Food Group Seeks Clarity on Soy-Milk Labels

(CN) — The Food and Drug Administration warned soy-milk producers to stop calling it "milk," but the agency has used the term and let companies use it for decades, a nonprofit claims.

The Good Food Institute, or GFI, a Washington, D.C.-based nonprofit that says it is "working toward a healthy, humane, and sustainable food supply," sued the Food and Drug Administration in D.C. Federal Court on Monday.

The dispute stems in part from nonparty Soyfoods Association of America allegedly asking the FDA to formally recognize "soy milk" as the common name for "liquid food derived from the cooking and processing of whole soybeans with water" in 1997.

Though the agency never responded, it has since used the name soy milk, which entered the U.S. market decades ago but has "a long history dating back centuries," Monday's complaint states.

Yet the FDA issued warnings to San Diego-based Lifesoy Inc. and San Francisco-based Fong Kee Tofu Co., in 2008 and 2012, respectively, that "soy milk" is improper because the product does not contain dairy milk, the plaintiff says.

"Notwithstanding FDA's varying positions on the matter, many major brands of soy milk continue to label their products as 'soy milk' or 'soymilk,'" the complaint states. "This has resulted in consumer confusion and an uneven competitive landscape."

Nonparty National Milk Producers Federation and several dairy state senators allegedly sent letters urging the FDA to enforce the standards of its warning letters in 2010 and 2012.

"These calls for regulation (originating from the producers of competitive products) have created significant regulatory uncertainty regarding these products," according to the complaint. (Parentheses in original).

GFI, in turn, submitted three Freedom of Information Act, or FOIA, requests to the FDA on April 7, 2016, seeking information related to the warning letters.

One of the San Francisco District Office's final responses, issued May 3, "consisted entirely of inspection reports of the Fong Kee Tofu Co. facility," the complaint states.

"The response letter did not identify any documents being withheld or explain the scope of the search conducted, and did not explain FDA's decision not to search the electronic records identified," the lawsuit continues.

GFI says it filed an administrative appeal with the agency Friday.

Its request allegedly "was not even forwarded to [the Center for Food Safety and Applied Nutrition, or CFSAN] or any other component at FDA besides the two field offices."

In response to the request for information related to the senators' and National Milk Producers' letters, the FDA sent GFI the senators' letter without attachments or enclosures, as well as the agency's reply to Sen. Dan Coats, according to the complaint.

The FDA "indicated that it would conduct a further search, and on May 23, informed GFI by email that GFI's request was 'still pending' with CFSAN," the complaint states.

The four-count complaint alleges failure to comply with the 20-working-day statutory deadline for FOIA requests, make reasonable efforts to search for responsive records, and make compliance determination and notification, as well as unlawful withholding of agency records.

GFI seeks an order to conduct a reasonable search and promptly disclose all responsive records, as well as costs and fees.

The institute's attorney, Nigel Barrella in D.C., said "the underlying issue regarding the labeling of soy milk is the interesting part."

"Everyone calls it that (including FDA and [U.S. Department of Agriculture] at times), but then suddenly you see warning letters like these and that creates uncertainty," Barrella wrote. (Parentheses in original).

"Ultimately we would like to see FDA take a clearer position on this issue, but short of that, we at least hope to find out what has driven FDA's past statements," Barrella added.

FDA spokeswoman Lauren Kotwicki said the agency cannot comment on pending litigation.

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