US FDA

1. US FDA • The Federal Food, Drug, & Cosmetic Act is a multitude of laws that ensure the safety and efficacy of foods, cosmetics, medical devices, drugs, biological products, and radiation emitting devices distributed in the United States (www.fda.gov/opacom/laws/fdcact/fdctoc.htm). • The US FDA is responsible for enforcing the laws contained within the FD&C Act.

2. FD&C Act, Section 801 • Various sections within the FD&C Act, especially Section 801, require US CBP to deliver samples of FDA regulated commodities, offered for import into the United States, to the FDA. • FDA relies on HTS codes to correctly classify commodities (FD0, FD1, FD2, FD3, & FD4) to ensure FDA is aware of regulated commodities offered for import. • As the amount and complexity of FDA regulated imports has grown tremendously, FDA officers are responsible for examining and sampling regulated commodities offered for import.

3. US FDA/US CBP & Liquidated Damages • During the process of examination and sampling, FDA relies on US CBP to keep the commodities from being distributed. • US CBP requires importation bonds for regulated commodities of 3 times the entered value to ensure the commodities are available for FDA examination or returned to the sender if refused entry by FDA (19 USC 1623).

4. US FDA/US CBP & Seizures • If, during the process of examination, FDA officers find regulated commodities that pose immediate risk to public health, FDA will request US CBP to exercise their authority to seize the commodities. • According to US CBP law, commodities may be seized if their importation is subject to any restriction that is imposed by law relating to health, safety, or conservation (19 USC 1595a(c)(2)A).

5. US FDA/US CBP & Penalties • FDA relies upon US CBP to issue monetary penalties and/or restrictions to all parties involved in the intentional/unintentional act of falsifying or omitting materials used during the importation of regulated commodities. • US CBP can penalize for intentional (fraud) and unintentional (negligence) acts to include monetary penalties and revocation of broker license (19 USC 1592). • Penalties are an effective tool used by US CBP, at the request of FDA, to ensure brokers exercise responsibility when supplying information to FDA (19 USC 1641).

6. RADIATION EMITTING PRODUCTS • Articles, under CDRH purview, (a) that are operated by an electrical current and emit (with or without radiation shielding) electronic product radiation (ionizing (X rays), non-ionizing (UV, visible, IR, microwaves, radiowaves), sonic, infrasonic, and ultrasonic), (b) which are used as a component of (a). • Affirmation of Compliance for Radiation Emitting Products (often on the 2877, but rarely legible): • RAA (1=prior to standard, 2=exclude b/c, 3=personal(3units), 4=repair/return, 5=components (no diagnostic Xrays), 6=prototypes (QUAN limited), 7=export only) • RAB (1=ACC, 2=unknown MAN) • RAC (1=research/training/investigation (TIB), 2=trade show (TIB)) • RAD (1=approved petition (petition not uploaded but attached), 2=petition request (TIB), 3=request to be submitted (TIB ). • MDL (product model number) • ACC (accession number) • WWW.FDA.GOV

7. COSMETICS • Articles, under the purview of CFSAN, (a) intended to be rubbed, poured, … or otherwise applied to the human body for cleansing, beautifying, … or altering the appearance, (b) intended for use as a component of (a). • Common types of import: • Bulk ingredients • CAS number is always helpful for identification of bulk ingredients. • Color Additives: • Subject to and exempt from batch certification www.cfsan.fda.gov/~dms/opa-col2.html • Finished product • Use the ~45 characters in the product description field to identify product • WWW.FDA.GOV

8. HUMAN DRUGS • Articles, under CDER purview, (a) recognized in USP-NF or HP, (b) intended for use in the diagnosis, treatment, or prevention of disease, (c) intended to affect (other than food) structure and function of the body, (d) intended for the use as a component of (a), (b), or (c). • Common types of import: • BULK API • BULK FINISHED • Affirmations of Compliance for bulk entries: • DLS (drug listing number) • NDA (new drug application number) • ANDA (abbreviated new drug application number) • IND (investigational new drug) • IFE • PERSONAL IMPORTATION OF MEDICINES • Two routes: • Medical necessity, under physician care, for treatment that cannot be obtained in US. • Continuation of treatment that began in another country. • WWW.FDA.GOV

9. MEDICAL DEVICES • Medical devices, under CDRH purview, are instruments, ... in vitro reagents, ... components, parts, or accessories which are (a) intended for use in the diagnosis/treatment of disease or (b) intended to affect the structure or function of the body. • Common types of import: • Components for further manufacture • Finished devices (class I to III) • Miscellaneous (investigational, R&D, personal use) • Affirmations of Compliance: • DEV (facility registration) • LST (product listing) • PMN (pre-market notification aka 510k) • PMA (pre-market approval) • IDE (investigational device exemption) • IRC (impact resistance certificate for pesky sunglass entries) • IFE • WWW.FDA.GOV

10. BIOLOGICAL PRODUCTS • Biological products, under CBER purview, consist of viruses, serums, (anti) toxins, vaccines, blood, blood components/derivatives, human tissue, and allergenic products used to diagnose, treat, prevent disease in humans. • Common types of import: • Licensed products (blood, plasma, vaccines, allergenic products) • Combination biologic/drug (anticoagulants in blood collection bags) • Combination biologic/devices (systems that test blood or aid in blood collection) • Miscellaneous (products in short supply, autologous blood, R&D) • Affirmations of Compliance: • BFL (Biological Establishment License) OR • BPL (Biological Product License Number) • Combination bio/drug :IND or NDA and DLS • Combination bio/device :IDE or PMN and LST • IFE • WWW.FDA.GOV

