Overview of Importing Foreign Cosmetic and OTC Products

Speaker

Instructor: Marc Sanchez
Product ID: 703379

Location
  • Duration: 60 Min
This webinar will cover key definitions like cosmetics, new drugs, adulteration and misbranding, including key concepts like color additive restrictions and labeling requirements. Attendees will learn best practices for responding to Warning Letters.
RECORDED TRAINING
Last Recorded Date: May-2014

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Why Should You Attend:

Cosmetics are a unique area of regulation. The complexity of the regulations is compounded when importing a foreign cosmetic. Even if the cosmetic is manufactured in a country with well-developed regulations and oversight of cosmetics, it will not ensure that the product is in compliance with FDA regulations. When foreign manufacturers or domestic distributors import products without understanding the regulations, it leads to detention of the imports by the FDA and Customs and Border control. A refusal notice means the shipment must either be returned to the country of origin or destroyed. It also leads to an Import Alert, or Detention Without Physical Examination (DWPE), which are expensive to resolve and result in lengthy delays.

It is therefore important to understand key definitions like what is a cosmetic and how is it different from an OTC drug in order to import into the US.

This webinar will cover the concepts that need to be understood to import cosmetics. It will discuss key definitions like cosmetics, new drugs, adulteration and misbranding. It will touch on key concepts like color additive restrictions and modifying labels. It will also discuss “cosmecuticals” and what makes some cosmetics, like sunscreens, a drug.

Areas Covered in the Webinar:

Key Definitions
  • Cosmetic, Drug, Medical Device
  • Adulteration
  • Misbranding
FDA Approval Process
  • Does the FDA approve cosmetics?
  • How does the FDA approve color additives?
Labeling
  • Labeling requirements
  • Common errors made on foreign labels
  • When do labeling claims go too far (e.g. new drug claims)?
Adulteration
  • Are my ingredients allowed?
  • How to use new ingredients?
  • Does my ingredient make my product a drug?
Common Enforcement Actions
  • Tips on responding to a refusal notice
  • Best practices for responding to Warning Letter

Who Will Benefit:

  • Cosmetic/OTC Industry Executives
  • Cosmetic/OTC Manufacturers/Distributors
  • Medical Device Manufacturers/Distributors
  • In-House Legal Counsel
  • Regulatory Affairs
  • Government Affairs
  • Distributors and Manufacturers
  • Customs Brokers
  • FDA/Food & Drug Attorneys

Instructor Profile:

Professor Marc Sanchez, represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. He also teaches as part-time adjunct professor at Northeastern University on regulatory topics including US and international food law and regulation. Professor Sanchez is a frequent national speaker on FDA compliance issues.

Professor Sanchez is the founder of Contract In-House Counsel and Consultants, LLC. His firm utilizes a cost effective model of adding a contact in-house attorney to small and mid-sized companies to provide expert counsel on a short and long-term basis. He currently serves clients across the US, EU, China, and Middle East.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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