December 14, 2018
On Nov. 20, 2018, based on an investigation into an outbreak of E. coli O157:H7, the FDA and CDC issued a broad public warning that advised consumers not to consume romaine lettuce. They also asked retailers and restaurants to stop serving and selling all romaine lettuce. The alert included all romaine no matter where or when it was grown/harvested. On November 23, six companies from the leafy green community secretly entered into negotiations with the FDA to develop a voluntary labeling initiative to identify the harvest location and date of romaine to allow for reintroduction of product into the market. On Monday, Nov. 26, the FDA released a public statement from the commissioner with updated information on this outbreak as well as recommendations on this new labeling system. On December 13, FDA identified one farm in Santa Barbara County, California, Adams Bros. Farms, likely linked to the E. coli outbreak and narrowed the list of counties to where the public advisory applies. See below questions and answers that have been created jointly by the Food Marketing Institute (FMI) and the National Grocers Association (NGA) in an attempt to address some of the questions our organizations have been receiving from retail and wholesale members. We anticipate additional questions will arise during this process and this Q&A document will be updated and adjusted with new information as it comes in. Please don’t hesitate to contact either organization with additional questions.
Did the FDA issue an official recall of romaine lettuce? How will that impact my business?
So far, only Adams Bros. Farms has initiated a voluntary recall for product supplied from its farm. See here FDA’s statement on its new findings: FDA UPDATE (12/13/18)
In a previous statement, FDA said:
Currently, the FDA does not have enough traceback information to identify the source of the contamination that would allow us to request a targeted recall from specific suppliers. On November 20, FDA recommended that the most efficient way to ensure that contaminated romaine is off the market would be for industry to voluntarily withdraw product from the market, and to withhold distribution of romaine until public health authorities can ensure the outbreak is over and/or until FDA can identify a specific source of contamination. On November 20, the United Fresh Produce Association and the Leafy Greens Marketing Agreement issued statements committing to withdraw the potentially contaminated romaine from the market.
In the interest of consumer safety, retailers voluntarily complied with the FDA/CDC request that all romaine be withdrawn from the market and that retailers stop selling/serving any romaine products.
Is this outbreak over?
No, according to the CDC, as of this date, the investigation is not over, and the outbreak is listed as “ongoing.”
What growing regions are not linked to the outbreak?
Using illness onset data, traceback information, and harvesting dates and locations, current evidence indicates the romaine responsible for this outbreak was harvested in the Central Coast growing regions of northern and central California. On December 13, FDA narrowed the warning to romaine lettuce from Santa Barbara, Monterey, and San Benito counties. Romaine harvested from locations other than these counties does not appear to be related to the current outbreak. For example, romaine lettuce harvested from areas that include, but are not limited to the desert growing region near Yuma, the California desert growing region near Imperial County and Riverside County, the state of Florida, and Mexico, does not appear to be related to the current outbreak. Additionally, there is no evidence hydroponically- and greenhouse-grown romaine is related to the current outbreak.
What products are covered by this label from the produce supplier?
This recommendation includes any and all products that use any form of romaine lettuce (including baby romaine and red romaine).
Does the labeling program for the produce industry apply to other leafy greens?
At this time, the approach is limited to products containing all forms of romaine lettuce.
What is this new labeling initiative for packages/boxes of romaine lettuce?
The suppliers from other growing areas that are now harvesting or scheduled to harvest romaine lettuce want to reassure customers and consumers that the supply of romaine now entering the market is not linked to the outbreak. The produce industry, working with FDA, has proposed a new voluntary label to expedite the return of Romaine lettuce to the marketplace. The label will indicate the origin (harvest location) and the date of harvest (harvested on/or after date). For bagged product, this information would be printed on the consumer-level package. Romaine lettuce not in a consumer-package or that does not have another means of conveying harvest location/date (such as a twist tie, tag, etc.) will carry a label on the carton or shipping case. Therefore, this label is intended to convey that this romaine was harvested subsequent to the outbreak and is from a region not implicated in the outbreak.
What new information will be on the label?
Based on discussions between FDA and the produce industry, it is suggested that the voluntary label for both consumer-level packages or cases say: Romaine grown in (source/location) and harvested on/or after (date).
Is this a new regulation or requirement from FDA?
No, the use of this label is not a new regulation or requirement. The use of this new label is voluntary.
Do retailers have to use the label?
No, this is a voluntary label initiated by the produce industry and not by any regulatory authority. However, be aware that FDA and CDC are encouraging consumers to look for/ask for this information when purchasing or eating romaine.
If the romaine now coming into the marketplace is not from the region under investigation why are these labels necessary?
According to FDA,, it is vital that consumers and retailers have an easy way to identify romaine lettuce by both harvest date and harvest location. Labeling with this information on each bag of romaine or signage in stores where labels are not an option would easily differentiate for consumers romaine from unaffected growing regions.
NOTE: This is a new recommendation from FDA. Previously, when recalled or withdrawn product is replaced at retail with a new supply of the same product (not linked to an outbreak) no such consumer notification or labeling was requested. Following a recall/withdrawal, retailers only restock with non-implicated products.
If retail/wholesale or distributors verify that romaine has not been sourced from the implicated region (such as checking the case labels) must the store still post a sign?
This is a voluntary produce industry labeling initiative. There is no requirement that retail stores, restaurants or other end users post signs to indicate the romaine harvest location. No action will be taken against a facility that opts not to post signs. However, be aware that FDA and CDC are encouraging consumers to look for/ask for this information when purchasing or eating romaine. Further, the CDC has advised, “If the romaine lettuce is not labeled with a harvest growing region, do not buy, serve, sell, or eat it.” Some consumers may want to see this information or be provided the information upon request.
What information should the in-store point of sale signage contain?
Retailers are asked by the FDA to clearly and prominently label at the point of sale the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores). (FDA Press Release, Nov 26, 2018)
Retailers are asked by the FDA to voluntarily label romaine at the point of sale with the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores). Although FDA did not specify a specific format, font size, location, or material for signs, they did suggest that signage be clearly and prominently displayed.
When will this labeling program start and stop? Will all suppliers be participating?
The labeling program is still recommended until further notice. . Because the program is voluntary, suppliers do not have to participate. However, it appears that many, if not all, suppliers will be using the new labels. FDA Commissioner Dr. Gottlieb has commented that this labeling will be the “new normal” so that if there are outbreaks moving forward, FDA can limit advisories to affected regions, and consumers would be able to readily discern if they had product from a potentially affected area.