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SalmonellaTests Prompt Cartilage Complex Recall

A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.

AMS Health Sciences is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of Salmonella.

Product from this lot was sold to consumers through the internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same Lot No. have tested negative for Salmonella.

William Marler: Time for a Warning Label on Sprouts

Another sprout-related E. coli outbreak earlier this month has prompted the attorneys of the Seattle law firm, Marler Clark, to call on the Food and Drug Administration (FDA) to require warnings on packaging of all raw sprouts.

“According the FDA’s own 1999 advisory, Recommendations on Sprouted Seeds, sprouts have been increasingly implicated in foodborne outbreaks. The time has come to label sprouts as potentially hazardous,” said William Marler, the firm’s managing partner.

He suggests this labeling mirror the requirements now found on unpasteurized juices:

WARNING: This product may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

Epidemiology and traceback investigations conducted by local, state, and federal officials indicated that contaminated raw clover sprouts produced by Evergreen Fresh Sprouts, LLC of Idaho are the likely source of this outbreak.  In interviews, 12 (86%) of 14 ill persons reported eating raw clover sprouts in the week before becoming ill.

As of June 9, 2014, a total of 17 persons infected with the outbreak strain of Shiga toxin-producing Escherichia coli O121 (STEC O121) have been reported from five states.  The number of ill persons identified in each state is as follows:  Idaho (3), Michigan (1), Montana (2), Utah (1), and Washington (10).  47% of ill persons have been hospitalized. No ill persons have developed hemolytic uremic syndrome (HUS), and no deaths have been reported.

The FDA conducted an inspection of Evergreen Fresh Sprouts’ facility on May 22-23, 2014; May 27-30, 2014; and June 6, 2014. During the inspection, FDA investigators observed a number of unsanitary conditions, including condensate and irrigation water dripping from rusty valves; a rusty and corroded mung bean room watering system; tennis rackets that had scratches, chips, and frayed plastic” used to scoop mung bean sprouts; a pitchfork with corroded metal being used to transfer mung bean sprouts; and a squeegee with visible corroded metal and non-treated wood being used to agitate mung bean sprouts inside a soak vat.

Raw clover sprouts have not been recalled from Evergreen Fresh Sprouts. Because contaminated sprouts may still be available on the market, CDC recommends that consumers do not eat any raw clover sprouts produced by Evergreen Fresh Sprouts.  The Washington State Department of Health and the Idaho Department of Health and Welfare are also advising people not to eat raw clover sprouts produced by Evergreen Fresh Sprouts.

Barfblog does a great job of tracking sprout outbreak through 2012.  Outbreak Database carries on – through 2014.

As far back as September 1998, the FDA issued a warning against sprouts urging:

children, pregnant women and the elderly should not eat alfalfa sprouts until growers find a way to reduce the risk of a potentially deadly bacteria that infects some sprouts, the Food and Drug Administration said this week. The FDA, which is investigating sprout industry practices, said children, the elderly and people with weakened immune systems should avoid eating sprouts. The agency’s statement, issued Monday, repeated similar but little-noticed advice the U.S. Centers for Disease Control gave to doctors and researchers a year ago.

Here is the CDC warning :

Sprouts Not Healthy Food for Everyone

Children, the elderly, and persons whose immune systems are not functioning well should not eat raw sprouts, because current treatments of seeds and sprouts cannot get rid of all bacteria present.

Persons who are at high risk for complications from foodborne illness should probably not eat raw sprouts, according to an article in the current issue of Emerging Infectious Diseases, CDC’s peer-reviewed journal, which tracks new and reemerging infectious diseases worldwide.

Although sprouts are often considered a “health food,” the warm, humid conditions needed for growing sprouts from seeds are also ideal for bacteria to flourish. Salmonella, E. coli, and other bacteria can grow to high levels without affecting the appearance of the sprouts.

