EDF Health

Selected tag(s): Consumer products

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

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Posted in Adverse health effects, Broken GRAS, FDA, Food, Health hazards, Industry influence, Risk assessment, Risk evaluation / Also tagged , , , , , , | Authors: , / Read 1 Response

EPA Should Use U.S. Chemical Safety Law to Turn Off PFAS Tap

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: June 30, 2023

The word

PFAS is a group of synthetic chemicals used in industrial processes and consumer products, including water-repellent clothing, such as outdoor wear, and food packaging. Once these “forever chemicals” are produced and used, they often make their way into the environment and our bodies. Many pose serious threats due to their toxic effects (often at trace levels) and their ability to build up in people, animals and the environment. Studies show that they are in almost all of us.

To make matters worse, people are exposed to multiple PFAS, not individual PFAS in isolation. Yet under the nation’s primary chemical safety law, EPA evaluates the safety of PFAS chemicals one at a time and does not consider the combined risks from exposures to multiple PFAS. Combined exposures increase the risk of harmful effects, thus magnifying the risks and the need for action.

Current Situation: All Costs, No Benefits

PFAS move easily throughout the environment and are difficult to destroy. They have contaminated drinking water, food, farms, wildlife, and the environment more broadly. At the local, state and federal levels, the U.S. is spending millions of dollars to clean up PFAS contamination. Some states, such as Michigan and Maine, are trying to recoup the costs their residents have had to bear to clean-up PFAS contamination of their water and land. The federal government is also taking action to address the widespread PFAS contamination. The costs for cleaning up PFAS contamination are imposed on society by the domestic producers, importers and users of PFAS who profit from their production and use.

Yet, despite the well-documented risks and costs to society of these chemicals, companies still continue to produce, import, and use PFAS. It is time to ban all PFAS or—if there are truly essential uses for these chemicals—limit how they are produced, imported and used so that their impact on us and the environment is minimal.

Urgent Need: Revisit, Reassess, and Regulate All PFAS

While EPA has recently tightened up approvals for new PFAS entering the market, it has yet to take significant action on those that are already on the market, which includes the hundreds of PFAS the agency approved over the past few decades. It is clear these PFAS have not been produced responsibly as demonstrated by the environmental contamination associated with many of the PFAS manufacturing facilities. And yet, many of these PFAS are still on the market. They are being produced and released into the environment, are in products we use every day, and continue to contaminate us and our environment.

Many of EPA’s approvals were made 10 to 20 years ago, before we had a full picture of the pervasiveness and degree of PFAS contamination. The data on the extent of the environmental contamination of these persistent PFAS, their ability to move through the environment, and the significant difficulty in destroying them was not as robust as it is today. Furthermore, mounting evidence shows that even trace levels of PFAS can cause developmental issues in children, reduced fertility, hormonal disruptions, and certain types of cancer.

In addition, these approvals did not consider risks to vulnerable groups, such as pregnant women and children as currently required by the law. Many communities are exposed to multiple PFAS, particularly those who live, work and play near where PFAS are made and used.

Addressing the production, import and use of PFAS would limit further pollution of our water supplies, safeguard the health of our communities, and be consistent with other strong EPA actions to address PFAS, including its recent robust proposed drinking water standards.

Effective regulation of these harmful chemicals at their source would also accelerate efforts to seek out and adopt safer alternatives. Leaving chemicals with such well-documented harms on the market makes it more difficult for innovative, safer substitutes to enter it. Failing to address these risks in effect puts a thumb on the scale in support of older harmful technologies.

Our Take

EPA should re-evaluate each of the PFAS it has approved. During that re-evaluation, EPA should use the best available science and consider the full picture of PFAS exposure. Considering each PFAS in isolation rather than the multiple PFAS people, particularly those in vulnerable groups, are exposed to will underestimate their risk.

EPA should use the Toxic Substances Control Act to take action to ban these legacy PFAS, or restrict them if the uses are truly essential, rather than continuing to allow the production, import and use of these demonstrably harmful “forever chemicals.”

Go Deeper

Learn more about EDF’s concerns about PFAS and read our follow-up blog  on how EPA can use TSCA to turn off the PFAS tap.

