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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

FDA, will it or will in not use its mandatory recall authority on Evergreen Produce Sprouts?

Screen shot 2011-07-01 at 7.11.46 AM.pngOn June 27, 2011 the CDC reported a total of 21 persons with the outbreak strain of Salmonella Enteritidis from 5 states: Idaho (3), Montana (7), North Dakota (1), New Jersey (1) and Washington (9). The CDC further said that investigative efforts of local, state, and federal public health and regulatory agencies have linked this outbreak to Evergreen Produce brand alfalfa sprouts and spicy sprouts. The sprouts were distributed to various customers in Idaho, Montana, Washington State, and possibly to retailers in neighboring states.

On the same day the FDA then took the step of issuing the following warning:

• The FDA is warning consumers not to eat alfalfa sprouts or spicy sprouts from plastic bags labeled “Evergreen Produce” or “Evergreen Produce Inc.”

• The sprouts are possibly linked to 20 reported cases, including one hospitalization, of Salmonella Enteritidis in Idaho, Montana, New Jersey, North Dakota and Washington State.

• The elderly, infants and those with impaired immune systems are more likely to have a severe illness from Salmonella infection.

• Consumers, retailers and others who have alfalfa sprouts or spicy sprouts in plastic bags labeled “Evergreen Produce” or “Evergreen Produce Inc.” should discard them in a sealed container so people and animals, including wild animals, cannot eat them.

Although asked by the FDA to recall its sprouts, Evergreen Produce has thus far refused to despite the epidemiologic link to 21 illnesses. In the past (pre-FSMA), the FDA could request a recall, but not mandate one. It has been four days since the CDC’s outbreak announcement and four days since the FDA warning.  However, to date the FDA has been silent on if it will use its mandatory recall authority or not.

I certainly may be wrong, but I think this is the first time post-FSMA that the FDA has asked for a recall and been refused.  It will be interesting to see if the FDA moves forward with its newly acquired recall powers or not.  Either way, SOMEONE should ask the FDA, why or why not recall?  Is there anyone in the real press still out there?

Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov

  • Doc Mudd

    C’mon FDA. Takesage the advice of Davy Crockett: “Make sure you are right, then go ahead!”.

  • Walt

    Yes, once again the public is left to fend for its collective self. Is it that the FDA doesn’t trust the epidemiologic evidence?

  • Bix

    “Interestingly the FDA press release indicates that the sprouts are “possibly linked” but the FSMA states that there has to be “a reasonable probability”. While this may appear a trivial difference to some it could have major legal ramifications, and I would bet that FDA is looking earnestly to take the “possibly” to the “reasonable probability” level; and if they do I would not be surprised to see our first FDA mandatory recall post FSMA.”
    – David Acheson, former Assistant Commissioner for Food Protection, FDA

  • Under pressure, Idaho producer recalls sprouts
    Associated Press
    WASHINGTON (AP) – An Idaho sprout producer has recalled its alfalfa and spicy sprouts because they may be linked to 21 cases of salmonella poisoning.
    Evergreen Produce of Moyie Springs, Idaho, initially refused to recall its sprouts after the Food and Drug Administration said the sprouts may be linked to the illnesses in Idaho, Montana, Washington state, North Dakota and New Jersey.
    But the company relented under agency pressure.
    The FDA warned people on Monday not to eat the sprouts.
    Salmonella is an organism that can cause serious and sometimes fatal infections in people with weakened immune systems.
    Raw sprouts often cause foodborne illness because they’re grown in moist, warm conditions that bacteria enjoy.
    An unrelated European E. coli outbreak believed to be caused by sprouts has killed 49 people and sickened 4,000.