Executive Director, Registrar Corp FDA BASICS November 2016 Russell K. Statman Executive Director, Registrar Corp 144 Research Drive Hampton, Virginia USA 23666 +1-757-224-0177 1 1

The Goal Clear U.S. Customs and U.S. FDA without detention Conduct Business in the USA Profitably and Competitively 2

PREDICT PREDICT establishes a risk score by analyzing shipment information according to FDA-developed risk criteria, including exporter and manufacturer compliance history, product risk, etc. Word to the Wise: The Best Way to Stay Out of Trouble with FDA is To Stay Out of Trouble With FDA! 3 3 3

First Advice 4 4

Products Regulated by the FDA Food and Beverages Dietary Supplements Food additives and food contact substances Drugs and Biologics Cosmetics Medical Devices Radiation Emitting Devices Tobacco 5 5 5

Background Basic Requirements 6 6 6

FOOD Facilities must be registered with FDA biennially, with Designation of “US Agent” and Consent to Inspection Food must be labeled properly-New Rules!!!!! Compliance Date: 26 July 2018 for > $10M Compliance Date: 26 July 2019 for < $10M Good Manufacturing Practices and FSMA For shelf-stable, sealed foods, “FCE” registration and process filing may be required Prior Notice Before Each Entry of Imported Food 7 7

Drugs Establishments must be registered with FDA Drugs must be listed with FDA Drugs must be labeled properly Good Manufacturing Practices must be followed Drugs must not be “Adulterated” 8 8 8

DRUGS *Some exception exist for “grandfathered” drugs, research, etc. Manufacturing, Labeling, Distributing, and Promoting Drugs Must: Follow the “ Drug Monograph” for that drug OR Follow an approved “New Drug Application” (NDA) *Some exception exist for “grandfathered” drugs, research, etc. 9 9

Cosmetics Must be labeled properly Good Manufacturing Practices Colors and Ingredients Are Regulated and Frequently Cause Detentions and Refusals *Registration of Cosmetic Establishments and filing of Cosmetic Product Ingredient Statements are voluntary. 10 10 10

Medical Devices Establishments must be registered with FDA Devices must be listed with FDA and label with GUDID Devices must be labeled properly (Unique Device ID) Good Manufacturing Practices must be followed For some devices, a 510(k) pre-market notification or PMA (premarket approval) may be required 11 11 11

Identifying the Product in the FDA World The intended use of a product determines whether it is a “Drug,” a “Cosmetic,” or both. The intended use of a product determines whether it is a “Medical Device” and how it is classified as a Medical Device. The intended use of a product determines whether it is a “Drug” or a “Dietary Supplement.” 12 12 12

Intended Use May be Established By Claims stated on the product labeling, in advertising, on the Internet, or in other promotion materials Consumer perception, which may be established through the product’s reputation Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use 13 13 13

Label Labeling http://www.healthysuppy.com/products 14 14 14

Drug – an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or function of the body” Cosmetic – an article intended to be “applied to the human body… for cleansing, beatifying, promoting attractiveness, or altering the appearance” 15 15 15

Drug Cosmetic Source: http://www.supplierlist.com/photo_images/24976/Deodorant.jpg Source: http://www.drorganic.co.uk/lavender-products.asp 16 16 16

Drug – an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or function of the body” Dietary supplement - a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. 17 17 17

Medical Devices Device - an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 18 18 18

Radiation Emitting Devices All REDs must designate a U.S. Agent for service of process Product Reports Annual Reports “Accession Number” Form 2877 19 19 19

Summary of FDA registration and listing requirements Food (human and animal) - FFR, FCE, SID Drugs (human and animal)- Establishment Registration, listing Medical Devices (human only) – Establishment registration, listing, GUDID registration Cosmetics – No registration or listing requirements but may be deemed a drug by “labeling” – watch colors and ingredients! Radiation-Emitting Devices – Product Reports, Annual Reports, “Accession number” Performance Standards Form 2877 20 20

DETENTION WITHOUT PHYSICAL EXAMINATION IMPORT ALERTS: DETENTION WITHOUT PHYSICAL EXAMINATION 21

Detention without Physical Examination (“DWPE”) Green lists Red lists Yellow Lists Removal from Import Alert 22

FDA Detention “Notice of Action” Sampling Opportunity to Present “Testimony” Reconditioning (Form 766) Release or Refusal Released “with comment” Re-Export or Destruction “Redelivery” 23

NOTICE OF ACTION 24

“Notice of FDA Action” Issued by FDA and sent to two parties: Importer of Record Customs Broker Time sensitive with a respond by deadline 25 25 25

Final Advice 26 26

Registrar Corp Headquarters Questions? Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: info@registrarcorp.com www.registrarcorp.com 27 27

Registrar Corp Worldwide Offices 28 28