I have traveled to China about 35 times since 1984, both on FDA business when I was with the agency and, subsequently, as a consultant. I have spent about 18 months in the country, have been to many of China's major cities, small towns and villages, through much of the countryside and to countless farms and food manufacturing facilities. In these past 26 years, I have witnessed a truly remarkable transition of China's food sector.

In the early 80's, just a few years after the disastrous Cultural Revolution, China's food processing industry was in disarray, extremely small and operating with, at best, 1950's technology. Now, it is huge, with many manufacturers using state-of-the-art facilities to produce high-quality foods that can compete successfully in today's international markets. China is now a world leader in production of seafood, canned vegetables, fruit juices, honey and a wide variety of other foods that are exported to many countries, including the United States (about 22,000 Chinese food facilities are now registered with FDA). Yet, as we have seen in the last few years, concern over the safety of foods exported from China has seriously threatened the continuing growth and success of the Chinese food industry.

China has led the world recently in major food safety incidents, concerning seafood (animal drugs), milk (melamine), fresh vegetables (pesticides), honey (animal drugs) or pet foods (melamine and Salmonella). So, what exactly is the problem? Why has China seemingly been unable to implement effective food safety controls across its food sector? Certainly, it is not from a lack of regulations. China has numerous food safety regulations that address, in principle, most of the same safety attributes covered, for example, by FDA regulations. On the contrary, there may actually be too many duplicative regulations enforced by multiple government agencies that contribute to sporadic and often ineffective enforcement by the government. Indeed, in China, foods are regulated according to where they are in the production and distribution channel. One agency regulates a food at the farm, another regulates the same food at the factory, another in domestic distribution, a separate agency at the retail marketplace and a final agency at import/export level. While the government has taken some recent steps to strengthen and simplify the system, it remains an overly complicated and difficult to understand environment for food producers and regulators alike.

The enormous size of the agri-food industry and differences in level of sophistication within the industry are also major impediments to consistent production of safe, adequately inspected/controlled food. An associate of mine -- a senior official from AQSIQ, China's principal regulatory and enforcement agency at the international level -- recently put China's agri-food industry into perspective for me. According to him, there are now some 600 million small farmers (including aquaculture farmers) producing China's foods. There are some two million "food producers" -- only 27,000 of which are relatively well controlled "large producers". There are also about eight million "food distributors". The vast majority of these producers and distributors are located "in the countryside", away from China's large cities and away from modern transport and cold storage facilities.

So, the overwhelming majority of food producers/manufacturers/distributors in China are very small enterprises that lack either a basic understanding of modern food safety principles or the means by which to implement effective food safety controls. Yet, it is exactly these millions of "mom and pop" enterprises that are feeding the supply chain for the larger, export oriented producers. It is not surprising that serious food safety problems arise from this situation, whether from unintentional non-compliance with Chinese (or foreign) regulations or through unscrupulous producers or middlemen seeking illicit profit by marketing intentionally adulterated food, as was the case with the melamine/milk/pet food incidents.

China's food industry and the country's government food safety authorities will not be able to consistently guaranty the safety of foods produced in China until and unless the extraordinarily large number of small and medium size food production and distribution enterprises are brought under much better control. A fundamental first step in this process is development and implementation of a comprehensive, national education and training program in modern food safety principles, good manufacturing practices and inspectional approaches. In this regard, there is much opportunity for cooperation between China and the United States. FDA's China Office may wish to consider investment in food safety training in China as an integral component of its long-term strategy for ensuring the safety of foods imported into the United States from China. The two countries share a common goal of ensuring the safety of all foods available to their consumers and each will benefit markedly when China's small scale food producers implement strong and effective food safety controls.

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Who's Who at EAS
Meet EAS Senior Consultant John Jones

John Jones is a former Food and Drug Administration official who is an expert in international food safety and trade issues. Immediately prior to his retirement from the agency in 2006 he was the associate director for Asia and the Pacific, Office of International Programs, Office of the Commissioner, where he coordinated the agency's interactions with counterpart agencies in Asia.

Dr. Jones holds a Ph.D. in analytical chemistry from the University of Maryland. During his early career at FDA, he was a laboratory scientist specializing in analytical methods for chemical contaminants in foods. He went on to serve in senior management roles, including that of program manager for the agency's Pesticide and Chemical Contaminants Program. He was responsible for coordinating FDA's national monitoring and enforcement programs for pesticide residues, environmental chemical contaminants and natural toxins.

As Associate Director for International Affairs at CFSAN, he developed broad international experience. After his retirement from FDA in 2006, he became a senior fellow at the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland where he participates in JIFSAN's international education and training programs. He is also principal in his own firm, Food Safety Consulting Services International, LLC.

Dr. Jones has exceptional knowledge of the Chinese food sector. He has an extensive network of food safety contacts inside China, including influential government and food industry officials. In that context, he brings strong credentials to EAS that can assist both U.S. and Chinese food companies in strengthening and expanding their activities in the two countries, such as in the seafood, dairy product, canned food, fruit and vegetable and dietary supplement sectors.

