Import Alert 66-41

Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

NOTE:
Revision to this Import Alert dated 10/19/2010 updates the language to the "Reason for Alert" and "Guidance" sections. Changes are noted and bracketed by three asterisks (***).

*** Unapproved drugs present serious safety and effectiveness concerns.

When evidence exists for the marketing or promotion of unapproved drugs to individuals residing in the United States, the products should be considered for detention without physical examination.

Evidence of marketing or promotion may consist of information contained in: solicitations for mail orders; press releases; internet websites; advertising materials; label indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. ***

REFERENCE:
Compliance Policy Guide (CPG) 120.500 (formerly 7150.10): "Health Fraud" Factors in Considering Regulatory Action" http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073838.htm

Regulatory Procedures Manual Chapter 9, Subchapter: "Coverage of Personal Importations" http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179266.htm

CHARGE:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]"
*** OASIS charge code: UNAPPROVED ***

When unaccompanied by labeling which makes drug claims, but other evidence attributable to the manufacturer, owner or consignee,*** importer of record, or end-user *** exists which establishes the product's intended use as a drug, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]"
*** OASIS charge code: DIRECTIONS ***

RECOMMENDING
OFFICE:
Division of Import Operations and Policy (HFC-170)
Center for Drug Evaluation and Research, Office of Compliance (HFD-300)

*** Districts may detain without physical examination shipments of the unapproved and/or misbranded drugs listed in the attachments to this Import Alert.

Districts may detain shipments of unapproved and/or misbranded drugs which upon examination do not appear to comply with and/or which fail to meet the criteria for discretionary release found in the Regulatory Procedures Manual Chapter 9, Subchapter: "Coverage of Personal Importations".

Districts should contact *** the CDER/Office of Compliance/Imports Exports Compliance Branch at cderimportsexports@fda.hhs.gov*** before detaining any OTC product that appears to only meet the misbranding criteria and would therefore be detained on misbranding charges exclusively ***; or gives the appearance of not meeting a final OTC monograph; or may not, otherwise, be covered by FDA¿s OTC Drug Review ***. When detaining products which appear to meet these Criteria are not listed in the attachment, districts should forward documentation to DIOP for consideration for inclusion in this alert.

Products subject to DWPE are generally not amenable to the use of enforcement discretion as indicated in RPM Chapter 9, Subchapter: "Coverage of Personal Importations" ***

SPECIAL NOTE:
Districts should continue to enforce, as appropriate, related import alerts restricting fraudulent, dangerous and commercial unapproved and/or misbranded drug importations.
.

Unapproved new drugs, *** Misbranded drugs ***

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]".

OASIS Charge Code - UNAPPROVED

*** When unaccompanied by labeling which makes drug claims, but other evidence attributable to the manufacturer, owner, or consignee exists which establishes the product's intended use as a a drug, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]". ***

OASIS Charge Code - DIRSEXMPT