Researchers have treated both seeds and sprouts with heat or washed them in solutions of chlorine, alcohol, and other chemicals. Some of these disinfectants reduced the levels of bacteria, but a potential hazard remained, especially for persons with weak immune systems. High temperatures that would kill the bacteria on the seeds would also keep them from sprouting. Until an effective way is found to prevent illness from sprouts, they should be eaten with caution, if at all.

Raw Milk Bill Dies in Louisiana

The Advocate reported that Farmers’ efforts to sell raw milk in Louisiana died Wednesday in a state Senate committee.

Supporters of House Bill 1279 pinned on “I love raw milk” buttons, assembled information packets and gathered 800 signatures on a petition. They pitched their product as a cure for medical concerns, including osteoporosis and lactose intolerance. They lobbied legislators. They even suggested that God is on their side.

“When God brought the Israelites to the land of milk and honey, he didn’t tell them to boil their milk first,” Rocky Branch farmer Matt Napier told the Senate Committee on Health and Welfare.

However, the bill clashed with concerns about the safety of unpasteurized milk.

State Agriculture and Forestry Commissioner Mike Strain predicted people would get sick from drinking raw milk. He said the health risk is 150 times greater than drinking pasteurized milk.

“We are charged, you and I, with public health, protection of public health,” Strain said.

Only one committee member voted in favor of advancing HB1279. Four others voted against it.

In an E. coli Outbreak and Recall, why are Restaurants Protected?

In a large meat recall earlier this year – without known illnesses – Food Safety News reported that a Bush administration decision (continued under the Obama administration) thwarts transparency in where recalled product was ultimately sold and consumed.  According to Food Safety News, it turns out that restaurants that make direct purchases from establishments involved in the recall are excluded from the retail recall list.  Here is the link to the Regulation.

Why do restaurants get a free pass on disclosure?

According to Food Safety News, Dr. Richard Raymond, USDA Under Secretary for Food Safety during President George W. Bush’s second term, was head of FSIS when the agency began releasing retail recall lists. Raymond said that when he sent the regulation permitting FSIS to issue retail lists over to the Office of Management and Budget for its approval, restaurants were dropped.


Looking back over the last several years of recalls, how often were the names of restaurants and others excluded from publication?


USDA Awards $24 Million in Research Grants to Improve Food Safety

The U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) today announced 35 research projects totaling nearly $24 million have been selected for funding to improve food safety by helping control microbial and chemical contamination in various foods.

“Foodborne illness affects approximately one in six Americans each year, making USDA’s investment in food safety science a high priority that will have direct impact on thousands of lives,” said Sonny Ramaswamy, NIFA director. “Our goal is to reduce the number of illnesses and protect the food supply through research, education and Extension efforts focused on all levels of the food chain – from farm to fork.”

NIFA made the awards through its Agriculture and Food Research Initiative’s (AFRI) Food Safety program. The program’s goal is to protect consumers from microbial and chemical contaminants that may occur in the food chain, from production to consumption. This year, AFRI’s Food Safety program focused on developing effective mitigation strategies for antimicrobial resistance, understanding the physical and molecular mechanisms of food contamination, and improving the safety of fresh and fresh-cut fruits and vegetables. In addition, the program addressed critical and emerging food safety hazards to help prevent contamination and outbreaks.

The AFRI Food Safety program comprises four sub-programs. The following projects have been selected for awards in each sub-program:

Addressing Critical and Emerging Food Safety Issues

  • University of Georgia, Athens, Ga., $298,799
  • Iowa State University, Ames, Iowa, $298,686
  • Michigan State University, East Lansing, Mich., $299,999
  • Michigan State University, East Lansing, Mich., $299,999
  • University of Nebraska, Lincoln, Neb., $299,989
  • Ohio State University, Columbus, Ohio, $299,955

Effective Mitigation Strategies for Antimicrobial Resistance

  • University of Arizona, Tucson, Ariz., $29,872
  • Kansas State University, Manhattan, Kan., $800,000
  • Ohio State University, Columbus, Ohio, $799,958

