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Karen Dodson, Compliance Officer

FDA:  Import Operations Seminar

A Joint Collaboration between the FDA & the AIFBA of Atlanta.

November 10, 2015

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA Action

The "Notice of FDA Action," satisfies the requirements of the law for "giving notice

thereof to the owner or consignee." as defined in Sec. 801 (21 USC 381)

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA ActionA Notice of FDA Action provides specific information on the actions taken broken down by each entry line; for example:

• Sample collected• Detained• Released• Refused

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA Action Release

–Release: Product released after examination. This is not assurance of compliance and it does not preclude future action.

–Release after detention

–Release with comment:• Product appears to have minor violations• The agency exercises its enforcement discretion• Future entries violating the Act may be detained

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA ActionDetention and Hearing

– Product appears to be in violation of the law or,

– It may be subject to refusal of admission under acts and regulations enforced by FDA.

– The notice shall specify the nature of the violation.

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA ActionDetention and Hearing

– Is issued to the filer (Broker), the importer of record (IOR) and the consignee.

– The importer is entitled an informal hearing and is given 10 days to introduce testimony in support of admissibility of the article.

– To indicate why the material should not be refused entry or to discuss how the product will be brought into compliance with the law.

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Compliance Operations Compliance Operations at a Glanceat a Glance

Notices of FDA ActionRefusal

• Final Decision indicating that an entry of merchandise appears violative and that it is refused admission into the U.S.

• This occurs after the importer has been provided an opportunity to present testimony concerning the violation.

• The shipment must be exported or destroyed under FDA or CBP’s supervision within 90 days.

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Notice of Detention and Notice of Detention and HearingHearing

• Imported articles which appear violative under the laws FDA enforces must be held intact.

• Detained articles may be released if brought into compliance, otherwise they will be refused.

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Notice of Detention and Notice of Detention and HearingHearing

1.The "Notice of Detention and Hearing" gives notice of the right to a hearing on the detention for appearance of a violation (21 CFR 1.94).

2.Identifies charges that an import entry may violate under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Public Health Service Act (PHS Act) or other acts enforced by the Food and Drug Administration.

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Notice of Detention and Notice of Detention and HearingHearing

Who can introduce evidence during the detention process?

• The IOR: person who has the right under the provisions of the law (19 USC 1483; 1484; 1485). Owner or consignee as defined in 21 CFR 1.83.

• The Customs Broker who will exercise “responsible supervision and control” over Customs business it conducts (19 USC 1641(b)(4).

• Any other party appointed in writing by the IOR (i.e., Attorneys, Private Laboratory Representative, etc.).

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COMMON VIOLATIONS REASONS FOR DETENTIONS

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Acidified & Low-Acid Canned Foods

REASONS FOR PRODUCT DETENTION

– Establishment is not registered (FCE #)

– Establishment has not filed process information with the FDA (SID #)

– Maybe subject to Import Alert 99-12 and 99-37

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Acidified & Low-Acid Canned Foods

REASONS FOR PRODUCT DETENTION

– SAMPLES COLLECTED BY FDA:

• Microbiological Findings

• Water Activity Controlled Products Based on pH and Aw Findings

• A can with a seam defect (droops, false seams, loose seams, etc.)

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Reasons for detentionsReasons for detentionsFood Items Common Label violations

• Label is not in EnglishLabel is not in English

• Incorrect or missing statement of identity, or name of the foodIncorrect or missing statement of identity, or name of the food

• Label lacks the name and place of business of the manufacturer, Label lacks the name and place of business of the manufacturer, packer, or distributorpacker, or distributor

• Fails to list potential allergensist potential allergens

• Fails to declare ingredients

• Fails to bear nutrition labeling or the nutrition label is in incorrect format.

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Reasons for detentionsReasons for detentionsFood Items Common Label violations

• Color additives

– Unsafe or not declared on label

– Color additives declared using unaccepted codes (i.e. E102 or CI15985) not accepted.

