FDA acts on fluorinated plastic packaging. What are next steps?
August 10, 2021
Read the full article by Tom Neltner (EDF)
"The Food and Drug Administration (FDA) took an important step last week to protect food from PFAS contamination from plastic packaging. On August 5, the agency sent a letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles reminding them that these articles must be made under specific conditions to comply with existing regulation or otherwise the food contact articles “are not lawful.” Therefore, the food that contacted them should not be permitted for sale. The agency gave three examples of manufacturing processes that do not comply with the regulation. We flagged concerns with fluorinated plastic packaging in a July blog and applaud the agency for this action.
This significant first step needs to be followed:
- Investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether their products complied with the law. If not, then alert food manufacturers and retailers so they can recall the adulterated food and cosmetics.
- Reassess whether the process FDA approved in 1983 for fluorinating polyethylene generates PFAS and whether it should still be considered safe.
Investigate companies that provided fluorinated plastic packaging
In the letter, FDA’s Office of Food Additive Safety (OFAS) states that “available information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA’s regulation.” It identified three specific examples and says that “these alternative processes for fluorination of polyethylene are not compliant with 21 CFR § 177.1615, and are not lawful for use in food contact articles.” The three examples of unlawful manufacturing processes are:
- “Fluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container.”
- “Use of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.”
- Incorporation of oxygen into the fluorinating mixture to modify the properties of the final container.