Cosmetics export certificate

  • Cosmetics certificates are issued for product lines that meet the definition of a cosmetic as defined in section 201(i)
    of the FD&C Act (21 U.S.C. 321(i)).
  • The FDA doesn’t issue these certificates for products that make drug claims, such as cleansers that claim to treat acne.
  • The FDA could only issue cosmetic export accreditations for products that are solely intended for cosmetic use.
    A cosmetic is an article destined to be rubbed, poured, scattered, or splashed on, introduced into, or otherwise
    applied to the body or any part for cleanup, beautifying, boosting attractiveness, as well as articles intended
    to be used as a component of any such articles, except soap.
  • Under U.S. law, drugs are products that are destined to impact the structure or function of the human
    body or to have a therapeutic efficacy such as preventing or treating disease (21 U.S.C. 321(g) (1)).
    Cosmetics (i.e., if they do not match the definition of “soap” in 21 CFR 701.20(a)) or drugs governed
    by the FDA may be marketed as “soap.”
  • Claims being made on the label, in Online information, or in other marketing materials
    such as advertising; Consumer perception; and Ingredients with a well-known therapeutic
    use can all be used to determine intended use.
  • The issuance of a certificate does not indicate or imply that the FDA has approved or sanctioned
    the firm’s product labels and labeling, or that the firm’s goods comply with the standards of the FD&C Act,
    the FPLA, or associated regulations.
  • The issuing of a certificate does not prevent FDA from taking future enforcement action against such products
    if warranted. A certificate also does not constitute the FDA’s admission, agreement, or determination that an item
    is a cosmetic as defined in section 201(i) of the FD&C Act.
  • Some foreign governments will accept certificates from a state or local health department, a trade board, or a trade association.

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  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.
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FDA documents received online Regular Service

Fee

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  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.
ORDER

FDA documents received online Expedited Service

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  • No need to ship your document. You may upload it here.
  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.