FDA issues draft guidance on mandatory recall authority

The US Food and Drug Administration (FDA) has published draft guidance on mandatory food recall authority as part of the Food Safety Modernization Act of 2011 (FSMA).
The guidance gives the government authority to order a responsible party to recall food when FDA determines there is a reasonable probability that the food is adulterated or misbranded, and that the use of the food will cause serious adverse health consequences or death to humans or animals. Dietary supplements also are included under this guidance.
After the FDA decides a product should be recalled, it must give the company the opportunity to recall it voluntarily. If the company chooses not to conduct a voluntary recall, FDA can order it to stop selling the food and hold a hearing. After that, the FDA commissioner can order a recall.
Food is considered adulterated if it has any “poisonous or deleterious substance which may render it injurious to health; consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; or has been prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health.” Dietary supplements are adulterated when an ingredient presents a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling; or is a new ingredient that is not assured of safety; or poses an imminent hazard to public health or safety.”
Since 2011, FDA has used this power twice: a recall of Salmonella-contaminated pet treats in 2013, and the recall of OxyElite Pro Dietary Supplements in 2014.

FDA issues guidance to industry on preparation, submission of food additive petitions

The US Food and Drug Administration issued its guidance to industry for preparation and submission of food additive petitions. The FDA Guidance for Industry document 221 is titled, Recommendations for Preparation and Submission of Animal Food Additive Petitions. 
The document urges early and regular contact with FDA's Center for Veterinary Medicine, including pre-petition consultations and consultations to address issues related to target animal safety studies. It also recommends any Food Additive Petitions include a proposed regulation with information to ensure the additive's safety under all conditions of use.  

FDA to issue new 'Salmonella in Food for Animals' Compliance Policy Guide

On July 16 in its Federal Register, the US Food and Drug Administration will issue a new Compliance Policy Guide for Salmonella in Food for Animals. 
The Compliance Policy Guide "provides guidance to FDA staff on Salmonella-contaminated food for animals."
According to the guide, the final document is the conclusion of a process that begin in August 2010 when the draft (690.800) Salmonella in Animal Feed was issued. 
This guide coincides with another notice issued by FDA of the withdrawal of CPG 690.700, Salmonella Contamination of Dry Dog Food. Additionally, the term "petfood" is now used throughout the guide and is defined as "food for pets and includes treats and chews for pets." Comments may be submitted at any time on the new guide. 

FDA Annual Report criticized for omitting status of regulations

In August, the US Food and Drug Administration submitted its second Annual Report on Food Facilities, Food Imports and FDA Foreign Offices, as required by the Food Safety Modernization Act, which details the progress FDA has made in protecting petfood and food safety.
However, organizations criticize FDA because the Report does not include the status of some regulations the Food Safety Modernization Act required to be publicized, including:
• Hazard Analysis and Risk-Based Preventive Controls (Section 103);
• Current Good Manufacturing Practices and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (Section 103);
• Produce Safety Regulations (Section 105);
• Protection Against Intentional Adulteration of Food (Section 106); and
• Foreign Supplier Verification Program (Section 301).
As a result, two organizations, the Center for Food Safety and the Center for Environmental Health filed a complaint against Margaret Hamburg, commissioner of FDA, and Jeffrey Zients, acting director of office of management and budget, in the US Federal District Court for the Northern District of California, USA. In the complaint, the two organizations alleged that:
• FDA has missed seven deadlines so far in failing to implement FSMA’s major food safety regulations. FDA has submitted several of these unlawfully delayed regulations to the OMB, where they are still awaiting approval. However, FDA has authority to promulgate the regulations without OMB approval, the organizations say.
• In the complaint, entitled, Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., the organizations further allege that “at least nine additional FSMA deadlines will come due in early 2013” and express concern that “[b]ased on FDA’s lack of progress to date, [the Centers] have serious concerns regarding the likelihood that these future deadlines will be met.”
The groups have asked the court for various relief, including a declaration that FDA has violated FSMA by "failing to promulgate regulations by the statutory deadlines and ordering FDA to promulgate all FSMA regulations as soon as reasonably practicable, according to Court-imposed deadlines," according to reports. 

