Food Law Prof Blog

Melamine-tainted eggs in China

By now it is certainly not news that melamine is toxic to humans, or that melamine can raise the apparent protein level of a food to which it is added, or that melamine actually was added to milk in China.  But now melamine has been found in some Chinese eggs.  How did it get into the eggs?  (It was in the feed, evidently.)  Here's the Reuters article:

China vows penalties as melamine eggs scare spreads

By Michael Wei and Ian Ransom

BEIJING (Reuters) - Authorities in a northeastern Chinese city on Wednesday vowed severe punishment for those responsible for melamine-tainted eggs turning up in Hong Kong, as the health scare spread to another city in eastern China.

. . .

Chinese eggs have now come under the spotlight, after Hong Kong food safety authorities over the weekend found melamine-tainted eggs produced by Hanwei Group in the northeastern port city of Dalian on local shelves.

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LLM in Ag Law and Food Law Studies

I think this may be an official name change.  The University of Arkansas graduate program sent this announcement:

Now Accepting Applications for LL.M. Program for Fall 2009      
Agricultural Law and Food Law Studies

While issues involving food and agriculture have always been important, recent concerns about our food system have highlighted critical issues of agricultural law. Similarly, environmental issues, biotechnology, international trade, sustainability, and other compelling new challenges face our food system. The Graduate Program in Agricultural Law at the University of Arkansas School of Law offers the nation's only advanced LL.M. degree in agricultural law.

We take pride in offering a curriculum covering the full spectrum of law and policy from the perspective of the farmer, the processor, the retailer, and the consumer.  And, our new course offerings address the most current aspects of food law, labeling law, and food policy, including issues of local and sustainable food sources.

Our nine month course of study attracts attorneys from throughout the United States and from abroad. While many of our students are recent law school graduates, others enter the program as experienced practitioners. Our alumni are among the leaders in the agricultural law and food law communities.

The University of Arkansas School of Law is located in Fayetteville, Arkansas, a fast-growing college-town in the scenic Ozark Mountains of Northwest Arkansas described in the new York Times as "flush with youth, culture, and natural beauty."  Julie Besonen, 36 Hours, N.Y. Times, Apr. 21, 2006.

We began accepting applications for Fall 2009 on October 1, 2008.  We will be able to offer merit-based graduate assistantships to a limited number of those admitted to the class as LL.M. candidates. These assistantships provide a tuition waiver plus a small stipend.

Interested students are encouraged to apply to the Program as soon as possible. Visit our website (available at http://law.uark.edu/llm/), e-mail us for information at llm@uark.edu or call 479-575-3706.

Additional information about our Program is posted on our aglawllm blog.  And, for a lively discussion of agricultural law and food law, visit the agricultural law blog, part of the Jurisdynamic Network developed by Dean Jim Chen.

Food Companies Creating their own Nutritional Standards

Coming soon:  A new nutrition icon on the front of some food packages.  The "Smart Choices" icon is the outcome of a Keystone Center project, the Food and Nutrition Roundtable, which is "made up of consumer and health advocates, food producers and distributors, nutrition and public health experts and observers from relevant federal agencies."

From the New York Times:

Some Big Food Companies Adopt Nutrient Standards , by Andrew Martin

In an effort to reduce confusion in the grocery aisle and help consumers buy healthier foods, some of the nation’s largest food and beverage companies have agreed to accept common nutritional standards and to use the same logo on their packages to denote the products that qualify. . . .

The products that qualify must "meet science-based nutrition criteria including:

• Nutrients to limit: total fat, saturated fat, trans fat, cholesterol, added sugars and sodium;
• Nutrients to encourage: calcium, potassium, fiber, magnesium, vitamin A, vitamin C, vitamin E; and,
• Food groups to encourage: fruits and vegetables, whole grains, low-fat or fat free dairy

The criteria are based on the 2005 Dietary Guidelines for Americans and other sources.

The Food Stamp Program And Older Americans

Information on Food Stamps and Nutrition Assistance for older Americans from the AARP Public Policy Institute:

The Food Stamp Program And Older Americans Fact Sheet, Jean C. Accius, October 2008— This AARP Public Policy Institute Fact Sheet by Jean Accius highlights recent changes in the Food Stamp Program, including expanded program access due to the reauthorization of the 2008 Farm Bill. Data are provided on the characteristics of older participants, participation rates, eligibility, benefits, and special provisions for older households. 

