FDA Release Webpage on Microplastics and Nanoplastics in Foods

There has been increasing news on microplastics and nanoplastics in our food supply.  FDA published a webpage to share their current thinking on the topic. 

Here are some of the items of note:

• Plastics "originate when then break down from weathering in the environment over time into small particles called microplastics and nanoplastics."
• Environment a more important source than migration from food packaging - "Microplastics and nanoplastics may be present in food, primarily from environmental contamination where foods are grown or raised. There is not sufficient scientific evidence to show that microplastics and nanoplastics from plastic food packaging migrate into foods and beverages."
• No demonstrated impact on health  - "While many studies have reported the presence of microplastics in several foods, including salt, seafood, sugar, beer, bottled water, honey, milk, and tea, current scientific evidence does not demonstrate that the levels of microplastics or nanoplastics detected in foods pose a risk to human health".
• More research is needed - "While there are many studies on microplastics in food, the current state of science is limited in its ability to inform regulatory risk assessment. This is due to several factors, including a continued lack of standardized definitions, reference materials, sample collection and preparation procedures, and appropriate quality controls, to name a few. There have been fewer studies on nanoplastics because available scientific measurement methods are not very reliable at detecting polymer particles with such small sizes."

https://www.fda.gov/food/environmental-contaminants-food/microplastics-and-nanoplastics-foods
Microplastics and Nanoplastics in Foods

Key Points:

• Some evidence suggests that microplastics and nanoplastics are entering the food supply, primarily through the environment.
• Current scientific evidence does not demonstrate that levels of microplastics or nanoplastics detected in foods pose a risk to human health.
• The FDA continues to monitor the research on microplastics and nanoplastics in foods and is taking steps to advance the science and ensure our food remains safe.

Plastics are used in a wide array of consumer and industrial products including toys, household appliances, cosmetics, medical applications, automotive parts, textiles, packaging, and building and construction materials. Limited amounts of plastics are recycled or incinerated, leaving most plastic waste to accumulate in landfills and the environment. Plastic pollution can be found throughout the environment from land to streams and inland waterways to the coast and the ocean. Most plastics do not biodegrade and instead break down from weathering in the environment over time into small particles called microplastics and nanoplastics.

Microplastics and nanoplastics may be present in food, primarily from environmental contamination where foods are grown or raised. There is not sufficient scientific evidence to show that microplastics and nanoplastics from plastic food packaging migrate into foods and beverages. People may be exposed to microplastics and nanoplastics through the air, food, and absorption through the skin from the use of personal care products.

Microplastics and nanoplastics are found in a wide variety of sizes, shapes, and colors, as well as varying polymer types, states of degradation, and presence of chemical additives included in plastics during the manufacturing process. Microplastics are very small pieces of plastic that are typically considered less than five millimeters in size in at least one dimension. Microplastics can be manufactured to be that size, such as resin pellets used for plastic production, or degraded to that size from larger plastics discarded into the environment. Nanoplastics are even smaller, typically considered to be less than one µm, or micron, in size. For reference, the diameter of a human hair is about 70 microns. The FDA provides these descriptions of size for reference; however, there are currently no standard definitions for the size of microplastics or nanoplastics. This complex variety of characteristics makes the unique identification and assessment of their potential impacts challenging.

The presence of environmentally derived microplastics and nanoplastics in food alone does not indicate a risk and does not violate FDA regulations unless it creates a health concern. While many studies have reported the presence of microplastics in several foods, including salt, seafood, sugar, beer, bottled water, honey, milk, and tea, current scientific evidence does not demonstrate that the levels of microplastics or nanoplastics detected in foods pose a risk to human health. Additionally, because there are no standardized methods for how to detect, quantify, or characterize microplastics and nanoplastics, many of the scientific studies have used methods of variable, questionable, and/or limited accuracy and specificity.

The FDA continues to monitor the research on microplastics and nanoplastics. If the FDA determines, based on scientific evidence, that microplastics or nanoplastics in food, including packaged food and beverages, adversely affect human health, the FDA can take regulatory action to protect public health.

Health Effects Information

Microplastics and nanoplastics have been found in human samples, including urine, stool, blood, and organs, but there is not enough known about their potential health effects and more research is needed to fill data gaps. The U.S. Agency for Toxic Substances and Disease Registry formed a microplastics workgroup in partnership with the Centers for Disease Control and Prevention’s National Center for Environmental Health to define human health risks from microplastics and nanoplastics. They are studying the short and long-term effects on public health and will share their findings with scientists when published.

