Selected tag(s): FDA

Lost opportunity for safer food additives

In DC, “Take Out the Trash Day” refers to federal agencies releasing unpopular decisions on Friday when the media and public are not watching.  It is especially common around the holidays or in August when many people, especially those in Congress are on vacation.  On Friday, August 12, FDA took out the trash by issuing a final rule regarding chemicals added to food more than two weeks before a court ordered deadline

Tom Neltner, J.D.is Chemicals Policy Director

On August 12, the Food and Drug Administration (FDA) issued a final rule defining how companies should voluntarily notify the agency when they conclude that a chemical added to or used to make food is “Generally Recognized as Safe” (GRAS).

The decision is a lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification to or review by FDA. The rule allows the industry to continue making secret decisions about what we eat without the agency’s – or the public’s – knowledge.  The agency has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.

Just two years ago, the senior FDA official overseeing food safety acknowledged that the agency “cannot vouch for the safety of many of these chemicals” as a result of the GRAS loophole. Read More »

Posted in FDA, Food, GRAS, Health Policy, Regulation| Also tagged , , , | Comments are closed

FDA accepting public comments on the safety of ortho-phthalates

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| Also tagged , , , , , , , , , , , | Comments are closed

Senator Markey asks: What if people could buy food they know is free of secret ingredients?

Senator Markey (D-MA) asked FDA if it can require a label to tell consumers when the food they are eating contains chemicals it has not reviewed for safety. In his April 26 letter, he asked the agency to respond by May 17.

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

In May 2015, 36% of consumers said that chemicals in food was their most important food safety issue and 23% of consumer said they changed their purchase habits out of concern with chemicals in their food. Leading food manufacturers responded by reformulating their products to remove artificial flavors and colors.

What if these same consumers knew that chemicals added to their food had not been reviewed for safety by the Food and Drug Administration (FDA)? As the Natural Resources Defense Council made clear two years ago, 56 food additive makers chose to avoid FDA’s scrutiny by taking advantage of a loophole in the law for “Generally Recognized as Safe” (GRAS) substances. They purposely chose not to be transparent by keeping secret the safety evaluation conducted by their employees or consultants. These companies appear to make only a few of the estimated 1000 chemicals that FDA has not checked for safety or is aware they exist.

In February, we learned that 51% of consumers think that safety means not only that a product is free of harmful ingredients but that its labeling is clear and accurate. Forty-seven percent want clear information on ingredients and sourcing. With this in mind, it’s fair to assume that consumers also expect that all food chemicals are safe and known to the FDA. Many consumers would likely not buy products where the labeling failed to disclose that the food they serve their families contained ingredients the FDA has admitted it “cannot vouch for their safety".

On April 26, Senator Edward Markey (D-MA) put the issue front and center when he asked FDA whether it has “sufficient authority to require a special label on any foods or beverages containing ingredients that have been self-determined to be GRAS without an FDA review?” If FDA had sufficient authority, then “what would the label look like?” Read More »

Posted in FDA, Food, GRAS, Markets and Retail, Regulation, Uncategorized| Also tagged , , , | Comments are closed

FDA agrees to reconsider safety of ortho-phthalates

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, Regulation| Also tagged , , , , , , , , | Comments are closed

Seeing Red on Food Dyes

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

The Center for Science in the Public Interest’s (CSPI) “Seeing Red: Time for Action on Food Dyes” report, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and consumers should take action to protect children from the behavior problems associated with these chemicals.

What are color additives?

  • The FD&C number on a color means it is a “certified” color pursuant to 21 CFR Part 74. These colors are synthetically made from oil or coal. Decades ago, FDA determined they were safe and only certifies that each batch meets quality standards and does do not contain particularly dangerous contaminants.
  • A color additive is not safe unless there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use.”
  • FDA labeling rules maintain that all added colors to food are artificial. Technically, there are no natural colors – not even beet juice – since they mask the natural color of the food.
  • FDA does not limit the amount of a certified color that can be added to food except in one case. The food manufacturer decides how much is needed.

Last Friday, FDA released a stream of five consecutive tweets telling people why certified artificial color additives, commonly known by their FD&C number, are used and how to avoid them if people are sensitive to them. The tweets, while true, said nothing about who may be sensitive to the chemicals. They should have said that any child may be sensitive and that the 6.4 million children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) appear to be particularly sensitive.

So what prompted FDA’s tweets? Most likely the agency anticipated CSPI’s report “Seeing Red: Time for Action on Food Dyes” issued January 19. It follows on the organization’s 2010 “Food Dyes: Rainbow of Risks” report and its 2008 citizens petition calling on the agency to: 1) revoke its approvals of eight synthetic food dyes; 2) require warning labels on the package in the interim; and 3) correct statements about the dyes on its website and other materials.

While FDA has yet to take action on the citizens petition, the marketplace has already passed judgment. In 2015, leading food manufacturer and restaurants committed to reformulating their iconic brands to remove certified artificial colors. They follow the lead of major retailers who reformulated their private brands to remove the chemicals.

Read More »

Posted in FDA, Food| Also tagged , , , , , , , , , , , , , , , | Comments are closed

Evidence mounts on BPA’s adverse effects on human health

Lindsay McCormick is a Research Analyst.

Bisphenol A (BPA) is a high production volume chemical that is used to make polycarbonate plastics and epoxy resins.  It is commonly found in food and beverage packaging, such as plastic bottles and the lining of food cans, as well as thermal paper receipts (see our previous blog).  BPA is widely-recognized as an endocrine-disrupting chemical, meaning that it can alter the normal functioning of the body’s hormonal system.  Hundreds of studies have been published associating BPA exposure with health effects, ranging from cancer to obesity to attention-deficit hyperactivity disorder.  Data from the Center for Disease and Control (CDC) show that nearly all people tested have BPA in their bodies.

Despite a plethora of data, numerous calls for action (for example, see here, here and here), and comprehensive regulation in France, it does not seem that national regulation of BPA in food packaging in the U.S. will be happening any time soon.  The official position of the U.S. Food and Drug Administration (FDA) is that, while BPA exhibits endocrine-disrupting properties at high doses, it is safe at the current levels occurring in food.  Although the FDA banned the use of BPA-based materials in baby bottles, sippy cups, and infant formula packaging in 2012, FDA said it based this action on changes in the market, rather than safety concerns.

In the fall of 2014, FDA completed a four-year review of the literature, including more than 300 scientific studies, and concluded that the information does not “prompt a revision of FDA’s safety assessment of BPA in food packaging at this time.”

The European Food Safety Authority (EFSA) recently followed suit with their announcement that BPA does not pose a health risk to consumers, including children, at current exposure levels.  (This is in contrast to the action of several EU member states, which have banned BPA in food contact materials for children under 3 years of age over the past few years.)

Meanwhile, scientists continue to churn out studies linking low-level BPA exposure to a variety of health effects.  In this post, we discuss several new studies.   Read More »

Posted in Emerging Science, Health Science| Also tagged | Comments are closed
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