IMPORTING WITHOUT UNEXPECTED FDA DETENTION

1. IMPORTING WITHOUTUNEXPECTED FDA DETENTION Presented by Russell K Statman Executive Director Registrar Corp

2. The Goal Clear Customs and FDA without detention

3. Products Regulated by the FDA • Food and Beverages • Dietary Supplements • Food additives and food contact substances • Drugs • Cosmetics • Medical Devices • Also Radiation Emitting Devices, Biologics, Tobacco

4. What Gets Refused and Why?

5. Source: Registrar Corp Analysis of FDA Import Refusal Reports for May through July, 2009

6. Source: Registrar Corp Analysis of FDA Import Refusal Reports for May through July, 2009

7. Background Some Basic Requirements

8. 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”

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

10. Drug Monograph The “recipe” for an approved drug

11. DRUG MONOGRAPHS United States Code of Federal Regulations TITLE 21 C.F.R. — Food and Drugs CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER D — DRUGS FOR HUMAN USE PART 331 — ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE PART 332 — ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 333 — TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 335 — ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 336 — ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 338 — NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 340 — STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 341 — COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 343 — INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 344 — TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 346 — ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 347 — SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 348 — EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 349 — OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 350 — ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 352 — SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] PART 355 — ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 357 — MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE PART 358 — MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

12. New Drug Application(“NDA” or “ANDA”) Must be approved by FDA

13. Any product that has the intended use of a “drug” may be deemed a “New Drug” unless there is an approved monograph

14. An “Unapproved New Drug” might be a cosmetic product or dietary supplement that has been labeled in a way that causes FDA to deem it a “drug.”

15. The intended use of a product determines whether it is a “Drug,” a “Cosmetic,” or both.

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” Cosmetic– an article intended to be “applied to the human body… for cleansing, beatifying, promoting attractiveness, or altering the appearance”

17. What cosmetic claims are acceptable?

18. Cosmetics • Must be labeled properly • Good Manufacturing Practices must be followed *Registration of Cosmetic Establishments and filing of Cosmetic Product Ingredient Statements are voluntary.

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

20. Food (Including Supplements) • Facilities must be registered with FDA (Bioterrorism Act) • Food must be labeled properly • Good Manufacturing Practices must be followed • Food must not be “Adulterated” • For shelf-stable, sealed foods, “FCE” registration and process filing may be required

21. The intended use of a product determines whether it is a “Drug” or a “Dietary Supplement.”

22. 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.

23. Example: Calcium Supplement Claim: Calcium Builds Strong Bones = Dietary Supplement Claim: Calcium Prevents Osteoporosis = Drug

24. Food Canning Establishment (FCE) Low Acid and Acidified Foods (LACF) Tommy's rule of thumb... If it must be refrigerated after opening, it probably requires a process filing.

25. Medical Devices • Establishments must be registered with FDA • Devices must be listed with FDA • Devices must be labeled properly • Good Manufacturing Practices must be followed • For some devices, a 510(k) pre-market notification or PMA (premarket approval) may be required

26. The intended use of a product determines whether it is a “Medical Device” and how it is classified as a Medical Device.

27. 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.

28. Medical Devices • A product that typically is not a Medical Device could have labeling claims that may cause FDA to deem it a Medical Device • Some devices are detained for failure to obtain a 510(k) because of labeling claims that may cause FDA to require a 510(k) for a device which may be otherwise exempt

29. 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

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

31. Source: Registrar Corp Analysis of FDA Import Refusal Reports for May through July, 2009

32. Anti-Detention Checklist • Verify that the product is labeled properly for its intended use • Verify that facilities or establishments have been registered • Verify that listings (for drugs and medical devices) or process filings (for low acid and acidified foods) have been accepted by FDA prior to shipping

33. Questions and Answers . Main Office 144 Research Drive Hampton, Virginia USA 23666 P: +1-757-224-0177 F: +1-757-224-0179 E: info@registrarcorp.com http://www.registrarcorp.com