Setting the record straight: Response to American Academy of Pediatrics report

You may have read or heard about a recent report by the American Academy of Pediatrics (AAP) that is creating concerns about the safety of food packaging, additives and plastics containers. Unfortunately, the report has created the false idea that the U.S. Food and Drug Administration (FDA) is not doing enough to ensure the safety of the products Americans use and consume.

The public deserves better from organizations like AAP, and a report like this should be closely vetted for scientific accuracy before being published. We believe most medical professionals and scientists would agree that is a reasonable expectation.

Current Food Packaging Regulations

We should always consider how we can improve our laws and regulatory systems, but the reality is that food packaging in the U.S. is best in class. They are strictly regulated by the FDA using comprehensive legal and regulatory checks that apply rigorous scientific standards for health and safety.

The fact is that all food packaging materials are regulated by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are comprehensive and science-based. FDA has an entire office—the Division of Food Contact Notifications—employing chemists, toxicologists and other scientific staff with extensive knowledge and training that evaluate the safety and environmental impact of chemicals used to produce packaging.

And contrary to the recent statements from AAP, the FDA evaluates the safety of food packaging materials under conditions where they will be used, including heating and cooking conditions such as in the microwave. Many manufacturers of food containers also label these products to help consumers know when they are safe for use in a microwave.

The Importance of Modern Food Packaging

Modern food packaging, which depends on a variety of innovative chemistries, is essential to the quality and integrity of food, extends shelf life and helps in the safe transport and storage of food. Without it, many people would not have as much access to fruits, vegetables, meat and other important staples of a healthy diet. The reality is that not everyone, especially in low income areas, has access to fresh food straight from the farm.

For example, a cucumber wrapped in plastic can stay fresh for up to 14 days, while an unwrapped cucumber stays fresh for about five days. Also, every year in the United States, people throw away up to 40 percent of the meat, poultry and seafood they purchase. Vacuum-sealed plastic packaging is key to preventing oxidation of meats. It can double the amount of time red meat stays fresh, taking shelf life from about three days to about six.

Providing the Facts

To help provide facts about the issue, we’ve put together a myth and fact sheet below.

ROBUST & TRANSPARENT REGULATION

MYTH: Food packaging is a public health threat in the US.

FACT: Food packaging in the U.S. is best in class for health and safety. It is strictly regulated by the U.S. Food and Drug Administration, using a comprehensive legal and regulatory framework that applies rigorous scientific standards of safety. The agency regulates the safety of substances added to food, as well as how most food is processed, packaged, and labeled in the United States. As part of its regulatory process, FDA conducts pre-market review of most compounds.

FDA regulates all food packaging materials “from which components can reasonably be expected to migrate into a food. The agency’s safety evaluations focus on three factors. These include the cumulative exposure to food contact substances that migrate into foods and beverages, the nature of the packaging components, and the safe levels of exposure.” https://www.fda.gov/food/ingredientspackaginglabeling/foodadditivesingredients/ucm355155.htm

MYTH: Food packaging isn’t well-regulated.

FACT: All food packaging materials are regulated by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are comprehensive and science-based. FDA has an entire office—the Division of Food Contact Notifications—employing chemists, toxicologists, and other scientific staff with extensive knowledge and training that evaluate the safety and environmental impact of chemicals used to produce packaging.

Safety assessments are thorough. FDA says “an assessment of the safety of a food substance generally involves an evaluation of information about its safety and functionality including all studies and tests of a food additive on animals and humans and all studies and tests of a food additive for identity, stability, purity, potency, performance, and usefulness.” https://www.fda.gov/Food/GuidanceRegulation/ucm300661.htm#IIA

MYTH: The migration, or the transfer of chemicals from packaging to food, is a surprising new discovery.

FACT: Migration, or the transfer of chemicals from packaging to food, is at the heart of how FDA regulates the safety of food packaging. FDA’s regulations take into account the fact that substances can transfer from packaging into food by requiring the amount of migration and potential dietary exposure to be demonstrated to be safe on the basis of available toxicological data. Different foods need different kinds of packaging. For example, some foods are well-known to be acidic—like tomato products and orange juice. The packaging selected for these products needs to “stand up” to the food. Liquids and “wet” foods can’t be packaged directly in paper and cardboard or they will soak through. One of the reasons plastics are so popular for use in food contact is that they are considered inert (resistant to the breakdown into food) and non-toxic, in addition to having other qualities (such as water resistance and resistance to acidic foods).

MYTH: FDA doesn’t review all food packaging materials for safety.