EPA’s information on PFAS

Posted in Chemical exposure, Chemical regulation, Contamination, Cumulative impact, Cumulative risk assessment, Emerging testing methods, Food, Food packaging, Health hazards, Health science, PFAS, Public health, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Also tagged , , , , , , , , , , | Authors: / Comments are closed

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Also tagged , , , , | Authors: , / Comments are closed

Walmart Makes Progress on Its Sustainable Chemistry Policy

By Jennifer McPartland / Published: April 25, 2016

Boma Brown-West is a Manager, Consumer Health Corporate Partnerships Program and Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program

It’s been two and a half years since Walmart first committed to adopting a sustainable chemistry policy. Since then, consumers, companies and advocates have been watching the retailer with interest. Today, Walmart released its ninth annual Global Responsibility Report (GRR), which outlines its environmental and social activities for the past year. For the first time, this report includes information about the progress it has made against its Sustainable Chemistry Policy adopted in 2013, which aimed for more transparency of product ingredients and safer formulations of products.

According to Walmart, it has reduced the usage (by weight) of its designated high priority chemicals by 95 percent, a pretty sizeable number. Walmart has said that it will post more specifics in the coming weeks on its Sustainability Hub, including quantitative results on all aspects of the policy’s implementation guide and details about how they achieved the substantial reduction

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Posted in Health policy, Markets and Retail / Tagged | Comments are closed

Making “safer” accessible to all

By Lindsay McCormick / Published: April 4, 2016

Lindsay McCormick is a Research Analyst.

I find purchasing shampoo and other common personal care products to be a surprisingly stressful experience – I pace the aisles at the drugstore for a good 10-15 minutes, read every product ingredient list, contemplate the legitimacy of claims like “paraben-free” or “no artificial colors or fragrances,” and weigh the impact on my wallet. In the end, I usually choose a moderately priced product with some sort of ingredient safety claim brightly printed on the front label, and hope the extra $2 I spent will actually reduce my exposure to hazardous chemicals.

Many consumers are hungry for information and solutions that help reduce their exposure to toxic chemicals.  As more research links exposures to common ingredients in personal care products and health impacts – like certain parabens to reduced fertility; certain phthalates to asthma, reproductive disorders, and neurological effects; and triclosan to obesity – many consumers want to feel empowered to take action. That’s why the results of a recent intervention study are so intriguing: researchers found that exposures to certain chemicals fell in a population of low-income Latina girls after using personal care products labeled as being free of such chemicals for three days.

The implications of this study raise several interesting questions that I’ll explore in this post. Specifically, are personal shopping choices an effective way to avoid chemical exposures?  And, is this strategy equally available to everyone in our society?   Read More »

Posted in Emerging science, FDA, Health policy, Health science, Markets and Retail / Also tagged , | Comments are closed

New Wristband Technology Illuminates Chemical Asthmagens in our Environment

By Lindsay McCormick / Published: November 19, 2015

Lindsay McCormick is a Research Analyst.

Asthma presents a huge public health challenge.  Over the past few decades, asthma rates in the U.S. have nearly tripled – increasing from 3.1% in 1980 to 8.4% in 2010. Today, more than 25 million people suffer from this chronic respiratory illness.

While air pollution and allergens like pet dander are clearly big triggers for asthma, we know that certain chemical exposures play an important role as well.  A number of chemicals used in everyday consumer products – from household cleaners and building materials to shampoos and cosmetics – are known or suspected “asthmagens”– environmental agents that cause or exacerbate asthma.  Unfortunately, such chemicals are poorly regulated and we, as individuals, rarely have any way of knowing which ones are lurking in our environment.

EDF recently conducted a pilot project to explore which chemicals we are exposed to in our day-to-day lives.  The project employed simple chemical-detecting wristbands that absorb certain chemicals present in the environment.  We enlisted 28 volunteers to become “environmental sensors” for a week by wearing the wristbands.

Among the results:  Over the course of that week, the participants came into contact with a total of 57 potentially hazardous chemicals, 16 of which are linked to respiratory health effects such as asthma.   Read More »

Posted in Emerging testing methods, Health policy, Health science / Also tagged , , , , , | Read 2 Responses