North Carolina Department of Agriculture and Consumer Services Food and Drug Division 4000 Reedy Creek Road Raleigh, NC Harold McDowell, RS Food Regulatory Specialist II

FDA Food Recalls AlertsAlerts WarningsWarnings FDA Seizure/InjunctionFDA Seizure/Injunction FDA DetentionFDA Detention NCDA & CS EmbargoNCDA & CS Embargo Market WithdrawalMarket Withdrawal Industry Voluntary RecallIndustry Voluntary Recall

FDA Alert Letter/Public announcement generally regarding hazards regarding a device or food (e.g. the use of tanning devices and washing produce).

FDA Alert This is a letter to a firm resulting from violative observations from an inspection to give individuals and/or firms an opportunity to take voluntary and prompt corrective action before an enforcement action is initiated. FDA Warning

FDA Seizure/Injunction A Seizure is a judicial civil action directed against specific offending goods to prevent their entry into interstate commerce that is accomplished under a court order.

FDA Detention Administrative Detention differs from Seizures/Injunctions in that it protects the consumer by preventing imported foods, drugs, cosmetic, and/or medical devices suspected of being injurious from entering the country.

NCDA & CS Embargo Under the NC Food, Drug and Cosmetic Act, Article 12, Chapter 106, General Statues of North Carolina: Food, Drug, Cosmetic or Device products suspected of being adulterated or misbranded may not be moved, discarded, or sold except upon authorization by an agent of the NCDA&CS or by the courts.

MARKET WITHDRAWAL These are non-safety related manufacturing firm initiated product retrievals generally associated with an identified or suspect quality issue for foods, cosmetics, drugs, or medical devices.

INDUSTRY VOLUNTARY RECALL Recalls are currently voluntary for FDA regulated products (i.e. food, including animal feed; drugs, including animal drugs; medical and radiological devices; cosmetics; human biological products including blood; and human tissue). Certain statutory provisions authorize mandatory recalls of infant formula (21 USC § 350a(e)-(g)), medical devices (21 USC § 360h(e)), and human biological products (42 USC § 262). Bioterrorism Preparedness and Response Act of 2002 H.R. 2749/House Bill by John Dingle

INDUSTRY RECALL SUBMISSION TO FDA Product Information (name, description, model, physical attributes, etc.) Codes (lot numbers, expiration dates, UPC, serial numbers, etc.) Recalling firm (contacts, manufacturing locations, addresses, phone numbers, FDA Registration, etc.) Identify Problem, reason for recall, and occurrence locations (be very detailed)

INDUSTRY RECALL SUBMISSION TO FDA (Cont.) Provide a Health Hazard Assessment – Defective products and misbranded products where a health hazard does not exist are still in violation of the law and should be recalled. Provide the volume of recalled product (dates produced, quantity distributed, amt. on hold, etc.)

INDUSTRY RECALL SUBMISSION TO FDA (Cont.) Provide the number of direct accounts/customers where product(s) are being sold. Provide a recall strategy. Reference: /ucm htm

FDA FD&C ACT A food shall be deemed adulterated: Sec 402.(a)(1) “If it bears or contains any poisonous or deleterious substance which may render it injurious to health or...” Sec 402.(a)(3) “If it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food or…” Sec 402.(a)(4) “If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health or…”

FOOD, DRUG & PROTECTION DIVISION Keep the Public Informed/Restore confidence. Confirm Industry’s Corrective Actions have been effective, determine whether recalled products have been removed from commerce, and initiate the recovery cycle to return industry to the market place. Utilize Embargo Power if necessary to remove products from retail sales.

FDA Report References Recalls, Market Withdrawals, & Safety Alerts – Archives, Enforcement Reports, industry guidance, and major recalls.