FACT: FDA has different levels of review depending on the substance and use. For substances that migrate into food, FDA reviews the safety of those substances through the Food Contact Notification program. If a substance doesn’t migrate into food at all, consumers won’t have dietary exposure to it, and FDA doesn’t need to review and approve it in advance – like the printing on the exterior of a metal can. FDA makes these exceptions on a case by case basis. Some food additives are also considered Generally Recognized As Safe (GRAS) substances. General recognition of safety requires general agreement among the experts in a field, based on published data indicating that a substance will be safe for its intended use.

MYTH: Safety laws for food packaging are outdated.

FACT: FDA overwhelmingly conducts its review of food-contact materials through the Food Contact Notification (FCN) program, which is considered by experts to be a highly successful and transparent regulatory process. Under this program, a manufacturer or supplier of a food-contact material must provide objective data for the manufacturing, chemistry, toxicology, and environmental aspects of the production and its use of the food-contact material along with information supporting the conclusion that the material is safe for the intended use.

In addition to the FNC program, Congress passed the Food Safety Modernization Act (FSMA) in 2010 to modernize food safety oversight by mandating a new approach that incorporates updated and contemporary scientific principles and risk analysis.

MYTH: Imported foods aren’t regulated by FDA at all.

FACT: All packaging material that is used in contact with food in the United States must comply with U.S. laws and regulations, including packaging materials that are produced abroad. Indeed, many manufacturers produce materials for sale worldwide. They often rely upon a clearance and/or a safety determination established under the U.S. regulatory system to support sale of the product in other countries.

MYTH: FDA doesn’t do ongoing, updated reviews of food-contact materials after the initial review.

FACT: FDA conducts ongoing safety reviews of important food contact materials where needed.

After a material is cleared by FDA, the agency continues to monitor public information and safety data that may question whether the use of the material continues to be safe. FDA can also consider the safety of approved materials in stakeholder petitions and routinely does so.

Example: BPA. FDA has been very active in ongoing safety reviews of BPA, and it continues to confirm its safety. In the fall of 2014, FDA experts, specializing in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields, completed a four-year review of more than 300 scientific studies. In addition, the CLARITY Core Study—the largest, most significant study ever conducted on BPA—was undertaken by expert scientists at an FDA laboratory.

Example: ADA. FDA has been very active in ongoing safety reviews of azodicarbonamide, a chemical substance approved for use as a whitening agent in cereal flour and as a dough conditioner in bread baking. FDA approved the use of ADA as a food additive in cereal flour and as a dough conditioner based on a comprehensive review of safety studies, including multi-year feeding studies. FDA has continued to evaluate the safe use of ADA in foods. In 2016, the agency conducted a comprehensive exposure assessment of semicarbazide (SEM) —a breakdown chemical that forms from ADA during bread making. This exposure assessment was presented at the 251st National Meeting of the American Chemical Society on March 15, 2016.

HEALTH & SAFETY

MYTH: Food packaging isn’t safe for infants and children.

FACT: Infants and children are considered in FDA’s reviews. When a manufacturer or the FDA evaluates a packaging material, one of the primary considerations is the intended use. In all cases, the safety of a packaging material is determined on the basis that there is the potential for exposure to a material through the entirety of a person’s lifetime. In some cases, there may be reason to believe that infants and children may have the potential for heightened exposure because one particular type of packaging material is used in contact with a high percentage of the diet. A good example of this is infant formula, where an infant may consume all of its formula from one specific packaging type. For many years, FDA has paid particular attention to the safety and nutrition provided by infant formula. Manufacturers are required to notify FDA before placing infant formula on the market, and the packaging material is one component of the notification.

Both FDA and packaging manufacturers have increased their focus on the safety of packaging materials that could be used in contact with food for infants and children in response to new developments in the areas of infant toxicology and developmental toxicology. The safety evaluation for such materials may require separate consideration of the potential dietary exposure to infants, accounting for the smaller body weight of infants and children, and the potential for high level intake of certain foods. This separate evaluation may result in the need for additional toxicity data to support safety and to address additional infant-specific considerations.

MYTH: Plastic food packaging could potentially disrupt human endocrine systems.

FACT: FDA’s review of plastics used in food contact considers science on the potential effects on human reproduction and development (where needed). In addition, while the science of better understanding endocrine active substances is still developing, it is clear that many of the foods contained in food packaging are themselves endocrine active. Some examples include soy milk, tofu, flaxseed, whole grains, beans, vegetables, berries, and nuts. While some advocacy groups have alleged broad concerns about plastic packaging, they’ve been heavily criticized for failing to explain that endocrine active substances can also have no effect at all or can have healthy effects. FDA itself is careful to explain that endocrine disruptors, which it considers to have adverse human health effects, are not the same thing as the much broader category of endocrine active substances. Some advocacy groups improperly conflate these concepts or use European definitions that the FDA doesn’t, which creates confusion.