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How FDA Wants to Deal with GRAS Substances

Steven Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, provided an insight into FDA's thinking with regard to GRAS substances, in an April 27 food regulatory update in Washington, D.C., hosted by the Food Laws and Regulations Division of the Institute of Food Technologists.

Sundlof said it was "unfortunate" that the recent report by the Government Accountability Office on the regulation of GRAS substances treats the self-determination and notification processes as if they were the same. The GAO report, titled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe, points out that a growing number of substances considered to be GRAS may be effectively excluded from federal oversight because of the way the system is set up.

The report urges the agency to require companies that conduct a GRAS determination to provide basic information about it, including the substance's identity and intended uses. In addition, it says the agency should monitor companies' GRAS determinations through random audits or some other means, and it calls for guidance on how to document the GRAS determinations.

Sundlof said the key question raised in the report was how the agency can know GRAS substances are safe if it does not have information on the substances. The agency's preferred solution would be mandatory GRAS notification, he said.

In 1997, the agency released a proposed rule that set forth the criteria for the voluntary GRAS notification program. But a final rule has yet to emerge.

• McNeil Recalls Infant and Children's Liquid Products Including Tylenol and Motrin April 30, 2010


• FDA Approves Chagas Disease Screening Test for Blood, Tissue and Organ Donors April 30, 2010


• FDA Takes Steps to Increase Safety of Foods During Transport April 30, 2010


• FDA Offers Consumer Tips about Shopping at the Store on FoodSafety.gov April 29, 2010


• FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer April 29, 2010


• FDA Urges Industry to Take Additional Steps to Prevent Cargo Theft April 28, 2010


• FDA Seeks Comment, Information, Data on Front-of-Package Labeling and Shelf-Tag Symbols April 28, 2010


• FDA Approves New Device for Adults with Severe and Persistent Asthma April 27, 2010


• FDA Warns Users about Faulty Components in 14 External Defibrillator Models April 27, 2010


• FDA Changes Process for Medical Device Advisory Committees April 26, 2010


• FDA Launches Initiative to Reduce Infusion Pump Risks April 23, 2010


• Two Arrests Made in Contaminated Food Case April 23, 2010


• FDA Announces Draft Revised Guidance on Transparency and Advisory Committees April 21, 2010


• FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System April 20, 2010


• FDA Statement on IOM Sodium Report April 20, 2010


• FDA to Address Challenges of Using Complex Medical Devices in the Home April 20, 2010


• Buckley Woman Sentenced to Jail Time, Home Detention for False Claim of Glass in Bottled Water April 20, 2010


• Federal Prisoner Serving Time for Health Care Fraud Charged with Distributing Misbranded Drugs that were Labeled as "All Natural" Sexual Enhancement April 20, 2010


• FDA Seeks Injunction Against Florida Animal Drug Compounder April 19, 2010


• FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site April 19, 2010


• FDA Issues Guidance on New Safety Rules for Shell Eggs April 15, 2010


• Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available April 13, 2010


• FDA Approves Pancreatic Enzyme Product, Pancreaze April 12, 2010


• FDA Holds Public Meeting on Prescription Drug User Fee Act April 09, 2010


• FDA Provides Information to Consumers about Triclosan April 08, 2010


• FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension April 07, 2010


• FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure April 07, 2010


• FDA Approves New Formulation for OxyContin April 05, 2010


• FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery April 05, 2010


• Federal Government Seizes Dozens of Misbranded Drug Products April 05, 2010


• Medical Device Manufacturer Guidant Pleads Guilty for not Reporting Defibrillator Safety Problems to FDA April 05, 2010


• Federal Government Seeks Permanent Injunction Against Texas Egg Roll Manufacturer April 01, 2010

• McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants' and Children's Products April 30, 2010


• Northern Food I/E Issues Alert on Undeclared Sulfites in Havista White Fungus April 29, 2010


• Humei Trading Inc. Issues Alert on Undeclared Sulfites in Dried Pachyrhizus, Product of China April 29, 2010


• MiDAS Foods International Recalls Instant Beef Soup Mix and Instant Beef Stroganoff Sauce Mix Because Of Possible Health Risk April 27, 2010


• Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes April 23, 2010


• Purina Mills Undertakes Limited Recall of Strategy® Horse Feed and Layena® Poultry Feed April 16, 2010


• Undeclared Sulfites in "Nut Tree Health Mix" April 16, 2010


• StarKist Co. Initiates Limited Regional Voluntary Recall of Two SeaSations® Products Due to Undeclared Allergen April 15, 2010


• My-A & Co, Recalls Ground Black Pepper Double Golden Fish 3.5oz Jars Due to Salmonella Contamination April 14, 2010


• Response Products Voluntarily Recalls Advanced Cetyl M Joint Action Formula for Dogs Because of Possible Salmonella Health Risk April 12, 2010


• Atlas Operations, Inc. Announces Expansion of its Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements April 12, 2010


