Date(s) - 03/31/2020
10:00 am - 1:00 pm
FDA regulates both finished dietary supplement products and dietary ingredients.
FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
- FDA is responsible for taking action against anyadulterated or misbranded dietary supplement product after it reaches the market
Why you should Attend: To gain a fundamental understanding of dietary supplement cGMPs.
Areas Covered in the Session:
- Definition of Dietary Supplement
- Current Good Manufacturing Practices
Who Will Benefit:
- Regulatory Professionals Working in the Field of Dietary Supplements
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.
Dr. Colonna’s consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.