MYTH: People should avoid plastics in the microwave or dishwasher.

FACT: FDA evaluates the safety of food packaging under conditions where it will be used, including heating and cooking conditions such as in the microwave. The bottom line is to follow manufacturers’ directions. Containers appropriate for use in the microwave will have instructions for microwave use or will say they are “microwave-safe” or have a corresponding logo.[1]

FDA says it best: “Use microwave-safe containers. Use cookware specially manufactured for use in the microwave oven.” Guidance also says, “And you should not use some plastic containers because heated food can cause them to melt. The FDA recommends using glass, ceramic, and plastic containers labeled for microwave oven use.”[2]

FDA has issued guidance specific to melamine, which is appropriate to serve food but not designed for the microwave: “[f]oods and drinks should not be heated on melamine-based dinnerware in microwave ovens.”[3]

The Harvard Medical School points out that “[c]ontrary to popular belief, some Styrofoam and other polystyrene containers can safely be used in the microwave. Just follow the same rule you follow for using other plastic containers in the microwave: Check the label.”[4]

MYTH: Chemicals of “increasing concern” include bisphenols, phthalates, nonpersistent pesticides, perfluoroalkyl chemicals (PFCs), and perchlorate.

FACT: This myth implies that FDA has reached such a conclusion, which it has not. This is the editorial opinion of the authors. FDA withdraws approvals of food contact substances that do not meet safety requirements. 

MYTH: The same scientific concerns apply to all chemicals in a group that sound the same—like “bisphenols,” “phthalates,” or “perfluoroalkyl chemicals.”

FACT: Chemicals with similar sounding names, or that seem to be part of the same family, don’t always have a similar toxicological profile. For example, petroleum is something you put in your car, but petroleum jelly is something the American Academy of Dermatology recommends parents use to treat diaper rash. Assertions that an entire group of chemicals all share the same qualities should be viewed with skepticism and not relied upon unless properly supported.

MYTH: BPA, used in the lining of metal cans, is an increasing health concern.

FACT: FDA has continually reviewed BPA in recent years and confirms that “based on its most recent safety assessment… BPA is safe at the current levels occurring in foods.”

FACT: The CLARITY study, conducted by FDA senior scientestits for the express purpose of resolving any remaining uncertainties about the safety of BPA, is the largest study ever conducted on BPA. The study results (released earlier this year) indicate that BPA has very little potential to cause health effects, even when people are exposed to it throughout their lives. In a statement released by Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at FDA, BPA’s safety is reaffirmed: “our initial review supports our determination that currently authorized uses of BPA continue to be safe for consumers.”

There is no mention of the CLARITY study in the technical report, related policy statement or news statement from AAP, despite AAP acknowledging BPA “has been the focus of significant research and attention.”

The myth that this health concern is “increasing” is also factually unfounded not just based on science, but also based on actual can manufacturing practices, which have shifted to different plastic linings for cans. As of early 2018, the Can Manufacturers Institute reported that at least 90 percent of today’s food cans contain different linings, typically acrylic and polyester.[5]

MYTH: People should avoid certain plastics with recycling codes (3), (6) and (7).

FACT: Recycling codes are available to help identify and sort plastics for recycling – they have nothing to do with the health and safety of the plastics. In fact, all plastics approved by FDA for use in contact with foods have met the same stringent safety standard. Consumers should feel confident that they can use plastic food packaging in accordance with manufacturer’s directions.

Some advocacy groups have targeted PVC, epoxy resin can linings with BPA, and polystyrene as somehow less “safe” than other plastics, and this seems to drive the associated “recommendations” tied to recycling codes. This is misplaced. Consumers should feel confident to use any FDA-approved food packaging as meeting the same standard of safety. Beyond that:

  • Little to no consumer food contact packaging is PVC in the first place (#3).
  • The #7 code is a “catchall” for other and new plastics, including those that are made from bio-based products such as corn, potato starch and sugar cane, as well as plastics that have acrylic, fiberglass, nylon and so forth. Epoxy-resin lined metal cans do not carry a plastic recycling code because the can is recycled as a steel can, not with the plastic recycling stream.
  • Polystyrene, the #6 code, is widely used in foodservice. Some suggested a recent NTP review cast doubt on its decades of safe use, but NTP Director Dr. Linda Birnbaum, Ph.D. debunked that in June 2011, saying: “[l]et me put your mind at ease right away about [polystyrene foam] … [the levels of styrene from polystyrene containers] are hundreds if not thousands of times lower than have occurred in the occupational setting…In finished products, certainly styrene is not an issue.”[6]

MYTH: Number #3 plastics contain phthalates.

