FDA revises warning letter over HFCS and 100% natural claims to ‘avoid any confusion’
The revision came after eagle-eyed food law attorney Ivan Wasserman, partner in the Washington DC office at law firm Manatt, Phelps and Phillips, alerted FoodNavigator-USA to a paragraph on HFCS in a May 18 warning letter to seafood firm Seamus LLC over its 100% Natural Fresh Water Eel products.
Given the torrent of civil litigation over ‘natural’ claims coupled with the ubiquity of HFCS in food products, the reference to HFCS immediately got Wasserman’s attention, given that opportunistic plaintiff’s attorneys routinely refer to FDA warning letters in false advertising lawsuits, even though they are not legally binding.
It is also fairly unusual for the FDA to talk about natural claims in warning letters. Indeed, the agency's failure to come up with a more precise definition or what is - and isn't - considered natural, is an ongoing source of frustration in the trade, so any time it raises the topic, regulatory affairs experts tend to pay close attention.
The FDA said: “Your product label declares the terms ‘100% Natural’ and ‘all natural’; however the formulation for your product reveals that high fructose com syrup… is used in its manufacture. Use of the term ‘natural’ means that nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be in the food… If your claims are intended to describe the finished product, the term ‘natural’ may not be used in association with this product."
FDA: The letter will be re-posted once corrections are made
So is this a signal that the FDA is now cracking down on HFCS as un-natural?
Apparently not.
When quizzed about whether the warning letter to Seamus signaled new thinking on the naturalness or otherwise of HFCS, an FDA spokesman told FoodNavigator-USA that the letter would be re-posted, minus the section on HFCS.
He added: “The agency will be removing any reference to HFCS and the use of the term ‘natural’ in the Seamus LLC warning letter, dated May 18, 2015 to avoid any confusion with the agency’s policy. The letter will be re-posted once corrections are made.”
Wasserman told FoodNavigator-USA: “I was surprised when I saw that [reference to HFCS] in the Warning Letter since it seemed to contradict FDA’s last word on the issue, and thought it was apropos if the Agency was trying to be slippery, and wiggle in a revised policy by including it in a warning letter about eels. But, it seems it turned out to be not so electric after all. That’s amore!”
What is 'natural'?
The agency maintains its policy regarding the use of ‘natural’ as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. Further, the agency will continue to distinguish between natural and artificial flavors as outlined in 21 CFR 101.22. [58 Federal Register 2302 at page 2407 (January 6, 1993)]. The use of the term “natural” should be used in a manner that is truthful and not misleading. The Food and Drug Administration (FDA), July 9, 2015
FDA in 2008: You can call HFCS 'natural' provided it's been processed in a certain way
So what is the FDA's policy on HFCS and 'natural' claims?
The matter appeared to be settled in 2008, when, in a frequently-cited letter to the Corn Refiners Association, Geraldine June from the FDA's product evaluation and labeling team said HFCS could be labeled ‘natural’ provided it was processed in a certain way.
The CRA immediately posted the letter on its website, where it states that: "High fructose corn syrup contains no artificial or synthetic ingredients or color additives and meets the FDA requirements for use of the term 'natural'."
FDA in 2010: We don't have an official policy on whether HFCS is 'natural'
Two years later, however, Michael M. Landa, acting director, Center for Food Safety and Applied Nutrition at the FDA, wrote to a judge handling a class action lawsuit over HFCS claims in New Jersey (Coyle V. Hornell Brewing Co., Inc, et al. Civil Number 08-2797) noting that "Geraldine's letter... is an informal communication and does not provide a binding agency determination for the court to follow."
He then went on to "respectfully decline" the judge's request for an administrative determination of whether HFCS qualifies as 'natural'.
Land of confusion
Somewhat confusingly, however, given that there apparently isn't an official policy on the naturalness of HFCS, the FDA spokesman we've been corresponding with still refers to the 2008 letter and refer's to "CFSAN's policy" on the ingredient:
“The 2008 letter that the FDA wrote to the Corn Refiners Association to say that HFCS may be labeled ‘natural’ when synthetic fixing agents do not come into contact with it during manufacturing is process specific to the process described by CRA and not an all-encompassing statement about HFCS.
“At present, we do not have enough information about the processing of the HFCS in [Seamus LLC's] Mirin Style Sweet Cooking Seasoning (which is used on the Fresh Water Eel) to determine if CFSAN’s policy can be enforced.”
When is HFCS 'natural'?
So if you are a food manufacturer using high fructose corn syrup in your recipes, how can you be sure you are using the kind that meets the criteria laid out in the FDA's 2008 letter?
Andrew Resnick, director of public affairs at the Corn Refiners Association (CRA), told us: "We understand that HFCS produced by CRA members fits the criteria laid out in the 2008 guidance letter, and therefore qualifies as natural under FDA’s natural policy. [However], we obviously cannot comment on how food manufacturers chose to label their products, which may contain HFCS and other ingredients."
The FDA position on HFCS and 'natural' claims
In a letter to the Corn Refiners Association in 2008, Geraldine June from the FDA's product evaluation and labeling team, said the agency would "not object to the use of the term 'natural' on a product containing HFCS" provided synthetic fixing agents do not come into contact with it during manufacturing, or if the acids used to obtain the starch hydrolysate meet certain criteria.
In 2010, however, Michael M. Landa, acting director, Center for Food Safety and Applied Nutrition at the FDA, wrote to a judge handling a class action lawsuit over HFCS claims in New Jersey noting that "Geraldine's letter... is an informal communication and does not provide a binding agency determination for the court to follow." He then went on to "respectfully decline" the judge's request for an administrative determination of whether HFCS qualifies as 'natural'.
Corn sugar spat to go to trial
In other HFCS-related news, a long-running and extremely bitter legal dispute between sugar and corn refiners over the way their respective products are marketed looks set to go to trial this year after a federal judge in Los Angeles denied motions filed by both sides in the Western Sugar Cooperative, et al. v. Archer-Daniels-Midland Company, et al. litigation.
Click HERE to read about the background to the litigation.
