Public Workshops on the FDA Reportable Food Registry

FDA announced three public workshops on the Reportable Food Registry. The public workshops are to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.

Electronic registration is encouraged. Please go to Reportable Food Registry Public Workshops for more information.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, § 1005(a)(4)).

The Secretary has delegated to the Commissioner of FDA the responsibility for administering FD&C Act section 417. To further the development of the Reportable Food Registry, section 417 requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(FD&C Act § 417(a)(2)). "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S.

The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June 2009). This guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

Comical Case Names

Drunkenness image via Wikipedia

From Lowering the Bar. Legal Humor. Seriously, by Kevin Underhill:

United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat’s Shoo-Fly Powders for Drunkenness, 40 F. Supp. 208 (W D.N.Y. 1941) (holding product was misbranded because it was not in fact a cure or treatment for drunkenness).

Julius Goldman's Egg City v. United States, 464 U.S. 814 (1983).

United States v. Approximately 64,695 Pounds of Shark Fins, No. 05-56274 (9th Cir. Mar. 17, 2008).

A Scary Reminder that Restaurant Allergen Negligence Can be Fatal

I sat up half the night with an Epi-pen watching my wife to see if she was still breathing. The restaurant we ate at that night contaminated my wife’s meal with tree nuts. Although we had told the server that my wife was allergic to nuts -- and the server assured us there would be no nuts -- someone or some system failed at the restaurant.

The restaurant, Gulfstream, an upscale eatery in Orange Country, California, looked beautiful. Everyone at the restaurant presented a polite façade, but ultimately seemed unconcerned about their negligence, which could have killed one of their patrons. The restaurant management has not answered or returned my phone calls.

The Orange Country HCA Environmental Health agency was perhaps worse. The agency would not take my complaint on food contaminated with hidden allergens. The HCA person acknowledged the agency inspected the restaurant, but she thought allergens were solely the consumers’ responsibility. Moreover, the health agency employee seemed unaware that allergic reactions could be serious or even fatal. She dismissed my complaint as not their concern.

Someone ought to instruct Orange County government about the contents of the FDA Food Code, which is adopted by the state of California. We clearly have a ways to go on educating food service managers and health inspectors about food safety.

FSIS and FDA to Host a Public Meeting on Listeria Risk Assessment

FSIS and FDA to host a public meeting to discuss the interagency retail Listeria monocytogenes risk assessment on June 23 in Washington, DC, to discuss the background, approach and scope of a new interagency risk assessment.

Today's Hearing on the Draft Food Safety Enhancement Act of 2009

Documents and video from today's Energy & Commerce Subcommittee on Health hearing on “Food Safety Enhancement Act of 2009” are available here.

Stalemate at the USDA

Tom Laskawy at the Beyond Green blog has an interest post on the reasons why Vilsack “can't find anyone to run the USDA's Food Safety and Inspection Service. You wouldn't think it would be that hard. There must be dozens of scientists and food safety experts who fit the bill.”  . . . “The three candidates mentioned for the post so far, Michael Osterholm, Michael Taylor (though it's unclear if he was really up for the job) and Mike Doyle (so many Mikes!) are all champions of what Marion Nestle likes to call "late-stage techno-fixes." Or, as Obamafoodorama puts it, ‘Zap the crap!’" . . .

The President's Food Safety Working Group has a “spanking new website, [but] the administration hasn't released the names of anyone who's serving on it. The administration's food safety stalemate applies over there as well.”

Read the whole article here.

Search Warrants-What Happens When the FDA Storm Arrives

FDA’s use of criminal search warrants is increasing according to John R. Fleder in his recent article in Update, “Search Warrants—What Happens When the FDA Storm Arrives.” The article offers precautionary steps to ensure a business is prepared to deal with the possibility of a FDA search.

Summary of Discussion Draft of the Food Safety Enhancement Act of 2009

Representatives John D. Dingell, Henry A. Waxman, Frank Pallone, Bart Stupak, Diana DeGette, and Betty Sutton released a discussion draft of the Food Safety Enhancement Act of 2009. The draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak, and Pallone. The Food Safety Enhancement Act of 2009 incorporates technical assistance from the new Administration as well as other stakeholders. The legislation grants the Food and Drug Administration (FDA) the authorities and resources it needs to better ensure the safety of the nation's food supply. The Committee has scheduled a legislative hearing for June 3, 2009.

From the Summary of Discussion Draft of the Food Safety Enhancement Act of 2009:

Food Safety

1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.

3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.

4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.

6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic — making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.

7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.

8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.

9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.

12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.

13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.

15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.

16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.

 

General Provisions

1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.

2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.

3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

4. Grants FDA new authority to subpoena records related to possible violations.

5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

IFT Annual Meeting & Food Expo

The Institute for Food Laws & Regulations (IFLR) will be at the IFT Annual Meeting & Food Expo June 6-9. Stop by and see us at booth #602.

