The FDA Is Charged
With Protecting Consumers From Unsafe Foods
One of the FDAs key missions is to promote and protect
public health by ensuring that foods reaching the market are safe, wholesome, and properly
labeled. To that end, Congress empowered the FDA to enforce the Federal Food, Drug, and
Cosmetic Act (FFDCA), which prohibits the interstate shipment of unsafe
("adulterated") foods.(53) In addition,
the FDA is authorized under the Public Health Service Act (PHSA) to adopt regulations to
prevent the spread of communicable diseases, including foodborne illnesses.(54)
Under the FFDCA, a food is "adulterated" when it
contains an added "poisonous or deleterious" substance that may make the food
harmful to health.(55) There is no doubt that Vibrio
vulnificus-contaminated raw molluscan shellfish can harm consumers. Moreover, courts
have concluded that a substance is "added" to a food when some demonstrable
human intervention is involved.(56) Although Vibrio
vulnificus is a naturally occurring bacterium, its levels increase dramatically after
the shellfish are harvested during warmer months, due to conditions on the vessel and
In fact, the bacterium can increase 10- to 100-fold in Gulf Coast shellfish from the time
of harvest to retail sale, because of lack of refrigeration or other factors related to
human intervention.(58) Thus, Gulf Coast shellfish
harvested during warmer months pose a threat of adulteration that is significant enough
that the FDA should establish regulations to ensure that Vibrio vulnificus-contaminated
shellfish are not sold for raw consumption.
|The FDA also can use its PHSA mandate to promulgate regulations requiring the
shellfish industry to ensure that its products are free from Vibrio vulnificus.
In 1987, for example, the FDA used the PHSA to require food producers to pasteurize milk
and milk products before selling them to consumers.(59)
More recently, in response to food-poisoning outbreaks linked to unpasteurized juices,
such as a 1996 outbreak that sickened 66 people and killed one, the FDA published a
regulation to require juice makers to use pasteurization or similar processes to
significantly reduce pathogen levels in their products.(60)
|Other pathogens can contaminate raw shellfish. In
1997, Vibrio parahaemolyticus-tainted oysters caused more than 400 illnesses in 13 states.
In 1998, raw oysters transmitted the Norwalk virus to about 300 people in California.
CSPI, Outbreak Alert!
But instead of using the FFDCA or PHSA to protect the
public from Vibrio vulnificus, the FDA in effect delegated its authority for
addressing the problem to the ISSC.