Related resource from the Center on Budget and Policy Priorities, Food Stamp Provisions of the Final 2008 Farm Bill

Nutrition Assistance for Older Americans  / Fact Sheet
October 2008— This AARP Public Policy Institute Fact Sheet by Jean Accius describes the federal programs that provide nutrition assistance to older Americans and the funding sources that support these programs. Information is included on food stamps, congregate and home-delivered meals, and food programs.

Thank you to Mary Ann Archer, Warren E. Burger Library, William Mitchell College of Law, for this information!

USDA: Proposed Rule on Organic Dairy Pasture Requirements

USDA has just published its Proposed Rule on Access to Pasture for organic dairy operations.  The pasture requirements of the National Organic Standards have been a source of controversy for years.  The proposed rules are not confined to the pasture requirement, however, but also "clarify" rules about replacement animals and add bees and aquatic animals to the definition of "livestock." 

The existing National Organic Program regulations are here (7 CFR Part 205).

Commentary on Proposed Rule from Cornucopia Institute -- Cornucopia recommends that the new changes not be combined with the long-awaited pasture access rule:

“We are pleased that the USDA has finally addressed the concerns of the organic dairy community, ” said Mark Kastel, Senior Farm Policy Analyst at The Cornucopia Institute, “but it appears that the department has once again monkeywrenched this process by incorporating a number of red herrings – major policy proposals that have never been reviewed by the industry, or, as Congress mandated, by the National Organic Standards Board (NOSB).”

It is feared that these added proposals have the potential to crash the other needed changes addressed by this rule and indefinitely delay enforcement.

Proposed Rule on Access to Pasture, Federal Register, 10-24-2008

The replacement animal rules.  Under the general rule, sec. 205.236(a)(2), organic "milk or milk products must be from animals that have been under continuous organic management" for at least one year.

So, as I understand it, this means that a dairy could manage some of its conventional cows organically for one year and then sell the milk as organic.  Moreover, the dairy could buy additional cows that have been raised conventionally and manage them organically for one year and then sell the milk as organic.

There are three exceptions to this rule:

(i) When a whole farm transitions to organic production (a 3-year process) its cows can eat crops and forage from that farm during the third transitional year,

(ii) if a whole herd is converted, the feed for the first nine months of the year prior to milk production only has to be 80% organic, and

(iii) once a whole herd has been converted to organic production, replacement animals have to be raised organically from the third trimester of gestation.

The proposed rule will specifically make exception (iii) only apply to whole herds that were certified under exception (i) or (ii). It will read as follows:

‘‘Once an operation has been certified for organic production using the exception in paragraph (a)(2)(i) or (ii) of this section, all dairy animals brought onto the operation shall be under organic management from the last third of gestation.’’

Dairies that raise some or all of their cows on all organic feed and pasture for one year can continue to add conventional cows to organic production by managing them organically for one year.  Thus there are two "tracks" -- one year of organic management cow by cow, or whole herds converted under the transitional farm or 80% rules.  Dairies whose whole herds were converted under these rules can only add organic-from-the-womb cows, while other dairies can continually add conventionally raised cows.

If I got this wrong, someone please let me know!  I found the rule change (or "clarification") difficult to understand from the Federal Register alone.  -- DMB

Two Open CRS Reports on Food Imports (from China)

Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview
September 22, 2008

China is a major source of U.S. imports of consumer products (such as toys) and an increasingly important supplier of various food products. Reports of unsafe seafood, pet food, toys, tires, and other products imported from China over the past year or so have raised concern in the United States over the health, safety, and quality of imported Chinese products. This report provides an overview of this issue and implications for U.S.-China trade relations and will be updated as events warrant.