Thousands of food industry professionals from around the globe convene at IFT to learn about the latest developments in scientific research, technologies, new products, food law, and consumer trends. The IFT Annual Meeting & Food Expo brings together decision-makers from all of the many disciplines involved in food science, technology, law, and more. The meeting packs in tremendous educational sessions as well as offering great networking for professionals in R&D and other scientific/technical positions, as well as in corporate management, purchasing, consulting, academia, government/regulatory, and technical sales and marketing.

Hope to see you in Anaheim!

Seminar on Food Import Safety May 26-27

Neal Fortin will be speaking on food import law on May 27 in Madison, Wisconsin. The seminar titled, Food Import Safety: Systems, Infrastructure, and Governance, is sponsored by the Center for World Affairs and the Global Economy at University of Wisconsin – Madison. More information and the agenda are available here, here, and here.

To register, send an email to chpra@engr.wisc.edu with the following information: Name, Title, Affiliation, Mailing Address, Telephone Number, Fax Number, and E-mail. The conference is free-of-charge but space is limited. For a map of the UW campus, see http://www.map.wisc.edu/.

Food counterfeiting, John Spink Video Presentation

Food counterfeiting, contamination outpace international regulatory systems

John Spink discusses food counterfeiting and contamination. Watch>>

PDF of Spink's presentation

From MSU News, Special Report available at: http://special.news.msu.edu/aaas2009/food_release.php

CHICAGO — Intentionally contaminated Chinese milk killed several children and sickened 300,000 more, causing concern around an increasingly connected world economy. Demand for inexpensive products virtually guarantees future repeats of food adulteration and counterfeiting from overseas, Michigan State University researchers said, as trade volumes overwhelm regulatory oversight.

Nobody can guarantee safe food, said Ewen Todd, but governments need to improve controls by promoting increased corporate responsibility, identifying vulnerabilities and assessing risks. Todd, a professor of advertising, public relations and retailing, conducted a symposium on the safety of imported food today at the American Association for the Advancement of Science annual meeting held in Chicago.

Increasing risk-based inspections and sampling; improving the detection of food system signals that indicate contamination; improving immediate response to contamination events; and improving risk communication all should be part of a more stringent regimen, Todd said.

The U.S. Food and Drug Administration inspects less than 2 percent of the food coming into the country, while 13 percent of America’s food is imported, Todd said.

“It’s a worldwide trend. First of all, transportation is easier, trade is easier,” he said, while consumers are increasingly well traveled and have higher expectations. “We want stuff in the winter when we can’t grow it.”

Between the extremes of accidentally contaminated food and terrorism via intentional contamination lies the counterfeiter, seeking not to harm but to hide the act for profit. The melamine incidents are such examples. As an industrial chemical that mimics protein content in tests was added to milk and subsequently created kidney problems for children.

Product counterfeiting is the focus of a presentation by John Spink, an instructor at the National Food Safety and Toxicology Center and director of the Packaging for Food and Product Protection (P-FAPP) initiative, both at MSU. He is developing a criminal justice program focused on food counterfeiting.

“We take a risk-based approach to analyze where the gaps are and look closer at where there is a higher reward for fraud,” he said.

“Counterfeiting goes back to Roman times, when French wine had a seal of Roman origin,” he said. “Products are moving around the world so fast now that there’s more opportunity for fraud. When food was distributed more regionally, there was less potential for large-scale fraud, or outbreaks of any kind.”

Recent instances of counterfeiting or contamination include conventionally grown vegetables sold as organic; fish sold as a more premium species; milk and pet food adulterated with melamine; catfish containing banned antibiotics; toothpaste contaminated with diethylene glycol (a base chemical in antifreeze); and canned energy drinks of unknown origin labeled with brand names.

Pharmaceutical counterfeiting has attracted most of regulators’ attention until recently, he said, but those companies are required to report adverse affects or similar problems, while food companies and other manufacturers are not.

“At MSU, our approach to anti-counterfeiting strategy is extremely interdisciplinary to address the many aspects of the risk,” Spink said, including public health communication, supply chain and packaging security. “Overall, we take a holistic, strategic perspective on the human element that led an individual to perceive an opportunity and then act — this perspective is led by criminal justice, social anthropology and basic business economics. Of course other important disciplines are intellectual property rights law, food law, medicine, nursing, public health, international trade, psychology, consumer behavior, retailing, management, economics and business.”

MSU’s international experience also gives it a valuable perspective by understanding source country economies and cultures, Spink said.

FDA Comments on Nutrition Symbols Public Hearing

FDA developed a memorandum discussing the agency’s September 2007 Public Hearing, Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria. The memorandum responds to the comments submitted and presented by participants of the public hearing.

The document also explains the FDA still lacks sufficient data to answer all the questions surrounding the use of front-of-pack nutrition symbols. In particular, FDA received little information on consumer understanding and use of nutrition symbols or the economic impacts of nutrition symbols on food labels.

The full document is available here.

What Do Bill Marler and Ashton Kutcher Have in Common?

In a Twitter challenge to reach one million followers, Ashton Kutcher donated 10,000 bed nets to fight malaria in Africa.  Now the Bill Marler set out a challenge to reach just 25,000 followers by the end of the month. If he does, he will donate $25,000 to the best charity suggested by the Twitter folks.

