A new ingredient that has been cropping up in products ranging from toothpaste to facial cleansers —polyethylene microbeads — has been causing a stir ever since dental hygienists noticed the tiny blue bits embedded the gums of patients who use Crest toothpaste.
The tiny beads were already on the radar of environmentalists who say that because polyethylene doesn’t break down, the microbeads are making their way into oceans and other bodies of water and causing problems there.
In a statement, Procter and Gamble, which has included microbeads in some types of Crest toothpaste, says they are Food and Drug Administration-approved and not a health risk, but is planning to remove the ingredient in the next year and a half.
"Today, some of P&G's most popular products do not contain microbeads including Crest Whitening + Scope, Crest Baking Soda Peroxide, Crest Extra Whitening, Crest Cavity, and Crest Tartar + Whitening," the company said in a statement. "In those that do, P&G has begun removing them. In fact, the majority of Crest's product volume will be microbead-free by March 2015. Crest will complete removal process by March of 2016."
The FDA, for its part, says it has never approved microbeads to be put in toothpaste, which it considers to be an over-the-counter drug. Polyethylene is allowed to come in contact with food, but there has been no ruling saying it is safe to consume.
And since the microbeads are not considered to be an active ingredient in toothpaste, the FDA hasn’t been monitoring them. The agency puts the onus on manufacturers to determine the safety of inactive ingredients in OTC drugs.
“For over-the-counter monograph drug products, such as Crest toothpaste, manufacturers have the responsibility to ensure that all inactive ingredients are safe and suitable for their intended use,” said FDA spokesman Jeff Ventura. “If a product’s inactive ingredients are determined by the agency to pose a health risk for consumers, the agency may have the manufacturer address the issue, or take other appropriate enforcement actions. FDA is not immediately aware of any safety issues with this product.”
As for claims that the FDA has approved polyethylene’s use as an additive in foods, which would mean it’s OK to add it to toothpaste, the FDA responded that that is wrong on two fronts.
“By definition, food additives are for their intended use in food,” Ventura said. “Toothpaste is regulated as a drug product and is not considered food.”
“Polyethylene is the subject of several effective food contact notifications and is included in several food additive regulations for use in food contact materials. It is approved for use in several indirect or food contact applications, but not for direct addition to food. It is also approved for use as a protective coating on some certain fresh fruits and vegetables (such as bananas), and certain nuts in shells. Food contact substance applications for polyethylene include: plastic wraps, bags and food containers.”
For its part, the American Dental Association said in a statement that it sees no harm in the microbeads.
“At this time, clinically relevant dental health studies do not indicate that the Seal should be removed from toothpastes that contain polyethylene microbeads,” an ADA statement read. “Polyethylene microbeads are commonly used as scrub beads, such as in exfoliating products, but are also sometimes used in chewing gum and toothpaste, as part of the product design. Small quantities of the colored polyethylene specks are included in some of Crest’s toothpastes, including Crest Pro Health, which has the ADA Seal of Acceptance.”
Linda Carroll is a regular contributor to NBCNews.com and TODAY.com. She is co-author of "The Concussion Crisis: Anatomy of a Silent Epidemic” and the recently released “Duel for the Crown: Affirmed, Alydar, and Racing’s Greatest Rivalry”