Letter to Margaret Hamburg, Commissioner of the Food and Drug Administration - Urging FDA to Evaluate Safety of Plastic Microbeads in Oral Care Products
Letter
The Honorable Margaret A. Hamburg
Commissioner
Food and Drug Administration
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg:
We are writing to address the Food and Drug Administration's (FDA) treatment of polyethylene microbeads in oral care products. Though it appears no clinical investigation of the issue has been conducted to substantiate this concern, a growing body of anecdotal evidence from consumers and dental professionals suggests that closer monitoring is needed to confirm that in fact, products containing microbeads pose no risk to human health.
Together we have worked to address the environmental impacts of microbeads in personal care products, leading to the introduction of the Microbead-Free Waters Act. Synthetic plastic microbeads are difficult to trap or catch in the sewage system, which unfortunately leads to these tiny plastic particles ending up in local streams, rivers and larger bodies of water. Scientists have found evidence of microbeads in numerous bodies of water in the U.S., including the Great Lakes, the world's largest source of freshwater. In addition to contributing to the buildup of plastic pollution in waterways, microbeads can often be mistaken by fish and other organisms as food. If consumed, the chemicals found in synthetic plastic microbeads can then be passed on to other wildlife and humans.
However, accounts from consumers and dental professionals suggest that microbeads pose a potential threat to oral health as well. In many users of associated toothpastes, these microbeads may get trapped in the gingival sulcus, trapping bacteria as well, leading to gingivitis and adversely impacting oral health. Because microbeads are not biodegradable, the buildup of bacteria over time can ultimately lead to advanced periodontal disease, affecting the surrounding soft tissue and bone, which imposes even greater impacts on physical health.
Our concern arises largely from FDA's regulatory approach in these over the counter products. 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. 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.
In light of the growing concern over the use of microbeads from both environmental and oral health standpoints, and the widespread use of microbeads in oral health products from gum to toothpaste, we are glad that Proctor and Gamble has voluntarily chosen to phase out the use of microbeads in all oral care products by March of 2016.
However, relying entirely on self-regulation may jeopardize public health. Normal use of these products, as recommended by the products' manufacturers and by dental professionals, may significantly impact oral health. Given the agency's mission to safeguard consumers and in light of growing concerns from consumers and dental professionals, we ask that FDA undertake greater measures to ensure the safety of oral care products that utilize polyethylene microbeads.
We appreciate your consideration of these concerns and look forward to your response. If you have any questions, please contact Tuley Wright with Representative Pallone at tuley.wright@mail.house.gov or Jordan Baugh with Senator Gillibrand at jordan_baugh@gillibrand.senate.gov.
Sincerely,
FRANK PALLONE, JR. KIRSTEN GILLIBRAND
Member of Congress United States Senator
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