Improving the Safety of Fresh and Fresh-Cut Produce

  • University of Arkansas, Fayetteville, Ark., $414,185
  • Virginia Tech, Blacksburg, Va., $424,955
  • University of Idaho, Moscow, Idaho, $424,930
  • Purdue University, West Lafayette, Ind., $423,204
  • Iowa State University, Ames, Iowa, $424,846
  • Western Kentucky University, Bowling Green, Ky., $209,928
  • University of Maryland, College Park, Md., $424,999
  • Lincoln University, Jefferson City, Mo., $147,110
  • North Dakota State University, Fargo, N.D., $147,603
  • University of Houston, Houston, Texas, $304,163
  • University of Wisconsin, Madison, Wisc., $424,983

Physical and Molecular Mechanisms of Food Contamination

  • University of California, Davis, Calif., $499, 921
  • University of California, Davis, Calif., $499, 946
  • University of Delaware, Newark, Del., $499, 802
  • Georgia Tech, Atlanta, Ga., $500, 000
  • Georgia Tech, Atlanta, Ga., $499, 953
  • University of Georgia, Athens, Ga., $499, 848
  • University of Hawaii, Honolulu, Hawaii, $498, 413
  • Illinois Institute of Technology, Chicago, Ill., $499, 429
  • University of Illinois, Urbana, Ill., $499, 941
  • University of Massachusetts, Amherst, Mass., $495, 950
  • Michigan State University, East Lansing, Mich., $380, 121
  • North Carolina Central University, Durham, N.C., $497, 723
  • Ohio State University, Columbus, Ohio, $499, 568
  • Ohio State University, Columbus, Ohio, $500, 000
  • Oklahoma State University, Stillwater, Okla., $27, 500

AFRI is NIFA’s flagship competitive grants program and was established under the 2008 Farm Bill. The five AFRI challenge areas – food safety, global food security, childhood obesity prevention, sustainable bioenergy and climate adaptation – advance fundamental sciences and deliver science-based knowledge to people, allowing them to make informed practical decisions.

Through federal funding and leadership for research, education and Extension programs, NIFA focuses on investing in science and solving critical issues impacting people’s daily lives and the nation’s future. For more information, visit www.nifa.usda.gov.

Restaurants Pose Twice the Risk of Foodborne Outbreaks as Homes, CSPI Data Show

Raw Milk is Disproportionately Responsible for Milk-Related Outbreaks

Outbreak data show that Americans are twice as likely to get food poisoning from food prepared at a restaurant than food prepared at home, according to the Center for Science in the Public Interest. The nonprofit food safety watchdog group analyzed “solved” outbreaks of foodborne illness over a 10-year period—those outbreaks where both a food and a pathogen were identified by investigators—and found that 1,610 outbreaks in restaurants sickened more than 28,000 people. In contrast, 893 outbreaks linked to private homes caused nearly 13,000 cases of foodborne illnesses. Unfortunately, fewer and fewer outbreaks were solved by public health officials over the 10-year period, leaving a lot of important information undiscovered in the data.

Raw-milk proponents may find another of CSPI’s findings disquieting: Of 104 outbreaks of illness linked to milk, 70 percent were caused by raw milk. In other words, although less than one percent of consumers drink raw milk, they bear 70 percent of the burden of illnesses caused by milk-borne outbreaks.

“Pasteurization of milk is one of the most important public health advances of the last 100 years, sparing countless people from infections and deaths caused by Salmonella, E. coli, and Listeria,” said CSPI senior food safety attorney Sarah Klein. “Consumers should avoid raw milk, and lawmakers should not expand its availability.”

CSPI also documented a trend of decreased reporting of foodborne illness outbreaks. States reported 42 percent fewer outbreaks to the Centers for Disease Control and Prevention in 2011 than they did in 2002. Fewer reported outbreaks, though, doesn’t necessarily mean that fewer Americans are getting sick. The recent recession, influenza pandemics, and post-9/11 bioterrorism investments have all diverted state public health budgets and attention away from identifying outbreaks and figuring out their causes.

