Selected tag(s): safety

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
  • About this blog

    Science, health, and business experts at Environmental Defense Fund comment on chemical and nanotechnology issues of the day.
    Our work: Chemicals

  • Get new posts by email

    We'll deliver new blog posts to your inbox.

    Subscribe via RSS

  • Filter posts by tags

    • 6th Court of Appeals (1)
    • ADHD (1)
    • aggregate exposure (10)
    • Air Pollution (2)
    • Alternatives assessment (3)
    • American Chemistry Council (ACC) (58)
    • Ami Zota (1)
    • arsenic (3)
    • artificial colors (1)
    • asthma (4)
    • Australia (1)
    • baby food (1)
    • Baltimore (1)
    • Barley (1)
    • BBDR (1)
    • behavior (1)
    • Behind the Label (1)
    • benzophenone (1)
    • biomonitoring (9)
    • bipartisan (6)
    • bisphenol A (23)
    • Bleach (1)
    • blue (1)
    • bologna (2)
    • BP Oil Disaster (18)
    • BPA (2)
    • BPS (1)
    • Brain Development (1)
    • building code (1)
    • building code official (1)
    • California (3)
    • Canada (7)
    • carbon nanotubes (24)
    • carcinogen (22)
    • Carcinogenic Mutagenic or Toxic for Reproduction (CMR) (12)
    • Carrots (1)
    • CDC (9)
    • Center for Science in the Public Interest (1)
    • certified colors (1)
    • Chemical Assessment and Management Program (ChAMP) (13)
    • chemical exposure (3)
    • chemical identity (32)
    • chemical testing (4)
    • Chemicals Added to Food (1)
    • Chemicals in Commerce Act (3)
    • Chicago Tribune (6)
    • Children (1)
    • Children's health (2)
    • children's safety (24)
    • China (10)
    • chlorate (1)
    • CHPAC (1)
    • Cincinnati (2)
    • citizens petition (2)
    • Cleveland (1)
    • Climate change (1)
    • Clinton (1)
    • Collard Greens (1)
    • color (1)
    • color additive (1)
    • Compliance (1)
    • computational toxicology (11)
    • ConAgra (1)
    • Confidential Business Information (CBI) (61)
    • conflict of interest (9)
    • Congress (1)
    • Congressman Israel (1)
    • consumer products (52)
    • Consumer Specialty Products Association (CSPA) (4)
    • contamination (4)
    • CPSC (1)
    • CSPI (1)
    • cumulative exposure (4)
    • Dallas (1)
    • data requirements (47)
    • degradation (1)
    • DEHP (1)
    • Denver (1)
    • dermal exposure (1)
    • Design for Environment (1)
    • development (2)
    • developmental (1)
    • diabetes (4)
    • disclosure (4)
    • DNA methylation (4)
    • Dourson (21)
    • Drinking Water (15)
    • drinking wtaer (1)
    • dry food (1)
    • DuPont (11)
    • Durbin (1)
    • dust (1)
    • dust/soil (1)
    • endocrine (2)
    • endocrine disruption (31)
    • environmental justice (1)
    • EPA (18)
    • EPA scientists (1)
    • epigenetics (4)
    • exposure and hazard (49)
    • fast food (1)
    • FD&C (1)
    • FDA (20)
    • fees (1)
    • Firemaster (2)
    • First Trimester (1)
    • flame retardants (25)
    • Flint (1)
    • Food (3)
    • food additive (3)
    • food additive petition (2)
    • food additives (4)
    • Food Advisory Comittee (1)
    • food contact substances (1)
    • food dyes (1)
    • formaldehyde (15)
    • fragrances (1)
    • front group (13)
    • fT4 (1)
    • Funding (1)
    • GAO (1)
    • general interest (22)
    • Generally Recognizes as Safe (1)
    • George Washington University (1)
    • Georgia (1)
    • Georgia Health News (1)
    • Globally Harmonized System (GHS) (5)
    • Government Accountability Office (5)
    • GRAS (5)
    • haz (1)
    • hazard (6)
    • health-based benchmark (3)
    • High Production Volume (HPV) (23)
    • home buyers (1)
    • home sales (1)
    • Household action level (3)
    • HUD (5)
    • hypochlorite (2)
    • hypochlorite bleach (2)
    • Hypothyroxinemia (1)
    • ICC (1)
    • IEUBK (1)
    • in vitro (14)
    • in vivo (11)
    • Indiana (1)
    • industry tactics (45)
    • inf (1)
    • Infants (1)
    • informed substitution (1)
    • Infrastructure (1)
    • inhalation (18)
    • International Code Council (1)
    • IUR/CDR (27)
    • Japan (3)
    • Lautenberg Act (78)
    • LCR (2)
    • lead (37)
    • Lead 1950 (1)