FDA releases guidelines on therapeutic pet food labeling, distribution

The US Food and Drug Administration recently released draft guidelines on how it plans to regulate compliance with federal requirements for the labeling and distribution of therapeutic dog and cat foods.
The guides will serve to enforce the animal drug provisions of the federal Food, Drug and Cosmetic Act, according to FDA.
“Since 1988, the Center for Veterinary Medicine has observed an increase in the number of dog and cat food products making such claims that are sold with, or without, the direction of a licensed veterinarian,” the FDA states in its notice. “Because of this increase, and to help ensure animal safety, CVM is issuing this draft compliance policy guide to set out its current thinking with respect to factors it will consider before determining whether to take regulatory action against dog and cat food products intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.”
In its policy guide, FDA recommends to therapeutic petfood manufacturers:
• The product should be made available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian.
• The product should not be marketed as an alternative to approved new animal drugs.
• The manufacturer must be registered under section 415 of the Food, Drug and Cosmetic Act.
• The product’s labeling must comply with all food labeling requirements.
• The product should not include indications for a disease claim on the label.
• Distribution of labeling and promotional materials with any disease claims should be limited to veterinary professionals.
• Electronic resources that disseminate labeling information and promotional materials should be secured so that they are available only to veterinary professionals.
• The product must contain only ingredients that are generally recognized as safe, approved food additives or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials.
• The labeling of the product should not be false or misleading in other respects.
Comments to FDA can be made through the online federal register until November 9. 

FDA releases Reportable Food Registry Report

The US Food and Drug Administration released its second Reportable Food Registry Report. 
The Reportable Food Registry requires manufacturers, processors, packers and holders (warehousers, distributors, etc.) of Food and Drug Administration-regulated foods/feeds to quickly report any foods, feeds or ingredients that could result in serious adverse health consequences to humans or animals, via the administration's online Safety Reporting Portal.
The report shows the Reportable Food Registry has increased the speed with which the Food and Drug Administration and its state and local partners investigate reports and take appropriate follow-up action, including removing reportable foods from commerce when necessary; improved the administration's understanding of how products are distributed through commodity supply chains, increasing its ability to trace reportable foods upstream and downstream; helped the administration and industry identify key commodity risk points and develop guidance for establishing preventive controls; improved coordination among the administration's headquarters, field staff, and state and local regulators; provided data for the administration to issue import alerts and import bulletins; and supplied information to help the administration target inspections, plan work, and identify and prioritize risks.
The report summarizes the Registry’s second year of operation and finds that it logged 225 primary reports – initial reports about a safety concern with a food or animal feed (including food ingredients); 483 subsequent reports from suppliers or recipients of a food or feed for which a primary report had been submitted; and 174 amended reports to correct or add information to previously submitted reports. Reports were received from both domestic and foreign sources.
The 225 primary reports for the second year involved products in 22 commodity categories. Salmonella accounted for 38.2 percent of hazards, Undeclared Allergens accounted for 33.3 percent and Listeria monocytogenes accounted for 17.8 percent. The 229 primary reports in the first year involved 25 commodity categories with Salmonella accounting for 37.6 percent, Undeclared Allergens for 30.1 percent and Listeria monocytogenes for 14.4 percent.

Petfood industry critic challenges FDA consumer education video

A recently released video from the US Food and Drug Administration aimed at educating consumers about petfood is now being challenged by a petfood industry critic, who posted her own video challenging the US Food and Drug Administration’s claims. 
The six-minute video from the US Food and Drug Administration’s Center for Veterinary Medicine, “FDA and Pet Food,” informs consumers of the information required by law to be included on pet food packaging, such as a pet food ingredients list that uses the “common or usual” name for each ingredient.
“The rules for listing and naming ingredients allow purchasers to know what was used to make the product and to compare ingredients in one brand of food to another,” video narrator and Center for Veterinary Medicine veterinarian, Bill Burkholder, says.

