Food Recalls and the FDA

1. Food Recallsand theFDA Sean M. Cheney Recall & Emergency Coordinator Dallas District Office/ FDA

2. The Food and Drug Administration is one of the nation's oldest and most respected consumer protection agencies. Stated most simply, FDA's mission is: - to promote and protect the public health by helping safe and effective products reach the market in a timely way, - To monitor products for continued safety after they are in use, and - To help the public get the accurate, science-based information needed to improve health. We've come a long way from the time when the safety of food additives was determined by feeding them to a "Poison Squad" of federal employees. Congress laid the foundation for modern food and drug law when it passed the Food and Drugs Act of 1906. This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines. The Food and Drug Administration is one of the nation's oldest and most respected consumer protection agencies. Stated most simply, FDA's mission is: - to promote and protect the public health by helping safe and effective products reach the market in a timely way, - To monitor products for continued safety after they are in use, and - To help the public get the accurate, science-based information needed to improve health. We've come a long way from the time when the safety of food additives was determined by feeding them to a "Poison Squad" of federal employees. Congress laid the foundation for modern food and drug law when it passed the Food and Drugs Act of 1906. This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines.

3. Agency Organization The FDA is an agency under the DHHS. The agency is organized into various centers based on the commodities under FDA�s jurisdiction: CDER, the Center for Drug Evaluation and Research CBER, the Center for Biologics Evaluation and Research CDRH, the Center for Devices and Radiological Health CVM, the Center for Veterinary Medicine CFSAN, the Center for Food Safety and Applied Nutrition (also works with cosmetics and colors) NCTR, the National Center for Toxicological Research ORA, the Office of Regulatory Affairs, also known as �the field�, spreads across the country. I work for ORA. We are currently assigned to 5 geographical regions: SWR, NER, PAR, CER and SER. I currently report to the SWR. Each region is further organized into districts, each covering various states. In the case of the SWR, we have: DALDO, Dallas District Office covering AR, OK and TX. DENDO, Denver District Office covering CO, NM, UT and WY. KANDO, Kansas City Office covering IA, KS, MO and NE. SWID, our Southwest Imports District, covers imports for the entire Southwest Region plus the entire Mexico-US border all the way from the Gulf of Mexico to the Pacific Ocean. ARL is the Arkansas Regional Laboratory in Jefferson County, Arkansas. ORA is undergoing a transformation�The FDA is an agency under the DHHS. The agency is organized into various centers based on the commodities under FDA�s jurisdiction: CDER, the Center for Drug Evaluation and Research CBER, the Center for Biologics Evaluation and Research CDRH, the Center for Devices and Radiological Health CVM, the Center for Veterinary Medicine CFSAN, the Center for Food Safety and Applied Nutrition (also works with cosmetics and colors) NCTR, the National Center for Toxicological Research ORA, the Office of Regulatory Affairs, also known as �the field�, spreads across the country. I work for ORA. We are currently assigned to 5 geographical regions: SWR, NER, PAR, CER and SER. I currently report to the SWR. Each region is further organized into districts, each covering various states. In the case of the SWR, we have: DALDO, Dallas District Office covering AR, OK and TX. DENDO, Denver District Office covering CO, NM, UT and WY. KANDO, Kansas City Office covering IA, KS, MO and NE. SWID, our Southwest Imports District, covers imports for the entire Southwest Region plus the entire Mexico-US border all the way from the Gulf of Mexico to the Pacific Ocean. ARL is the Arkansas Regional Laboratory in Jefferson County, Arkansas. ORA is undergoing a transformation�

4. FDA Regions Here are the 5 regions in graphical form. The Northeast region is smaller in area, but more densely populated in terms of constituents and regulated industries. The Southwest and Pacific Regions are larger geographically, but less densely populated. It just costs us more to get from point A to point B when we travel.Here are the 5 regions in graphical form. The Northeast region is smaller in area, but more densely populated in terms of constituents and regulated industries. The Southwest and Pacific Regions are larger geographically, but less densely populated. It just costs us more to get from point A to point B when we travel.

5. To carry out its mission, FDA employs some 9,000 people who work in locations around the country. The network of field offices is generally the first point of contact for the public and regulated manufacturers. The employees in these offices focus on inspection and surveillance, laboratory work, and public and industry education. The FDA staff who work in the greater Washington, D.C., area focus on product review and regulatory policy. To carry out its mission, FDA employs some 9,000 people who work in locations around the country. The network of field offices is generally the first point of contact for the public and regulated manufacturers. The employees in these offices focus on inspection and surveillance, laboratory work, and public and industry education. The FDA staff who work in the greater Washington, D.C., area focus on product review and regulatory policy.

