Per and Polyfluoroalkyl Substances (PFAS)
Per- and polyfluoroalkyl substances (PFAS) are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 different types of PFAS, some of which have been more widely used and studied than others. Many PFAS are resistant to grease, oil, water, and heat. For this reason, beginning in the 1940’s, PFAS have been used in a variety of applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints, and fire-fighting foams. Certain PFAS are also authorized by the FDA for limited use in cookware, food packaging, and food processing equipment.
The widespread use of PFAS and their ability to remain intact in the environment means that over time PFAS levels from past and current uses can result in increasing levels of environmental contamination. Accumulation of certain PFAS has also been shown through blood tests to occur in humans and animals. While the science surrounding potential health effects of this bioaccumulation of certain PFAS is developing, evidence suggests it may cause serious health conditions.
To advance knowledge of potential exposure to PFAS from food, the FDA conducts limited testing of foods from the general food supply. The FDA also conducts limited testing of food grown or processed in areas with environmental contamination to detect and evaluate potential contamination of human and animal food.
In addition, as part of the FDA’s role in authorizing substances for use in food contact applications, we monitor developments in scientific data on authorized substances, including those containing PFAS. As with all authorized food contact substances, when the FDA identifies health concerns associated with the food contact use of specific substances containing PFAS, we take action to ensure that these substances are no longer used in food contact applications.
As the science on PFAS advances, the FDA will continue working with other Department of Health and Human Services agencies including the National Institutes of Health and the Centers for Disease Control and Prevention, as well as other federal agencies, including the U.S. Environmental Protection Agency, the U.S. Department of Agriculture, and the U.S. Department of Defense, in addition to our state and local partners, to identify routes of PFAS exposure, understand associated health risks, and reduce the public’s exposure to those health risks.
For more information and recent announcements, please visit:
- Statement from FDA Commissioner Stephen M. Hahn, M.D., and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition: FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging (July 31, 2020)
- Constituent Update: FDA Announces the Voluntary Phase-Out by Industry of Certain PFAS Used in Food Packaging (July 31, 2020)
- Questions and Answers (July 31, 2020)
To ensure that food contact substances used in packaging, cookware, and food processing equipment are safe for their intended use, the FDA conducts a rigorous review of scientific data prior to their authorization. Prior to 2000, the FDA authorized the use of food contact substances through the food additive petition process, which resulted in a regulation establishing safe conditions of use in Title 21 of the Code of Federal Regulations. Since 2000, the FDA authorizes the use of food contact substances through the Food Contact Notification (FCN) program. The Inventory of Effective Food Contact Substance (FCS) Notifications is a publicly available database of all uses of food contact substances authorized through the FCN program.
Certain PFAS are currently authorized for use in specific applications related to their non-stick and grease, oil, and water-resistant properties. Whether these PFAS migrate to food depends on the molecular structure of the PFAS and the conditions of use. For example, the PFAS used in non-stick coatings on cookware and sealing gaskets for food processing equipment do not migrate to food. However, PFAS used to make oil- and water-resistant coatings on paper food packaging have the potential to migrate to food. The specific authorized uses for PFAS in food packaging take into consideration this potential for migration and these authorized uses are limited to ensure safe levels of exposure.
The FDA reviews updated scientific information on food contact substances as it becomes available. The agency can revoke food contact authorizations when scientific data demonstrate that the authorized uses of a food contact substance are no longer safe. In addition, the FDA can also work with industry to remove food contact substances from the market through voluntary agreements. For example, the FDA has reached voluntary agreements with manufacturers to phase out their sales of certain PFAS authorized for use in food contact applications.
Market Phase-Out of Certain Short-Chain PFAS
There are 15 Food Contact Notifications (FCNs) held by four manufacturers for 11 compounds that may contain a short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH). In the spring of 2020, the FDA published findings from a post-market scientific review and analysis of data from rodent studies. The data raise questions about the potential human health risks from dietary exposure resulting from authorized food contact applications for short-chain PFAS that contain 6:2 FTOH. Because the data showed biopersistence of 6:2 FTOH in rodents and a higher level of toxicity compared to other types of short-chain PFAS, along with a lack of long-term data on the safety of these substances, the FDA contacted the manufacturers to discuss data needs with respect to the potential human health risks from these authorized food contact uses.
In July 2020, three manufacturers voluntarily agreed to a 3-year phase-out of their sales of these compounds for use in food contact applications in the United States, beginning in January 2021. After the 3-year period, it is anticipated that it may take up to 18 months to exhaust existing stocks of products containing these food contact substances from the market. The fourth manufacturer informed the FDA in 2019 that it had already stopped sales of its food contact substances that may contain 6:2 FTOH for food contact use in the U.S. market.
