FDA Export Certification 
Guidance for Industry
 
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6  This version of the guidance replaces the one made available in February 2019.  This revision 
7  of the guidance includes changes to reflect existing FDA policies concerning the issuance of 
8  export certifications, including with respect to the issuance of certain export certifications for 
9  food for humans or animals pursuant to section 801(e)(4) of the Federal Food, Drug, and 
10  Cosmetic Act. 
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12  Additional copies of the guidance are available from: 
13   
14  Office of Communication, Outreach and Development  
15  Center for Biologics Evaluation and Research  
16  Food and Drug Administration  
17  10903 New Hampshire Ave., WO71, Room 3103   
18  Silver Spring, MD 20993  
19  Phone: 800-835-4709 or 240-402-8010 
20  ocod@fda.hhs.gov   
21  https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-
22  informationbiologics/biologics-guidances 
23   
24  Office of Communications, Division of Drug Information  
25  Center for Drug Evaluation and Research 
26  Food and Drug Administration 
27  10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
28  Silver Spring, MD 20993-0002  
29  Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
30  Email: druginfo@fda.hhs.gov  
31  https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.ht
32  m 
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34  Office of Policy  
35  Center for Devices and Radiological Health 
36  Food and Drug Administration 
37  10903 New Hampshire Ave., Bldg. 66, Rm. 5431 
38  Silver Spring, MD 20993-0002 
39  Email: CDRH-Guidance@fda.hhs.gov 
40  https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
41  assistance/guidance-documents-medical-devices-and-radiation-emitting-products 
42   
43  Policy and Regulations Staff, HFV-6 
44  Center for Veterinary Medicine 
45  Food and Drug Administration 
46  7500 Standish Place 
47   Rockville, MD 20855   
48  Phone: 240-402-7002 
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50  International Affairs Staff, HFS-550 
51  Center for Food Safety and Applied Nutrition 
52  Food and Drug Administration 
53  5001 Campus Drive 
54  College Park, MD 20740  
55  Phone: 240-402-2380 
56  https://www.fda.gov/FoodGuidances 
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59  For questions on the content of this document, please refer to the appropriate FDA 
60  Center based on product jurisdiction. 
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62  Biological Products for Human Use: The Center for Biologics Evaluation and Research 
63  (CBER) CBERExportCert@fda.hhs.gov, CBERBECATS@fda.hhs.gov or 240-402-
64  9155 
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66  Drugs for Human Use: The Center for Drug Evaluation and Research (CDER) 
67  CDERExportCertificateProgram@fda.hhs.gov or 301-796-4950 
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69  Medical Devices: The Center for Devices and Radiological Health (CDRH) 
70  exportcert@cdrh.fda.gov or 301-796-7400 Press 3 
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72  Food for Human Consumption: The Center for Food Safety and Applied Nutrition (CFSAN) 
73  CFSANExportCertification@fda.hhs.gov or 240-402-2307 
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75  Cosmetics: The Center for Food Safety and Applied Nutrition (CFSAN)  
76  CAP-OCAC-CFSAN@fda.hhs.gov  
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78  Veterinary Medicine and Animal Food: The Center for Veterinary Medicine (CVM) 
79  CVMExportCertification@fda.hhs.gov or 240-402-2412                                                                                                                                                                                                                                                                 
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82  U.S. Department of Health and Human Services  
83  Food and Drug Administration                                                                                    
84  Center for Biologics Evaluation and Research (CBER)                                                        
85  Center for Drug Evaluation and Research (CDER)                                    
86  Center for Devices and Radiological Health (CDRH)                                                           
87  Center for Food Safety and Applied Nutrition (CFSAN) 
88  Center for Veterinary Medicine (CVM) 
89  July 2004 
90  Corrected: April 2005 
91  Corrected: February 2019 
92  Updated: August 2021  
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94  TABLE OF CONTENTS 
95  I.  INTRODUCTION .........................................................................1 
96  II.  WHAT IS FDA EXPORT CERTIFICATION? .....................................2 
97  III.  WHY DO FOREIGN GOVERNMENTS WANT FDA EXPORT 
