EDF Health

Broken GRAS: FDA must declare abandoned uses of ortho-phthalates are not GRAS.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 25, 2022

Maricel Maffini, EDF consultant and Tom Neltner, Chemicals Policy Director

This blog is the sixth in our Broken GRAS series where we explore the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) voluntary notification system for novel chemicals added to food.

In May, FDA removed its approval for all uses of 19 ortho-phthalates (aka phthalates) and some uses for two more because it agreed with the industry petition claiming the uses had been abandoned. During the comment period when the petition was filed and again when the decision was published, Earthjustice, EDF, and others warned FDA that despite the removal of approvals, a company could still use any of the abandoned phthalates without the agency’s knowledge by determining on its own that the use was Generally Recognized as Safe (GRAS).

In its decision, FDA implicitly acknowledged that this could indeed happen. After explaining what a GRAS safety determination[1] entails and how its voluntary GRAS notification program[2] works, the agency said:

In the future, if a manufacturer wishes to establish safe conditions of use for one or more of these substances in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification prior to market entry because these intended uses were previously authorized under section 409 of the FD&C Act.[3]

Since the agency has no way of knowing that a company determined a substance’s use was GRAS or that it was actually in use, FDA’s expectation is little more than a hope. The agency’s own studies show that the abandoned phthalates show up in food and in food contact materials. Many other studies have shown the same thing, including one that found an unapproved phthalate in fast food.

Read More »

Posted in FDA, Food, GRAS / Tagged , | Comments are closed

FDA acts on fluorinated plastic packaging. What are next steps?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 9, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) took an important step last week to protect food from PFAS contamination from plastic packaging. On August 5, the agency sent a letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles reminding them that these articles must be made under specific conditions to comply with existing regulation or otherwise the food contact articles “are not lawful.” Therefore, the food that contacted them should not be permitted for sale. The agency gave three examples of manufacturing processes that do not comply with the regulation. We flagged concerns with fluorinated plastic packaging in a July blog and applaud the agency for this action.

This significant first step needs to be followed:

  1. Investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether their products complied with the law. If not, then alert food manufacturers and retailers so they can recall the adulterated food and cosmetics.
  2. Reassess whether the process FDA approved in 1983 for fluorinating polyethylene generates PFAS and whether it should still be considered safe.

Investigate companies that provided fluorinated plastic packaging

In the letter, FDA’s Office of Food Additive Safety (OFAS) states that “available information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA’s regulation.” It identified three specific examples and says that “these alternative processes for fluorination of polyethylene are not compliant with 21 CFR § 177.1615, and are not lawful for use in food contact articles.” The three examples of unlawful manufacturing processes are:

  1. “Fluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container.”
  2. “Use of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.”
  3. Incorporation of oxygen into the fluorinating mixture to modify the properties of the final container.

A market search shows several brands that have in-mold fluorination of high-density polyethylene (HDPE), (here and here) and another that may use oxygen or other gases in combination with fluorine.

With the letter public, FDA’s Office of Regulatory Affairs (ORA), which handles field inspections and sampling for the agency, should ensure compliance by food manufacturers all along the supply chain. Where it finds a violation, it would manage the recall of the adulterated food.

Reassess whether the allowed use generates PFAS and should still be considered safe

About a week before FDA sent out the letter, the agency responded to our May 2021 FOIA request for the documentation that resulted in its 1983 approval of fluorinated polyethylene packaging at 21 CFR § 177.1615. The approval came in response to a 1979 food additive petition by Union Carbide.

As with most of FDA’s FOIA responses, the 233-page document has extensive redactions of health and safety information. However, two things come through clearly:

  1. Nitrogen and fluorine only: In its petition and communications with FDA, Union Carbide was inconsistent when it explained whether nitrogen was only an example of an acceptable inert gas. FDA scientists demanded clarity and the company agreed that only nitrogen would be allowed. In its recent letter, FDA reminds companies that only this condition is approved.
  2. Fluorinated organics: The petition included studies of the chemicals that migrated into a simulated food such as water or alcohol. The study evaluated the residue that remained after the food simulant was evaporated off. Union Carbide maintained that fluorine in the residue was almost entirely ionic fluorine – the kind added to toothpaste – and showed that the exposure was within tolerated levels. FDA scientists kept pushing back explaining that there was evidence the residue contained substances with a carbon-fluorine bond – a indicator of what we now refer to as PFAS. FDA finally relented, stating that “our general conclusion is that low molecular weight fluorocarbon-oxygen compounds should not be present in significant quantities.” (see page 195 of FOIA response).