• Consumer Alert Precautionary Recall issued for H-E-B French Onion Dip April 09, 2010


• Mccormick & Company Recalls Mccormick Fajitas Seasoning Mix Due To Unlabeled Wheat And Milk Ingredients April 07, 2010


• Del Bueno Amends Recall of Queso Fresco Cheese Because of Possible Health Risk April 06, 2010


• Del Bueno Recalls Queso Fresco Because of Possible Health Risk April 05, 2010


• Whole Foods Market Voluntarily Recalls Frozen Whole Catch Yellow Fin Tuna Steaks Due to Possible Health Risks April 04, 2010


• Golden Pacific Foods, Inc. Issues Allergy Alert for Undeclared Milk and Soy in Marco Polo Brand Shrimp Snacks April 02, 2010


• Kanec USA Inc., Issues a Voluntary Nationwide Recall of Stud Capsule For Men Marketed as Dietary Supplements April 02, 2010


• US Oftalmi Announces Voluntary Recall of the Camolyn Eye Drops Product Line, and Fisiolin Nasal Drops. Includes All Lots of 15mL Bottles April 02, 2010


• NY Gourmet Salads Inc. Recalls Chick Pea Salad Because of Possible Health Risk April 02, 2010

• 04/13/2010 Regulation of Pseudoephedrine
  Charles J. Ganley, M.D., before the Senate Caucus on International Narcotics Control

• April 28, 2010
• April 21, 2010
• April 14, 2010
• April 07, 2010

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

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Bruce D. Elsner is the latest addition to the EAS team of senior consultants. With almost 30 years of experience at three Fortune 500 corporations, he has in-depth knowledge of cGMP compliance requirements and broad expertise in quality systems development and improvement. His experience covers the world of ethical and OTC drugs, cosmetics, medical devices and dietary supplements.

Mr. Elsner began his career in 1968 at what was then E. R. Squibb & Sons, Inc. managing process support and control laboratories. In 1974, he moved to Richardson-Vicks, where he served in a divisional technical services role. His work included management of a pilot plant and a package testing laboratory. He became plant QA manager in 1984. Four years later, after the acquisition of RVI by Procter & Gamble, he led multiple quality systems transition teams addressing validation, vendor quality, stability, computer systems, copy/artwork, GMP self-inspection issues. In 1991 his role as Group Manager – QA Capability & Standards involved managing an electronic specifications and standard procedures program across all plants, contract sites and the Health Care and Beauty Care R&D groups. This position included responsibility for cGMP auditing and quality systems improvement work that doubled QA capability ratings at four plants and 30 contract manufacturing sites.

Since 1996, Mr. Elsner has operated his own consulting business working with companies producing drug, dietary supplement and cosmetic products. His work includes cGMP compliance assessments, development of master plans for managing improvement needs, coaching and hands-on work to develop standard operating procedures, validation master plans, validation protocols and quality control procedures.

"I am delighted to welcome Bruce Elsner to our team of senior consultants," says EAS President Ed Steele. "He will offer our customers valuable expertise in the areas of cGMP compliance, quality systems and standard operating procedures."

EAS will take on an aspiring regulatory affairs professional as an intern this summer. Parth Dave, a native of India who grew up in Canada and is now resident in the United States, is studying for a Professional Masters Degree (Pro-M.S.) in Industrial Microbiology at Michigan State University. In addition, he will be taking the Regulatory Affairs Certificate (RAC) exam for U.S regulations in November.

Parth is also completing a Business Management and Communications Certificate through the Eli Broad College of Business and the Michigan State University Graduate School. The course includes managerial finance, project management and marketing elements.

"I am thankful for the opportunity and look forward to learning from some of the best regulatory consultants," he says. "Working for EAS will be a great first step in establishing a great career."

EAS has joined the Tobacco Merchants Association and will be exhibiting at the group's annual meeting in Williamsburg, VA, May 23-25. As the Food and Drug Administration gets to grips with its new regulatory role for tobacco products, EAS experts will be available to offer assistance to this industry on compliance and other regulatory matters. For details, contact EAS Vice President Dean Cirotta.

EAS has scheduled the latest in its series of in-depth, two-day seminars on food labeling compliance May 26-27 at its Alexandria, VA training center. Here is a chance to learn about FDA's latest thinking on front-of-pack calorie and nutrient labeling and other "hot" regulatory issues. Learn FDA's food labeling requirements from experts who helped to develop and implement the current regulations. Instructors for this timely event include Elizabeth (Betty) Campbell, who served as head of FDA's Office of Food Labeling before becoming a labeling consultant in 1999. Ms. Campbell played a key role in writing and implementing the Nutrition Labeling and Education Act (NLEA) regulations. Other trainers for this event are James E. Hoadley, Ph.D., another former FDA official who participated in the development of NLEA-implementing nutrition labeling and health claim regulations, and Gisela Leon, who has more than 20 years of experience in international labeling of food.

Click here for more details.

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