Microsoft word - fru april 2012.doc

Food Regulatory Update
April 2012
FDA Presents Second Annual Reportable Food Registry Data
FDA released its second annual Reportable Food Registry (RFR) report which shows anincrease of food safety problems in raw produce, seasonings and baked goods. The RFRrequires all responsible parties to report to FDA’s portal about a food/feed product inwhich exposure will cause serious adverse health consequences or death to humans oranimals. Health officials may voluntarily submit reports as well. The recently releasedreport shows 225 primary reports, which are classified as initial reports about a safetyconcern with a food or animal feed including food ingredients, 483 subsequent reportsfrom suppliers or recipients of a food or feed for which a primary report had beensubmitted, and 174 amended reports to correct or add information to previouslysubmitted reports. The top microbial threat reported in the second annual RFR isSalmonella. The majority of Salmonella reports came from companies handling animalfood/feeds, nut/nut products, seed products, fresh produce, and spices and seasonings. Ofthe 225 primary reports, 56 concerned imported foods or ingredients, coming from atleast 19 different countries. The leading countries with reports include China with 16reports, India with seven reports and Canada with six reports. See: FDA Rejects Petition to Ban Bisphenol A
In June 2010, the Natural Resources Defense Council (NRDC) sued FDA for its failure toact on its 2008 petition asking FDA to ban Bisphenol A (BPA) in food packaging, foodcontainers and other materials likely to come into contact with food. Citing scientificevidence about the dangers of using BPA in food packaging, the group asked FDA torevoke all regulations permitting its use as a food additive. On December 7, 2011, FDAsettled the case with NRDC and agreed to make a final decision on the petition by March31, 2012. On March 30, FDA denied the petition because NRDC did not providesufficient scientific evidence to change current regulations; however, FDA says it willcontinue to support research examining the safety of BPA. In a letter to NRDC, DavidDorsey, FDA’s Acting Associate Commissioner for Policy and Planning, describesFDA’s framework for assessing BPA, the limitations in studies cited by NRDC in itspetition, and its federally financed studies currently underway.
See: FDA OC Letter to Natural Resources Defense Council Petition Denial, available at, FDA Issues Nanotechnology Guidelines
FDA issued two draft guidance documents on the potential safety issues related to the useof nanotechnology in food additives, color additives and food contact substances (FCS).
The documents, The Draft Guidance for Industry: Assessing the Effects of SignificantManufacturing Process Changes, Including Emerging Technologies, on the Safety andRegulatory Status of Food Ingredients and Food Contact Substances, Including FoodIngredients that are Color Additives, and The Guidance for Industry: Safety ofNanomaterials in Cosmetic Products, advise companies to consult with FDA regarding asignificant change in manufacturing process for a food substance already in the market,particularly when the change in manufacturing process involves emerging technology.
FDA emphasizes that “alterations in particle size distribution on the nanometer scale,which alter the physical and/or chemical properties of food ingredients and FCSs, cansometimes be significant in manufacturing changes”. Therefore, FDA advises that it isprudent to consult the agency irrespective of whether the change in the manufacturingprocess alters the safety or regulatory status of the food substance. See: FDA Moves to Phase Out Growth Promotion Drugs
FDA released a final guidance, draft guidance, and a proposal to phase out the use ofmedically important antibiotics as growth promoters in animal production. The finalversion of The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, (Guidance #209), maps out FDA’s strategy for phasing out theagricultural production use of medically important drugs and phasing in veterinaryoversight of therapeutic uses of these drugs. The draft guidance, New Animal Drugs andNew Animal Drug Combination Products Administered in or on Medicated Feed orDrinking Water of Food-Producing Animals: Recommendations for Drug Sponsors forVoluntarily Aligning Product Use Conditions with GFI #209, (Guidance #213), providesmore detail to industry on how to comply with the phase-out process and pursue approvalof therapeutic uses. Finally, the proposal, Veterinary Feed Directive (VFD); Draft Textfor Proposed Regulation, outlines ways veterinarians can authorize the use of certainanimal drugs in feed. FDA anticipates the phase-out of production uses of antimicrobialsand establishment of veterinary oversight for the remaining ones to take up to three years.