Food and Agricultural Imports from China
September 26, 2008

China is now the third largest source of U.S. agricultural and seafood imports. A series of incidents have raised public concerns about the safety of these products. In September 2008, U.S. authorities said they broadened their testing of milk-derived products from China, following reports that melamine-contaminated baby formula has sickened tens of thousands of Chinese children. They also announced a recall of some coffee products that may contain melamine. Early in 2007, evidence emerged that adulterated pet food ingredients from China had caused the deaths of a large number of dogs and cats. In late June 2007, the U.S. Food and Drug Administration (FDA) announced that it was detaining all imports of farm-raised seafood from China until shippers could confirm they are free of unapproved drug residues. U.S. imports of Chinese agricultural and seafood products increased roughly fourfold, from 433,000 metric tons (MT) and $1 billion in 1997 to 2.1 million MT and $4.9 billion in 2007. However, the United States exported a much larger volume of these products to China in 2007: 14.7 million MT, valued at $8.8 billion. Two federal agencies -- FDA and the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) -- are primarily responsible for the government's food regulatory system, although a number of other federal, state, and local agencies also have important roles. For imports, FSIS (which regulates the safety of most meat and poultry) relies on a very different regulatory system than FDA (which regulates the safety of all other foods). Although all imported food products must meet the same safety standards as domestically produced foods, international trade rules permit a foreign country to apply its own, differing, regulatory authorities and institutional systems in meeting such standards, under an internationally recognized concept known as "equivalence." China officials assert that they have been moving aggressively to improve their food safety system and to close unsafe plants. China in late 2007 concluded a memorandum of agreement with the United States aimed at improving the safety of traded food and feed products. Nonetheless, some Members of Congress continue to express sharp criticism of both China's food safety record and U.S. efforts to insure import safety. In the 110th Congress, committees on both sides of Capitol Hill held hearings on food safety concerns generally and on the China situation. Numerous bills were introduced focusing on imported food safety or containing such provisions, which would apply equally to Chinese imports. These bills include H.R. 2997, S. 1776, H.R. 1148/S. 654, H.R. 2108/S. 1274, H.R. 3100, H.R. 3610, H.R. 3624, H.R. 3937, H.R. 3967, and S. 2418. A provision in the FDA Amendments Act of 2007 (P.L. 110-85), passed in September 2007, requires an annual report to Congress with detailed data on FDA-regulated food imports. Also in 2007, Congress cleared a consolidated appropriation act for FY2008 which includes a provision blocking an FSIS rule to allow certain poultry products to be imported from China.

Genetically engineered animals

In September, FDA released draft guidance on GE animals (blogged here). JAVMA, the Journal of the American Veterinary Medicine Association, has posted an article describing the draft guidance, and it has PICTURES of genetically engineered animals!!

Click to go to Genetically Engineered Animals in the Food Supply on the JAVMA website.

Caffeine in . . . Soap?!

Interesting article on Time.com about the proliferation of caffeinated products, including some personal hygiene products (Bath Buzz anyone?)

. . . But recently companies began unleashing a barrage of unfamiliar products packed with extreme amounts of caffeine. The trend started with super-caffeinated energy drinks in the '90s, but more recently scientists and marketers have created caffeinated foods and even personal-hygiene products. . . .

Read more: Hey! Who Put Caffeine in my Soap? by John Cloud

Ethical Brands -- Turn on, Tune in, Sell out

The American Enterprise Institute has posted a short article by Jon Entine, Ethical Brands--Turn On, Tune In, Sell Out.  Here's the blurb:

During the past decade, multinationals have been gobbling up small, ethical brands. Are ethical firms and their founders turning their backs on “capitalism with a conscience”—the very principles they claim motivated them to start their businesses in the first place—by selling out to larger corporations? The challenge for ethical brands that choose to scale up and sell out, risking the alienation of the customers who carried them to success, is to preserve their reputations as socially responsible businesses.

Read the article

Michael Pollan's letter to the next President -- Food Policy is a National Security Issue

Michael Pollan (author of Omnivore's Dilemma) published an Open Letter to the next President in the NY Times Magazine last week.

". . .with a suddenness that has taken us all by surprise, the era of cheap and abundant food appears to be drawing to a close. What this means is that you, like so many other leaders through history, will find yourself confronting the fact — so easy to overlook these past few years — that the health of a nation’s food system is a critical issue of national security. Food is about to demand your attention."

Read more on the NYT website

CSPI -- GAO Food Labeling findings "disturbing"

The Government Accountability Office (GAO) report on Food Labeling (blogged here) is summarized in a Center for Science in the Public Interest (CSPI) news release.  CSPI calls the results "disturbing:"

“Americans rely on food labels for accurate nutrition information to improve their diets and reduce their risk of heart disease, cancer, and diabetes,” said CSPI legal affairs director Bruce Silverglade. “These disturbing findings basically show that the FDA is looking the other way while consumers are being misled.”

