Overview of Importing Foreign Cosmetic and OTC Products

Instructor: Marc Sanchez
Product ID: 703379
  • Duration: 60 Min

recorded version

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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.

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 requirements
  • Common errors made on foreign labels
  • When do labeling claims go too far (e.g. new drug claims)?
  • 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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