Public Meeting on Economically Motivated Adulteration

Meeting announcement below. Link to FDA site is here.

The U.S. Food and Drug Administration is announcing a Public Meeting pertaining to economically motivated adulteration (EMA). The purpose of the meeting is to stimulate and focus a discussion about ways in which the food, (including dietary supplements and animal food), drug, medical device and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration. FDA invites interested individuals, organizations, and other stakeholders, including industry representatives, to present information pertaining to predicting and preventing EMA of food, (including dietary supplements and animal food), drugs, medical devices and cosmetics. The agency also requests interested parties to submit comments on this issue to the public docket.

Meeting attendees are encouraged to register on-line or contact Deborah Harris, EDJ Associates, Inc., 11300 Rockville Pike, Suite 1001, Rockville, MD 20852, 240-221-4326, email: dharris@edjassociates.com; FAX: 301-945-4295.

For general questions about the meeting, to request on-site parking or for special accommodations due to a disability, contact: Juanita Yates, Center for Food Safety and Applied Nutrition, 301-436-1731, e-mail: juanita.yates@fda.hhs.gov.

Federal Register Notice of Meeting

Register Online

Please note the following important dates:

April 16, 2009: Closing date for requests to make an oral presentation
April 23, 2009: Closing date for:
Advance Registration
Provide a brief description of an oral presentation and any written material for the presentation, and
Request special accommodations due to a disability
April 27, 2009: Closing date to request onsite parking

Traceability in the Food Supply Chain and More Melamine...

The Minnesota Department of Agriculture has found melamine in Fortuna brand sugar crackers. How much melamine is unknown at this point. The tainted product was found at Dragon Star market in St. Paul. Customers are urged to throw out any of these crackers that they may have purchased.

If only we could throw out all the regulations that prevent the public from knowing the source of their food. The Fortuna crackers are reported to have been imported to the U.S. by an Indonesian company. But that's probably all we'll know about the crackers. According to a federal report released today, the government conducted tests to determine the effectiveness of the existing tracing system and food supply chain for 40 food items, and determined that most records of what went where and when were woefully light on detail.

The link to the FULL REPORT can be found by clicking here.

Or cut and paste this into your browser.

http://www.oig.hhs.gov/oei/reports/oei-02-06-00210.pdf

"Complete Review" of FDA Ordered

President Obama has ordered a review of the FDA in light of several recent cases of food contamination and safety issues, which included melamine-tainted pet food and infant formula.

FDA Release Comprehensive List of Tested US Infant Formula

The FDA released a complete list of the US manufactured infant formulas they tested for melamine and cyanuric acid contamination.
The full list can be found that this link.
More from the Daily Green here.

Melamine: Cocoa and Wafer Rolls

The FDA has announced a recall of G&J Gourmet Market Cocoa Products due to melamine contamination. Big Lots and Shopko were distributors of the products. The Associated Press is reporting that Topaz Wafer Rolls have been recalled by the manufacturer National Brands due to melamine contamination.

Who's Got The Melamine

Associated Press corrects information that was originally reported yesterday. Article is here. The updated information comes from FDA, who gave misinformation to AP. Nestle and Mead Johnson melamine test results were flip-flopped on FDA spreadsheets, and have since been corrected. See article for correction. Still no word on a recall. Although it seems appropriate. To say that no level of melamine is acceptable in infant formula, only to allow certain levels once it's found makes the FDA look untrustworthy.

Is Melamine Testing Reliable?

It may be difficult for families to get reliable information from the FDA and manufacturers of infant formula. A Reuters follow-up story to yesterday's news provides conflicting information especially about makers of Enfamil.
Melamine Blog agrees with Connecticut Democratic Rep. Rosa DeLauro who says:

"The FDA should work with industry immediately on an action plan that eliminates melamine from the manufacturing process. This must happen in days not weeks," she said.