However, petfood industry critic Susan Thixton's five-minute “Response to FDA Pet Food Video” on her website criticizes the Food and Drug Administration video, saying it is “full of misleading statements”about information such as pet food ingredients and their names. Thixton says in her video that “a consumer must become their own private detective to learn the truth about what they’re feeding their pet.”
The Administration’s Center for Veterinary Medicine did not comment on the video. Kurt Gallagher, spokesman for the Pet Food Institute, said Thixton’s video was “rife with inaccuracies and misrepresentations.”
“Petfood is the most highly regulated food product, with the exception of infant formula,” Gallagher said.

Webinar on FDA pet food regulation to be held February 23

On Febrary 23, a 90-minute webinar training event will provide an introduction to the US Food and Drug Administration's rules governing petfood product development; formulation, manufacturing and labeling; and marketing and promotion.
The webinar will by instructed by Karl Nobert, a food and drug regulatory attorney with Squire Sanders law firm in Washington, D.C., USA. Specific topics covered include FDA's regulation of pet food products; various components of a pet food label; the process for introducing a new ingredient or feed additive to the market; differences between the Pre-Market Clearance Process, the Food Additive Petition Process and the process for having an ingredient deemed Generally Recognized As Safe; update on the status of the Proposed GRAS Self-Affirmation Notification Program; a summary of FDA's recent enforcement activity, and recent trends and areas of particular enforcement risks; FDA's regulation of those veterinary products marketed and sold as dietary supplement and nutraceutical in the US; and a brief introduction to the animal drug approval process.
More information on registering for this upcoming webinar is available online. 

FDA may get US$50 million for food safety from US Senate

The US Food and Drug Administration may receive additional funding when the 2012 fiscal year starts October 1, 2011, as the Senate Appropriations Committee considers a bill that sets the organization's spending limit, according to reports. 

The report says the Senate's version of the budget bill would allocate approximately US$350 million more than the appropriations bill passed in the House in June. This would be nearly US$50 million more than FDA's fiscal 2011 budget allowed, due to Senate efforts to increase funding for FDA's implementation of the Food Safety Modernization Act. In contrast, the House bill would cut FDA's fiscal 2012 budget by 11%, or US$285 million, compared with fiscal 2011, including an US$87 million cut to food safety.

Former FDA member challenges FSMA pet food regulations

According to Benjamin England, founder and CEO of FDAImports.com, food importers and foreign manufacturers are in for a surprise starting October 1, when a provision of the Food Safety Modernization Act becomes effective requiring the US Food and Drug Administration collect a fee for costs associated with re-inspection of imported food shipments. England is currently launching a coalition of interested manufacturers and food importers to challenge FDA’s broad interpretation of this FSMA provision.

England says the re-inspection fees will cripple the food industry, leaving no other choice but to pass the costs on to consumers. In its Federal Register notice issued August 1, FDA invited comments about the re-inspection fees, which will be accepted until October 31. England points out that the fees, however, will go into effect 30 days before the comment period has closed. Through his coalition, England is working with pet food manufacturers to officially comment on and rally against these new fees.

England, a former 17-year FDA member, will speak about the Food Safety Modernization Act and the FDA re-inspection fees at the upcoming Virtual Petfood Forum 2011 on October 6. Those interested in attending Virtual Petfood Forum can register online to learn more about the Food Safety Modernization Act and other issues affecting the petfood industry.