“Underreporting of outbreaks has reached epidemic proportions,” said CSPI food safety director Caroline Smith DeWaal. “Yet the details gleaned from outbreak investigations provide essential information so public health officials can shape food safety policy and make science-based recommendations to consumers. Despite the improvements in food safety policy in the past decade, far too many Americans still are getting sick, being hospitalized, or even dying due to contaminated food.”

Fresh produce, seafood, and packaged foods regulated by the Food and Drug Administration were responsible for more than twice as many solved outbreaks as meat and poultry products, which are regulated by the U.S. Department of Agriculture. The FDA Food Safety Modernization Act, signed into law in January 2011, was designed to give the agency the authority it needs to conduct more frequent inspections of food processing facilities, particularly higher-risk ones. But the agency has been slow to finalize a number of complex regulations—and Congress, in turn, has been unwilling to provide sufficient funds for the FDA to bring the reform law into full effect, says CSPI.

CSPI’s Outbreak Alert! database includes 7,461 unique and solved outbreaks of foodborne illness that occurred from 1990 through 2011. The report issued today examined the 3,933 outbreaks that occurred in the most recent 10-year period. Those outbreaks sickened 98,399 people. The CDC estimates that 48 million people are sickened annually, of which 128 thousand are hospitalized and 3,000 die.

Click here to read the CSPI 2014 Outbreak Alert.

NIOSH Takes Exception to FSIS Over Worker Safety

April 7, 2014

The Honorable Alfred V. Almanza
Administrator, Food Safety and Inspection Service
U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, D.C. 20250

Dear Mr. Almanza:

I am writing to express a concern of the National Institute for Occupational Safety and Health (NIOSH) about misinterpretations by the U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), of findings from a NIOSH evaluation of a poultry processing plant.[1]

At the request of USDA/FSIS, NIOSH agreed to evaluate the effects of waivers of line speed restrictions on employee health, with a focus on musculoskeletal disorders and acute traumatic injuries. USDA/FSIS required that establishments that were to be granted waivers for regulatory line speeds under the Salmonella Initiative Program (SIP) cooperate with a NIOSH investigation.[2]

The July 13, 2011 Federal Register Notice announcing the SIP stated in pertinent part:

“FSIS also recognizes that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety. To obtain preliminary data on this matter, FSIS has asked the National Institute for Occupational Safety and Health (NIOSH) to evaluate the effects of increased line speed as part of the SIP waiver program. NIOSH has stated its willingness to evaluate the effects of increased production volume on employee health, with a focus on musculoskeletal disorders and acute traumatic injuries. NIOSH’s activities may ultimately include observation of work processes and practices; collection of company payroll, personnel, and injury and illness records; interviews with plant managers, supervisors, and employees; health surveys of employees; and videotaping and measurement of specific aspects of job tasks. NIOSH will prepare a report based on its findings of short-, intermediate-, and long-term effects from the process modifications. NIOSH will make recommendations as needed. FSIS will use any available data from NIOSH activities to inform its decisions as it moves forward with planned regulatory reform. FSIS will require that establishments granted waivers for regulatory line speeds under SIP cooperate with NIOSH.”

Based on USDA/FSIS’ stated concern about the effect of waivers of line speed restrictions on employee safety, NIOSH agreed to conduct an evaluation through its Health Hazard Evaluation (HHE) Program when it received a request from an establishment in response to the SIP.

The first poultry processing plant to request an evaluation from NIOSH based on the SIP was a poultry processing plant in South Carolina. In its evaluation of the plant before any production line speed changes had occurred, NIOSH investigators found an alarming 42% prevalence of carpal tunnel syndrome (CTS) in exposed workers. The CTS risk, confirmed by a nerve conduction study, was not unexpected considering the repetitive and forceful motions required by exposed workers to process poultry. In addition to noting the alarming prevalence of CTS in exposed workers, NIOSH made 31 health and safety recommendations to prevent CTS, other musculoskeletal disorders, and traumatic injuries in new workers, and to limit further physical damage to those workers who were already affected by CTS.