After Guidance #219 becomes final, animal drug companies will have three months tonotify FDA of their plans to voluntarily withdraw approved production uses of theirmedically important antimicrobial new animal drugs and combination new animal drugproducts. The drugs would change from over-the-counter (OTC) to VFD status formedicated feed products and from OTC to prescription status for medicated drinkingwater products.
See: 77 Fed. Reg. 22328 (Apr. 13, 2012) at, and,See: 77 Fed. Reg. 22327 (Apr. 13, 2012) at, and,See: 77 Fed. Reg. 22247 (Apr. 13, 2012) at, Durbin Asks FDA to Evaluate Caffeine Levels in Energy Drinks
Senator Dick Durbin (D-Ill.) sent a letter to FDA asking the agency to address safetyconcerns surrounding energy drinks. Durbin raises his concerns in light of a recent reportof a 14 year old girl’s death after consuming two 24-ounce Monster Energy drinks in a24-hour period. A report by the Substance Abuse and Mental Health ServicesAdministration shows an increase in the number of emergency room visits due to energydrinks from 1,128 in 2005 to 13,114 in 2009. Durbin blames the increase inhospitalizations on the high level of caffeine in energy drinks. In his letter, Durbin urgesFDA to enforce regulatory authority over the caffeine levels in energy drinks, includingRed Bull and AMP, currently marketed as beverages, and to investigate caffeine levels inenergy drinks marketed as supplements. Furthermore, he mentions that the distinctionbetween dietary supplements and foods with dietary ingredient additives is not alwaysclear, leaving room for some food and beverage products to be marketed as dietarysupplements in order to circumvent the safety standards required for food additives.
Therefore, Durbin asks FDA to clarify the definition of conventional foods and itsauthority to oversee the safety of foods, including energy drinks, containing dietarysupplement ingredients. Moreover, Durbin specifically asks the agency to investigateenergy drinks such as Monster Energy, Rockstar, and Full Throttle to ensure they are notin fact conventional foods, based on FDA’s 2009 “Guidance for Industry: Factors thatDistinguish Liquid Supplements from Beverages”. Finally, the Senator would like FDAto address the safety concerns posed by additives in energy drinks by requiringmanufacturers to provide scientific evidence that ingredients such as guarana, taurine,and ginseng are safe for their intended use and when used in combination with otheringredients and caffeine.
See: Tuna Backmeat Linked to Salmonella Outbreak
On April 18, FDA announced that Moon Marine USA Corporation (MMI), a Cupertino,California based company voluntarily recalled 58,828 pounds of frozen raw yellowfintuna following an investigation that linked it to a recent Salmonella Bareilly outbreak.
The product was sold through distributors to restaurants and grocery stores in boxeslabeled Nakaochi AA or AAA. Nakaochi Scrape is tuna backmeat that is scraped off thebones and looks like a ground product. FDA says Nakaochi Scrape may have been usedto make sushi, sashimi, ceviche and similar dishes in restaurants and grocery stores. Atotal of 116 illnesses have been reported in 20 states and the District of Columbia. Manyof the people who reported their illnesses had consumed raw tuna in sushi as “spicytuna”.