    • lead and copper rule (4)
    • lead dust hazard (2)
    • Lead Dust Standards (1)
    • Lead Exposure (7)
    • lead hazard (2)
    • Lead in Drinking Water (9)
    • lead in food (1)
    • lead in water (1)
    • lead paint (2)
    • lead poisoning preventon (1)
    • Lead Service Line (4)
    • lead service line replacement (2)
    • Lead Service Lines (6)
    • lead-based paint (6)
    • Lead-safe (1)
    • lead-safe renovations firms (1)
    • lead-safe renovator (1)
    • Legislation (1)
    • Los Angeles (1)
    • LSHR (1)
    • LSL (1)
    • LSL Replacement Collaborative (1)
    • Mapping (1)
    • markets (1)
    • Markey (1)
    • MCHM (1)
    • mercury (4)
    • methyl eugenol (1)
    • methylene chloride (3)
    • methylmercury (2)
    • microbiome (3)
    • Milken Institute School of Public Health (1)
    • model (2)
    • NAAQS (1)
    • nanodelay (4)
    • nanosilver (6)
    • National Academy of Sciences (NAS) (20)
    • National Institute for Occupational Safety and Health (NIOSH) (7)
    • National Institute of Environmental Health Sciences (NIEHS) (5)
    • National Nanotechnology Initiative (NNI) (7)
    • National Toxicology Program (1)
    • NCHH (1)
    • NDWA (1)
    • NDWAC (2)
    • neurodevelopment (1)
    • Neurotoxin (1)
    • New chemicals (14)
    • Newark (1)
    • NHANES (2)
    • Nitrates (1)
    • NL Industries (1)
    • NMP (3)
    • NYC (1)
    • Oatmeal (1)
    • Obama (1)
    • obesity (6)
    • Occupational Safety and Health Administration (OSHA) (3)
    • Office of Information and Regulatory Affairs (OIRA) (4)
    • Office of Management and Budget (OMB) (16)
    • Office of Pollution Prevention and Toxics (OPPT) (3)
    • Ohio (1)
    • oil dispersant (18)
    • ortho-phthalate (1)
    • ortho-phthalates (2)
    • packaging (1)
    • paint (2)
    • PBDEs (19)
    • peer review (1)
    • Pennsylvania (2)
    • perchlorate (8)
    • Persistent Bioaccumulative and Toxic (PBT) (22)
    • personal care products (1)
    • pesticide (1)
    • pesticides (8)
    • PFOA (1)
    • Philadelphia (1)
    • phthalate (1)
    • phthalates (21)
    • pipes (1)
    • plastic packaging (1)
    • Podcast (9)
    • polycyclic aromatic hydrocarbons (PAH) (5)
    • Pregnant Women (1)
    • prenatal (6)
    • prioritization (40)
    • Private Property (1)
    • Pruitt (1)
    • Public Nuisance (1)
    • Public Water Supplier (1)
    • PWS Water Board (1)
    • Quigley (1)
    • real estate (1)
    • red (1)
    • Redfin (1)
    • Reference Dose (1)
    • Regulatory Accountability Act (3)
    • Regulatory Reform (1)
    • renovation (1)
    • rental (1)
    • renters (2)
    • report on carcinogens (1)
    • reproductive (2)
    • residential code (1)
    • revised CSIA (4)
    • Rice (1)
    • rice cereal (1)
    • right-to-know (1)
    • risk assessment (73)
    • Risk Communication (1)
    • risk evaluation (2)
    • RRP (1)
    • Safe Chemicals Act (24)
    • Safer Chemicals Healthy Families (33)
    • safety (2)
    • salami (2)
    • SB 1398 (1)
    • Science Advisory Board (1)
    • SDWA (1)
    • Seattle (1)
    • secrecy (1)
    • SHEDS (1)
    • Sherwin Williams (1)
    • Sierra Club (1)
    • Significant New Use Rule (SNUR) (23)
    • Small business (1)
    • snur (1)
    • soil (1)
    • soil lead hazard (1)
    • South Korea (4)
    • State Senator Levya (1)
    • styrene (7)
    • Substances of Very High Concern (SVHC) (15)
    • synthetic dyes (1)
    • systematic review (1)
    • T4 (1)
    • TBB (2)
    • TDS (1)
    • test rule (18)
    • Thiocyanate (1)
    • Toddlers (1)
    • toolkit (1)
    • total diet study (2)
    • Tox21 (5)
    • ToxCast (10)
    • toxic substances control act (1)
    • Transparency (2)
    • tributyltin (3)
    • trichloroethylene (TCE) (10)
    • TSCA inventory (2)
    • TSCA Modernization Act (15)
    • TSCA Reform (1)
    • TSCA Title IV (1)
    • Turkey (3)
    • U.S. states (19)
    • User Service Line (1)
    • Utility Commission (1)
    • Voluntary (1)
    • vulnerable populations (1)
    • Walmart (3)
    • Washington Post (1)
    • WebMD (1)
    • Wisconsin (2)
    • worker safety (24)
    • wristband (2)
    • WV chemical spill (12)
    • yellow (1)
    • York (1)
    • Zillow (1)