When NIOSH returned to the plant only a short time after modification of the plant’s production lines, NIOSH observed a continuing high prevalence of musculoskeletal symptoms. Given what NIOSH observed upon its second visit relative to changes made to the production lines, NIOSH would not have expected to find an increase or a decrease in musculoskeletal symptom prevalence.

First, the amount of intervening time (10 months) between the first and second visits was not sufficient to result in a change in health status. Second, as NIOSH discovered during the second visit, the manner in which the plant had modified the production lines resulted in no change in exposure to repetitive and forceful motions for any individual worker. Third, NIOSH also found that most of its 31 recommendations, including NIOSH’s primary recommendation to redesign the jobs to reduce the risk of CTS due to forceful and repetitive motions, and to address the alarming prevalence of CTS found on its first visit, had not been implemented.

NIOSH was quite surprised by the FSIS/USDA Administrator’s blog entry of March 27, 2014.[3]

First, the FSIS Administrator’s blog entry stated that NIOSH “…made several recommendations to improve worker safety at this facility, but slowing the evisceration line speed was not among them.” This statement is misleading. Line speed affects the periodicity of repetitive and forceful movements, which are key causes of musculoskeletal disorders. Many of the NIOSH recommendations address the design of job tasks to minimize these factors.

Second, the Administrator’s blog entry of March 27, 2014 stated that NIOSH found that “…the increase in evisceration line speed was not a significant factor in worker safety.” The truth of the matter is that the HHE Report draws no such conclusion. In fact, NIOSH investigators found during their second visit that the changes made by the plant to production line speed did not result in an increase in production volume for the individual worker or the plant, but actually resulted in a reduction of the number of birds processed from 180 to 175 birds per minute. Therefore, no conclusion can be drawn regarding the effect of line speed changes and health status.

Third, the Administrator’s blog entry of March 27, 2014 generalized the findings from the plant to the poultry industry as a whole even though the NIOSH HHE Report states that “[T]his plant may not be representative of other poultry processing plants.”

In sum, no conclusion can be drawn from this one HHE regarding the effect of line speed changes on worker health.

NIOSH regrets that USDA/FSIS did not provide NIOSH with an opportunity to review and comment on the Administrator’s blog entry prior to its posting. A NIOSH review could have assisted USDA/FSIS in better understanding the findings from the HHE at the South Carolina poultry processing plant.

NIOSH conducts health hazard evaluations with the aim of improving the health and safety of American workers. NIOSH supports USDA/FSIS’ recognition “that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety.”

NIOSH would be pleased to assist USDA/FSIS in accurately characterizing the results of the HHE conducted at a poultry processing plant in South Carolina. Please contact the NIOSH Chief of Staff, Frank Hearl, at 202.245.0625 if NIOSH can be of assistance.

Thank you.


John Howard

Adam Tarr, Chief of Staff, FSIS, USDA
Frank Hearl, Chief of Staff, NIOSH, CDC, HHS
Lucero Ortiz, Chief of Staff, OSHA, DOL

PDF Version: LetterApril72014.pdf 

[1] Musolin K et al. Evaluation of Musculoskeletal Disorders and Traumatic Injuries Among Employees at a Poultry Processing Plant. Available at http://www.cdc.gov/niosh/hhe/reports/pdfs/2012-0125-3204.pdf 

[2] 76 Federal Register 41186 (July 13, 2011) Seehttps://www.federalregister.gov/articles/2011/07/13/2011-17625/salmonella-verification-sampling-program-response-to-comments-on-new-agency-policies-and

[3] See http://blogs.usda.gov/2014/03/26/food-safety-and-worker-safety-can-improve-in-poultry-facilities/#more-50820

FDA Shutters Seattle Smokehouse Due to Listeria

The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.