FDA launches PETNet petfood incident tracking

The Partnership for Food Protection and the US Food and Drug Administration launched the Pet Event Tracking Network, PETNet, which is a secure, Web-based information exchange system for pet food-related incidents.
PETNet’s voluntary information exchange, surveillance and alert system provides real-time information sharing about emerging petfood-related illnesses and product defects among FDA, and other federal and state agencies. PETNet is currently made up of more than 200 representatives from four federal agencies, all 50 states and Puerto Rico.
The system will be accessible to PETNet members that are federal, state and territorial government officials responsible for the regulation of petfood products and the investigation of disease outbreaks in companion animals. Members can enter “events” into the system after they have identified a trend or a suspicious incident or defect associated with pet food products. Once entered on the standardized form, the information will be immediately available to all other PETNet members, allowing other members to track the emergence of such data and to evaluate the need for action within individual jurisdictions.

FDA unveils global food safety strategy

The US Food and Drug Administration unveiled its "new global strategy" for increasing food safety inspections under the Food Safety and Modernization Act.
FDA's report, "Pathway to Global Product Safety and Quality," outlines four main approaches the agency will take to better monitor foreign food suppliers.
FDA says it will work with foreign counterparts to assemble global coalitions of regulators; develop a global information system and networks that will allow regulators to share real-time data and resources across markets; expand intelligence gathering capabilities, with an increased focus on risk analytics and modernized information technology capabilities; and will allocate its resources based on risk, using third parties from the public and private sectors to audit and verify compliance of international suppliers with US food safety requirements.
"The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face," said Dr. Margaret Hamburg, commissioner of food and drugs. "The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources."

FDA seeks public comment on Food Safety Modernization Act

The US Food and Drug Administration is seeking public comments and recommendations on measures relating to the Food Safety Modernization Act, which requires manufacturers of food and animal feed to implement measures for safe production and mitigation of risks.
The deadline for comment is August 22, and FDA said it expects the proposed rule to be published in fall 2011. The public may submit comments electronically or via mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Maryland, USA, 20852.
"The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety. It's imperative that we get information, data and feedback from industry and other stakeholders," said Michael R. Taylor, deputy FDA commissioner for foods.

FDA to host public meeting on Food Safety Modernization Act April 20

The US Food and Drug Administration will host a public meeting on the recently enacted Food Safety Modernization Act, allowing those interested to discuss implementing preventative controls in petfood facilities.
The meeting, "FDA Food Safety Modernization Act: Focus on Preventative Controls for Factilites," will give FDA the chance to discuss information on preventative controls used by facilities to identify and address hazards associated with specific types of food and specific processes. The public will have an opportunity to provide information and share views for the development of guidance and regulations on preventive controls for food facilities that manufacture, process, pack or hold human food or animal food, including petfood. FDA speakers include: Michael Taylor, deputy commissioner for foods; Murray Lumpkin, deputy commissioner for international programs; and Donald Kraemer and Daniel McChesney, chairs of the implementation team for preventive standards.
FDA's meeting will be held on April 20, from 9:00 a.m. to 5:30 p.m., in the Great Room at White Oaks Campus in Silver Spring, Maryland, USA. The public should register to present remarks during the Open Public Comment session.

FDA announces new strategic plan for fighting antimicrobial resistance

The Food and Drug Administration's Center for Veterinary Medicine has announced a new National Antimicrobial Monitoring System Strategic Plan, "dedicated to the protection of human and animal health through integrated monitoring of antimicrobial resistance among enteric bacteria."
NARMS has four strategic goals: to develop, implement and optimize a shared database; to make sampling more representative and more applicable to trend analysis; to strengthen collaborative research; and to support international activities that promote food safety. The hope is that things like more representative sampling will catch more cases of contaminated petfood products before they hit store shelves. In addition, more oversight could check the conditions of food animals, preventing the overmedication that can lead to antimicrobial resistance.
The revised plan incorporates several recommendations made beginning with the initial program review in March 2007.