We now know that levels of PFAS that were considered insignificant by FDA in the 1980s pose significant risks as evidenced by some of the agency’s recent actions. For those reasons, we reaffirm our call in our July 2021 blog and in the June 2021 citizens petition submitted by 11 organizations to FDA to reassess the safety of PFAS uses, including fluorinated polyethylene.

As part of that reassessment, FDA needs to revisit the concerns raised by the agency scientists in 1983 in light of the risks posed by PFAS. Specifically:

  • Nitrogen: In its August 5 letter, FDA states that a form of PFAS known as perfluoroalkyl carboxylic acids “can form when the fluorination of HDPE occurs in the presence of oxygen or water, but not in the presence of nitrogen.” However, the agency does not acknowledge that commercially available nitrogen contains contaminants like oxygen. Food-grade nitrogen can have as much as 10,000 parts per million (ppm) of oxygen and 55 ppm of water. These levels could well be sufficient to generate significant amounts of PFAS.
  • PFAS leaching into food: Since the amount of PFAS in food considered “significant” is dramatically lower than in 1983 when FDA made its decision, the agency needs to evaluate whether it is practical – even with the purest nitrogen – to fluorinate plastic without making PFAS.

If the agency determines that the fluorine gas treatment process creates any PFAS, the law explicitly requires that FDA evaluate safety after taking into account the cumulative effects of related substances in the diet that have related health impacts. As with virtually all of its decisions, the agency failed to do that for its 1983 approval. Given the pervasive presence of PFAS in the environment and the additional PFAS FDA authorized for use in food packaging, this type of review is even more important.

Conclusion

In summary, FDA’s August 5, 2021 letter is an important step in the effort to protect consumers from PFAS in food. Now the agency needs to investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether the products complied with the law and take action. It must also reassess the safety of the packaging even if it complies with the specific conditions in its 1983 approval.

Posted in FDA, Food, Food contact materials, Health policy, PFAS, Regulation / Tagged , , , | Authors: / Comments are closed

FDA accepting public comments on the safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 19, 2016

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

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves. Read More »

Posted in FDA, Food, Health policy, Regulation / Tagged , , , , , , , , , , , | Authors: / Comments are closed

FDA agrees to reconsider safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2016

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

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered “food additives.”

FDA acted in response to a food additive petition submitted by the Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, and Learning Disabilities Association of America – groups all concerned by the adverse health effects of ortho-phthalates at the levels typically seen in food.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

Read More »

Posted in FDA, Food, Health policy, Phthalates, Regulation / Tagged , , , , , , , , , | Authors: / Comments are closed

FDA decides 3 PFCs are unsafe: Detailed look at the decision

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2016

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

FDA’s decision to remove its approval of three long-chain perfluorinated compounds sets important precedents on the assessment of food ingredients, food contact substances, and chemicals used to make food.

[pullquote]

FDA concluded:

  • Class: All long-chain chemicals with at least one linear, perfluorinated chain of eight or more carbon atoms should be considered a class.
  • Data gaps: Where reproductive and developmental toxicity data are lacking for any chemical in this class, the data available for perfluorinated octanoic acid (PFOA) should be used to fill the gaps.
  • Study methods: If a chemical is biopersistent in the body, standard toxicology methods used to evaluate food additives need to be upgraded.

[/pullquote]On Jan. 4, 2016, the Food and Drug Administration (FDA) announced that it changed its regulations to remove the agency’s approval of three specific long-chain perfluorinated compounds (PFCs) as food additives. The agency approved use of these chemicals between 1967 and 1997, allowing them to be added to paper and paperboard that comes in contact with aqueous and fatty foods. Until the late 2000s, they were commonly used in pizza boxes, sandwich wrappers, and paper in frozen food packaging – virtually anywhere a food manufacturer wanted to use paper packaging that would repel oil and water.

Domestic PFC manufacturers report that these food contact substance (FCS) uses have been abandoned, although others report trace levels still appearing in paper products used for food, most likely as a result of contamination. There are reports, however, that foreign companies have begun producing PFCs. As long as these additives are officially allowed by FDA, there is a possibility that food manufacturers who are not diligent could resume their use without knowing it. The agency’s decision makes it less likely that will happen.

FDA’s decision marks the first time it has used a food additive petition to remove an approval based on safety concerns; a few years ago, it removed approvals for use of bisphenol A in infant formula packaging and baby bottles and sippy cups – but those removals were based on market abandonment, not safety. This safety-driven decision sets a precedent and serves as a roadmap for how safety decisions should be made for all additives including those considered by industry to be ‘generally recognized as safe’ (GRAS).