98  CERTIFICATION?................................................................................................2 
99  IV.  WHAT TYPES OF EXPORT CERTIFICATES DOES FDA ISSUE? .........2 
100  V.  WHAT DOES FDA MEAN WHEN IT STATES IN AN EXPORT 
101  CERTIFICATION THAT AN ESTABLISHMENT IS IN COMPLIANCE 
102  WITH CURRENT GOOD MANUFACTURING PRACTICE (CGMP) 
103  REGULATIONS OR OTHER APPLICABLE 
104  REQUIREMENTS?...................................................4 
105  VI.  DOES FDA ISSUE EXPORT CERTIFICATION FOR PRODUCTS THAT 
106  MAY NOT BE LEGALLY MARKETED IN THE UNITED STATES?........5 
107  VII.  WHAT CONDITIONS PREVENT ISSUANCE OF EXPORT  
108  CERTIFICATION? .......................................................................5 
109  VIII.  DOES FDA CHARGE A FEE FOR EXPORT CERTIFICATION? ............6 
110  IX.  WHERE DO I GET MORE INFORMATION? .....................................6 
111   
112   
113   
114  FDA Export Certification 
115  Guidance for Industry1 
116      
117  This guidance represents the current thinking of the Food and Drug Administration (FDA or the 
118  Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
119  public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
120  regulations.  To discuss an alternative approach, contact the FDA office responsible for this guidance as 
121  listed on the title page.   
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125  I.  INTRODUCTION 
126  This guidance document is intended to provide a general description of Food and Drug 
127  Administration (FDA or the Agency) export certification to industry and foreign 
128  governments.  Firms exporting products from the United States are often asked by foreign 
129  customers or foreign governments to supply a certification relating to products subject to the 
130  Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other statutes FDA administers.  
 
1 This guidance has been prepared by CBER, CDER, CDRH, CFSAN, and CVM at FDA.  You may submit 
comments on this guidance at any time.  Submit comments to Docket No. FDA-2017-D-6821 (available at 
https://www.regulations.gov/docket?D=FDA-2017-D-6821).  Submit written comments referencing Docket No. 
FDA-2017-D-6821 to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.  See the instructions in Docket No. FDA-2017-D-6821 for submitting 
comments on this and other Level 2 guidances. 
 
 
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131  This guidance supersedes the document issued under this title in July 2004, as corrected in 
132  April 2005 and February 2019. 
133   
134  The contents of this document do not have the force and effect of law and are not meant to 
135  bind the public in any way, unless specifically incorporated into a contract.  This document is 
136  intended only to provide clarity to the public regarding existing requirements under the law.  
137  FDA guidance documents, including this guidance, should be viewed only as 
138  recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
139  the word should in Agency guidances means that something is suggested or recommended, 
140  but not required. 
141  II.  WHAT IS FDA EXPORT CERTIFICATION?  
142  FDA export certification provides information concerning a product and/or establishments 
143  regulatory or marketing status, based on available information at the time FDA issues the 
144  certification (including, as appropriate, attestations provided by the person seeking the export 
145  certification).  For some Centers, if a product has received approval or clearance from FDA, it 
146  will be indicated on the export certification and/or a copy of approved labeling will be 
147  appended, as appropriate.  Upon the request of external stakeholders, FDA might issue an 
148  export certification to facilitate export of FDA-regulated products from the United States.   
149  The exporter is responsible for ensuring that the export of the product(s) to the intended 
150  destination(s) is in compliance with all other applicable U.S. statutes and regulations at the 
151  time of certification, such as provisions administered by the Department of Commerces 
152  Bureau of Industry and Security and the Department of Treasurys Office of Foreign Assets 
153  Control.  The fact that FDA has issued an export certification does not preclude FDA from 
154  taking appropriate regulatory action against an establishment or product covered by the 
155  certification.  For example, FDA might take regulatory action against an establishment or 
156  product covered by export certification if additional information about the regulatory or 
157  marketing status of the product becomes available. 
158   
159  Submitting false or misleading information in a request for certification, substituting a product 
160  under a certification, counterfeiting or altering a certificate, or fraudulently using a certification 
161  may violate federal law and subject those responsible to civil and/or criminal liability. 
