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Export Document Application Program
Frequently Asked Questions

What is the California Department of Public Health – Food and Drug Branch’s (CDPH-FDB) authority to issue Export Documents?

California Health and Safety Code (HSC) Section 110190 authorizes a person who ships to another state or country to request export documents, which state that CDPH does not object to the sale of the food, drug, device, or cosmetic in this state or the shipment of the product to any state or country.

Export document application requirements can be viewed at http://www.cdph.ca.gov/services/Documents/fdbSFDCA.pdf of the California Health and Safety Code Section (HSC) 110190-110241 commencing on page 14.

What types of Export documents does CDPH issue?

  • Free Sale or Export Certificate: Issued only for CDPH licensed/registered firms that manufacture products in California. The name of the manufacturer and products will appear on the certificate.
  • Distributor Certificate: Issued only for CDPH licensed/registered firms that manufacture products in California. The name of the distributor and products will appear on the certificate.
  • Manufacturer Certificate: Issued only for CDPH licensed/registered firms. This document is not an export document. It is a document that may be used to demonstrate license, registrations, permit, or certification status within the CDPH. Distributors name and special wording will not be included on Manufacturer Certificates.

Does a CDPH-FDB issued export document have an expiration date?

All export, free sale, distributor and manufacturer certificates expire one year after the date of issuance.

What are the methods to apply for an Export Document?

CDPH is required to accept requests for export documents via:
  • Online: Electronic Export Document Application (EDA)
  • Email: FDBExports@cdph.ca.gov
  • Facsimile: (916) 440-5552
  • Regular mail:
     California Department of Public Health
     Food and Drug Branch
     PO Box 997435, MS 7602
     Sacramento, CA 95899-7435
  • Overnight mail:
     California Department of Public Health
     Food and Drug Branch
     Export Document Program
     1500 Capitol Avenue, MS 7602
     Sacramento, CA 95814

What items must be submitted for issuance of Export documents?

  • Completed application
  • Fees payable by either:
    • Major Credit card
    • Check, money order, or cashier’s check
      All fees must be provided to, and received by, CDPH within five business days after an application submission.
  • Legible, English labels for each of the products that you plan to ship.
  • Prepaid Fed Ex or UPS shipping label

Is there a limit to the number of Export documents that can be requested for the same application?

No, there is no limit to the number of certificates than can be requested per application.

Can a distributor be issued Export documents in their name only?

Yes, if the distributor holds a valid CDPH license/registration number.

What is the maximum number of countries that may be requested on an Export Document application?

An applicant can request certificates for up to four (4) countries per application.

What are the label requirements?

  • A copy of the label must be submitted for each product
  • Product labels must be in English
  • Labels may be submitted as scanned images or in PDF format
  • If uploading labels on online, labels must be compiled into only one ZIP or PDF file

Are labels required with every application?

Yes, if applying for export, free sale, and distributor certificates, labels must be submitted with every application. Only manufacturer certificates do not require product labels.

Can food and non-food products be submitted on one application?

No, separate applications must be submitted different product types.

Can Bulk and Consumer Labels be submitted on one application?

No, bulk and consumer labels must be submitted on separate applications.

What is the maximum number of products that can be requested on one Export Document application?

Twenty-five (25) products may be requested for each Export Document application.

Does CDPH issue export documents for products manufactured outside of California?

No, please contact the U.S. Food and Drug Administration or the state where the products are manufactured.

What are the fees for CDPH-FDB issued Export documents?

  • $25 fee for each Export, Free Sale or Distributor certificate requested
  • $15 fee for each Manufacturer Certificate requested
  • $10 notary fee per certificate (if requested)
  • $100.00 One-time fee per application (if required)
    *Applicants are only required to pay the one-time fee for the first-time that Export documents are requested for that license or registration number.
  • $80 Special wording fee per application (if requested)
    Special wording may include listing both the Manufacturers’ or Distributors’ name or adding the phrase “this product is fit for human consumption.” All Special Wording is subject to FDB approval.