“It’s astounding that FDA lacks reliable mechanisms to ensure that the Nutrition Facts label is accurate and that health-related claims are trustworthy,” said CSPI senior staff attorney Ilene Ringel Heller. “FDA needs to reorganize its labeling division and be given a new mandate from Congress to modernize food labels. Millions of Americans are counting on label information to protect their health.”

CSPI news release

Who owns Hummus?

From National Public Radio: Lebanon (by way of Lebanese businessmen) wants to sue Israel for exclusive rights to name products with labels like "hummus" and "falafel" and others.  They claim this is what France has done with "champagne" and Greece with "feta".

Listen to the report here: http://www.theworld.org/?q=node/21630&answer=true

William Mitchell College of Law student Peter Hemberger (who sent me this story) comments:

Trademarking a cultural item that has mingled with several cultures for centuries?  Who has priority: the first to register or the one that can prove they have been using the mark the longest? 

What sort of international law would make this sort of exclusive use possible?

Food for thought I guess.

I note that the Hebrew word for garbanzo bean is "humus" so the name of the spread is really just "garbanzo beans."  DMB 

GAO Report on Food Safety: Improvements Needed in FDA Oversight of Fresh Produce

The full text of the Government Accountability Office (GAO) report to Congressional Requesters is available as a PDF file on the GAO website.  Here's their blurb:

Why GAO Did This Study

In recent years, both domestic and imported produce have been linked to reported outbreaks of foodborne illness. Contamination in produce is of particular concern because produce is often consumed raw. The Food and Drug Administration (FDA) has primary responsibility for ensuring the safety of both domestic and imported fresh produce. GAO was asked to examine (1) the resources FDA has spent on fresh produce safety and how it has allocated those resources, (2) the effectiveness of FDA’s actions to oversee fresh produce safety, and (3) the extent to which FDA’s planned actions to enhance fresh produce oversight address identified challenges. For this review, GAO analyzed FDA spending data and estimates and FDA activities data, reviewed FDA plans, and interviewed FDA officials and others.

What GAO Recommends

GAO recommends, among other things, that the Commissioner of FDA update its guidance on good agricultural practices and its regulations on current good manufacturing practice for food, and seek explicit authority from the Congress to adopt preventive controls for high-risk foods and authority for enhanced access to records.

FDA agreed with most of GAO’s recommendations but believed that it had sought authority from the Congress. FDA should continue to take steps to obtain these authorities so that it can conduct its oversight responsibilities.

USDA's new regulations on genetically engineered crops

The Union of Concerned Scientists and the Center for Food Safety have both criticized proposed U.S. Department of Agriculture (USDA) rules governing genetically engineered crops, including food crops engineered to produce pharmaceutical and industrial products.

"The proposed rules, UCS charged, would not protect the U.S. food supply from potential contamination by drugs from "pharma" crops, and could allow drugs that it deems "safe" to enter the food supply. This contamination could occur through cross-pollination or seed mixing between pharma food crops and crops intended for consumption. " (UCS--link to press release)

The Center for Food Safety press release explains that:

". . .the proposed rules remove established criteria vital in determining the very scope of regulation. Previously, regulation of GE crops was based on the presence of genetic elements from a list of "plant pests" codified under Section 340.2. This fairly comprehensive list covered almost all of the genetic elements companies used to engineer crops. However, under the new policy, the USDA proposes "deleting the list of organisms which are or contain plant pests," effectively removing triggers to regulation and leaving the decision to the discretion of the USDA or even biotech companies themselves.

CFS continues:

"Whether a GE crop falls within the scope of regulation or not will now be much more open to interpretation," continued Freese. "We can expect the range of GE organisms subject to oversight to decrease over time, allowing for future food safety regulatory failures."

The USDA also failed to address the epidemic of herbicide-resistant weeds associated with ubiquitous herbicide-tolerant GE crops. Resistant weeds have led to increased use of chemical weed killers, rising production costs for growers, and in some cases accelerated soil erosion caused by the additional mechanical tillage required to remove resistant weeds.

Another overlooked key area is the use of food crops for biopharming. The USDA proposal will continue to allow the controversial practice of growing food crops engineered as "biofactories" for pharmaceuticals and industrial compounds. Over the last several years, these crops have come dangerously close to being comingled with those destined for the human food supply, raising the possibility of untested pharmaceutical proteins ending up in our food.