6. What are Laws? The basic enabling authority enacted by Congress Food, Drug and Cosmetic Act (FD&C) FDA Modernization Act (FDAMA) Orphan Drug Act Prescription Drug User Fee Act (PDUFA) Medical Device User Fee and Modernization Act (MDUFMA) Laws are enacted by Congress. They grant authority to entities like FDA and DEA to issue regulations. Some examples are, the Federal Food, Drug and Cosmetic Act or FD&C Act, the FDA Modernization Act or FDAMA, the Orphan Drug Act, the Prescription Drug User Fee Act or PDUFA, and the Medical Device User Fee and Modernization Act or MDUFMA. Needless to say, laws are legally binding on both the agency and the industry.Laws are enacted by Congress. They grant authority to entities like FDA and DEA to issue regulations. Some examples are, the Federal Food, Drug and Cosmetic Act or FD&C Act, the FDA Modernization Act or FDAMA, the Orphan Drug Act, the Prescription Drug User Fee Act or PDUFA, and the Medical Device User Fee and Modernization Act or MDUFMA. Needless to say, laws are legally binding on both the agency and the industry.

7. What are Regulations? Implement the provisions of the law based on the authority provided by the law The development of regulations must follow specific procedures that allow public notice and comment Legally binding on industry and the agency Regulations implement the provisions of the law based on the authority provided by the law. The development of regulations must follow specific procedures that allow for public notices and comments. You probably have heard the terms �Advanced Notice of Proposed Rule Making� and �Notice of Proposed Rule Making� and �Request for Comments�. Note that regulations are as legally binding on the agency and on industry as laws!Regulations implement the provisions of the law based on the authority provided by the law. The development of regulations must follow specific procedures that allow for public notices and comments. You probably have heard the terms �Advanced Notice of Proposed Rule Making� and �Notice of Proposed Rule Making� and �Request for Comments�. Note that regulations are as legally binding on the agency and on industry as laws!

8. Federal Register Official daily publication Notices Proposed Rules Final Rules Free online through www.gpo.gov or www.fda.gov GPO subscription Here�s where those notices and requests for comments publish: The Federal Register is the official daily publication for Regulations, Proposed Regulations, Public Meeting and Workshop Announcements and Notices in general for all the Federal agencies. The final regulations published in the Federal Register end up in the Code of Federal Regulation on its next publishing. The federal register is available free online at gpo.gov and at fda.gov. You can also subscribe to receive hardcopies from the Government Printing Office.Here�s where those notices and requests for comments publish: The Federal Register is the official daily publication for Regulations, Proposed Regulations, Public Meeting and Workshop Announcements and Notices in general for all the Federal agencies. The final regulations published in the Federal Register end up in the Code of Federal Regulation on its next publishing. The federal register is available free online at gpo.gov and at fda.gov. You can also subscribe to receive hardcopies from the Government Printing Office.

9. Code of Federal Regulations Title 21, Food and Drugs Published yearly Free online through www.gpo.gov www.fda.gov Order through GPO at 1-866-512-1800 Title 21 of the Code of Federal Regulations is a codification of our regulations. These regulations, also known as rules, are first published in the Federal Register, then in the next yearly edition of the CFR. Searchable versions of this document are available free online at gpo.gov and fda.gov. You can purchase hard copies of the CFR from the Government Printing Office.Title 21 of the Code of Federal Regulations is a codification of our regulations. These regulations, also known as rules, are first published in the Federal Register, then in the next yearly edition of the CFR. Searchable versions of this document are available free online at gpo.gov and fda.gov. You can purchase hard copies of the CFR from the Government Printing Office.

10. Guidance Documents... ...Policy Statements and Advisory Opinions Serve to provide the Agency�s interpretation of the law and applicable regulations The preamble to a regulation has the status of an advisory opinion Are not legally binding on the public or the agency Guidance documents, policy statements, and advisory opinions serve to provide the agency's interpretation of the laws and regulations. The preamble to a regulation, published on the Federal Register within the notice of proposed rule making and final rule, is considered an advisory opinion. These types of documents are not legally binding on industry or the agency. However, they are very useful documents aiding to best comply with the laws and regulations.Guidance documents, policy statements, and advisory opinions serve to provide the agency's interpretation of the laws and regulations. The preamble to a regulation, published on the Federal Register within the notice of proposed rule making and final rule, is considered an advisory opinion. These types of documents are not legally binding on industry or the agency. However, they are very useful documents aiding to best comply with the laws and regulations.