What payment types does CDPH-FDB accept?

Major credit cards, checks, money orders or cashier’s checks are accepted.

Can one check be submitted to pay for more than one application?

No, only one check can be accepted for payment per application.

What is CDPH-FDB’s Export Document Program Refund Policy?

All Export Document Program fees are nonrefundable in accordance with California Health and Safety Code Section 110210 (a).

What is the delivery and timing to receive completed Export documents?

Application completion and certificate issuance varies depending on the complexity of the requests, whether or not all of required fees and items have been submitted, and there are no product label deficiencies. Once the application is completed and certificates issued, certificates will be shipped within 48 hours.

A prepaid shipping label addressed to the recipient of the certificates must be provided with each Export Document application submission.

Are Export Document Applications with any label deficiencies eligible to be renewed?

Any Export Document Application with label deficiencies whether or not corrected cannot be submitted for renewal.

Technical FAQ

How does an applicant apply for a user account?

Before logging into EDA, an online account will need to be created for each user who wishes to apply for California Department of Public Health – Food and Drug Branch (CDPH-FDB) issued Export documents. To request an account, send an e-mail to FDBExports@cdph.ca.gov with the following information.
  • Requestor’s Name
  • Requestor’s Address
  • Requestor’s Email
  • Requestor’s Phone Number
  • Requestor’s Role (e.g., Manufacturer, Distributor, or Broker)
  • California Department of Public Health issued Manufacturer’s License or Registration Number(s) for the Export Document Applications that the requestor plans to submit
  • Manufacturer’s Product Type (e.g., Food, Drug, Medical Device, Cosmetic, Pet Food, and Seafood)
Requests for new user accounts will be followed up via e-mail within three business days. .

How can an applicant submit a new Export application?

Once the user navigates to the EDA program and logs into their user account, they will be able to create a new Export application by following the steps laid out in the User Guide.

How does an applicant copy an existing Export application to submit a new one?

In the Dashboard screen, the user will see a list of all of applications submitted with their user account. Once an application has been submitted, a “COPY” button will appear next to the “VIEW” button. Clicking the “Copy” button will create a new application and copy all the previously entered information from the copied application.

Please note: document attachments will not be copied into new applications. The user will need to upload new product labels and a new pre-paid return shipping label before submitting the new application.

How does an applicant attach documentation to an Export application?

When filling out the application, under the “Products” screen, the user will be prompted to upload product labels for any products added to the application. If the user requests certificate for multiple products, all product labels must be compiled into a single file. FDB recommends that the user compress the individual label files into a single .ZIP file or the user may submit these files as one Microsoft Word or PDF document.

Under the “Shipping” screen, users will be prompted to upload a shipping label to return the final certificates back to the requestor.

For questions about how to compile product labels into a single zip file, please refer to the How is a zip file created? of this Technical FAQ.

How does an applicant attach additional documentation to an Export application?

Applicants are only prompted to upload Labels and Pre-paid shipping labels. Should FDB determine that additional documentation is required from the applicant, FDB will request additional documentation after an application has been submitted and reviewed.

How can an applicant attach additional documentation requested by FDB to an existing Export application?

If additional documentation is required, the user will receive a notification from FDB indicating what additional documentation is needed. The user will be directed to sign back into EDA to access the application and then will be prompted to upload additional documentation.

How does an applicant check the status of an Export application?

Upon logging into EDA and checking the Dashboard screen, the user will be able to view all of the Export applications created under that particular username. The status of each application will be displayed in the Dashboard, and users can click on “View” to see more detailed information about the application.

Please note: EDA Account login and password information is not to be shared with other users.

What is the meaning of the various EDA Application statuses?

