Florida GEMS: A Case Study of Saw Palmetto Supply Chain Management, Guaranteeing Purity, Efficacy and Sustainability

3-4pm

Saw palmetto extract (SPE), consumed for centuries, is used widely for prostate and lower urinary tract support. Legitimate SPE comes only from ripened berries that grow on private and public Florida land, harvested annually each fall. Validating SPE authenticity is key to substantiating efficacy and supporting sustainable cultivation. Join Valensa, USP, the American Botanical Council and the Florida Department of Agriculture in an active discussion about steps being taken to address concerns around adulteration; highlighting the link between supply chain, purity, efficacy and sustainability as a model of corporate and industry responsibility.

Speakers:

Mark Blumenthal, Founder & Executive Director, American Botanical Council

Dr. Ken Redcross, MD, CEO, Redcross Concierge

Steve Rosenman, Vice President, Marketing & BD, IVC Corporation

Umasudhan, CEO, Valensa

Botanical Adulteration Concerns

4-4:30pm

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) has published 43 peer-reviewed publications (as of August 2018) confirming adulteration of various botanical raw materials, extracts, and essential oils in the global marketplace. Included are Laboratory Guidance Documents assessing the reliability of various laboratory analytical methods. Further, BAPP has published the draft “Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles” – a new initiative that will help empower increased self-regulation in the herb and dietary supplement industry by supporting industry members in the appropriate removal of adulterated materials from the supply chain.

Speaker:

Mark Blumenthal, Founder & Executive Director, American Botanical Council

Supplements at Your Fingertips: Two Dietary Supplement Databases Designed to Change the Way We See the Marketplace

2-2:30pm

Two authoritative databases exist for dietary supplements: the Dietary Supplement Label Database (DSLD) and the Supplement OWL. Both are web-based and free to use by all stakeholders. They contain information submitted voluntarily by participants making it easier than ever for regulators, researchers, industry, and consumers to view the marketplace. The two databases are: The DSLD, created by the National Institutes of Health (NIH), is a searchable database of product label information taken from dietary supplements available in the U.S. marketplace. Intended primarily for researchers, the database is easily useable by consumers and regulators but the DSLD only features information found on dietary supplement product labels. The Supplement OWL is an industry-supported, self-regulatory initiative that allows manufacturers to upload labels and additional information to increase product and ingredient transparency. There are several levels to the OWL database that contain specific types of information made exclusively available to interested parties. This presentation will help attendees fully-understand the role of each database in the dietary supplement industry, the significance of these tools, and how stakeholders can participate.

Speakers:

Joseph Betz, Acting Director, NIH Office of Dietary Supplements

Duffy MacKay, N.D., Senior Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition

SSCI – Driving Supplement Safety and Compliance for the Industry

2:30-3pm

SSCI is a retailer led, industry stakeholder driven initiative, providing guidance and thought leadership regarding the controls necessary to assure the authenticity, safety & cGMP compliance of dietary supplements throughout the supply chain. SSCI was created through collaboration between leading industry experts from retail, manufacturing, certifying bodies, quality control and raw material ingredient processors. This presentation will introduce the audience to the critical work ongoing and how industry members can participate in the initiative.

Speakers:

Guru Ramanathan, Ph. D, Chief Innovation Officer and Senior VP, GNC (General Nutrition Corp.)

Dadrion Gaston, R.Ph, CCEP, CHC, Senior Director, Corporate Ethics & Compliance, Walmart, Inc.

Lee Mayberry, Global Legal Regulatory Coordinator, Whole Foods Market