Regulatory Open Forum

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  • 1.  Coconut Oil - Cosmetic and a Food?

    Posted 07-Jun-2017 13:07

    Hello,
    I have a question about Coconut Oil. Can a Coconut Oil product be marketed simultaneously as a Functional Food and as a Cosmetic? Let's say hypothetically a product's suggested use states the following on the label:

    "Incredibly healthful ABC
    Coconut Oil makes a perfect addition to
    health drinks such as smoothies and
    protein shakes, and blends well into
    almost all drinks made with ABC.
    This unique coconut
    oil can also be used as a healthy
    substitute for shortening in baked
    foods, and adds excellent flavor and
    texture to dressings and spreads. It can
    be used in a reduced-calorie diet plan,
    as a healthful source of fatty acids to
    support healthy weight management.
    ABC Coconut Oil is also prized as a topical
    skin moisturizer and protective barrier
    against dryness."

    Appreciate any info/direction.



    ------------------------------
    Mark Amrit
    Documentation Manager
    Valley Stream NY
    United States
    ------------------------------


  • 2.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 08-Jun-2017 08:31
    Hi Mark.

    I'm not and never have been a big fan of using the same label for food and cosmetic use.  The reason is simple - there are different requirements for the labels of these products and as such I have been a strong believer in separating the labels by "purpose".  For example, there is no Nutritional labeling required on cosmetics and ingredient listing in theory has a different set of rules (like being able to list the name of the combination ingredients by some common name like "enriched flour" and then parenthetically listing the ingredients in the flour). 

    I would strongly recommend considering a separate label design for these two different uses of the same product.

    ------------------------------
    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
    ------------------------------



  • 3.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 08-Jun-2017 17:17
    Hi,
    Agree with Marks comment, you need to have two labels as they have two types of requirement, and this is also true for ex USA, on a global label you can not use the same label for food and for cosmetic.
    Regards,

    ------------------------------
    Maritza Moncayo
    IRIS GLOBAL LLC
    www.irisgra.com
    Pleasant Prairie WI
    United States
    ------------------------------



  • 4.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 08-Jun-2017 20:28
    I agree with Victor  It will be practically impossible to comply wih food labeling in 21 CFR 101 and cosmetic labeling in 701  And then there's dual language labeling for both if it crosses the border in Canada.

    ------------------------------
    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
    ------------------------------



  • 5.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 07-Jul-2017 10:54
    Hi Mark,
     
    It can be sold for multiple uses, as long as the product you are referring to is the primary "raw" material, which can be added in different formulations (like formulation A for a body cream, formulation B for a cooking additive, etc.). Same as happens with cinnamon (which is sold in tablets and we also use it for cooking and is also used in candies).
     
    My husband actually works for a company involved on the distribution of compounding and nutraceuticals. My background before I joined the medical industry is food industry.
     
    Regards.
     
    Celia Encinas
    Regulatory Affairs Specialist
    Medtronic México
    Paseo Cucapah #10510 | Tijuana, B.C.22210 México
    Office (USA): 949-798-39-13 | Office (TJ): 664 903-11-13
     
    LET'S TAKE HEALTHCARE
    FURTHER, TOGETHER
     
     
     
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  • 6.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 07-Jul-2017 12:41
    As I remember same question has been posted earlier 2-3 months back.

    Please check the previous posts, may be that will help too.

    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
    ------------------------------



  • 7.  RE: Coconut Oil - Cosmetic and a Food?

    Posted 08-Jul-2017 08:20
    Be careful of your claims that you have proof that it does what you are saying.

    However, all coconut oil used in foods is chemically refined. The crude oil  must be treated with caustic soda to form water soluble soaps of the free fatty acids. The oil is separated and than can be used for food. If you use the crude material it will taste like soap and not function as a food additive in your examples. The same is true for cosmetics.

    David Steinberg, FRAPS
    President
     

    SteinbergAndAssociates.net
    Office: 609-799-1575
    Fax: 609-799-5271 

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