  • New
    A new application has been created or a previously submitted application has been copied. The application has not yet been submitted and can still be edited. Copied applications will need new product and shipping labels uploaded.
  • Renew
    A previously submitted and approved application with a status of "Resolved-Approved" has been renewed through the "Renew" button in the Dashboard. The application has not yet been submitted, and no changes may be made to the application except to upload a new shipping label in the "Shipping" screen. Product labels are copied over, so no new labels need to be uploaded.
  • Open-Waiting-CC-Approval
    The application has been submitted with "Credit" selected as the payment type. EDA is awaiting confirmation from the credit payment processor that the application fees have been paid.
  • Open-Waiting-Check
    The application has been submitted with "Check" selected as the payment type. FDB Export Document Program is waiting to receive the check payment.
  • Open-CC-Payment-Approved
    The credit payment has been approved.
  • Open-CC-Payment-Declined
    The credit payment has been declined, and payment must be re-submitted. To resubmit payment, view the application from the dashboard and click again on the "ePay Now" button.
  • Pending-Additional-Info
    The application requires more information to complete processing. This could be due to a missing or incomplete payment, incorrect or missing product or shipping labels, or a change needed in the requested special wording. Applications with this status require action from the applicant, and will be displayed in the applicant's WorkList. An e-mail notification will be sent to the applicant informing them that action is required.
  • Pending-Processing-Review
    The applicant has responded to a Request for More Information and clicked "Submit." FDB Export Document Program Staff will now review the additional information submitted and continue processing the application.
  • Pending-Technical-Review
    The application has been assigned to a label reviewer to review the product labels.
  • Pending-Initial-Deny
    The Reviewer has determined a deficiency in one or more product labels. Applicant must choose one of the three options.
    • Accept Partial approval: Applicant may choose to accept a partial approval. If partial approval is selected FDB Export will only issue certificate(s) for all products marked non-deficient.
    • Deny Entire Application: Applicant may also choose to cancel the entire application at this point by selecting "Deny Entire Application."
    • Upload Revised Labels: Applicant will be required to upload revised labels or supplemental documents for a final review.
    If none of the three options is selected within 30 days the application will be denied by default. Please note that all application fees are non-refundable. Applications with this status require action from the applicant, and will be displayed in the applicant's WorkList. An e-mail notification will be sent to the applicant informing them that action is required.
  • Resolved-Deny
    The supplemental information and/or revised labels provided by the applicant after an Initial Denial were determined to be deficient or the revision period of 30 days has lapsed. FDB Export Document Program Staff will issue a certificate(s) for all products marked non-deficient, if any. If the applicant wishes to try again, they must start a new application and pay new fees.
  • Resolved-Partial-Approve
    Applicant has accepted partial approval and will be issued the requested certificate(s) with only products determined to be non-deficient.
  • Resolved-Approved
    Entire application has been processed and approved. FDB Export will issue all requested certificates to the applicant.

How does an applicant learn the explanation of their Export application denial?

An applicant will receive an e-mail indicating the denial of an application. If the Export application was submitted online, they can also log into EDA and select to view the denied application from the Dashboard. While viewing application, reasons for deficiency can be reviewed.

Can an Export application be cancelled?

An application can only be cancelled/deleted before the application has been submitted. When editing/filling out an application, the user may click “delete” in the upper right corner of the top action bar. This will cancel the application and remove it from the user’s Dashboard and WorkList. Once submitted, applications cannot be cancelled/deleted, and application fees cannot be refunded.

What is the process to request an Export certificate renewal?

The applicant will log into EDA and search for the application in the Dashboard which they would like to renew. Once the application is found in the Dashboard, the applicant will see a “RENEW” button next to the “COPY” button. Please note, only applications with a “Resolved-Approved” status can be renewed.

How does an applicant find the amount due for an Export application submission?

The “Fees” screen calculates the amount due based on the options selected. Users may view the amount due for an application that has already been submitted, by viewing the application from the Dashboard and then selecting the “Fees Information” Sub-tab under the “Application” tab.

What is the process to submit Export application fees online?

