplement industry and Pharmavite specifically. Support for increased FDA funding to enforce the Dietary Supplement Health and Education act. Work towards a health care reform wellness demonostration project.

Food safety issues and its impact on the dietary supplement industry. Support for increased FDA funding to implement DSHEA.

Food safety issues and its impact on the dietary supplement industry. Increased funding for FDA to implement dietary supplement GMPs, to enforce DSHEA and for food safety activities.

Food safety issues and its impact on the dietary supplement industry Increased funding for FDA to implement dietary supplement GMPs and to enforce DSHEA and for food safety activities.

Implementation of serious adverse event reporting bill Details of multivitamin provision of the Farm bill Food safety issues and its impact on the dietary supplement industry Increased funding for FDA to implement GMPs and to enforce DSHEA

Please refer to report dated 7/18/08.

Discussion of various drafts of legislation focused on food safety, support for the multivitamin provision in the Nutrition title of the Farm bill, support for the Dietary Supplement Caucus, suppport for additional funding for FDA to enforce DSHEA and food safety efforts.

Support for the Dietary Supplement Health and Education Act (DSHEA), increased funding for FDA to enforce DSHEA, support for multivitamin provision in Farm bill, food safety legislation efforts, support for HR 1107, support for the Dietary supplement Caucus, support for FSA and deductibility for certain dietary supplements with health claims.

Good manufacturing practices for dietary supplements - implementation Implementation of serious adverse event reporting for dietary supplements Inclusion of multivitamins for food stamp recipients in Farm Bill

Good manufacturing practices for dietary supplements Implementation of serious Adverse Event reporting bill

Support for implementation of DSHEA, primarily Good Manufacturing Practices for the dietary supplement industry Support for S. bill 3546 in both the House and the Senate.