See: IOM Gives Advice for Improving Global Inspections
On April 4, the Institute of Medicine (IOM) released a report titled, Ensuring Safe Foodsand Medical Products through Stronger Regulatory Systems Abroad. In the report, IOMmaps out a multi-year plan for FDA and its counterparts to help low and middle incomecountries that are selling a greater percentage of medical products and foods toAmericans. The report includes several suggestions the FDA should undergo in order tosuccessfully meet its aggressive foreign inspection mandate under the Food SafetyModernization Act (FSMA). IOM suggests countries with stringent regulatory agenciesshould convene a working group on sharing inspection reports, with the longer-term goalof establishing a system of mutual recognition of inspections. IOM further suggests thatgovernment agencies should begin investing in surveillance systems in developingcountries, training FDA staff on international compliance with US standards and addingmedical product and food safety issues to G20 meetings among world leaders. IOMrecommends, in the next two years, that FDA and USDA write up cooperative researchand development agreements to encourage businesses and academia to develop low-costtechnologies for countries to prevent fraud and control the supply chain. For IOM’s fullreport, please see: Advocates Persistent for FDA Action on Sodium Reduction
The Canadian Medical Association Journal published an article that points to a widefluctuation of salt content in six fast food chains across six different countries. Forexample, several categories of fast food in the United Kingdom had 15% less sodiumthan in the United States. Based on the results, the researchers concluded that Americanfast food companies have room to reduce sodium in their products, translating to largegains for population health. On a related note, Michael Jacobsen, executive director atthe Center for Science in the Public Interest (CSPI), sent a letter to FDA urging theagency to issue strong rules for sodium reduction in America’s food supply. In his letter,Jacobsen tells FDA Commissioner Margaret Hamburg that over 100,000 lives could besaved annually if sodium levels in packaged and restaurant foods were halved, and thatdirect medical costs would be cut by $18 billion annually if sodium consumption werereduced from the current recommendation of 3,400 milligrams per day to 2,300 mg perday.
See: FDA Releases its Global Engagement Report
FDA released its Global Engagement Report in which the agency outlines itsinternational programs, inspections, and harmonization efforts in Africa, Asia, Europe,Latin America and the Middle East with regard to safeguarding food and medical productsupplies. In its report, FDA discusses the agency’s plans to collaborate with foreignregulatory counterparts to share laboratory and inspection information. Some of thetopics covered in the report include rapid screening technologies now being tested inChina and India to look for toxic metals, diethylene glycol in drug syrups, sibutramine inweight loss products, and melamine in milk powder. FDA also lays out its agenda to prepare for countries with developing economies to export more products to the US. Theagency plans to build global coalitions of regulators to shore up product safety nets;develop a global data information system; expand intelligence gathering; and allocateresources based on risk while leveraging the resources of other governments, industry,and third parties.
See: Food and Drug Law Institute’s 55th Annual Conference
The Food and Drug Law Institute (FDLI) held its 55th Annual Conference from April 24-25 in Washington, DC. This year’s event featured addresses from FDA CommissionerMargaret Hamburg, Deputy Commissioners Deborah Autor, Stephen Spielberg, and MikeTaylor, representatives from FDA’s six product centers, Chief Counsel ElizabethDickinson, and former Chief Counsels. The Conference covered a range of topicsincluding, regulatory science, global developments and emerging markets, economic, andlegal and regulatory challenges of innovation. FDLI provides access to several articleson topics covered during the panels and breakout sessions. Please see: Dairy Cow Tests Positive for BSE
On April 24, USDA reported the US’s fourth case of Bovine Spongiform Encephalopathy(BSE), commonly referred to as “mad cow” disease. The disease was detected in a dairycow in California. The animal was singled out as part of a routine USDA surveillanceprogram that tests approximately 40,000 cows each year for the disease. Samples fromthe infected animal were tested at USDA’s National Veterinary Services Laboratories inAmes, Iowa. The tests confirmed the animal was positive for atypical BSE, a rare formof the disease not generally associated with an animal consuming infected feed. Shortlyafter revealing the test results, USDA announced that the infected cow was euthanizedand its carcass will be destroyed. During a press release, USDA Chief VeterinaryOfficer, John Clifford, advised reporters that the infected animal was never presented forslaughter for human consumption. He further assured consumers that milk does nottransmit BSE, therefore the animal never presented a risk to the food supply or humanhealth. See: USDA Accepts Applications for Labeling LFTB
USDA has agreed to approve beef industry requests to voluntarily label productscontaining lean finely textured beef (LFTB), commonly referred to as “pink slime”, andsimilar leftover beef trimmings treated with chemicals besides ammonia. It will be up toeach company that seeks labeling approval to determine the wording of their request.