11. Recalls�what are they (or, at least, what does FDA say that they are)? Class Participation: How much do recalls cost the country annually? Recalls of consumer products (all industries, not just FDA) cost the country over 700 billion dollars annually. Costs of Recalling include: Loss of product and/or the costs of corrections/reworks Loss of production time when your people are working on recalls Costs of liability if your product causes injury, illness, or death. Loss of business, customer�s trust in your product When things go wrong, recalls are a necessary evil. You can minimize these costs by: Vigilance in ensuring your products are safe and in compliance, and If you have to recall, ensuring you are prepared to act quickly and effectively. Class Participation: How much do recalls cost the country annually? Recalls of consumer products (all industries, not just FDA) cost the country over 700 billion dollars annually. Costs of Recalling include: Loss of product and/or the costs of corrections/reworks Loss of production time when your people are working on recalls Costs of liability if your product causes injury, illness, or death. Loss of business, customer�s trust in your product When things go wrong, recalls are a necessary evil. You can minimize these costs by: Vigilance in ensuring your products are safe and in compliance, and If you have to recall, ensuring you are prepared to act quickly and effectively.

12. Code of Federal Regulations 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) � Guidelines on Policy, Procedures, and Industry Responsibility http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr7_04.html �...provides guidelines for manufacturers and distributors to follow with respect to their voluntary removal or correction of a marketed violative products.� Governs FDA policy for handling recalls.

13. Recall Definition (21 CFR 7.3(g)) Recall means a firm�s removal or correction of a marketed product(s) that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. FDA terminology vs. Firm Terminology The three elements of FDA definition: Removal or Correction Marketing, and Violation Class Participation No Violation = Market withdrawal 7.3(j) No Marketing = Stock Recovery 7.3(k) FDA does not monitor Market Withdrawals or Stock RecoveriesFDA terminology vs. Firm Terminology The three elements of FDA definition: Removal or Correction Marketing, and Violation Class Participation No Violation = Market withdrawal 7.3(j) No Marketing = Stock Recovery 7.3(k) FDA does not monitor Market Withdrawals or Stock Recoveries

14. Market Withdrawal (21 CFR 7.3(j)) Removal or Correction Marketed Product Minor or NO Violation

15. Stock Recovery (21 CFR 7.3(k)) Removal or Correction Violation No Marketing: product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.

16. 21 CFR Part 7 Recall is a voluntary action by a firm 7.40 (a), Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public 7.40(b), Recall may be undertaken voluntarily at any time by manufacturers and distributors. Most food recalls are voluntary recalls. If a firm doesn�t voluntarily recall, in urgent situations the FDA may officially request the responsible firm to conduct a recall. 7.40 (b) FDA may take a court action such as Seizure when (7.40 (c)): A firm refuses to undertake a recall requested by the FDA The agency has reason to believe that a recall would not be effective Determines that a recall is ineffective, or Discovers that a violation is continuing Class Participation: What else (other than seizure) might the FDA do to minimize the risk to consumers? Answer: Publicize/ Press ReleaseMost food recalls are voluntary recalls. If a firm doesn�t voluntarily recall, in urgent situations the FDA may officially request the responsible firm to conduct a recall. 7.40 (b) FDA may take a court action such as Seizure when (7.40 (c)): A firm refuses to undertake a recall requested by the FDA The agency has reason to believe that a recall would not be effective Determines that a recall is ineffective, or Discovers that a violation is continuing Class Participation: What else (other than seizure) might the FDA do to minimize the risk to consumers? Answer: Publicize/ Press Release

17. Recall Classification 7.41, FDA will perform a health hazard evaluation (HHE) to determine the level of hazard the recalled product poses. Based on the HHE FDA will assign a recall classification, 7.3(m). Health hazard evaluation includes: Diseases or injuries which have already occurred Existing conditions that can contribute to a clinical condition Population Seriousness of hazard Likelihood of occurrence of hazard Immediate and long term consequences Classification: The classification is a numerical designation to indicate the relative degree of health hazard presented by the product being recalled. FDA uses Class I, Class II, and Class IIIHealth hazard evaluation includes: Diseases or injuries which have already occurred Existing conditions that can contribute to a clinical condition Population Seriousness of hazard Likelihood of occurrence of hazard Immediate and long term consequences Classification: The classification is a numerical designation to indicate the relative degree of health hazard presented by the product being recalled. FDA uses Class I, Class II, and Class III

18. Recall Classification Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

19. Class I Examples The direct addition of peanuts to a product that is not labeled or promoted to contain peanuts. Other undeclared allergens: tree nuts, dairy/casein, soy, fish, shellfish, eggs or sulfites.

