Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes

Regulatory NewsRegulatory News
| 17 November 2014 | By Alexander Gaffney, RAC

Two US legislators are calling on the US Food and Drug Administration (FDA) to assess the "potential risks" associated with the use of polyethylene microbeads in consumer care products, including toothpastes, saying the products could pose a risk to public health.


Microbeads have found their way into dozens of consumer products in recent years, most notably including cosmetics. The small plastic beads are used to give consumer products a textured feel, which can be used to exfoliate the skin (in cosmetics and soaps), or for aesthetic reasons (in toothpastes and other consumer products).

However, environmental and health concerns about the use of microbeads have led to mandatory and voluntary restrictions in recent years. In Illinois, for example, the use of microbeads in consumer products is set to be phased out between 2017 and 2019 after environmental groups said the beads weren't biodegradable and were contaminating water supplies and being consumed by fish. Other states are considering similar bans, and legislation has been introduced in the US Senate to prohibit their sale as well.

In response to other concerns, the consumer products brand Procter & Gamble has pledged to remove the beads from its Crest toothpaste products. Some dentists said the beads were getting stuck in people's teeth and gums, causing them to raise concerns about the potential for infections. Both Procter & Gamble and the American Dental Association (ADA) have maintained the products are safe for use.

Supporting that stance is FDA's approval of the ingredient as a food additive, Procter & Gamble said in a statement. But that argument hasn't gained much support at FDA. In response to an investigation published earlier this year, an FDA spokesman told Todaythat polyethylene microbeads' status as a food additive has no bearing on its use in toothpaste—a drug product.

“By definition, food additives are for their intended use in food,” FDA spokesman Jeff Ventura told Today. “Toothpaste is regulated as a drug product and is not considered food.” In addition, Ventura noted that the microbeads haven't been approved for "direct addition to food." The product is only approved for use as a food contact material, Ventura said.

New Efforts to Study

Now two legislators are calling on FDA to study the matter. In a letter sent this week to FDA Commissioner Margaret Hamburg, Sen. Kirsten Gillibrand and Rep. Frank Pallone said the agency needs to study the use of the product to "confirm that products containing microbeads pose no risk to public health."

The legislators noted FDA has never explicitly said the products are safe to be ingested by consumers.

"Polyethylene has been approved by the FDA to come into contact with food products as a packaging material, but has never been approved specifically for use in this manner," they explained. "Toothpaste is often ingested in small amounts by users, which gives reason for concern, since FDA has never evaluated the safety of the product in this application. Additionally, manufacturers have continued to evade greater scrutiny from the agency by claiming that microbeads are intended as a cosmetic additive, and not an active ingredient, contrary to messages in advertising. Under this questionable classification, FDA defers regulation of the safety of products containing microbeads to manufacturers themselves. "

Pallone and Gillibrand concluded by asking FDA to "undertake greater measures to ensure the safety of oral care products that utilize polyethylene microbeads."


Gillibrand and Pallone Letter to FDA


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