The Center also believes that the USDA has failed to properly address the issue of conventional and organic crop contamination by GE varieties. This contamination often occurs through cross-pollination or seed dispersal, and has cost farmers hundreds of millions of dollars in lost sales and lowered profits. The new policy incorporates the USDA's Low Level Presence Policy, which states that "low level contamination" is no longer actionable. Given this, the USDA can choose to allow contamination of conventional or organic crops by untested GE experimental crops to occur without the need to stop interstate shipments of the contaminated crops.

"The USDA is treading dangerous new ground here," added Freese. "While they appear at first glance to be tightening regulation of an industry that desperately needs better oversight, the structure of the new proposal actually opens loopholes that can be exploited by biotech companies and expose consumers to more untested and unlabeled genetically engineered foods."

Made in USA foods could be contaminated

From The Epoch Times:

Food labeled as made in the U.S.A. could contain tainted ingredients from China. Amid recent concerns over the safety of food products from China, the Food and Drug Administration (FDA) says it has stepped up efforts to increase screening imports. The screening applies only to food products, and not to raw ingredientsץ

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FDA Detects Melamine Contamination in Flavored Drink

FDA News Release

The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products.  As a result of the FDA’s on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks.  The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings.  The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.

Other Recalls

On September 26, the FDA issued an alert to consumers that seven Mr. Brown instant coffee and milk tea products were being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are:

• Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
• Mr. Brown Arabica Instant Coffee (3-in-1)
• Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
• Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
• Mr. Brown French Vanilla Instant Coffee (3-in-1)
• Mr. Brown Mandhling Blend instant Coffee (2-in-1)
• Mr. Brown Milk Tea (3-in-1)

The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.

Sunny Maid Corp. Monterey Park, Calif., who is an importer and distributor of Mr. Brown Instant Coffee products, is recalling the products in the United States.

The FDA is working with regulatory agencies in the United States as well as with other countries. The California Department of Public Health and the New Zealand Food Safety Authority reported that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA continues to recommend that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.

A recall by QFCO Inc., Burlingame, Calif., of the White Rabbit Creamy Candies, is underway in the United States.

The FDA is closely monitoring these recalls and will continue to perform follow up activities of other recalls that may develop.

To date, the FDA is not aware of any illnesses in the United States stemming from consumption of Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or the Mr. Brown instant coffee and milk tea products.

Individuals who have experienced any health problems after consuming Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.

Background

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States.  That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China. 

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York.  To date, investigators have visited more than 1,800 retail markets and have not found Chinese infant formula present on shelves in these markets.

The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources. 

The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply.  In conjunction with state and local officials, the FDA will continue to visit Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.  In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources.  Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.

In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, Centers for Disease Control and Prevention, other federal agencies, and foreign governments.

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Interim Safety and Risk Assessment of Melamine and Its Analogues in Foods for Humans

Questions and Answers

Melamine Methodology:

• Determination of Melamine and Cyanuric Acid Residues in Infant Formula using LC-MS/MS
• Interim Method for Determination of Melamine and Cyanuric Acid Residues in Foods using LC-MS/MS

Additional Information

FDA Updates Health Information Advisory on Melamine Contamination (Sept. 26, 2008)
FDA Updates Health Information Advisory on Melamine Contamination (Sept. 23, 2008)
FDA Updates Health Information Advisory on Melamine Contamination (Sept. 20, 2008)
FDA Issues Health Information Advisory on Infant Formula (Sept. 12, 2008)

Mr. Brown 3-In-1 & and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (Oct. 1, 2008)
QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (Sept. 26, 2008)

FDA: Interim Safety and Risk Assessment of Melamine in Food

FDA News Release:

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.

The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China,  was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.  The FDA reviewed scientific literature on melamine toxicity.

Infant Formula

FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.  In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:

1. the consequences of the continuous use of infant formulas as the sole source of nutrition;
2. the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and
3. for premature infants with immature kidney function, the possibility that they may be  fed these formulas as the sole source of nutrition and thus on  a body weight basis experience greater levels of intake for a longer time than is experienced by term infants.

There is too much uncertainty to set a level in infant formula and rule out any public health concern.  However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.

Other Food Products

In food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk. 

FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.