You can get to Bill on Twitter at @bmarler.  Read more about the challenge here.

Stronger Partnerships for Safer Food

George Washington University Professor Michael R. Taylor and the Association of Food and Drug Officials (AFDO), the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO) today released a new report, Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System.

With attention direction toward federal food safety reform, the vital contributions of state and local agencies are often forgotten. Food safety reform will be incomplete and insufficient unless an integrated national food safety system takes full advantage of and enhances the contribution state and local agencies.

The report outlines the current roles of federal, state, and local agencies in protecting Americans against foodborne illness.  It contains 27 findings on the strengths and weaknesses in illness surveillance, outbreak response, regulation, and inspection. The report makes 19 specific recommendations for strengthening state and local roles and for building an integrated national food safety system that works effectively to prevent foodborne illness. It is the product of a collaborative project involving the GW School of Public Health and Health Services, AFDO, ASTHO, and NACCHO and funded by the Robert Wood Johnson Foundation.

"Cheat Death" Fruit Juice Ad Banned

An advertisement for POM Wonderful read, “Cheat Death. The antioxidant power of pomegranate juice.” POM Wonderful offered the “no one would take it serious” defense. While consumers are unlikely to believe the juice would make them immortal, some may believe the product somehow contributed to a longer life, concluded the UK Advertising Standards Authority. The claim for longer life was not substantiated and was banned. The article in the UK Telegraph is here.

Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?

This blog summarized the Trust for America’s Health report, “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services?” earlier.

More recently, Ricardo Carvajal published some insightful questions on the Blueprint and other proposals for a single Food Safety Administration (FSA).  These proposal raise the “question of whether FDA’s dietary supplements and cosmetics programs should be housed in a new FSA or in the medical products agency that would remain once FDA’s food safety functions have been split off.”

Dietary supplements are defined as foods under the Food, Drug, and Cosmetic Act.  Yet, the Blueprint appears to suggest that dietary supplements should be regulated by the medical products agency because they often are marketed for drug-like effects.

Ironically, the fear that FDA would regulate dietary supplement as drugs was a significant force behind passage of the Dietary Supplement and Health Education Act of 1994 (DSHEA). DSHEA was a significant rebuke to idea of treating dietary supplements like drugs.

Passing an statute to create a new Food Safety Administration is a monumental task. Hardly the time to exhume issues that Congress has already settled. This issue could kill the Blueprint’s chance of passage.

Mr. Carvajal  notes,

It strikes us as curious that the decision of where to house the dietary supplement and cosmetics programs would be based to any degree on the fact that unlawful marketing claims might be made for those products (a problem that needs to be addressed through enforcement), or that some consumers might seek those products out for their “drug-like” effects (what is to become of coffee?).  In any case, we thought that Congress had definitively settled the question as to how dietary supplements should be regulated – as food – and that nothing about the recent or current food safety crises suggests otherwise.  As for cosmetics, their regulatory paradigm has long resembled the one for foods much more strongly than the one for drugs.

Read all of  Ricardo Carvajal, “Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?” here.

FDA Seeking Comments on Retail HACCP Manual

FDA is seeking comments on its Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments. The Operator's Manual contains information and recommendations for operators of retail and foodservice establishments who wish to develop and implement a voluntary food safety management system based on Hazard Analysis and Critical Control Point (HACCP) principles. The Regulator's Manual contains recommendations for state, local, and tribal regulators on conducting risk-based inspections of retail and foodservice establishments, including recommendations about recordkeeping practices that can assist operators in preventing foodborne illness.  The full notice is available here.

GAO Report: Seafood Fraud

The Government Accountability Office (GAO) released a report, "Seafood Fraud: FDA Program Changes and Better Collaboration among Key Federal Agencies Could Improve Detection and Prevention." GAO-09-258 (Feb. 19, 2009).  Highlights are available at: http://www.gao.gov/highlights/d09258high.pdf.

People Will Make Healthier Choices If Restaurants Provide Nutritional Data, Study Finds

ScienceDaily reports on a new study showing potential benefits for nutrition labeling in restaurants. The study shows that nutritional information can help consumers moderate their eating over time. 

A field study, experiment, and consumer food diaries were used to explore how nutrition information disclosure on menus may influence consumers’ product evaluations and consumption behaviors.  Howlett et al., Coming to a Restaurant Near You? Potential Consumer Responses to Nutrition Information Disclosure on Menus. Journal of Consumer Research, 2009; 090325111256050 DOI: 10.1086/598799.

Save 20% on Food Regulation Text

Food Regulation: Law, Science, Policy, and Practice, provides an in-depth discussion of the federal statutes, regulations, and agencies involved in food regulation.  After an introduction to U.S. food and drug regulation, it covers current food regulations, inspection and enforcement, international law, the Internet, and ethics.  With detailed discussion of policies and case studies, the book remains accessible to students and professionals alike.  

If you would like more information, a summary is available here. The full Table of Contents is available here.  A free copy of Chapter One is available here. 

Save 20% until June 30, 2009! [click here]  Web orders, use promotion code WX9W5EE.  For other orders, use X3E9AEE.