FACT: The word “phthalate” is often used to describe a family of more than a dozen chemicals, many of which are used to add flexibility to polyvinyl chloride (PVC, or vinyl). Most food packaging does not contain phthalates because the plastic used is either not vinyl or is rigid vinyl made without plasticizers such as phthalates. In fact, the vast majority of plastic food packaging is polyethylene, PET, polypropylene, and polystyrene. Silicone is also popular in home cookwear.

FACT: The #3 recycling code denotes PVC plastic for purposes of recycling and collection. But PVC has very little use in consumer foodcontact packaging in the U.S.[7] 

MYTH: Perfluoroalkyl chemicals (PFCs), used in grease-proof food packaging and paper, are a concern.

FACT: Some PFC compounds are FDA-approved for use in food contact; others are not used in this application. The PFC compounds that are currently allowed to be used in food packaging are supported by a robust body of data demonstrating that these materials are safe for their intended use. These data show PFHxA does not exhibit carcinogenicity, mutagenicity, or genotoxicity. PFHxA is not an endocrine disruptor. PFHxA also does not exhibit adverse effects on reproduction, and developmental effects are mixed and occur at higher doses than other endpoints.

Data demonstrate that there is a high margin of safety for human exposure to PFHxA, including infants and children, from all routes of exposure and from food contact materials in the U.S. For example, a recent study found that potential exposure to infants up to 12 months of age from PFHxA in infant formula resulted in the highest estimated daily intake of 1 ng/kg-day, which is 320,000 times lower than the daily human threshold value derived by the French Directorate of Health.

MYTH: Perchlorate, a degradation product of bleach used to clean food manufacturing equipment, is a concern.

FACT: There is only one minor use of perchlorate in the food industry—as an antistatic agent in bulk dry food containers. It has been scientifically-demonstrated that there is no migration of perchlorate to food resulting from this application, which was central to FDA’s 2017 denial of a petition to ban the use of perchlorate in food-contact applications.

MYTH: Perfluoroalkyl chemicals (PFCs), used in grease-proof food packaging and paper, are a concern.

FACT: There are many PFC compounds used for many different things. Some are FDA-approved for use in food contact; others are not used in this application. The specific PFC compounds that FDA allows to be used in food packaging— and that are actually used in food packaging—do not contain, and cannot degrade to, perfluorohexane sulfonic acid (PFHxS), perfluorobutane sulfonate (PFBS), perfluorononanoic acid (PFNA), perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS)). 

MYTH: A chemical was reported to have been used in a particular food contact application five or ten years ago, so it must still be in use today.

FACT: Every year, new chemistries, formulations, and materials are developed with different properties to respond to the dynamic marketplace.

The fact that a particular chemical may have once been used in a particular food contact application does not mean that it is used today. The same is true with food contact materials like plastics.

A great example of this is glass condiment jars. Just a few years ago, the use of glass jars for ketchup and mayonnaise was more prevalent. Increasingly, plastic jars are used because they don’t break and because they’re lighter, they reduce shipping weight and fuel use. Data from just five years ago making claims about the use of glass or plastic for condiment packaging would already be outdated.


[1] FDA: “”Consumers can be confident as they heat (meals) or leftovers in the microwave that the FDA carefully reviews the substances used to make plastics designed for food use.” https://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/2002/602_plastic.html

[2] https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048953.htm

[3] https://www.fda.gov/food/resourcesforyou/consumers/ucm199525.htm

[4] https://www.health.harvard.edu/staying-healthy/microwaving-food-in-plastic-dangerous-or-not

[5] https://www.packagingdigest.com/food-packaging/most-food-cans-no-longer-use-bpa-in-their-linings-2018-02-20

[6] Associated Press, June 2011.

[7] “There are hundreds of plastics, but only very few are utilized in food packaging. The most common are polyolefin, copolymers of ethylene, substituted olefins, polyesters, polycarbonate, and polyamide (nylon). PET/polypropylene (PP) laminates with different barrier materials such as polyvinylidene chloride (PVDC), ethylene‐vinyl alcohol (EVOH), or polyethylene (PE) to provide improved structures.” See https://onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12028

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