Supplement Quality Workshop

Arsenic in my Ashwaganda? Mercury in my Multivitamins? (Supplement Quality Workshop)

November 16, 2011
 

More than half the adult population of the United States consumes dietary supplements, according to a recent National Health Interview Survey. The U.S. Food and Drug Administration (FDA) have found contamination of undeclared active pharmaceutical ingredients. In addition, a report conducted in 2010 by the US Government Accountability Office (GAO) found contamination of lead, arsenic, mercury, cadmium, and assorted pesticides in 37 of 40 products.

 

This course is designed to assist health care practitioners to navigate the complex regulatory world of dietary supplements to ensure safety for their patients and to protect their practice by deciphering which dietary supplements has met the strictest quality assurance and control. How can providers determine supplement quality when we recommend dietary supplements to our patients? What are the new NDI guidelines being put forth by the FDA and how will they affect supplement availability? In the current atmosphere of imported and possibly contaminated plant raw materials and nutritional supplements, determining dietary supplement quality can be an overwhelming task for healthcare providers. In addition, supplement raw materials may contain added excipients, preservatives, and flowing agents used in the process of manufacturing. Do they have biological effects? This presentation will take providers inside both the supplement manufacturing inspection and certification programs and the process of increasing FDA regulation. At the end of this activity, participants will have a thorough knowledge of potential contaminants in dietary supplements and quality assurance/quality control processes in the dietary supplement industry. This information will increase health care practitioners competence when decisions about dietary supplement quality.

 

At the conclusion of this educational activity, participants should be able to..

  1. Define the Dietary Supplements Health and Education Act (DSHEA) passed by Congress in 1994
    Describe how dietary supplements are regulated      
  2. Recognize the metrics that define quality in a dietary supplement according to “Good Manufacturing Practices (GMP) and Standard Operating Procedures”
  3. Appraise the American National Standards Institute (ANSI) accreditation process and NSF certification
  4. Select dietary supplements that comply with regulatory legal, and manufacturing requirements to protect patients and medical practice 6 Develop and implement a “Quality Assurance and Quality Control Questionnaire” to adequately screen a product or manufacture for quality.
Workshop Schedule

Wednesday, November 16, 2011

8:00 - 9:00 am          Getting up to Speed on Supplement Quality and Regulation...................................................Al Czap

9:00 - 10:00 am        Contamination in Dietary Supplements....................................................................................Ed Wyszumiala, NSF - National Sanitation Foundation International. "Founded in 1944, NSF International is committed to protecting and improving human health on a global scale. NSF International is an independent, not-for-profit organization that provides standards development, product certification, auditing, education and risk management for public health and the environment."

10:30 - 12:00 pm      Issues in Compliance/Quality Control in the Supplement Industry...........................................Casey Coy, NSF/DBA

1:00 - 2:30 pm          Dietary Supplement Quality; GMPs Contaminants and NDIs...................................................Carl Reynolds, FDA - Food and Drug Administration. "FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."

2:30 - 4:30 pm          Chromadex: How Do We Know if Contamination Occurs and How Can We Protect Ourselves and Our Patients?.....Frank Jaksch. "ChromaDex® was established in 1999 to become the market leader in the creation and supply of botanical reference standards along with related phytochemical products and services."

4:30 - 5:00 pm          Expert Panel

*Schedule subject to change

This is a one-day course taking place on Wednesday, November 16th.  One day courses on Thursday, November 17th include: