FDA Trans Fat Order Could Result in Food Product LitigationJun 29, 2015
The Food and Drug Administration (FDA) recently confirmed its 2013 preliminary determination that partially hydrogenated oils (PHOs) will no longer be considered "generally recognized as safe" (GRAS), and has given food manufacturers three years to remove them from products.
The three-year window to comply with the order would "allow for an orderly [transition] process." But Forbes reports that the Declaratory Order on trans fats essentially sets the table for an explosion of private lawsuits that could require PHO-containing products to either be reformulated, or removed from the market, far earlier than June 2018.
Under federal law, an FDA determination that a substance is no longer GRAS is not equivalent to the determination that the substance is "unsafe," but food manufacturers must seek approval to use non-GRAS food additives in their products. The agency's initial determination states that "any incremental increase in trans fat consumption increases the risk of CHD [coronary heart disease]," and the new order concludes that no measurable level exists at which PHOs will not increase disease risk. Forbes says these assertions pave the way for class action suits against food companies.
The FDA believes that "state or local laws that prohibit use of PHOs in food are not likely to be in conflict with federal law, or frustrate federal objectives." But successful state-law consumer protection suits, requiring immediate product withdrawal, could frustrate the objective of an orderly three-year transition.
Forbes says that two omissions in the order may encourage litigation for faster action on trans fats. The order did not include an explicit statement that products containing trans fats currently on the shelves or introduced into commerce up to June 2018 are marketed lawfully. And since products containing unapproved additives are considered adulterated and are subject to seizure, lawsuits could claim that the presence of PHOs renders a product illegal under federal law. The FDA could have said in the order that it would exercise enforcement discretion during the compliance period and would not seize PHO-containing food during that time, but such a statement is not in the order.
In addition, the FDA does not say the GRAS-status decision has only prospective effect. The food industry had sought assurances that PHO-containing products on the market since the 1950s had been marketed lawfully. Companies, concerned about the possibility of ruinous retroactive lawsuits, are seeking this clarification. According to Forbes, private class actions could assert product liability claims. 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.
Two days after the order was announced, a lawsuit was filed against Heinz, citing the GRAS decision about PHOs and claiming Heinz's frozen potato products are now unlawfully adulterated. An attorney involved in the lawsuit said the FDA's order "should have taken place at least 20 years ago, and there is no justification for any sort of further delay or phasing."
If the FDA does not provide additional guidance or measures to ensure orderly compliance with the PHO phase out, other branches of government may need to step in to "remind the agency of its duties under federal law," according to Forbes.