Possible examples could include: “Contains Lean Finely Textured Beef” or “Contains Finely Textured Beef” or “Contains Lean Beef Derived from Beef Trimmings.” TysonFoods and Cargill, Inc. are among the companies that have applied for LFTB labeling.
and hopes that labelswill restore consumer confidence in its product. Moreover, Representative ChelliePingree (D-ME), who previously demanded that USDA ban “pink slime” completelyfrom the school lunch program, introduced a bill that would require LFTB labeling.
Additionally, Representatives Rosa DeLauro (D-CT) and Sam Farr (D-CA) sent a letterto Agriculture Secretary Tom Vilsack urging USDA to require labeling of productscontaining LFTB. See:Pingree’s Bill:tp:// and, DeLauro and Farr Letter: DeLauro Asks USDA to Require Labeling of Mechanically Tenderized Beef
On April 5, Representative Rosa DeLauro sent a letter to Agriculture Secretary TomVilsack encouraging USDA to require labeling of all meat products that have beenmechanically tenderized by needles. In her letter, DeLauro says that labeling productsthat have been mechanically tenderized “is critical in enabling consumers to makeinformed purchase decisions and also in ensuring proper food handling and safety”.
USDA recommends a non-intact or mechanically tenderized cut of meat to be heated atan internal temperature of 160 degrees Fahrenheit to kill pathogens. DeLauro states thatbecause these products are not appropriately labeled as non-intact or mechanicallytenderized, consumers are unaware that the product is not a whole cut of meat and maynot cook them to the appropriate temperature. DeLauro refers to an outbreak of E. coliO157:H7 linked with mechanically tenderized steaks in December 2009 as an example ofthe danger posed by not fully cooking tenderized cuts of beef.
See: C. General
Judge Dismisses Lawsuit against McDonalds
On April 4, a California state judge dismissed a lawsuit against McDonalds that was filedin December 2010, by Monet Parham, a 41-year old mother of two young children, in theCalifornia Superior Court for San Francisco Country, in Sacramento. The Plaintiffargued that McDonald’s was violating state laws against deceptive and unfair marketingpractices by engaging in a “highly sophisticated scheme to use the bait of toys to exploitchildren’s developmental immaturity and subvert parental authority”. The complaintalleges the scheme “is designed to sell and get children to eat nutritionally unbalancedHappy Meals, which in turn promote obesity and other diet-related diseases”. Inresponse to the dismissal, CSPI’s executive director Michael Jacobsen released astatement in which he says “McDonald’s must stop exploiting children at some point,” and predicts that “in time, the practice of using toys to market junk food will seem asinappropriate and anachronistic as lead paint, child labor, and asbestos”. On the otherhand, McDonald’s was pleased with the court’s decision and believes the lawsuit waswithout merit and detracted from the important issue of children’s health and nutrition.
McDonald’s spokesperson Danya Proud says McDonalds vigorously defends its brand,reputation and food. See: Top Ten Foods Most Vulnerable to Economic Adulteration
The April issue of The Journal of Food Science by the Institute of Food Technologistsfeatures a report on the most vulnerable ingredients to food fraud. The authors of thearticle, Jeffrey Moore and Markus Lipp, scientists affiliated with the US PharmacopeialConvention (USP), along with John Spink, a food packaging specialist at Michigan StateUniversity, present data gathered from a new food fraud database created by the USP.
The USP food fraud database, created over a two-year period, is based off publiclyavailable reports of adulteration incidents between 1980 and 2010. The records aredivided by scholarly research (1,054 records) and media reports (251 records). USP’sresearchers identified specific food ingredients and food categories vulnerable toadulteration, analyzed the types of analytical detection methods used to discover thefraud, as well as the type of fraud using three categories: replacement, addition orremoval. In the article, the authors report that 95% of records involved either partial orcomplete replacement of an authentic material with another, less expensive substitute.