While some studies suggest there may be impacts to human health from exposure to microplastics and nanoplastics, the overall scientific evidence does not demonstrate that levels of microplastics or nanoplastics found in foods pose a risk to human health. The FDA will continue to monitor this issue and if it determines, based on scientific evidence, that microplastics or nanoplastics in food, including packaged food and beverages, are harmful to human health, the FDA will take regulatory action to protect public health.

Scientific Information

The FDA is aware of many studies on microplastics, and limited studies on nanoplastics, in the food supply, but significant research gaps exist. While there are many studies on microplastics in food, the current state of science is limited in its ability to inform regulatory risk assessment. This is due to several factors, including a continued lack of standardized definitions, reference materials, sample collection and preparation procedures, and appropriate quality controls, to name a few. There have been fewer studies on nanoplastics because available scientific measurement methods are not very reliable at detecting polymer particles with such small sizes.

Plastics range widely in terms of their characteristics and applications, creating difficulties in the ability to assess their potential toxicity and impact on human health. Some are created to be strong and rigid, while others are created to be flexible. They also range in density. Plastics may be produced with chemicals added during the manufacturing process, such as flame retardants, antimicrobial agents, or fillers, or some can be created as a blend or composite of materials. These varying characteristics affect how plastics degrade in the environment as they turn into microplastics and nanoplastics. Several scientific studies suggest potential toxicity would be a function of many variables and would need to consider characteristics like exposure, polymer type, and size and shape, among others.

Without standard, validated methods for sampling, sample preparation, detection, and characterization, scientists struggle to compare studies and reach reliable conclusions about current research on microplastics and nanoplastics. Variability in analytical methods for identifying, characterizing, and quantifying microplastics and nanoplastics creates barriers to assessing potential human health effects. Scientists at the FDA examined the state of knowledge about microplastics and nanoplastics in food and provided a general approach for developing, validating, and implementing analytical methodsExternal Link Disclaimer for the purpose of regulatory decision-making regarding microplastics and nanoplastics in food. But the FDA concludes that more research is needed before the agency can assess potential effects of microplastics and nanoplastics on human health.

The FDA continues to monitor the research while also working to advance the science through analysis of testing methodologies and other related work, including participation in the U.S. Government Nanoplastics Community of Interest and the new White House Interagency Policy Committee on Plastic Pollution and a Circular Economy.

Regulatory Information

Federal Regulations

There are no FDA regulations that authorize microplastics or nanoplastics as ingredients added to our foods. For plastics used in food contact applications, including packaging, processing equipment, food preparation surfaces, or cookware, the law requires that all materials used in products that come into contact with food are authorized by the FDA before being marketed for such use. As part of this process, the FDA analyzes testing data that demonstrate the amount of migration of a food contact substance to food based on its intended condition of use and toxicological data to ensure that the consumer exposure resulting from this migration is safe.

Food Packaging & Other Substances that Come in Contact with Food Information for Consumers
Understanding How the FDA Regulates Substances that Come into Contact with Food

It is the legal responsibility of companies that grow or produce foods, or manufacture products intended for use with foods sold in the U.S., to comply with the Federal Food, Drug, and Cosmetic Act and FDA’s regulations.

If the FDA determines that levels of microplastics or nanoplastics cause food to be unsafe, the agency will take regulatory action. This may include working with the manufacturer to resolve the issue, and as necessary, taking steps to prevent the product from entering, or remaining on, the U.S. market.

Bottled Water

Several studies have found microplastics and nanoplastics in both tap and bottled water; however, at this time, the scientific evidence does not demonstrate that levels of microplastics or nanoplastics in water pose a risk to human health. The presence of microplastics and nanoplastics in water alone, does not indicate a risk and does not violate FDA regulations unless it creates a health concern. Learn more about how the FDA keeps bottled water safe to drink.

Bottled water processors must comply with FDA regulations, or their products may be deemed adulterated or misbranded and the firm and/or the products may be subject to compliance advisory actions (for example, a Warning Letter) or enforcement actions (for example, seizure or injunction).

More information on FDA bottled water regulations:

21 CFR Part 129—Processing and Bottling of Bottled Drinking Water

21 CFR Part 165.110 – Bottled Water

The U.S. Environmental Protection Agency sets limits for contaminants in drinking (tap) water, but there currently are no regulatory levels set for microplastics or nanoplastics in drinking water.