Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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IS YOUR COSMETIC PRODUCT REALLY A DRUG?

In Junealone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

  1. The products were “misbranded” (lack of adequate directions for use, nutrient content and/or health claims, anti-ageing labeling claims rendering the product a drug; or
  2. The products were “adulterated” (unsafe addition of a color additive).
Definition of a Cosmetic vs. Drug
Misbranding may come down to whether the FDA believes the product is a drug (which is often based on the products intended use, and labeling claims). It is therefore important to know the difference in the way FDA defines cosmetics and drug products, to ensure you label your products correctly.
A product designed for “cleansing beautifying, promoting attractiveness, or altering the appearance,” is generally defined as a cosmeticby the FDA.
A drugon the other hand, is as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.”
Why Cosmetic Products will be Refused by the FDA
One prevalent reason the FDA refuses cosmetic products is because of the claims cosmetic products makes rendering the product a “drug”. A health claim is one example of a type of claim, specifically it is a claim that the product affects the structure and or function of the human body. If your product makes a […]
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