NEWS : Raw Oysters: FDA Declares More at Risk

The U.S. Food and Drug Administration has dramatically expanded its health warnings about the dangers of eating raw oysters for large groups of Americans.

A new booklet being distributed to the public by the FDA graphically details the risks of oyster consumption for individuals who are particularly vulnerable to a naturally occurring bacterium found commonly during warm weather months in oysters from the Gulf of Mexico.

Previously, the FDA issued only advisories--available mostly to the news media and other government agencies--about raw oysters. This is the first time the federal government has made the information widely available to the public in a booklet.

In addition, the list of those considered at risk for infection is much more comprehensive than in previous government advisories and includes the elderly as well as so-called moderate alcohol users--which the FDA defines as those consuming two or more alcoholic drinks a day.

An estimated 20 million Americans consume raw oysters each year, according to the FDA’s, “If You Eat Raw Oysters, You Need to Know . . .”

The danger of infection, illness and death is posed by Vibrio vulnificus, a bacterium commonly found in Gulf of Mexico oysters from April through October. The pathogen has been isolated in oysters from other United States growing regions, but areas such as California, the Pacific Northwest and New England are not mentioned in the publication. (The omission is in part because of findings that infectious doses of V. vulnificus are less likely from cold-water mollusks.)

The FDA is distributing 75,000 copies of the pamphlet to health professionals, medical associations and groups such as the American Diabetes Assn.

V. vulnificus is destroyed by thorough cooking, which would make oysters safe to consume for all groups.

The FDA’s advisory, despite its unprecedented scope, falls short of sufficiently educating consumers about the risks of eating uncooked seafood, says Caroline Smith DeWaal, food safety project director for the Washington-based Center for Science in the Public Interest.

“We have called for them to require warning labels [or signs] on the dangers of consuming any raw molluskan shellfish [oysters, clams, mussels] at the point were people are eating the product,” she said. “This brochure could be wonderfully printed and produced but if it does not convey the information at the time people are eating these foods, then it is not effective.”

Among those at “risk for serious illness or death from Vibrio vulnificus infection,” according to the FDA, include:

* People with liver disease, either as a result of excessive alcohol intake, viral hepatitis or other causes;

* Cancer patients;

* Individuals with immune disorders, including HIV infection;

* Diabetics;

* Those with persistent stomach ailments including previous stomach surgery or low-stomach acid from prolonged antacid use;

* Long-term steroid users, such as for asthma or arthritis;

* The elderly, and those with an iron disorder known as hemochromatosis.

The FDA expanded the list of people who may be at risk to include anyone who consumes two alcohol drinks per day. Regular alcohol consumption “can cause liver disease which may have no symptoms. . . . The risk of death is almost 200 times greater in those with liver disease then those without liver disease,” the FDA states.

The agency cites the National Institutes on Alcohol and Alcoholism in Bethesda, MD., as its source on the link between moderate alcohol consumption and liver disease.

“Chronic use of alcohol over a 10- to 20-year period can cause underlying liver disease that has no outward signs or symptoms,” said Ruth Welch, director of the Seafood Hotline program in the FDA’s Center for Food Safety and Applied Nutrition. Welch said the FDA used the definition of moderate drinking outlined in the U.S. Dietary Guidelines.

Smith DeWaal, of CSPI, said the FDA was correct in cautioning moderate alcohol consumers about V. vulnificus. However, she said others should have been included as at risk for infection.

“The victims of V. vulnificus are not necessarily those with high-risk profiles. Those without any of the risk factors stated by the FDA have no guarantee they won’t get sick from this pathogen,” she said.

Dr. W. Gary Hlady, director of epidemiological investigations for the Florida Department of Health and Rehabilitative Services in Tallahassee said that 21% of the V. vulnificus cases in his state between 1981 and 1994 exhibited no identifiable risk factor.

Florida, which reports more cases of V. vulnificus than any other state, does not maintain data on victims’ alcohol use. Hlady, however, recommends that moderate alcohol consumers check with their physician before habitually eating raw oysters.

In the pamphlet, the FDA emphasizes that contaminated oysters show no visible signs of V. vulnificus.

“The bacteria are not a result of pollution, so, although oysters should always be obtained from reputable sources, eating oysters from ‘clean’ waters or in reputable restaurants with high turnover does not provide protection,” the advisory states.

Typical symptoms of V. vulnificus including sudden chills, fever, nausea and vomiting. Advanced stages can lead to septicemia (blood poisoning). The fatality rate of those with V. vulnificus infection is 40%.

Since 1991, the California Health Services Department has required any retailer or restaurateur selling oysters from the Gulf of Mexico to place a warning alerting high-risk individuals of the dangers of V. vulnificus.

The requirement has caused sales of Gulf coast oysters to plummet in the state, according to Karl D. Turner, executive director of the Louisiana Seafood Promotion and Marketing Board in New Orleans.

Louisiana is the nation’s leading producer of Gulf oysters, with an annual harvest of 11 million pounds of oyster meat.

Turner said it was unfair for the FDA to single out Gulf of Mexico oysters.

“There have been instances of V. vulnificus illness and death on the East Coast from eating clams, and we don’t sell Louisiana clams. There have been cases in Virginia from oysters, as well. We know it exists on the East Coast,” Turner said.

He said he believes that a different Vibrio strain is also present on the West Coast.

“The Gulf oyster industry wants to be responsible and do what is right in terms of educating the public about this issue,” Turner said. “Where we have a problem with the FDA is that the message should be focused on those at risk rather than scaring the whole world.”

Turner said he has seen no scientific evidence showing that moderate drinkers are at risk from raw oysters.

“The people who have become ill and died are those who had cirrhosis of the liver. I don’t think cirrhosis comes from two drinks a day,” he said.

The FDA’s pamphlet also offers cooking and handling instruction for oysters. The agency recommends:

* In restaurants, order only fully cooked oysters.

* Cook live oysters, those still in the shell, in boiling water for three to five minutes or until after the shells pop open. Use small pots to boil or steam oysters. Do not cook too many oysters in the same pot because the ones in the middle may not get fully cooked.

* Discard any oysters that do not open during the cooking process.

* Steam live oysters four to nine minutes in a steamer that is already steaming.

* Shucked oysters should be boiled or simmered for at least three minutes or until the edges curl.

* Fry shucked oysters in oil for at least three minutes at 375 degrees.

* Broil shucked oysters three inches from heat for three minutes.

* Bake shucked oysters (as in Oysters Rockefeller) for 10 minutes at 450 degrees.

To obtain a copy of “If You Eat Raw Oysters, You Need to Know . . . “ call the FDA Seafood Hotline at (800) 332-4010.