FDA issues first injunction under Produce Safety Rule

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For the first time, FDA entered into a consent decree against a firm or grower for violations of the Produce Safety Rule.

For the first time, the U.S. Food and Drug Administration (FDA) has entered into consent decree of permanent injunction against a firm or grower for violation of the Produce Safety Rule, stepping up its enforcement actions in this area 1. Fortune Food Product, Inc., a farm mixed-type facility that processes sprouts and soybean products, reportedly has agreed to cease production until it takes remedial action and comes into compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA). The U.S. District Court for the Northern District of Illinois entered the consent decree of permanent injunction on September 15, 2020. According to FDA, the enforcement action followed several inspections by FDA, which found the company failed to comply with the Produce Safety Rule and Current Good Manufacturing Practices (cGMPs).

The complaint filed against the company alleges FDA’s inspections documented insanitary conditions showing the sprouts and soy products may have been contaminated with filth or may have been rendered injurious to public health, although FDA said it is not aware of any confirmed illnesses related to the company’s products. FDA previously had issued a Warning Letter to the company in July 2018 2, and the complaint filed against the company states that tests in 2018 and 2019 revealed the presence of Listeria spp. inside the facility and E. coli in water used to irrigate sprouts 3. The complaint also states the company did not provide a written response to the Warning Letter issued in 2018 or to the 483 issued to the company following the agency’s inspection in 2019.

While the Produce Safety Rule includes requirements specific to sprouts, it is notable that the violations cited in the complaint also include more generally applicable requirements, in addition to those specific to sprouts, such as using equipment and tools that can be adequately cleaned and maintained, maintaining and sanitizing food contact surfaces and equipment as necessary to protect against contamination, and following cGMPs.

The enforcement action demonstrates that FDA will take action to seek compliance with its regulations and underscores the importance of both adhering to the Produce Safety Rule and cGMPS requirements, as well as providing thorough responses to 483s and Warning Letters.

We will continue to monitor FDA’s enforcement of the Produce Safety Rule. 

  1. U.S. v. Fortune Food Product, Inc., No. 20 C 5356(N.D. Ill. Sept. 15, 2020), available at https://www.justice.gov/opa/press-release/file/1316981/download.
  2. Fortune Food Products, Inc. (July 19, 2018), available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fortune-food-product-inc-552180-07192018.
  3. Available at https://www.justice.gov/opa/press-release/file/1316976/download.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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