162  III.  WHY DO FOREIGN GOVERNMENTS WANT FDA EXPORT 
163  CERTIFICATION?  
164  In many cases, foreign governments are seeking official assurance that products exported 
165  from the United States to their countries can be marketed in the United States or meet specific 
166  U.S. regulations, for example, as applicable, current good manufacturing practice (CGMP) 
167  regulations.  A foreign government may also require export certification as part of the process 
168  to register or import a product into that country.  
169  IV.  WHAT TYPES OF EXPORT CERTIFICATES DOES FDA ISSUE?  
170  FDA may provide export certification in various forms as we determine to be appropriate, 
171  and export certificates are one means by which we provide export certification.  At present, 
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172  FDA issues several types of export certificates, although not all certificate types are issued 
173  for every FDA-regulated product.  Most of these certificates are issued under section 
174  801(e)(4) of the FD&C Act.  Section 801(e)(4) of the FD&C Act provides that FDA shall, 
175  upon request, issue a written export certification for a human drug (including a biological 
176  product), animal drug, device, or food (including animal food and food for human 
177  consumption) that says the product either (1) meets the applicable requirements of the FD&C 
178  Act (see Sections V and VII of this guidance), or (2) meets the requirements of section 
179  801(e)(1) or 802 of the FD&C Act2 and may be legally exported from the United States (see 
180  Sections VI and VII of this guidance).  As discussed in Section VIII of this guidance, export 
181  certification issued under section 801(e)(4) of the FD&C Act is subject to a fee. 
182   
183  The FD&C Act does not require FDA to issue export certification for cosmetics.  However, 
184  because foreign governments may require certificates for cosmetic products, FDA intends to 
185  continue to provide this service as resources permit.   
186   
187  The following are examples of export certificates FDA issues:    
188   
189    The Certificate of Free Sale as issued by CFSAN has historically been available for 
190  all foods for human consumption that are regulated by FDA and may be legally 
191  marketed in the United States or, if they cannot be legally marketed in the United 
192  States, meet the requirements of section 801(e) of the FD&C Act and may be legally 
193  exported.  These certificates are not issued under section 801(e)(4) of the FD&C Act.3  
194  CFSAN intends to continue issuing Certificates of Free Sale for medical foods, foods 
195  for special dietary use, dietary ingredients, and dietary supplements.  For other foods, 
196  CFSAN intends to phase out the use of Certificates of Free Sale.   
197   
198    The Certificate of Free Sale as issued by CVM is for the export of animal food, 
199  animal drugs, or medicated animal feed that meet the applicable requirements of the 
200  FD&C Act for marketing in the United States.  FDA issues these certificates under 
201  section 801(e)(4) of the FD&C Act.  
202   
203    The Certificate for Cosmetics is issued by CFSAN for products that meet the 
204  definition of a cosmetic under section 201(i) of the FD&C Act.  We do not issue these 
205  certificates for products marketed with drug claims, such as cleansers with acne 
206  treatment claims.  These certificates are not issued under section 801(e)(4) of the 
207  FD&C Act.   
208   
209    Health Certificates might be requested by other governments for human foods 
210  containing animal-derived ingredients; these requesters often seek FDA statements 
 
2 The text of sections 801(e) and 802 of the FD&C Act is available at https://www.fda.gov/regulatory-
information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act. 
3 FDA understands that some countries may have regulations that specifically require a document designated as a 
Certificate of Free Sale for human food product registration or acceptance of shipments.  CFSAN will, if 
requested by industry, add a subtitle of Certificate of Free Sale to a Certificate to a Foreign Government. 
When CFSAN does so, the Agency continues to consider the certificate to be a Certificate to a Foreign 
Government issued under section 801(e)(4) of the FD&C Act, and the certificate will include the same content as 
other Certificates to a Foreign Government and also be subject to the same fees as other Certificates to a 
Foreign Government.   
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211  with respect to compliance of the particular product with foreign regulations.  As a 
212  matter of policy, FDA generally does not issue certificates that attest to compliance 
213  with another countrys requirements.  Rather, FDA may work with other governments 
214  to develop mutually acceptable language for the health certificate.  The CFSAN-issued 
215  health certificates for collagen or gelatin products exported to the European Union are 
216  examples of these types of certificates.  FDA will consider requests for new health 
217  certificates on a case-by-case basis, as substantial time and resource commitments are 
218  required in negotiating the certificate language with a foreign government.  Depending 
219  on the certificate language, such a certificate may or may not be issued under section 
220  801(e)(4) of the FD&C Act.  These certificates are issued by CFSAN.      