11. ALL THINGS FOOD • Articles, under CFSAN purview, used for food or drink, chewing gum, and all components used to manufacture such articles (food and composing ingredients). • Any substance, under CFSAN purview, which results … directly or indirectly … in it becoming a component … of any food (food contact substances). • A dye, pigment, or other substance, under CFSAN purview, … when applied to a food … is capable of imparting color (color additives). • Problem areas for filers: • Low Acid or Acidified • Affirmations of Compliance: • FCE (food canning establishment number) • SID (schedule identifier number) • Seafood: • HACCP (MOU or accompanying documentation) • Food Contact Substances: • www.cfsan.fda.gov/~dms/opa-indt.html • Food Additives: • www.cfsan.fda.gov/~dms/eafus.html • Color Additives: • Subject to and exempt from batch certification • www.cfsan.fda.gov/~dms/opa-col2.html • WWW.FDA.GOV

12. Animal Friendly • Almost all products used to feed and treat animals are under CVM purview. • Most imported products for animal use must be submitted to FDA for review, but import regulations are often not the same for commodities intended for humans versus commodities intended for animals . • Devices for veterinary use will not be approved and listed and manufacturers will not be registered (radiation emitting devices must have valid product reports). • Generally, bulk animal drugs will need to be listed and approved, while personal importation of unapproved drugs are reviewed on a case-by-case basis by CVM. • Most animal biologics are regulated by USDA. • Animal cosmetics are not subject to FDA. • Animal feeds are subject to Prior Notice.

13. Prior Notice of Imported Foods • According to the Bioterrorism Act, FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the United States. • Exclusions include: • Food carried or otherwise accompanying an individual arriving in the U.S. for that individual’s personal use. • Food made by an individual in his/her residence and sent by that individual as a personal gift to an individual in the U.S. • Food that is exported without leaving the port of arrival until exported. • Meat, poultry, & egg products subject to USDA jurisdiction.

14. Foods • Food, as defined by the FD&C Act, is (a) any article used for food or drink for man or other animals, (b) chewing gum, (c) any article used as a component of (a) or (b) to exclude food contact substances and pesticides. • Food imported for use, storage, or distribution in U.S. to include gifts and trade (not manufactured in residence), QA/QC, and research samples. • Food transshipped through U.S. to another country (i.e. port of entry in U.S. and trucked across border to MX). • Food imported for future export, or food for use in a FTZ.

15. Submission of PN • PN may accompany the entry electronically ( ABI/ACS → OASIS ) or as a hardcopy generated from FDA’s PNSI. • PN will only be accepted by e-mail or fax when ABI/ACS/OASIS and PNSI are not functional.

16. PN Timeframe

17. WHO should submit PN • Any individual with knowledge of the required information to include manufacturers, exporters, brokers, importers, and designated U.S. agents. • WWW.FDA.GOV

18. FDA Product Coding • When importing FDA-regulated commodities, five data elements must be accurately submitted to FDA. • Commercial Description • FDA Manufacturer (actual manufacturer of goods) • FDA Shipper • FDA Country of Origin (country in which FDA manufacturer is located) • Product Code • These five elements are critical in determining the amount of time FDA will allocate to the review of the proposed entry (i.e. automated proceed via OASIS versus FDA officer proceed). • As FDA is moving toward a more risk-based approach to import regulation, the product code will be the greatest indicator of risk and thus the most important data element used in the determination of FDA review time.

19. Product Code Structure • The product code is seven characters divided into the following five fields: • Industry: (2) determines the broadest area into which a product falls (i.e. ’05’ cereal prep/breakfast food) • Class: (1) designates the food group, source, product, use, pharmacological action, category or animal species of the product (i.e. ‘A’ breakfast food RTE) • Subclass: (1) represents the container type, method of application, use, market class, or type of product (i.e. ‘M’ multiple container) • Process Indicator Code: (1) specifies either the process, storage or dosage form depending on the type of product (i.e. ‘ T ’ packaged NCS) • Product: (2) relates directly to a particular Industry/Class combination (i.e. ’05’ mixed flake RTE) • WWW.FDA.GOV

20. Filer Evaluations • Purpose: • To assure a filer can recognize FDA-regulated commodities in the FD1 category. • To assure a filer can correctly input data into ACS. • To assure the data entered accurately reflects the information known by the filer at the time of entry. • Method: • Stage 1: Filers will be evaluated by an initial ‘dual’ filing state that will require paper documentation to accompany electronic submission of all FD2 and FD1 imported products (at least 3 weeks an 50 entries) • If filer evaluation is ≤ 10%, filer moves to ‘paperless’ state. • If filer evaluation is > 10%, problems are identified and discussed and at least another 4 weeks is completed in ‘dual’ state. • Stage 2: Filers will be evaluated through periodic evaluations (not more that nine month intervals) to determine if the recognition, correct data input, and accuracy of information known at the time of entry is still being performed at a reasonable level (≤ 10%).

21. Filer Evaluations • Required data elements: • Commercial Description • FDA Manufacturer (actual manufacturer of goods) • FDA Shipper • FDA Country of Origin (country in which FDA manufacturer is located) • Product Code • Optional data elements • Affirmations of Compliance • Quantity • Value • Consignee • Discrepancies between data elements contained in paper documentation and electronic submission may be considered a filing error when encountered. • Q: Why submit optional data elements when I can be penalized for incorrect submission? • A: Correctly transmitted optional data elements greatly reduce FDA review time.

22. FDA IMPORT CONTACT Patricia Cochran, Import Manager Cincinnati District Office, Cincinnati, OH 513-679-2700