Small Amounts of Melamine in US Infant Formula

The Associated Press (story By MARTHA MENDOZA and JUSTIN PRITCHARD) is reporting that the FDA has found trace amounts of melamine in infant formula sold in the US. The article states that three firms manufacture more than 90 percent of the infant formula produced in the United States (Abbott Laboratories, Nestle and Mead Johnson) and goes on to say the results of the testing:

- "Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron. An FDA spreadsheet shows two tests were conducted on the Enfamil, with readings of 0.137 and 0.14 parts per million.
- Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid, a melamine byproduct.
- FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.

The article points out a contradiction, raising more concerns for families nationwide:

Sundlof told the AP the positive test results "so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine." That's different from the impression of zero tolerance the agency left on Oct. 3, when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."

Families need to call the manufacturer if they have any questions arising from the use of these products. They can also contact the FDA at 1-888-INFO-FDA (1-888-463-6332). Report any health problems to your health provider and I would suggest contacting the CDC at 800-CDC-INFO (800-232-4636).

Melamine in US Eggs?

I have been very careful to buy organic eggs lately. I am also very interested in speaking with ranches and producers of eggs about their livestock feed.

A few weeks ago, I wrote about the questions I have been asking the CDFA and the FSIS about eggs, melamine and livestock feed. 

Well, I wanted to update that info and try to get more answers. So today I called Norco Ranch, an egg producer in Riverside California. I spoke with a rep about the eggs labeled organic with vegetarian feed. I told him my family had purchased eggs labeled organic, and I wanted to clarify the labels and confirm the claims about cage-free access and animal feed on the carton. He assured me that the livestock that produce those eggs don't eat any animal scraps, only vegetarian feed including corn and soy. When I asked him if there was melamine in the animal feed, he said, "Not for the eggs you purchased". I was actually a little shocked at his reply. So naturally I asked him if there was melamine in the feed for the rest of the hens that produce the rest of the other caged, non-organic eggs, because I know sometimes melamine is used in feed as a binder. He replied that "sure, probably" there was melamine in the feed, that he "hasn't checked" but that there "probably is melamine" in that feed.

I called FSIS (my last post on this topic pointed out that I was directed to call them) and spoke with a rep who said I had to call the FDA. Good times! We both laughed an agreed that the phone would not be answered - it would just keep ringing. The FSIS said, "We're a federal agency and we can't even get through to the FDA." . Ugh. The FDA. In all seriousness, it's not funny. So I called the California Department of Food and Agriculture (last time I emailed them) because I found a link on their website that says they are the agency that oversees livestock feed on the state level in California. I spoke with a rep in Sacramento. She stated that CDFA does random testing for melamine at UC Davis. I asked her if I could get the results of those tests and she put me on hold then came back and referred me to the Head of the Investigation Team. I left him a message. I hope he calls me back.

In light of the recent information about melamine-tainted livestock feed causing melamine-tainted eggs, I think there needs to be more worldwide testing of the eggs we consume. And the results need to be publicized. Contrary to James McWilliams' Op-Ed in the New York Times, everyone doesn't have the choice to buy organic food. Organic food is expensive and people on fixed incomes, such as seniors, and millions of people who can barely afford the rising cost of food, do not simply have the choice to start buying organic to protect their family from poisonous food. Whether you can afford melamine-free food or organic food - or not, everyone deserves the same healthy choices.

Current Good Manufacturing Practices not revised since 1986

I suppose the results will either highlight (among many other things) that melamine is widely used to process food in plants and that is where previously stated traces in our food come from, that melamine is not widely used to process foods and that is not where traces in food come from, melamine is not widely used to process food therefore the traces are coming from somewhere else, or melamine is not widely used to process foods and their are no reportable traces of melamine in food processed in the US. Assuming the survey of food processing practices also includes surveys of food quality and testing for melamine. The following is from the CFSAN website, posted November 12th.

