FDA removes cancer-causing methylene chloride from color additives — but leaves the door open for other carcinogens used in food

WASHINGTON, D.C. - Today, FDA partially granted a petition submitted by EDF and partners to remove the use of three cancer-causing chemicals as color additives in food. FDA will no longer allow methylene chloride in inks used to mark fruit and vegetables, determining that this use is subject to the Delaney Clause, which prohibits FDA approval of cancer-causing chemicals in food.

The FDA denied the request to remove the two remaining chemicals - ethylene dichloride and trichloroethylene (TCE) - from color additive uses due to considering them impurities in the color additive, not color additives themselves. However, the agency stated that it will also remove approval of these uses after industry leaders petitioned FDA saying that they'd already abandoned the practice.

Exposure to ethylene dichloride, methylene chloride and trichloroethylene (TCE) has been linked to cancer, along with other serious health conditions like heart defects in babies and damage to the liver, kidney and immune system. By selectively removing these cancer-causing chemicals based on whether they're considered additives or impurities in additives - a distinction our bodies do not make - FDA leaves Americans exposed to unnecessary health risks.

FDA also denied the request to remove all three solvents as extraction agents for annatto extract, paprika oleoresin and turmeric oleoresin because the agency considers them "impurities in color additives" rather than "color additives." Classifying these cancer-causing chemicals as "impurities" does not eliminate their potential to harm people. FDA's reasoning, if continued in future decisions, threatens to leave Americans exposed to cancer causing chemicals in their food.

The FDA's decision is a step toward removing cancer-causing chemicals like methylene chloride from food. However, the agency's invented technicality leaves the door open for other carcinogens to enter our food.

Quotes from petitioners

"Carcinogens do not belong in Americans' food, regardless of their amount or how they're added. FDA's decision to remove cancer-causing methylene chloride from fruit and vegetable marking inks is a step toward protecting public health. However, the FDA must put consumer health ahead of industry interests to faithfully implement the Delaney Clause, which prohibits the use of cancer-causing ingredients in food. This means continuing to eliminate all uses of carcinogens still permitted in our food supply, regardless of industry buy-in."

• Maria Doa, PhD., Senior Director, Chemicals Policy, Environmental Defense Fund

" A chemical that is linked to cancer is still a chemical linked to cancer that has no place in our food. As usual, FDA is taking one step forward and one step back when it comes to the safety of our food. This decision, in combination with the recent FDA food safety failures, makes Congressional action even more urgent."

• Scott Faber, Senior Vice President, Government Affairs, Environmental Working Group

"Cancer-causing chemicals have no place in the foods we put into our bodies. The FDA has known this for decades. Today's decision by the agency to remove methylene chloride as diluent in fruit and vegetable marking inks is an important step forward. However, the FDA made up an "impurity" exception to deny our petition to revoke other cancer-causing additives in direct contravention of the law, science, and common sense. FDA needs to put people's health first and follow the law and if it will not then Congress needs to act."

• Thomas Fox, Senior Legislative Counsel, Toxic Exposures and Pollution Prevention, Center for Environmental Health

"Breast cancer doesn't negotiate - and neither should the FDA when it comes to cancer-causing chemicals in our food. Banning methylene chloride from fruit and vegetable marking inks is an important public health victory, but it cannot come at the expense of the broader protections guaranteed by the Delaney Clause. FDA's decision to exempt carcinogenic chemicals by classifying them as 'impurities' rather than additives sets a troubling precedent. A cancer-causing chemical doesn't become safer simply because the FDA gives it a different name. The agency must uphold both the letter and spirit of the law - and put public health ahead of regulatory loopholes. We demand the FDA ensures that cancer-causing chemicals have no place in our food."

• Nancy Buermeyer, Director of Program and Policy, Breast Cancer Prevention Partners

"FDA's decision to ban some of these notorious cancer-causing chemicals from being legally added to food is a step in the right direction, not only for consumers, but for workers and communities. But it is too little, too late. Just like with Red 3, the government knew for decades that these chemicals cause cancer, yet continued to allow them for use in food. FDA still has not acted on a related petition to remove other uses of these cancer-causing chemicals, including for decaffeinating coffee, even though safer alternatives exist. FDA should immediately take steps to ban all cancer-causing additives from the food supply. Not only does that make sense for our health, it's the law."

• Lisa Y. Lefferts, MSPH, Environmental Health Consultant

Background:

Today's announcement comes more than two years after Environmental Defense Fund petitioned the FDA to prohibit the use of methylene chloride, ethylene dichloride and trichloroethylene in food and color additives, together with Breast Cancer Prevention Partners, the Center for Environmental Health, Environmental Working Group and independent environmental health consultant, Lisa Lefferts.

The chemicals are known or reasonably expected to lead to multiple forms of cancer, including leukemia, non-Hodgkin lymphoma and cancers of the liver, kidney and lung.

Research shows all three chemicals carry other serious health impacts, including fetal cardiac defects (TCE), liver and kidney toxicity (TCE, ethylene dichloride) and Parkinson's Disease (TCE). Independent product tests have found methylene chloride in several common decaffeinated coffee products, raising concerns about exposure risks for pregnant people and other vulnerable groups.

A recent EDF analysis identified 25 cancer-linked chemicals allowed in Americans' food, including formaldehyde, asbestos and BHA. Today's decision is a significant step toward protecting Americans' health, but FDA's approach could allow other cancer-causing chemicals to remain in our food supply. The FDA must fulfill its job under the law by pursuing comprehensive reforms that get all carcinogens out of U.S. food for good.