FDA regulation of dietary supplement imports into the US

Duration: 60 Minutes
In 2010, FDA published the final rule governing import of all dietary supplements into the US. This rule consolidated the previous rules for GMP, documentation, packaging and labeling, ingredient testing, and adverse event reporting requirements. The rules describe in detail the import and marketing requirements for all dietary supplements prior to importing into the country or getting into the US market, if manufactured domestically. Additional requirements such as Foreign Supplier Verification Program (FSVP) and third-party audit program have been proposed to further regulate the import of dietary supplements into the US.
Import of Dietary Supplements
Instructor: Mukesh Kumar
Product ID: 500840

This webinar will provide practical instructions to meet the current requirements in the process of manufacture and import of dietary supplements including description of key terms, concepts, and common issues that dietary supplement manufacturers are likely to encounter.

Why Should you Attend:
This webinar is intended for manufacturers and importers of dietary supplements who wish to have a better understanding of how FDA regulates dietary supplements and the custom clearance requirements for such products. Attendees will be introduced to the various rules that apply to dietary supplements and how to navigate the Customs entry process. Attending this training will help you to better manage your import compliance activities and help support your logistics supply chain.

Objectives of the Presentation:
The objectives of the presentation are to learn about the:
  • Current rules of dietary supplement new ingredients
  • Documentation and labeling requirements
  • Facility registration for manufacturing sites
  • Import and domestic field exams
  • Import investigations and sampling
  • Role of US import agent
  • Dealing with refusal to entry or delay in entry hold
Who can Benefit:
  • U.S. Importers of Dietary Supplements
  • Foreign Exporters of Dietary Supplements
  • Compliance Officers
  • Logistics/Supply Chain Managers and Analysts
  • Trade Regulatory/Legislative Affairs Professionals
  • Sales/Marketing Personnel
  • International Business Operations
  • Customs or Trade Compliance Personnel or Officers
  • Import or Global Trade Directors or Managers
  • Import Supervisors
  • Customs Brokers
This webinar is a part of "Import Export Regulations" Webinar Series. Click here to know more.


$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
View More