EDF Health

Important insight from the organic certification approach to chemical additives in food

Tom Neltner, J.D.is Chemicals Policy Director

Since 2014, chemicals in food[1] have been consumers’ most important food safety issue, reaching a high of 35% in 2018, according to annual industry surveys by the International Food Information Council. For comparison, “foodborne illness from bacteria” was half that percent.

Food companies have responded to this growing consumer alarm by adopting policies banning artificial flavors, colors and other ingredients that sound like chemicals. This approach is unlikely to do more than serve as window dressing for the underlying problems since it’s not science-based – many of these additives may be safe. The Center for Science in the Public Interest called out this practice in its 2017 “Clean Label: Public Relations or Public Health?” report and pointed readers to its Chemical Cuisine system that rates common additives for health and safety.

There are some companies, like Panera Bread, that are taking a more systematic approach to the ingredients used in the food they sell, starting with the question of whether the additives used are essential and whether the ingredients pose health or safety concerns. As a result, the company worked closely with their suppliers and reformulated many of their products.

And now, thanks to a fascinating new report from the Environmental Working Group (EWG), we are learning about another structured approach that addresses health concerns with chemical additives – the Federal organic certification program for processed foods. To be honest, before reading the report, I viewed the organic program as narrowly focused on pesticides and was only vaguely aware of how it dealt with chemical additives. I was missing the bigger picture.

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Towards Safer Food Additives

Tom Neltner, J.D.is Chemicals Policy Director.

EDF strives to make safer food available by partnering with companies to reduce and eliminate potentially unsafe chemical food additives and supporting efforts to fix a broken regulatory system.

For many years this blog has focused on the safety of chemicals and nanomaterials used in industrial and consumer products.  Most of these substances are regulated federally by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA).  But we also encounter chemicals in other ways, including those present in or added to food.  Such chemicals are regulated under a different law, the Federal Food, Drug and Cosmetics Act (FFDCA), administered by the Food and Drug Administration (FDA).  This blog introduces EDF’s “Behind the Label” initiative to get unsafe and questionable chemicals out of our food by using dual levers of change—corporate leadershIFIC Charts - 5-16-16ip and public policy.   Making our food trustworthy demands leadership in both the private sector and the FDA.

The food market is changing rapidly as manufacturers work to keep up with consumer concerns about what’s in our food. And it’s not just about added sugar, salt and trans fats, or whether the food was grown locally or with or without pesticides. Public campaigns increasingly put the spotlight on many chemicals commonly used in food and food packaging—food additives—with growing scientific evidence questioning the safety of their use.

A respected industry survey released in May 2015 showed that 36% of consumers rated chemicals in food as their most important food safety concern – greater than pathogens, pesticides, animal antibiotics and allergens, and up from 23% in 2014 and 9% in 2011. These concerns translated into action; 23% of consumers reported changing their buying habits (corrected from 45% on May 16, 2016). Read More »

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Our experience with FDA’s food chemical program reinforces alarming findings from Politico investigation

Tom Neltner, Senior Director, Safer Chemicals and Maricel Maffini, consultant

A powerful investigative article by Politico’s Helena Bottemiller Evich revealed significant structural and leadership problems at the Food and Drug Administration’s (FDA) food program. The article articulated what has been implicitly understood by the food safety community. It led to demands from Congress for Commissioner Robert Califf to take aggressive action and even prompted calls for a new agency focused solely on food safety.

 

“Over the years, the food side of FDA has been so ignored and grown so dysfunctional that even former FDA commissioners readily acknowledged problems. There’s a long running joke among officials: The “F” in FDA is silent.”
—Helena Bottemiller Evich, Politico article

 

In response, FDA leadership has pointed to Congress for failing to adequately fund the program and touted examples of where the agency has taken action on food safety.

Yesterday, 30 groups representing food industry leaders, and consumer groups, including EDF, joined in a call for Califf to unify the FDA’s food program under a deputy commissioner for foods with direct line authority over all food-related programs.

We have been advocating for FDA to improve the safety of chemicals added to our food for more than a decade, often working with FDA officials to push for regulatory reforms. From that narrow but deep perspective on food safety, everything we have seen reinforces the shortcomings highlighted in the Politico article. Read More »

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FDA reinstates ban on lead added to hair dyes

Tom Neltner, Chemicals Policy Director

On October 7, FDA announced that it is reinstating its ban on lead acetate as the active ingredient in hair dyes that hide grey hair when used regularly. In 1980, the agency approved the chemical for hair dyes. In response to a color additive petition from the Environmental Defense Fund and others, in October 2018, the agency revoked its approval. Combe Inc, the maker of Grecian Formula, objected and forced the FDA to suspend its decision. With this new action, the FDA reinstates its decision effective January 6, 2022 and gives companies one year to reformulate lead acetate out of their products.

