FDA Order Phasing Out Trans Fats Could Lead to Spate of Litigation

FDA Order Phasing Out Trans Fats Could Lead to Litigation
FDA Order Phasing Out Trans Fats Could Lead to Litigation

FDA Order Phasing Out Trans Fats Could Lead to Litigation
FDA Order Phasing Out Trans Fats Could Lead to Litigation

In its order phasing out trans fats in the nation’s food supply, the Food and Drug Administration (FDA) may have opened the door to a spate of lawsuits over trans fats.

In 2013, the FDA issued a preliminary determination that partially hydrogenated oils (PHOs) will no longer be considered “generally recognized as safe” (GRAS). That determination was made final last week and food manufacturers were given three years to remove PHOs from products, Forbes reports.The three-year phase out would “allow for an orderly [transition] process.” But Forbes says the Declaratory Order on trans fats 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 is not equivalent to a determination that the substance is “unsafe.” Food manufacturers may seek approval to use non-GRAS food additives in their products. The agency’s initial determination on trans fats states “any incremental increase in trans fat consumption increases the risk of CHD [coronary heart disease].” The final 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 said it 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 derail an orderly three-year transition.

Forbes says there are two omissions in the final order that may lead to litigation seeking faster action on trans fats. The order did not say 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 products containing trans fats are now illegal under federal law. The order could have said that the FDA 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.

Food companies, concerned about the possibility of retroactive trans fat lawsuits, had sought FDA assurances from the FDA that products the market since the 1950s would be deemed to have been marketed lawfully. According to Forbes, class action suits could assert retroactive 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.

The first lawsuit came two days after the order was announced. A lawsuit was filed against Heinz, claiming Heinz’s frozen potato products are now unlawfully adulterated. The suit cited the FDA trans fat order. 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 writes that if the FDA does not provide 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.”