Examples cited by USP include the partial substitution of olive oil with hazelnut oil andthe partial replacement of low-quality spices with lead tetraoxide or lead chromate toimitate the color of higher-quality spices. Out of USP’s database of 1,305 records, theauthors presented the top ten foods most vulnerable to economic adulteration as follows:(1) olive oil with 167 reports; (2) milk with 143 reports; (3) honey with 71 reports; (4)saffron with 57 reports; (5) orange juice with 43 reports; (6) coffee with 34 reports; (7)apple juice with 20 reports; (8) grape wine with 16 reports; (9) maple syrup with 16reports; and (10) vanilla extract with 16 reports.
See: Maryland Bans Use of Arsenic-Containing Roxarsone
The Maryland General Assembly voted to ban the use, sale, or distribution of commercialfeed intended for use as poultry feed that contains roxarsone or any other additive thatcontains arsenic. Roxarsone, when used in combination with other animal drugs, helpsbirds fight parasitic disease such as coccidiosis, which infects the intestinal tracts inpoultry and can lead to death. It was also approved for weight gain, improvedpigmentation in chickens and feed efficiency. Roxarsone was pulled from the marketnationwide last year after low levels of inorganic arsenic were found in the livers ofchickens treated with it. Delegate Tom Hucker (D), who first introduced the bill in 2009,says the passing of this bill will allow the state of Maryland to keep up to 30,000 poundsof arsenic out of the environment each year.
Dietary Supplement Industry Issues Guidance for Suppliers
The Standardized Information on Dietary Ingredients (SIDI) Working Group, released adraft guideline, Dietary Supplement Component Supplier Qualification Guideline, whichoffers advice to suppliers on the risk factors associated with the intended use of theirparticular components in dietary supplements. The SIDI Working Group is made up ofrepresentatives from Consumer Healthcare Products Association, Council forResponsible Nutrition and the United Natural Products Alliance. Dietary supplementingredient suppliers and finished product manufacturers assisted the SIDI Working Groupwith creating the guidance. Duffy MacKay, chair of the SIDI Working Group’sExecutive Committee, explains that the guidance is for member companies to use inqualifying their suppliers under FDA’s good manufacturing practices (GMPs). Theguidance includes Pre-Assessment Criteria, which enables suppliers to perform apreliminary risk assessment to be used to determine whether the component or supplier issuitable to move to the next stages of formula development or pilot production. The draftguideline complements two documents, The SIDI Protocol, which offers standardizedinformation on dietary ingredients and SIDI’s Certificate of Analysis (CoA) Guideline,which standardizes the information the ingredient suppliers give finished productmanufacturers. The Working Group is accepting comments on their draft guidance untilJune 18, 2012. See: II. INTERNATIONAL NEWS
A. Europe
UK Food Standards Agency Issues Guidance on Moratorium on Desinewed Meat
As of April 28, British processors will not be allowed to produce ‘desinewed meat’(DSM) from cattle, sheep and goat bones. The European Commission has asked that amoratorium is put in place on the production of (DSM) from ruminant bones. Desinewedmeat is produced using a low pressure technique to remove meat from animal bones. TheFood Standards Agency (FSA) is clear that there is no evidence of any risk to humanhealth from eating meat produced from the low-pressure DSM technique. However, theEuropean Commission has decided that DSM does not comply with European Unionsingle market legislation and has therefore required the UK to impose the saidmoratorium. DSM may still be produced from poultry and pig bones but from the end ofMay it must be classed and specifically labeled as 'Mechanically Separated Meat' (MSM),and can no longer count towards the meat content of a product. The FSA has issuedguidance to help meat processors comply with the moratorium. See:



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Microsoft word - endotoxin limits.doc

USP Endotoxin Limits for Common Injectables Product name Endotoxin Limit Endotoxin Endotoxin Limit 3 (where applicable) (where applicable) total dose in ml at the expiration time) Suspension Amphotericin B for Injection 5 EU/mg for parenterals (1mg of mix of amp & sulb -0.67 and 0.33 mg, respectively) Phosphate Dextrose Solution Anticoagulant Heparin Solution Anticoagulant

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