Regulatory Open Forum

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  • 1.  Cosmetics Labeling Requirement

    Posted 15-Dec-2014 02:50
    Hi All, 
    One of my client is the distributor of the imported in United States. They just imports the products, and would like to know if there are any label templates for the distributor, such as how large the label should be, text font, etc. I find the labeling requirements from FDA, however they do not specify the details. Does anyone has experience? Thanks in advance.  

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    Sz. 
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  • 2.  RE: Cosmetics Labeling Requirement

    Posted 15-Dec-2014 09:07
    Hello Shuzhi!

    Labeling requirements are pretty straight forward for cosmetics.  They are all really contained within the regulations and read pretty simply.  The label is the label and that must be determined by the manufacturer/responsible party.  For example, some companies will place a "wrap around" label on tube products that provides for significant graphical area while others will place a "front" and "back" label which results in far less area.  The rule is whatever you decide is really based on your needs.  The required information must appear in some way on the product.

    Additionally, required information is not necessarily required to be on the package "label" itself (meaning the container could be so small as to provide insufficient space for that information).  In the case where there is not enough space, other options can be used - secondary packaging (like boxes or cartons), tags attached to the product itself with required information, or (lease useful in my experience and opinion) tear strips at the point of sale.  The point is that the information that is required to be made available to the end use consumer must be available at the point of sale.

    If you'd like to discuss this further, please feel free to contact me directly!

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    United States
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