20. Class I Examples (cont.) Pathogens of concern in ready to eat foods: Listeria monocytogenes Clostridium botulinum Escherichia Coli 0157:H7 Salmonella (all serotypes) Current examples in the news include Spinach contaminated with E. Coli and Peanut Butter with Salmonella.Current examples in the news include Spinach contaminated with E. Coli and Peanut Butter with Salmonella.

21. Classification Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

22. Class II Examples Undeclared wheat, Yellow # 5 and Yellow # 6. The product is packed in cans in which the soldered seams were found to contain lead (63%).� Product may contain glass particles. Product contains Stenotrophomonas maltophila and Staphylococcus warneri

23. Classification Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

24. Class III Examples Product is labeled to contain an allergen that the product actually does not contain. Products are spoiled due to yeast contamination. Products mislabeled as "fat free". The container lids are labeled as "fat free" while the plastic pint container cups bear the nutritional facts panel with the fat content.

25. 7.42, Recall Strategy Assess Hazard and Recall Scope What is the problem? When did the problem begin and end? Can additional lots/products be affected other than the lot/product analyzed and found adulterated Ease of identifying the product. Is the product coded with a lot number? How many different sizes and different labels? Degree to which the product deficiency is obvious to the consumer. Degree to which the product remains unused in the market-place. What is the shelf life of the product? Before initiating a recall we have to have a plan/strategy or our recall will be incomplete and in-effective. The strategy should be based on the hazard the product poses to the public. Class Participation: What tool is available to help a firm determine probable classification/hazard? Answer: Enforcement Report Caution: The ER is useful, but you may not know all of the conditions surrounding a recall and therefore the classification of your recall may be different. Before initiating a recall we have to have a plan/strategy or our recall will be incomplete and in-effective. The strategy should be based on the hazard the product poses to the public. Class Participation: What tool is available to help a firm determine probable classification/hazard? Answer: Enforcement Report Caution: The ER is useful, but you may not know all of the conditions surrounding a recall and therefore the classification of your recall may be different.

26. 7.42, Recall Strategy Recall Depth Class I generally to consumer/user depth via press release Class II generally to retail depth; some to consumer/user via press release Class III generally to wholesale depth when problem is obvious to consumer

27. 7.42, Recall Strategy Public Warning/ Press Releases Usually only necessary for Class I recalls. However, can be useful in some Class II recalls. Follow FDA models as closely as possible � �fill in the blanks� Do not change hazard statement � don�t take out �life threatening� Issue press release to Associated Press Provide FDA with confirmation that press release was sent to AP FDA will issue if firm will not or if firm�s press is inadequate Press Releases posted on FDA website NEW: FDA asks that a photograph/scan of the recalled product�s label be submitted along with the draft of the press release for inclusion on the FDA website. Occasionally, a press release is received that reads more like an add geared toward investors. The point of the press release is to protect the public, not to give investors warm fuzzies. Please don�t dilute the press release with extra info.; follow the model. Label to aid consumers in product identification.Occasionally, a press release is received that reads more like an add geared toward investors. The point of the press release is to protect the public, not to give investors warm fuzzies. Please don�t dilute the press release with extra info.; follow the model. Label to aid consumers in product identification.

28. 7.49, Recall Communications/ Recall Letters Clearly identify the name of the product Concisely explain the reason for the recall and the hazard involved Explain that further distribution or use of any remaining product should cease immediately Include instructions regarding what to do with the product. When appropriate, requests that the direct account should conduct a sub-recall Provide a means for the recipient to report back to the recalling firm. Recall letters should be brief and to the point Class Participation: What should the recall letter NOT include? Answer: Should not be diluted or camouflaged: Irrelevant qualifications Promotional materials, or Any other statement or information that may detract from the message. FDA Review: FDA would like to review your recall letter before it goes out. We can help you make the letter brief and to the point. This will prevent the possibility that you have to redo it. Recall letters should be brief and to the point Class Participation: What should the recall letter NOT include? Answer: Should not be diluted or camouflaged: Irrelevant qualifications Promotional materials, or Any other statement or information that may detract from the message. FDA Review: FDA would like to review your recall letter before it goes out. We can help you make the letter brief and to the point. This will prevent the possibility that you have to redo it.