Improved reporting makes petfood recalls more common, Reportable Food Registry better detect contamination

Petfood recalls are becoming more common partially due to improved reporting methods, according to a spokeswoman for the US Food and Drug Administration (FDA).
“Because of the Reportable Food Registry, the violations or problems are being reported to us, whereas before it was up to an inspection to find it," said Shannon Cameron, FDA spokeswoman. "Also, the agency has hired more personnel to follow up on complaints.”
FDA created the Reportable Food Registry in September 2009. The system mandates that manufacturers, packers and distributors of human food and animal feed report contamination or safety issues within 24 hours of detection. In addition, VIN News Service established an online recall center in response to complaints from veterinarians about the large number of recalls, which shows up-to-date lists of recalled feeds and veterinary drugs.

AFIA comments on implementation of Sanitary Food Transportation Act

The American Feed Industry Association (AFIA) submitted comments to the Food and Drug Administration (FDA) regarding the implementation of the Sanitary Food Transportation Act.
In its comments, AFIA highlighted the Safe Feed/Safe Food (SF/SF) Certification Program’s requirement that certified facilities have signed agreements with suppliers detailing the clean-out and inspection procedures for the transportation of feed and feed ingredients.
“AFIA expressed concern on the ability of feed and ingredient manufacturers to get information on previously hauled loads, especially by independent truckers and rail carriers,” said Keith Epperson, AFIA’s vice president of manufacturing and training. “Many companies own and maintain their own vehicles for transportation of products. This gives the company complete control over the vehicle with regard to feed safety.”
AFIA suggested to FDA that transporters should be required to maintain at least the previous supplier's records and items hauled in the containers, and make this information available to subsequent purchasers of products shipped in the same containers.

US FDA commissioner says China is improving food, drug safety

The US Food and Drug Administration (FDA) said China is improving oversight of its exporters after a number of a complaints about substandard or tainted food and drugs, including petfood ingredients.
FDA Commissioner Margaret Hamburg said she spoke with Chinese officials on a recent visit who were pursuing a "common agenda" to improve manufacturing practices and regulation of complex supply chains for the food and drug industries.
"I leave feeling very encouraged by the partnership we've developed here," Hamburg said. "This is a priority for China as it is for the United States."
FDA set up offices in three Chinese cities and is cooperating with officials on training, joint inspections and improving accountability. Currently, less than 1% of the expected 20 million FDA-regulated products imported this year are inspected.

AFIA calls for FDA revision of Reportable Food Registry

The American Feed Industry Association (AFIA) called on the Food and Drug Administration (FDA) to revise its Draft Guidance for Industry on its Reportable Food Registry to ensure the registry legally recognizes standard commercial feed industry practices for ensuring the safety of its ingredients. Further, AFIA said FDA must establish regulations for when actions taken to ensure human food safety should be applied to animal feeds.
Under current requirements of FDA Amendments Act of 2007, the Reportable Food Registry requires the reporting of any food, feed, ingredient or petfood deemed reasonably likely to cause serious adverse health effects or death in humans or animals. AFIA asked FDA to revise its draft guidance to include the following: “No reportable food report is required if a load of incoming product has been sampled, but legal transfer has not occurred, provided the trailer is on the premises of your facility only for as long as is necessary to sample, test and reject the shipment, and no longer. Your facility has not ‘held’ the reportable food. Therefore, you are not a ‘responsible party’ with regard to such food.”
AFIA Vice President Richard Sellers also asked for clarification of FDA’s definition of “reportable food.” The phrase, “…will cause serious adverse health consequences to humans or animals” in the current definition and FDA attempts to explain it, “leave many questions unanswered and may be subject to misinterpretation,” said Sellers.

FDA in need of change, government report says

The US Food and Drug Administration (FDA) is in need of an overhaul and cannot properly protect Americans from foodborne illness, according to a report by the Institute of Medicine (IOM).
Findings from the report show that FDA must switch its approach from being reactive to risk-based in order to identify and prevent foodborne illness. The report recommends giving FDA the authority to issue mandatory recalls of food products, improving the food safety inspection system and forming a single food safety agency.
The FDA currently oversees about 80% of the US food supply and sponsored the IOM report, which was requested by the US Congress.