For Immediate Release:

The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition

“The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging manufacturers and distributors to consult with us regarding the regulatory status of any manufacturing processes used to produce fluorinated polyethylene containers for use in contact with food.

We issued this letter out of an abundance of caution to remind industry that only certain fluorinated containers may be used in contact with food. It is important to note that there is no evidence of unlawful manufacturing processes being used for food containers. We will continue to work to ensure that substances used in contact with food comply with FDA regulations and are safe for their intended use.”

Additional Information

  • Today, the U.S. Food and Drug Administration issued a letter to industry reminding manufacturers that that only certain fluorinated polyethylene containers are authorized for food contact use. The letter is intended for food packaging manufacturers that produce or distribute these types of containers, and food manufacturers that use them.
  • The agency took this step to ensure that food packaging manufacturers that produce, use or distribute fluorinated polyethylene food contact containers are aware of the FDA’s regulation pertaining to requirements for fluorinating polyethylene containers used with food. Analytical studies indicate that fluorination processes that are not compliant with our regulations can result in the formation of certain types of per- and polyfluoroalkyl substances (PFAS), some of which are associated with adverse health effects.
  • Fluorination allows for improved chemical barrier properties in containers. Recently, based on testing performed by the Environmental Protection Agency (EPA), the FDA has become aware that certain per- and polyfluoroalkyl substances (PFAS) can form and migrate from some fluorinated high-density polyethylene (HDPE – a type of polyethylene) containers. The EPA’s testing was conducted on containers that are not regulated by the FDA (containers intended to hold mosquito-controlling pesticides not approved for direct use on food crops).

Related Information

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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