To read the commitment letters from industry, please visit:
- Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) (PDF: 380KB)
- AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) (PDF: 324KB)
- Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020) (PDF: 470KB)
- The Chemours Company Commitment Letter Regarding FCN No. 940 (August 2019) (PDF: 126KB)
- The Chemours Company Commitment Letter Regarding FCN Nos. 885 and 1027 (August 2019) (PDF: 129KB)
To read the FDA’s letters to industry acknowledging receipt of industry commitment letters, please visit:
- Acknowledgement Receipt to Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) (PDF: 57KB)
- Acknowledgement Receipt to AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) (PDF: 69KB)
- Acknowledgement Receipt to Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020) (PDF: 85KB)
- Acknowledgement Receipt to The Chemours Company Commitment Letter Regarding FCN Nos. 940, 885 and 1027 (July 2020) (PDF: 68KB)
Short-chain PFAS have 7 or less carbons (typically 6 carbons) and replaced long-chain PFAS as grease-proofing agents used in food contact paper and paperboard applications after the long-chain PFAS stopped being used due to safety concerns in 2011. Manufacturers of short-chain grease-proofing agents obtained authorization for the use of these substances in food contact paper packaging applications through the FDA’s Food Contact Notification (FCN) process.
At the time the FCNs for short-chain PFAS became effective, the scientific data available to FDA showed they were a safe alternative to the long-chain PFAS and did not indicate any potential for biopersistence. Subsequent studies on short-chain PFAS continued to be conducted after the FCNs became effective, and the FDA has continued its analysis of these data as they became available. In 2020, FDA researchers published two papers pertaining to additional available information on short-chain PFAS.
The first paper described the biopersistence of 6:2 FTOH in rodents. The second paper reviewed the available data in rodents, comparing the toxicity and biopersistence of 6:2 FTOH and another SC-PFAS, perfluorohexanoic acid (PFHxA). PFHxA has been proposed in the scientific literature as a representative substance when assessing toxicity for some short-chain PFAS. However, many SC-PFAS contain 6:2 FTOH either as a constituent or an impurity or may be metabolized or converted to 6:2 FTOH. FDA’s review found that 6:2 FTOH, in rodents, biopersists whereas PFHxA does not, and that 6:2 FTOH is more toxic than PFHxA. As a result, the FDA concluded that 6:2 FTOH is a more representative substance in evaluating the safety of certain short-chain PFAS that contain 6:2 FTOH.
For recent scientific articles from FDA researchers, please visit:
- Characterizing Biopersistence Potential of the Metabolite 5:3 Fluorotelomer Carboxylic Acid After Repeated Oral Exposure to the 6:2 Fluorotelomer Alcohol. (2020)
- Comparative analysis of the toxicological databases for 6:2 fluorotelomer alcohol (6:2 FTOH) and perfluorohexanoic acid (PFHxA). (2020)
Long-Chain PFAS
In 2011, the FDA obtained voluntary agreements with the manufacturers of certain long-chain PFAS compounds authorized under food contact notifications to remove those substances from food contact applications. In 2016, the FDA revoked the regulations that authorized the remaining uses of these long-chain PFAS in food packaging.
For more information about these FDA actions, please visit:
- Update on Perfluorinated Grease-proofing Agents
- FDA Removes Approval for the Use of PFCs in Food Packaging Based on the Abandonment (11/21/2016)
- FDA Revokes Food Additive Approval for the Use of Long-Chain Perfluorinated Compounds as Oil and Water Repellents for Paper Used in Food Packaging (12/31/2015)
PFAS can enter the food chain through environmental contamination, such as when crops are grown in contaminated soil or water is used from a contaminated source. Typically, contaminated groundwater and soil is limited to a specific geographic area, for example, near an industrial facility where PFAS were produced or used to manufacture other products, or an oil refinery, airfield or other location at which PFAS-containing products were used for firefighting.
Measuring PFAS concentrations in food, estimating dietary exposure, and determining the associated health effects is an emerging area of science. FDA scientists are at the forefront of developing new and more sensitive testing methods to measure low levels of PFAS in foods. In October 2019, the FDA made available the first single-lab validated method for testing for certain specific PFAS in a diverse group of foods. While the FDA continues to lead national efforts to estimate overall dietary exposure to PFAS, this is an important step in furthering collaboration between the FDA and states in assessing the safety of human and animal food from specific areas potentially affected by environmental contamination.