– Natural Colors need common name (i.e. carotene)

– Color additives have to be from an FDA certified batch unless exempted (FD&C Yellow #6)

– Product contains non-permitted color additives

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Reasons for detentionsReasons for detentionsFood Items Common Label violations

• Food Additives that are unsafe or not declared in label. (i.e. sulfites agents in seafood).

• Net Quantity (both Metric and U.S. Customary System ) e.g. Net wt. 1 lb. 8 oz. (680g) 21 CFR 101.105.

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Guidance for Industry: A Food Guidance for Industry: A Food Labeling GuideLabeling Guide

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm

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Common ViolationsCommon ViolationsDietary Supplements

Health Claims

• Product labeling is making unauthorized health claims.

“Assists in the treatment and prevention of diabetes.”

" Better Than Viagra”

“is … a natural anti-inflammatory and is commonly used to ease stiffness and pain [from] arthritis….”

If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered an unauthorized new drug and in violation of the applicable regulations and statutes.

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Common ViolationsCommon Violations

Dietary Supplements

Health Claims

• Undeclared Active Ingredients in Products Marketed as Dietary Supplements

FDA investigations have discovered products marketed as dietary supplements that contain the same active ingredients as in FDA-approved drug products. An example would be a product marketed as Herbal Viagra, which contained the undisclosed prescription drug ingredient Sildenafil or similar substances.

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Dietary supplements common labeling problems

• Lacks a (“Supplement Facts” panel), which is required under 21 CFR 101.36.

• These are examples of correct Supplement Facts Panels

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Dietary supplements common labeling problems

• Label lacks name of product and the term “dietary supplement” or “ herbal supplement” (see 21 CFR 101.3(g))

• Net quantity of contents

• Name and place of business of manufacturer, packer, or distributor

• Directions for use / Warnings

• Label is not in English

• Import alerts 54-13, 54-12 and 54-11

• “Disclaimer”: this product is not intended to "diagnose, treat, cure or prevent any disease,"

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Cosmetics Common ViolationsCosmetics Common Violations

Adulterated:• Micro contamination• Manufactured or held under insanitary conditions • Contains a non-permitted color additive

Misbranded:• Label not in English• Lacks ingredient labeling and statement of the net

quantity of contents • Lacks the name and place of business of responsible

firm• Lacks warnings and adequate directions for safe use

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Most currently marketed cosmetics which are also drugs are over-the-counter drugs.

Examples of products which are drugs (OTC) as well as cosmetics :

anticavity toothpaste (e.g., "fluoride" toothpaste) sun tanning preparations intended to protect against sunburn antiperspirants that are also deodorants antidandruff shampoos.

This products need to be listed (NDC number) and have a drug facts label.

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Therapeutic claims in cosmetic label

• Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic.

Erase dark spots, clears acne, skin retraction

• Ingredients that may cause a product to be considered a drug because they have a well known therapeutic use.

An example is fluoride in toothpaste

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Therapeutic claims in cosmetic label

IA 66-38 Import Alert in effect for cosmetics labeled with drug claims

• There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs. Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims. A claim such as "molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward" is a claim for an inner structural change that would usually cause a product to be a drug.

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Common ViolationsCommon Violations

Drug Products• All foreign firms :

– Register and list all drug products imported or offered for import into the U.S.

– Listed Drug products (API’s, finish drugs, OTC drugs, assigned National drug code (NDC #).

– Non-listed products are misbranded [502(0)] and in violation of 801(a)(3).

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Common ViolationsCommon Violations

Active Pharmaceutical Ingredients (API)

• Label in English

• Adequate directions for use [502(f)(1) & 21 CFR 201]

• API needs proper labeling…

– “Caution: For manufacturing, processing, or repacking”

– “Caution: For manufacturing, processing, or repacking of new drug limited by Federal Law to investigational use”

– “Caution: Federal law prohibits dispensing without prescription”

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Common ViolationsCommon Violations

Active Pharmaceutical Ingredients (API)

• The API is intended for use in a product without an approved NDA or ANDA.

• The API is not listed.

Depending on the API end use : for approved Rx or OTC, for Clinical studies, for pending NDA/ANDA, for teaching or Research, pharmacy compounding. An End-Use Letter may be required to explain the intended use of the API.