* U.S. Food and Drug Administration *
* Center for Food Safety and Applied Nutrition *
CONSTITUENT UPDATE
Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
Announcing a Pretest of FDA's Food CGMP Survey Instrument
In an effort to provide additional protection against foodborne illness, the Food and Drug Administration (FDA) has begun the process of bringing the Federal rules that govern the safe manufacturing, processing, packing and holding of food in the U.S. up to date with modern science and technology. These rules, known as the food current good manufacturing practices, or food CGMPs, describe the methods, equipment, physical plants, and controls for producing safe processed food. They were last revised in 1986.
FDA intends to conduct a statistical survey of some 2,700 large and small domestic food facilities. These facilities will be asked to respond to the survey instrument and may do so either via the Internet or via mail, as they choose. In the next few days, FDA will begin pretesting of the survey instrument. The purpose of the pretest, which will involve sending the instrument via Internet to 50 to 60 facilities, is to ensure that the survey instrument is clear, unambiguous, elicits the information the agency needs and does not impose an undue burden on industry respondents.
The survey will seek information about five key issues relevant to the food CGMP modernization effort:
Employee training
Sanitation and personal hygiene
Allergen controls
Process controls, and,
Recordkeeping.
The results of this survey will assist the FDA in characterizing current food industry practices. While entirely voluntary, industry participation is critical if FDA is to accurately identify safe, cost-effective industry practices for modernized food CGMPs.
Responses to the pretest, as well as the actual survey, will be kept strictly confidential. All data will be collected, compiled, and kept by the independent consulting firm, Eastern Research Group, Inc. (ERG). Responses will be used only for statistical purposes. The reports ERG will prepare on this study will summarize findings across the sample and will not associate responses with a specific company or individual. ERG will not provide information that identifies companies to anyone outside the ERG study team at any time.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

CFSAN Constituent Update
- Office of Food Defense, Communication and Emergency Response
- CFSAN Web site: http://www.cfsan.fda.gov/

Goooooood Morning, FDA!

Check out the Haphazard Gourmet Girls site for their take on the FDA's sudden revelation.

The "Burden" of Contaminated Food

The New York Times article about the FDA block on Chinese dairy products explains that the manufacturer and their customers will have to test their products and share the results with the FDA in order to clear the product. The article quotes Dr. Steven Solomon, FDA deputy associate commissioner.

“We’re taking this action because it’s the right thing to do for the public health,” said Dr. Steven Solomon, an F.D.A. deputy associate commissioner.
As a result, Chinese products that contain milk or milk powder will be detained until the manufacturer or its customer has the product tested and found to be free of contamination, or they show documentation indicating that the product does not contain milk or milk-derived ingredients.
“The burden shifts to the importer,” Dr. Solomon said.

I don't understand how this is supposed to be reassuring to consumers. Lotte Koala cookies and White Rabbit candies were found on store shelves at a discount weeks after they were found to contain melamine, and we are supposed to feel comfortable knowing that manufacturers and possibly distributors are providing the testing our health depends upon? Manufacturers may already be responsible for adulterating their product - and we are supposed to rely on them for testing? Doesn't the NYT article talk about shrimp producers breading refused shrimp to take advantage of loopholes? I understand that there will be enough food blocked up at the ports to wrap around the earth a few times over. But I don't understand why the FDA isn't doing any testing themselves. Or are they? Although he meant burden of proof, Dr. Solomon's choice of words hit the nail on the head: It's a burden. The FDA sees contaminated food as a burden. Yet it is part of the job that they are supposed to be doing. What about the Import Safety Action Plan? The issue is reliability. Who tests, and who examines the results. Will results be publicized? And is testing done accurately and can consumers rely on it?

Country Of Origin Labeling Needed on Processed Foods

Today's FDA's announcement makes me wonder about the food and feed meeting this criteria that has already entered the U.S. (and other countries) and is part of the channels of trade, i.e., already on store shelves. How are consumers supposed to know what foods contain raw ingredients from China? Does the FDA or another agency have a list of worldwide manufacturers that use Chinese-made raw ingredients? The FDA or other agencies also need to do some testing of food and feed manufactured in the U.S. as well to determine whether melamine is being used as an additive or a binder.

FDA Announces "Countrywide Import Alert"

The FDA announced today that they will be blocking imports of Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. This countrywide alert is welcomed news.