For the scientific method, please visit:
- Determination of 16 Per and Polyfluoroalkyl Substances (PFAS) in Food using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) (Version 2019).
It is important to note that PFAS contamination in the environment (air, water, and soil) where food is grown does not necessarily mean the food itself will contain detectable PFAS. This is because the amount of PFAS taken up by foods depends on many factors, including the specific type of PFAS and characteristics of the food. Limited FDA testing for certain PFAS chemicals has found that most foods have no or very low levels of PFAS.
When there is evidence of PFAS in food, the FDA conducts a safety assessment using the best available current science to evaluate whether the levels present a possible human health concern. Throughout this process, the FDA works closely with our federal partners as well as with state and local officials to assess each situation and take appropriate next steps.
The FDA safety assessment method used for chemical contaminants considers how much people eat of the specific food and the toxicity of the specific contaminant(s) to characterize the human health concern. When analyzing food that may contain PFAS because of environmental contamination, the FDA has used the Environmental Protection Agency’s reference doses (RfD) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), of 0.02 μg/kg bw/day as an appropriate toxicity reference value. This focus on PFOA and PFOS is because they are the two types of PFAS that have been produced in the largest quantities in the U.S. and are among the most studied.
- Dairy, 2018-2019: Samples were collected from two dairy farms (Farm A & Farm B) with PFAS contamination of groundwater. Based on the best available current science, the FDA has no indication that the levels of PFAS found in the limited sampling of milk from Farm B and cheese from Farm A present a human health concern. Milk samples from Farm A had levels of PFAS that were determined to be a potential human health concern and all milk from that farm was discarded and did not enter the food supply.
- Produce, 2018: Produce samples were analyzed from an area with PFAS environmental contamination, in addition to 1 sample purchased outside of the area as a control. Sixteen of the 20 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that these substances, at the levels found in the limited sampling, present a human health concern.
- Cranberries, 2016: Cranberry samples analyzed from a bog containing water with PFAS contamination. None of the 42 cranberry samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions.
- Produce, meat, dairy, and grain products, 2019: In 2019, samples that had been collected as part of the FY2018 Total Diet Study were analyzed for 16 types of PFAS chemicals. The sample sizes are limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that the PFAS at the levels found in the limited sampling present a human health concern.
- Results from the first set of TDS samples analyzed showed that two of the 91 samples had detectable levels of one type of PFAS
Analytical Results for PFAS in 2019 Total Diet Study Sampling (Parts Per Trillion)— Dataset—1 (PDF: 566 KB) - Results from the second set of TDS samples analyzed showed that one of the 88 samples had a detectable level of one type of PFAS.
Analytical Results for PFAS in 2019 Total Diet Study Sampling (Parts Per Trillion)— Dataset—2 (PDF: 538 KB)
- Results from the first set of TDS samples analyzed showed that two of the 91 samples had detectable levels of one type of PFAS
- Bottled Water, 2016: Samples of domestic and imported carbonated and non-carbonated bottled water were collected at retail locations in the Washington, D.C. metropolitan area and analyzed for PFAS. The samples included: purified, artesian, spring, mineral, and carbonated waters. None of the 30 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions.
- Seafood, 2013: Fish and shellfish samples from 13 species of fresh and saltwater fish from across the country were analyzed for PFAS. Eleven of the 46 samples had detectable levels of PFAS. This sample size is limited and cannot be used to draw definitive conclusions. Based on the best available current science, the FDA has no indication that these substances at the levels found in the limited sampling present a human health concern.
- Milk, 2012: Raw and retail milks were sampled from across the country and analyzed for PFAS. One of the 12 raw milk samples and none of the 49 retail milk samples had detectable levels of PFAS. The one raw milk sample with detectable PFAS was obtained from a dairy farm that had applied PFAS containing biosolids to its fields.
FDA Announcements (2019)
- Constituent Update: FDA Makes Available Results from Second Round of Testing for PFAS in Foods from the General Food Supply (December 20, 2019)
- Constituent Update: FDA Makes Available Testing Method for PFAS in Foods and Final Results from Recent Surveys (October 31, 2019)
- FDA Statement: Statement on FDA’s scientific work to measure certain per-and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys. (June 11, 2019)
Additional Information on PFAS from Other Federal Government Agencies
- Agency for Toxic Substances and Disease Registry, the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services: Per-and Polyfluoroalkyl Substances (PFAS) and Your Health
- The United States Environmental Protection Agency: Per-and Polyfluoroalkyl Substances (PFAS)