No longer safe – unpacking the agency’s reasoning for a class of chemicals and safety concerns Read More »

Posted in Emerging science, Emerging testing methods, FDA, Food, Health policy, Health science, PFAS, Regulation / Comments are closed

FDA Says We Are All Made of Chemicals So How Can Any Be Bad For You?

By EDF Blogs / Published: April 11, 2024

By Maria Doa, PhD, Senior Director, Chemicals Policy, Maricel Maffini, PhD, Consultant, and Liora Fiksel, Project Manager, Healthy Communities

 

Woman reading product label in grocery store

What happened

You may have seen news or online content from FDA about chemicals in our foods, including that our food – and everything else in the world – is made up of chemicals.

FDA’s online content also characterizes toxic chemicals such as lead and mercury simply as naturally occurring or naturally present in our environment. It further fails to distinguish the most harmful chemicals by asserting that for all chemicals, it is the amount of the chemical that matters when determining their harm.

Why it matters

It is true that everything, including our food, is made up of chemicals. However, that does not mean that we should treat all chemicals equally.

Highly toxic chemicals such as lead, mercury, PFAS, TCE, methylene chloride, and BPA are examples of substances that should not be in our food. These toxic metals and synthetic chemicals do not have nutritional benefits and are not equivalent to the chemicals that make up the proteins, fats and carbohydrates that are necessary for a healthy diet. We should not be exposed to toxic chemicals at any level.

The suggestion that toxic metals and synthetic chemicals such as PFAS in our food are just chemicals like essential elements such as potassium in bananas is misleading and harmful.

Unfortunately, FDA accomplished just that. In a webpage released earlier last week, the agency tried to address worries about chemicals in food, an issue that consumers have been concerned about for several years. In its attempt to bring confidence about the safety of the food supply, FDA tried to normalize the presence of toxic chemicals, including neurotoxicants, carcinogens and endocrine disruptors, in our food.

Our take

If a toxic chemical such as lead or mercury is naturally occurring, is it OK?

No. While there are very low levels of these metals that are naturally present in our environment the majority of what is now in our environment is not natural background but the result of pollution and other contamination due to human activities. These levels are not “naturally occurring.”

It is also essential to recognize that naturally occurring does not equate with safety. There is no safe level of exposure to lead and mercury which are potent neurotoxicants. They are particularly harmful to infants and small children and exposure to even small amounts can cause harm.

Is there always a safe level of exposure to a chemical?

Treating all chemicals in our food the same way ignores the science. Some chemicals, in addition to lead and mercury, are so toxic that essentially any amount of exposure is of concern:

  • Chemicals like TCE associated with multiple types of cancers and harm pregnant women and infants.
  • Chemicals like PFAS also known as forever chemicals because they are so difficult to destroy that can harm pregnant women, cause cancer and harm the immune system in vanishing small quantities. For two of the PFAS, EPA just declared that there is no safe level of exposure.
  • Chemicals like BPA that harm the immune and reproductive systems, disrupts the normal function of hormones and affects learning and memory at levels 20,000 times lower than previously estimated, and
  • Chemicals like methylene chloride are associated with cancer and liver toxicity.
  • Chemicals like phthalates that also disrupt the normal function of hormones specially during development of the male reproductive tract. These chemicals are strictly limited in children’s toys due to their toxicity.

And being exposed to more than one of these chemicals that cause the same harm, such as cancer, can increase the harmful effects.

Further, Congress also recognized that some chemicals should not be allowed to be added to our food. Period. Congress included a provision known as the Delaney Clause in our food safety laws that states a food additive cannot be deemed “safe if it is found to induce cancer when ingested by man or animal.” Yet unfortunately, some carcinogens continue to be allowed.

How can we be assured of a safe food supply if the agency that is supposed to ensure safety takes the same “it’s the amount that matters” approach to these toxic chemicals as it does to salt?

And how can we have confidence that FDA will fully consider consumers in determining food safety when the agency not only falsely equates toxic chemicals with the chemicals that make up the proteins, fats and carbohydrates in our diet but also takes a patronizing approach to the public by stating that “chemical names may sound complicated but that does not mean they are not safe.”

Next steps

In the last several years, public interest organizations have petitioned FDA to review the safety of chemicals known to pose risk to health.  Many petitions are still unresolved.

FDA should recognize toxic chemicals for what they are – chemicals that can harm our health and well-being – rather than camouflage them just as any other chemical. The science and the law demand that in making decisions about food safety, FDA recognize and act on the most toxic chemicals and fully consider consumers in its decision making.

 

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