The order follows the FDA’s analysis of environmental samples collected during its most recent inspection of the company’s facility, which confirmed the presence of Listeria monocytogenes (L. mono) in the facility, including in food processing and storage areas.

Jensen’s Old Fashioned Smokehouse Inc. is subject to a consent decree of permanent injunction, which was entered by the United States District Court for the Western District of Washington in 2001. Under the terms of the consent decree, the company agreed to comply with requirements to control food safety hazards and ensure that its products are not adulterated. 

The findings of the FDA’s most recent inspection establish that food in the company’s facility is adulterated and led the FDA to issue the order to cease operations under the terms of the consent decree.In order to resume operations, Jensen’s must meet several requirements, including thoroughly cleaning and sanitizing the facility and hiring an expert to develop a Sanitation Standard Operation Procedure and an environmental microbial monitoring program for L. mono. Jensen’s must also test representative samples of all vacuum-packaged smoked fishery products on hand at the company for L. mono and provide the results to the FDA.

Jensen’s processes smoked fish products and distributes or sells them in its retail store, online and through other businesses in Washington, Oregon and California.

L. mono can cause a serious illness called listeriosis, which can be fatal, especially in certain high-risk groups. These groups include older adults, people with compromised immune systems and certain chronic medical conditions (such as cancer) and unborn babies and newborns. In pregnant women, listeriosis can cause miscarriage, stillbirth and serious illness or death in newborn babies, though the mother herself rarely becomes seriously ill. To date, no illnesses have been reported to the FDA associated with Jensen’s smoked seafood products.

Why are Chicken Pet Treats Recalled for Salmonella, but Chicken for Human Consumption Not?

On November 4, 2013, Bailey’s Choice recalled its 5 oz. packages of chicken treats because they had the potential to be contaminated with Salmonella.  The potential for contamination was noted after routine testing by the Georgia Department of Agriculture (GDA) revealed the presence of Salmonella in some 5 oz. packages of chicken treats.

Over the last year the CDC reported a total of 481 persons infected with seven outbreak strains of Salmonella Heidelberg in 25 states and Puerto Rico and an earlier total of 134 persons infected with the outbreak strain of Salmonella Heidelberg in 13 states.  Although FSIS issued a Public Health Alert following the second outbreak announcement, no recall was issued despite the chicken products being linked to Foster Farms.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Salmonella outbreaks. The Salmonella lawyers of Marler Clark have represented thousands of victims of Salmonella and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Salmonella lawyers have litigated Salmonella cases stemming from outbreaks traced to a variety of foods, such as cantaloupe, tomatoes, ground turkey, salami, sprouts, cereal, peanut butter, and food served in restaurants.  The law firm has brought Salmonella lawsuits against such companies as Cargill, ConAgra, Peanut Corporation of America, Sheetz, Taco Bell, Subway and Wal-Mart.

Microbial Testing Now Required for Infant Formula

Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael R. Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”

While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75 percent of infants in the United States start out being breastfed. By age three months, two-thirds or 2.7 million U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.

The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination. This microbial testing includes testing representative samples of finished products to prevent the distribution of infant formula products contaminated with the pathogens Cronobacter and Salmonella. The interim final rule also establishes quality factor requirements to support healthy growth.

Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.

The two draft guidance documents published today provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems. For example, these infant formulas might be made for infants who are born extremely premature and have special dietary needs. This type of formula is not the subject of this interim final rule. The draft guidance provides information about the manufacture of such formulas in relation to the requirements for current good manufacturing practices, quality control procedures, the conduct of audits, and records and reports that apply to the infant formulas covered by the interim final rule.

The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.

The FDA is accepting comments from the public on the interim final rule for 45 days at www.regulations.gov (Docket Number FDA-1995-N-0036).