221   
222    The Certificate of a Pharmaceutical Product is issued for human drugs (including  
223  biological products) and animal drugs.  The certificate conforms to the format 
224  established by the World Health Organization (WHO) and is usually used by the 
225  importing country when considering whether to authorize the drug (including a 
226  biological product) in question for sale in that country.  These certificates are issued 
227  under section 801(e)(4) of the FD&C Act by CBER, CDER, and CVM.  
228   
229    The Non-Clinical Research Use Only Certificate is for the export of a product, 
230  material, or component for non-clinical research use only that is not intended for human 
231  use and which may be marketed in, and legally exported from, the United States under 
232  the FD&C Act.  These non-clinical research use only products, materials, or 
233  components must be labeled as authorized in the United States in accordance with 
234  21 CFR 312.160 or 809.10(c)(2).  These certificates are issued under section 801(e)(4) 
235  of the FD&C Act by CBER and CDRH.  
236   
237    The Certificate to Foreign Government is for the export of human food, human 
238  drugs (including biological products), animal drugs, animal food, medicated animal 
239  feed, and devices for humans or animals that meet the applicable requirements of the 
240  FD&C Act for marketing in the United States.  These certificates are issued under 
241  section 801(e)(4) of the FD&C Act by CBER, CDRH, CFSAN, and CVM. 
242   
243    The Certificate of Exportability is for the export of food, human drugs (including 
244  biological products), animal drugs, animal food, medicated animal feed, and devices for 
245  humans that cannot be legally marketed in the United States, but meet the requirements 
246  of section 801(e) or 802 of the FD&C Act and may be legally exported.  These 
247  certificates are issued under section 801(e)(4) by CBER, CDRH, CFSAN, and CVM.    
248  V.  WHAT DOES FDA MEAN WHEN IT STATES IN AN EXPORT 
249  CERTIFICATION THAT AN ESTABLISHMENT IS IN 
250  COMPLIANCE WITH CURRENT GOOD MANUFACTURING 
251  PRACTICE (CGMP) REGULATIONS OR OTHER APPLICABLE 
252  REQUIREMENTS?  
253  When FDA states in an export certification that an establishment is in compliance with 
254  CGMP regulations or other applicable requirements of the FD&C Act and FDA 
255  regulations, FDA bases this certification on the Agencys most recent inspection, if any, 
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256  of the relevant establishment(s) and other relevant information that is available to the 
257  Agency.  There are some situations in which FDA cannot issue a certification stating 
258  that an establishment is in compliance with CGMP regulations or other applicable 
259  requirements.  These include when an inspection is in progress or information from the 
260  inspection is under FDA review, in which case we might delay issuing a certification.  
261  Please refer to the appropriate FDA Center based on product jurisdiction for more 
262  information on applicable requirements for specific products.  
263  VI.  DOES FDA ISSUE EXPORT CERTIFICATION FOR PRODUCTS 
264  THAT MAY NOT BE LEGALLY MARKETED IN THE UNITED 
265  STATES? 
266  Section 801(e)(4) of the FD&C Act provides for export certification of products that cannot 
267  be legally marketed in the United States, including unapproved products, if they meet the 
268  requirements of section 801(e)(1) or 802 of the FD&C Act and may be legally exported from 
269  the United States.  Such certification includes Certificates of Exportability.   
270   
271  For unapproved new human drug products, CDER does not issue a Certificate of 
272  Exportability; instead, CDER issues a Certificate of a Pharmaceutical Product that includes a 
273  statement that the product is unapproved and meets the requirements of sections 801(e)(1) or 
274  802 of the FD&C Act.  For unapproved new animal drugs that meet the requirements of 
275  section 801(e)(1) of the FD&C Act, CVM may issue either a Certificate of Exportability or 
276  Certificate of Pharmaceutical Product. 
277   
278  Sections 801(e) and 802 of the FD&C Act contain numerous requirements for exporting 
279  unapproved products and other products that do not comply with the applicable requirements 
280  of the FD&C Act.  For further information on these export mechanisms, refer to the Guidance 
281  for Industry:  Exports Under the FDA Export Reform and Enhancement Act of 1996, available 
282  at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-
283  industry-exports-under-fda-export-reform-and-enhancement-act-1996. 