Grecian Formula reportedly stopped using lead acetate shortly before the FDA acted in 2018. From our searches, Youthair is the remaining brand that uses the chemical.

We applaud the FDA’s affirmation of its 2018 decision where it determined these products are not safe. The agency soundly rejects Combe’s arguments that low levels of lead are safe and concludes that “we have determined that there is no known level of exposure to lead that does not produce adverse effects” in adults. These adverse effects include heart and kidney damage.

People should not be spreading lead on their head! It gets through the skin where it can hurt their body in myriad of ways. While we applaud the decision, we don’t see anything in the record that explains why FDA took almost three years to reaffirm the obvious and allow consumers to unknowingly continue using the unsafe product. Therefore, it is even harder to understand why FDA chose to give Youthair another year – until January 2023 – to remove the product from the shelves.

The FDA has known for more than forty years that the lead in these hair dyes is absorbed through the scalp, especially when used every day to hide grey hair, but previously thought there was a safe level. Other federal agencies acknowledged a decade ago there is no known safe amount of exposure to lead in adults or children. The FDA’s action in 2018, reaffirmed today, brings it in line with the scientific consensus.

Beyond lead acetate hair dyes, the FDA needs to do more to drive down consumer’s exposures from all sources of lead in food and cosmetics by tightening limits on this heavy metal in common ingredients. To protect kids and adults, it needs to translate its recognition that there is no known safe level of lead exposure by updating its outdated standards for food additives, bottled water, metal cans, and brass faucets as we demanded in a petition last year. The agency’s Closer to Zero Action Plan for children’s foods is critical but not sufficient to protect adults.

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Lead in hair dye – one company considers it safe

Tom Neltner, J.D.Chemicals Policy Director

In October 2018, the Food and Drug Administration (FDA) banned the use of lead acetate in hair dyes in response to a March 2017 color additive petition from EDF and other health advocates. In December, we learned that Combe, Inc., the maker of the lead-acetate based hair dye Grecian Formula, objected to FDA’s decision, requested a formal evidentiary public hearing to review the decision, and claimed the use is safe. The objection puts the FDA’s decision on hold awaiting a process that may take years to resolve. Apparently, the company thinks it is safe for men to slather skin-soluble lead on their head every couple of days and to risk exposing their families to a heavy metal for which no safe level of exposure has been identified.

Combe’s action was somewhat surprising because the company told CBS News that it removed lead acetate from its Grecian Formula “quite a long time ago,” but was unable to provide an exact date. Presumably, someone in the know updated the product’s Wikipedia page, which says Grecian Formula does not contain lead acetate as of July 2018, although an earlier version of the page said April 2018.

Whatever the date it was reformulated, why would Combe block FDA’s decision when it has long sold a lead-free brand – Just For Men – and had already reportedly removed lead from Grecian Formula? From a market standpoint, objecting to FDA’s decision benefits Youthair, Combe’s main competitor, which continues to sell a leaded-version of progressive hair dye.

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Why are four notorious carcinogens approved by FDA for food?

By Liora Fiksel, Project Manager, Healthy Communities, and Lisa Lefferts, Environmental Health Consultant

Pregnant woman rests a cup of coffee on her belly.

While exposure data are scant, people who are choosing decaf coffee during pregnancy or for other health reasons may not realize that some popular brands contain methylene chloride.

What’s Happening?

On December 21, 2023, FDA filed a food-additive petition and a color-additive petition submitted by EDF and partners that asks FDA to revoke its approval for four carcinogenic chemicals approved for use in food.

There is broad agreement that benzene, trichloroethylene (TCE), methylene chloride, and ethylene dichloride are carcinogenic,1 and federal law2 is clear: additives that cause cancer in humans or animals are not considered “safe.” All the chemicals have been identified as causing cancer in humans or animals since the 1970s and 1980s.3 Read More »

Posted in Adverse health effects, Carcinogenic, Chemical exposure, Chemical regulation, FDA, Food, Health hazards, Public health, Vulnerable populations / Tagged , , , , , , | Authors: / Comments are closed