It is also good news that the "additional information" the FDA received about the scope of the melamine contamination will compel them to examine non-dairy items as well. While testing of food and feed that contains dairy from China has been the most recent focus, non-dairy ingredients from China such as wheat products, rice protein and vegetable proteins were found to be contaminated with melamine last year (pet food) and recent reports from Hong Kong indicate that Chinese animal feed (hen, fish) have been found to contain melamine as recently as last week. This indicates that the "scope" of the contamination goes beyond dairy. And beyond China. Hopefully the FDA is aware of this and will consider a wider alert that leads to better food safety and more informed consumers. Below is the update from the FDA website, Melamine section:

Update on FDA’s Investigation
November 13, 2008: As part of its ongoing strategy to address the present problem with melamine contamination of consumer products exported from the People’s Republic of China, FDA has expanded its import controls on Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. Since Oct. 10, 2008, FDA has had an import alert in place for specific products found contaminated with melamine and melamine-related compounds. FDA has collected additional information on the scope of the melamine contamination problem in China, and determined a countrywide import alert is warranted.
This action will help ensure that only Chinese dairy products and food and feed products manufactured in China that contain dairy ingredients are not contaminated with melamine and melamine-related compounds reach U.S. consumers. No adverse health effects have been reported in the United States from contamination with melamine of dairy products or dairy containing products. But melamine is not approved for direct addition to human or animal foods and no manufacturer is allowed to deliberately add it to any food for U.S. consumers.
As part of ongoing activities, FDA will also examine a range of protein-containing products beyond just dairy and dairy-containing products for contamination with melamine and melamine-related compounds. FDA will continue to take appropriate regulatory action if these efforts uncover additional contamination.

FDA’s Warnings/Advisories
The FDA is advising consumers not to consume the following products because of possible melamine contamination:
Fresh and Crispy Jacobina Biscuits New!
Koala’s March Crème filled Cookies
YILI Brand Sour Milk Drink
YILI Brand Pure Milk Drink
Blue Cat Flavored Drinks
White Rabbit Candies
Mr. Brown Mandehling 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 Mandheling Blend instant Coffee (2-in-1)
Mr. Brown Milk Tea (3-in-1)
Infant formula manufactured in China

Drugs, Vitamins and More

Drugs, vitamins and more. Read the New York Times article here. From the article:

Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. “This is a fundamentally broken agency,” Hutt told me earlier this year, “and it needs to be repaired.” (By GARDINER HARRIS
Published: October 31, 2008)

Food Task Force Created by FDA

Article from Medpagetoday.com
FDA Creates Task Force on International Food Contamination
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: October 31, 2008
GAITHERSBURG, Md., Oct. 31 -- Pointing to the hazards of melamine-containing products from China, the FDA said today it is creating an internal science and policy workgroup to keep a critical eye on the international food supply.
Detecting contamination in the increasingly international food supply is "a necessary job of the FDA," said Randall Lutter, Ph.D., the agency's deputy commissioner for policy, at a meeting of the agency's science board.
And after the melamine contaminations from China -- first in pet food last year, and more recently in milk -- it is vital to develop a strategy for identifying and preventing potential illnesses, he said. (See: FDA Finds Melamine in Asian Milk Drinks)
The workgroup will have the assignment of pinpointing companies that appear to be at a high risk for contaminating the food supply with chemicals.
"There is a fundamental need for us to understand better the economic incentives and cultural norms in other countries," said Dr. Lutter. This, he added, means recognizing when spiking the food supply with chemicals is likely when it means enough extra profit for a manufacturer so that it offsets any potential penalties.
During the recent melamine outbreak, FDA officials suspect that melamine may have been added to infant formula to inflate protein levels cheaply.
In some sectors of the food industry in China, manufacturers are paid by the amount of protein in a product. Melamine costs about $1.20 per each protein count per ton, while legitimate protein costs about $6 per protein count per ton.
Melamine, which is used in some pharmaceuticals, dyes, glues and plastics, is normally not harmful to humans, but when it commingles with cyanuric acid, it becomes insoluble and can cause kidney failure.
"The suggestion is that some clever scientist used a high-quality melamine that did not have cyanuric acid," said Dr. Lutter. "It was only later that the melamine was commingled with the cyanuric acid."
But "forecasting economic infiltration is hard," Dr. Lutter said, and food coming across U.S. borders is shipped from countries with disparate regulatory requirements.
The United States virtually eliminated problem of economically motivated contamination of food produced in its own borders, largely through the creation of the FDA, Dr. Lutter said.
"It's an old problem, but fortunately it was successfully remedied during the early part of the 20th Century," he said.
But then came globalization of the food market.
"It's a symbol that the world we lived in changed, and there is a new vulnerability," Dr. Lutter said.
President Bush signed an executive order last year to establish a task force that recently issued an import safety action plan, Dr. Lutter said.
Dr. Lutter declined to comment on the specifics of the workgroup, but said it will consist of FDA employees. It is unclear whether the workgroup will also monitor possible contamination of foreign drugs.

