Food Industry Concerned about Possibility of Litigation in Trans Fat Phase Out

Just days after the Food and Drug Administration (FDA) issued a Declaratory Order phasing out trans fats from the nation’s food supply, a lawsuit has been filed claiming a Heinz frozen potato product is adulterated and should be removed from the market. This may be just the beginning of litigation challenging what was expected to be an orderly three-year phase out.

In 2013, the FDA issued a preliminary determination that partially hydrogenated oils (PHOs) will no fall in the category “generally recognized as safe” (GRAS). That determination was made final last week, with an order that gave food manufacturers until June 2018 to remove partially hydrogenated oils (PHOs) from products, Forbes reports.

But the way the order was done could lead to an explosion of lawsuits seeking to require the reformulation or removal of PHO-containing products from the market earlier than the June 2018 deadline in the order.

Forbes explains that an FDA determination that a substance is no longer GRAS does not mean that the additive or ingredient has been declared “unsafe.” Food manufacturers may seek approval to use non-GRAS food additives in their products and some plan to petition for small amounts in certain products. In the initial determination on trans fats, the FDA said, “any incremental increase in trans fat consumption increases the risk of CHD [coronary heart disease].” The final order concludes that there is no measurable level at which PHOs will not increase disease risk. These statements, Forbes says, could open a path for class action suits against food companies.

The FDA believes that state or local laws prohibiting PHOs “are not likely to be in conflict with federal law, or frustrate federal objectives.” But successful state or local consumer protection suits that require immediate withdrawal of a product could interfere with the FDA’s timetable.

Forbes says two omissions in the final order are prompting the concerns about litigation. The order did not say that products containing trans fats currently on the shelves or introduced up to June 2018 are marketed lawfully. And because trans fats are now not GRAS, lawsuits could claim that such products are adulterated under FDA definition and are subject to seizure. The order did not say anything about the FDA exercising enforcement discretion during the transition period and not seizing PHO-containing foods.

Food companies have expressed concern about retroactive trans fat lawsuits, and the industry had sought FDA assurance that the thousands of products containing trans fats—from baked goods to snack foods to coffee creamers—that have been on shelves since the1950s would be deemed to have been marketed lawfully. In the absence of such assurances, class action suits could assert product liability claims and state attorneys general could sue for reimbursement of public health care expenditures for the costs of treating cardiovascular disease, Type 2 diabetes, and other conditions linked to trans fats, according to Forbes.

An attorney commenting on the FDA’s order said it “should have taken place at least 20 years ago, and there is no justification for any sort of further delay or phasing.” Forbes suggests that if the FDA does not provide guidance to ensure an orderly PHO phase out, other branches of government may need to step in to “remind the agency of its duties under federal law.”

 

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