Users may pay online by selecting the “Credit” payment method in the “Fees” screen. Once the application has been completed and submitted, an “ePay Now” button will appear in the confirmation page. Click the “ePay Now” button and a new window will open with a secure payment form to receive the credit card payment information. If this window does not open, please ensure that any pop-up blockers are not activated, or allow pop-ups from https://pubhealthapps.cdph.ca.gov/ceh/export.

If an application has already been submitted using EDA and payment has not been received, the user can view the application from their Dashboard, and the user will see the “ePay Now” button.

Are partial payments accepted?

FDB does not accept partial payments. FDB will only review applications that have been fully paid.

What are the recommended system requirements for a user’s computer?

  • Windows: 7, 8, XP Professional with SP2 (or higher), Vista
  • Internet Explorer 8 (32 bit), 9 (32 bit), 10
  • Firefox 5+
  • Safari release 5+ (on Mac and Windows)
  • Chrome 9+
  • Allow Pop ups from https://pubhealthapps.cdph.ca.gov/ceh/export
  • Allow Active X control to run (When accessing the web application, your browser may prompt you to run “Active X control…”, you must select “Allow…” to continue.)
  • For best viewing, monitor resolution of 1440 x 900 and above is recommended.

How is a zip file created?

If product labels are located in separate files, they must be combined into a single file to upload to EDA. Zip files allow users to compress multiple files into a single file. There are several ways to create zip files. In newer versions of windows, the user can select multiple files and right-click on one of them, opening the file dialog. Select “send to>compressed (zipped) folder,” and a zip file will be generated in the same location as the files.

Alternately, there are several software suites than can be used to create .zip files. Read this article for more information on creating zip files.

How can a shipping label be created?

Select a link to view instructions to create shipping labels for a courier delivery service indicated below.

I tried to upload my product labels, but when I browse to the file and select it, the path remains blank and nothing uploads

File path uploads are limited to a length of 64 characters, which includes the file path (C:\folder\subfolder\subfolder\) and the filename itself (product-labels.zip). This limitation applies to all file uploads in EDA. If you encounter this issue, please shorten the filename or move the file closer to the root directory of your hard drive or external drive.

Once you have selected the file you wish to upload and hit "open," the file path should show up in the text box under "Upload Product Label." You then must hit the "Upload" button to complete the transfer. Once the transfer is complete, the upload dialog should be replaced by a message saying "upload complete." You may then click "Next" to proceed to the next screen.

The sidebar is not visible, how can I make it visible?

If the browser window is too small, the sidebar will automatically disappear to free up more space for the screen contents. Users with low screen resolutions or are viewing EDA in a small browser window will not see the sidebar. To remedy this, maximize the browser window. If that doesn’t work, it is possible to “zoom out,” and imitate a higher resolution monitor. There are three easy methods to do this:
  • Click “View” in the toolbar and change the “Zoom” level to lower than 100%
  • Hit the Ctrl+Minus keyboard shortcut (CMD+Minus on Macintosh) to step down the zoom level. Ctrl+Plus increases the zoom level, and Ctrl+0 reverts the zoom level to 100%
  • Hold the Ctrl key and use the mouse scrollwheel to change the zoom level. Laptops with multi-touch touchpads should respond to the pinch gesture.

The website is not displaying properly, it looks like a jumbled mess. What’s wrong?

If Microsoft Internet Explorer isn’t displaying the website properly, it could be displaying it in compatibility mode--which is ironically incompatible with the EDA web application. If Internet Explorer mistakenly recognizes the webpage as needing to be viewed in compatibility mode, the Compatibility View button will appear on the Address bar. Click here for more information on how to turn on/off Compatibility Mode.

If you have any additional inquiries not addressed in the FAQs, please send an email to FDBExports@cdph.ca.gov and Export Document Program Staff will be glad to assist you.


 
 
Last modified on: 6/13/2014 4:24 PM