284  VII.  WHAT CONDITIONS PREVENT ISSUANCE OF EXPORT 
285  CERTIFICATION?  
286  When determining whether to issue export certification, FDA reviews records for relevant 
287  establishments and products and considers information and attestations provided by the 
288  person requesting the export certification.  FDA does not intend to issue export certification 
289  if it determines that the establishments or products are not eligible for the requested 
290  certification or if the Agency does not have adequate information to make the required 
291  determination.  
292  Some examples of circumstances that may prevent the issuance of export certification 
293  include:   
294   
295    FDA has determined that the manufacturing establishment(s) and/or product(s) are not 
296  in compliance with applicable CGMP regulations or other applicable requirements.  
297   
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298    FDA has determined that the manufacturing establishment(s) and/or product(s) lack the 
299  required FDA registration and/or listing.  
300   
301    FDA has initiated an enforcement action (e.g., a seizure or injunction) relevant to the 
302  establishment(s) and/or product(s). 
303   
304  When FDA does not issue an export certification, we generally will provide the reason(s) to the 
305  person requesting the export certification.4   
306  VIII. DOES FDA CHARGE A FEE FOR EXPORT CERTIFICATION?  
307  For export certifications for human food, human drugs (including biological products), animal 
308  food, animal drugs, medicated animal feed, and devices for humans or animals that FDA issues 
309  under section 801(e)(4) of the FD&C Act, we may charge a fee if we issue a certification 
310  within 20 days of receipt of a complete request for such a certification.  This fee may vary 
311  depending on the product type, but it will not exceed the statutory maximum.  FDA interprets 
312  the 20-day period to mean 20 government working days.   
313   
314  IX.  WHERE DO I GET MORE INFORMATION?  
315   
316  For further information on export certification processing for specific product areas, refer to 
317  the following websites: 
318   
319    For Biological Products visit Exporting CBER-Regulated Products   
320  https://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-
321  cber-regulated-products 
322   
323    For Drugs visit Human Drug Exports 
324  https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-
325  exports 
326   
327    For Medical Devices visit Exporting Medical Devices  
328  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExpo
329  rtingDevices/ExportingMedicalDevices/default.htm  
330   
331    For Veterinary Products visit Exporting - Animal Feed and Animal Drugs 
332  http://www.fda.gov/AnimalVeterinary/Products/ImportExports/ucm050074.htm 
333   
334    For Cosmetics visit Cosmetic Exporters  
335  https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-exporters 
336   
337    For Foods for Human Consumption visit Exporting Food Products from the 
 
4 For information on FDA denial of a Certificate to Foreign Government for a device, see FDAs guidance for 
industry and FDA, Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates for 
Devices (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-
fdas-decision-not-issue-certain-export-certificates-devices). 
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338  United States  
339  https://www.fda.gov/food/food-imports-exports/exporting-food-products-united-states 
340   
341   
342  FDA Export Certificate Web-based systems: 
343   
344  FDA offers web-based application systems for requesting certain export certificates.  These 
345  systems are an alternative to paper submissions and may offer several benefits, including a 
346  reduction in certificate processing time, real-time validation, and status updates.  Please click 
347  on the following link for available web-based export certification application systems:  
348  http://www.access.fda.gov. 
349   
350  FDA Export Certification forms: 
351   
352  FDA Export Certification forms (the Form Number 3613 series) can be found at 
353  https://www.fda.gov/about-fda/reports-manuals-forms/forms. 
354   
355  FDA References:  
356   
357  The Federal Food, Drug, and Cosmetic Act is available at https://www.fda.gov/regulatory-
358  information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act.   
359   
360  For further information on export mechanisms under sections 801(e) and 802 of the FD&C 
361  Act, refer to the Guidance for Industry  Exports Under the FDA Export Reform and 
362  Enhancement Act of 1996, available at https://www.fda.gov/regulatory-information/search-
363  fda-guidance-documents/guidance-industry-exports-under-fda-export-reform-and-
364  enhancement-act-1996. 
365   
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