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Common ViolationsCommon Violations

New Drug

– Contains a new chemical or– A chemical not previously used in medicine or– A different dosage

A new drug must be covered by an approved new drug application (NDA/ANDA) to be marketed in the U.S.

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OTC drugs

Drugs that can be used safely without medical supervision

Pre-approval is not required for OTC drugs subject to a final monograph. (labeling and

formula must meet final rule).

Must be listed (NDC #).

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Medical Devices

Common Violations

• Medical device not listed

• Foreign Manufacturer not registered

• Initial distributor (Importer) is not registered

• Investigational Device Needs IDE #

• False or misleading labeling

• Lack of PMA or 510(k)

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Detention Without Physical Examination

DWPE (Import Alerts)

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AUTHORITY

• Section 801 provides the importer with the right to "introduce testimony bearing on the admissibility of the articles”

• Information such as an article's violative history, among other things, may cause an article to appear adulterated, misbranded, or otherwise in violation of the FD&C Act, as described in Section 801(a).

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Importers should not wait until the Agency has issued a Notice

of Detention to determine whether articles they are offering

for import comply with the Act

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DWPE places the responsibility for ensuring compliance with the

law on the Importer

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Import AlertsMost Common

• IA 16-81 - "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella”

• IA 16-131 - "Detention Without Physical Examination of Aquacultured Catfish, Basa, Shrimp, Dace, and Eel from China- Presence of New Animal Drugs and/or Unsafe Food Additives"

• IA 45-02 - "Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors"

• IA 99-05 - "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"

• IA 99-14 - "Countrywide Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"

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Private Laboratory Testing

• Testing must be performed by an accredited US laboratory. http://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092191.pdf

• FDA does not endorse or recommend any laboratory in particular.

• For questions regarding science, science policy, sample collection, analysis, preparation, analytical methodology or confirmation tests, contact the Office of Regulatory Science.

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Private Laboratory Testing

• The laboratory will evaluate if the analytical package is acceptable according to published guidance.

• Then the laboratory will interpret and evaluate the analytical data.

• Results will be reported to the Compliance Officer handling the case.

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Private Laboratory Testing

In the case the package is acceptable and the results indicate negative the product

is releasable

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Private Laboratory Testing

In the case the package is not acceptable the results will not be evaluated and a

Notice of FDA Action will be issued

Importer might be given the opportunity to present corrected or new evidence.

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Private Laboratory Testing

In the case of confirmed positive results or lack of timely action by the importer,

the product will be refused and entry into the US will be denied.

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Reconditioning Form FDA 766Reconditioning Form FDA 766

• Application for Authorization to Recondition or to Perform Other Action.

• Is Formal request for permission to bring adulterated or misbranded products into compliance (i.e., relabeling, irradiation, etc.).

• Valid only during the detention period.

• Must be approved by a Compliance Officer.

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Reconditioning Form FDA 766Reconditioning Form FDA 766

• Submissions should include:

– A Complete description of proposal (attachments in original).

– Sampling ratio, segregate and identify lots, analytical / processing data, private lab methodology, example of proposed labeling, or other information as applicable.

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Reconditioning Form FDA 766Reconditioning Form FDA 766

• Maintain control over goods, do not distribute.

• Wait for its approval by a Compliance Officer.

• Report location upon completion to schedule FDA examination.

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Reconditioning Form FDA 766Reconditioning Form FDA 766

• Any sorting, reprocessing, or relabeling must be supervised by FDA, at the expense of the importer.

Note: Charges for Supervision Time and Travel apply.

Form is available on the web at:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM072766.pdf

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Refused Products

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Refusal NoticeRefusal Notice

• FDA determines product is not “in compliance”

• FDA Notice of Refusal is considered a FINAL Action

• FDA Notice of Refusal issued to IOR, consignee and filer

• Product must be exported or destroyed within 90 days

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Refusal NoticeRefusal Notice

Importer’s Options

• Destruction– Customs Form 3499– Contact FDA office to schedule destruction

• Exportation– Customs Form 7512– Contact CBP office for exportation

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?Questions