National Toxicology Program Report June 2008

Safemama.com reported in early October that a draft of a research paper created for the National Toxicology Program Board of Scientific Counselors Meeting of June 11-12, 2008 contains information about melamine in our food as well as in our dishware. The report is filled with links to various other research studies about melamine, cyanuric acid, melamine cyanurate (those are the crystals that cause kidney failure), melamine derivatives and melamine related triazines. The report recognizes:

"It should be emphasized that although the FDA/CFSAN Interim Melamine and Analogues Safety/Risk Assessment indicated that the scenario-driven consumption of meat products was “very unlikely to pose a human health risk” (10), the assessment did not take into account the currently known potent synergistic toxicological effect of melamine with cyanuric acid."

And, I bet this makes vegetarians feel good. NOT!

"Another potential source of human exposure is vegetarian food preparation practices involving high levels of gluten. In such a scenario, the level of intake of melamine and its analogues could be similar to or even slightly higher than the levels that elicit toxicity in animal tests."

In the left column of my blog I provide a link to an article by washingtonpost.com pointing out that the wheat gluten may not have been gluten after all, but actually highly contaminated wheat flour.
But here is one of my favorite excerpts from the report:

"Melamine resin, a hard thermosetting polymer made from melamine and formaldehyde, is widely used in the US in the form of kitchenware, including plates, bowls, mugs and utensils. Reports in the literature indicate that some kitchenware based on melamine resin leach
considerable amounts of melamine monomer. A migration of up to 2.5 mg melamine/ 100 cm2 was observed under conditions that simulate an exposure to hot acidic foods (13, 14)."

OK. If CONSIDERABLE levels of leaching, er, "migration" of melamine has been observed in dishware, then why on Earth would any level - any PPM level - be acceptable in our food. The food that we eat. The food that may be acidic. And heated...until it's HOT. Ugh. 

Finally:

"...the possibility that the human food chain may be indirectly or directly
contaminated with these triazines cannot be ignored. This possibility is of particular concern given the fact that in the US an estimated 13% of adults aged 20 or older present physiological evidence of chronic kidney disease (18) and as such may be particularly susceptible to such an exposure."

and

"It is critical for the FDA agencies to develop a good basic science understanding of the nephrotoxic potential of the concurrent human exposure to melamine and cyanuric acid."

FDA. What will they do next?

CPSC and Consumers Losing Out Due To Bailout

The Consumer Product Safety Commission had been trying to get people stationed in China to work for the agency to assist manufacturers in implementing product safety law. However the financial crisis diverted $20 billion in additional funds away from this effort, so manufacturers and regulators in China will have to wait a little longer for this oversight to happen there. In a previous post I wrote about the FDA opening offices in China, which still appears to be going forward.

China is Third Biggest Supplier to U.S.

David Lazarus of the L.A. Times echoing the sentiment that the FDA is probably too lax in their enforcement, oversight and testing of food products that could possibly contain melamine in the U.S.  

Lotte Koala - it's about time

FDA is recalling Lotte Koala cookies. I don't understand what took so long. So these cookies were definitely made in China and imported here, not manufactured here?