29. 7.42, Recall Strategy Recall Effectiveness Checks Conducted by the recalling firm. Performed to verify that all consignees have received notification of the recall and have taken appropriate action If not done, the firm is not meeting its obligation and responsibility to the consumer. Guidance Document, Methods for Conducting Recall Effectiveness Checks Levels: A (100%), B (<100% to >10%), C (10%), D (2%), E (None, 0%)

30. Reporting a Recall 7.46, A firm that recalls should immediately notify the appropriate FDA office. 21 CFR Part 107, Subpart E � Infant Formula Recalls, recalls of adulterated or misbranded infant formula that presents a risk to human health, must be reported to the FDA and the recall must be conducted in the manner specified in this part. In most cases (other than infant formula), reporting is not required. But, reporting is requested and suggested. Class Participation: Why do you think that reporting is requested? Answer: To ensure the recall is effective. We both have responsibility to ensure foods are safe and wholesome lets work together. We have lots of experience with recalls, we can actually help by providing guidance and evaluating strategy. To determine if other products may be involved and other recalls needed. We are going to find out about it during the next inspection, timely reporting prevents confusion to customers and consumers when the recall is reported in the Enforcement Report. In most cases (other than infant formula), reporting is not required. But, reporting is requested and suggested. Class Participation: Why do you think that reporting is requested? Answer: To ensure the recall is effective. We both have responsibility to ensure foods are safe and wholesome lets work together. We have lots of experience with recalls, we can actually help by providing guidance and evaluating strategy. To determine if other products may be involved and other recalls needed. We are going to find out about it during the next inspection, timely reporting prevents confusion to customers and consumers when the recall is reported in the Enforcement Report.

31. Where Do I Report? District Recall Coordinator see link: http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html#recall Recall Coordinators are a wealth of knowledge. Recalls are their daily business. It�s their job to ensure you do an effective recall. Use them!! District Recall Coordinators: See names and contact info in handout #1. District Recall Coordinators: See names and contact info in handout #1.

32. How/What do I Report? Guidance for Industry: Product Recalls, Including Removals and Corrections; 11/03: http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm Info needed by FDA includes: Product (identity, size and type of containers, brand names, lot numbers, whether refrigerated/ frozen/ shelf stable) Lot codes Amount and dates manufactured and distributed, Number of and types of consignees, area of distribution Reason for recall Consignee list Actual labels or clear photos of labels See handout #2 (Information Needed by FDA for Food/Cosmetic Recalls)See handout #2 (Information Needed by FDA for Food/Cosmetic Recalls)

33. Open Communication with FDA Discuss recall strategy with FDA early in the process. Let FDA review text of phone notifications, written recall notifications, press releases (follow models provided in FDA guidance) Discuss your plan for disposition of recalled product with your recall coordinator.

34. FDA Responsibilities Discuss and approve recall strategy � including press releases (district/center - Office of Public Affairs for press) Classify the recall (center) Monitor the recall by reviewing firm�s status reports and conducting audit checks (district) Terminate the recall (district for class II and III; center approval needed for class I)

35. Preparation Before A Recall Review available recall guidance Develop a recall plan Maintain manufacturing and distribution records in a manner to facilitate a timely and effective recall Identify finished products with a lot number/code Mock Recalls Mock recalls can give you an idea of where improvements can be made.Mock recalls can give you an idea of where improvements can be made.

36. Recall Info on FDA�s Website Click link to �Recalls, Product Safety� on the www.fda.gov home page Expanded industry guidance, model press releases, model recall communications

37. The FDA�s Web site is the entry point to a wealth of information about all of our programs and product areas. You can find information for consumers, health professionals, industry, and the latest news on FDA-regulated products.The FDA�s Web site is the entry point to a wealth of information about all of our programs and product areas. You can find information for consumers, health professionals, industry, and the latest news on FDA-regulated products.

40. Recall Info on FDA�s Website Regulatory Procedures Manual, Chapter 7 http://www.fda.gov/ora/compliance_ref/rpm/pdf/ch7.pdf Includes model recall letters, envelopes, response cards, etc�

41. Recall Info on FDA�s Website Investigations Operations Manual, Chapter 8 http://www.fda.gov/ora/inspect_ref/iom/contents/ch8_toc.html Methods for Conducting Recall Effectiveness Checks http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/76s0006/76s-0006-rec0001-01.pdf

42. Recall Info on FDA�s Website 21 CFR Part 7 - Enforcement Policy [for Recalls] http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr7_00.html

43. Food Recall Statistics by Class5 Year

44. Contact Info Sean M. Cheney Recall and Emergency Coordinator FDA Dallas District Office 4040 N. Central Expressway, Ste. 300 Dallas, TX 75204 214-253-5222 214-253-5314 (fax) sean.cheney@fda.hhs.gov

45. ANY QUESTIONS?