The new law that will ban the sale or distribution of plastic microbeads in over-the-counter and personal care products beginning in July 2017 could have an unintended effect: a negative impact on the development and acceptance of micro- and nanotechnology–based medical and diagnostic products.

Environmentalists and others cheered the new law for its potentially protective effects on the environment and ultimately on public health. And the unavailability of such products is not expected to adversely affect consumers, as there are alternatives to the scrubs and other products that contain these microbeads – and manufacturers have started to reformulate their products that contain plastic microbeads.

However, the ban could potentially do more harm than good if the message consumers hear is that microtechnology – and, by extension, nanotechnology – is bad, according to Dr. Adam Friedman, director of translational research in the department of dermatology at George Washington University, Washington, who is a Dermatology News Board Member.

“What I’m most concerned about is the impact on public perception, that this ban infers that micro- and nanotechnology is inherently bad, and therefore, how it might impact approval of both over-the-counter and prescription medications that incorporate microscopic carriers,” said Dr. Friedman, who has a particular interest in nanotechnology. He explained that nanomaterials have enormous potential for helping to deliver drugs that are unstable, difficult to administer, or even toxic in their bulk form.

How such materials can be evaluated from a safety and efficacy standpoint in order to facilitate approval is currently under investigation, and negativity toward this field of research could hinder the progress of related research, he added, noting that “not all nano- and microtechnology is created equal.”

“This [ban] is about microplastics specifically,” not microspheres, -particles, or -beads, overall, he pointed out.

The basis of the Microbead-Free Waters Act of 2015 – which was signed into law by President Barack Obama on Dec. 28 after it sailed through Congress with an unusual level of bipartisan consensus among lawmakers regarding its importance – is that the plastic microbeads used in products such as facial scrubs and toothpaste pose a threat to marine life and ultimately to humans via the food chain.

Researchers have found that tiny microbeads – an estimated 11 billion daily – slip through wastewater treatment systems into the environment, where they appear to attract harmful chemicals that could make them toxic to marine life and ultimately to humans.

In fact, the biological dangers associated with microbeads upon which the ban was based are hypothetical, Dr. Friedman countered, noting that much of the argument against microbeads is based on an oft-cited publication that is actually a non-peer-reviewed editorial in support of a microbead ban ( Environ Sci Technol. 2015;49:10759-61 ). The authors cited studies demonstrating the inability of current sanitation measures to effectively remove the microbeads from the water supply. They also observed that “the argument has been raised that there is not yet enough scientific evidence to support banning microbeads,” but added, “though there are gaps in our understanding of the precise impact of microbeads on aquatic ecosystems, this should not delay action.”

Indeed, there is reason to believe that microplastics could contain endocrine-disrupting chemicals linked with a host of intractable human diseases, and that they may otherwise pose a threat to human health – particularly by attracting and collecting pesticides, bisphenol A (BPA), and phthalates and binding to them, then entering the food chain, noted Deborah M. Kurrasch, Ph.D., of the department of medical genetics at the University of Calgary, Alberta, in an interview. However, there is no direct evidence of this, she agreed.

“Common sense says that might be the case, but there are no data to support that,” said Dr. Kurrasch, who is currently studying how environmental insults, including those from plastics and herbicides, affect the brain.

“There is lots of interest in plastics, and this ban is more of an environmental toxicology ban … the leap to a human problem is very vague,” she commented.

In fact, the plastics in microbeads are generally considered “safe plastics,” as opposed to those containing BPA, for example, Dr. Kurrasch said. However, she added that she doesn’t think there is such a thing as a safe plastic.

“Ninety-one percent of plastics have been shown to leach compounds that affect estrogen signaling, and the fact that microbeads are made of plastic means they are likely to have some sort of effect down the road,” she said. “But the route of exposure? We just don’t know.”

Dr. Kurrasch believes the ban is a step in the right direction, and that it’s good that attention is being paid to protecting wildlife and humans from the potential harms of plastics.

Dr. Naissan O. Wesley , a dermatologist in private practice in Beverly Hills, noted that she, too is pleased about the concern regarding potential detrimental effects of microbeads.

“This is a huge step in skin care for products that are healthy for us and our environment,” she said, adding that while the quality of some products may be affected by the microbead ban, there are plenty of alternative scrubs, including sugar- or salt-based products.

“There are also other ways to achieve exfoliation, such as with things like the Clarisonic brush once a day, glycolic acid washes, Retin-A [tretinoin], chemical peels, microdermabrasion, or hydrofacials, and lasers,” Dr. Wesley, who is also a Dermatology News Board Member, noted. “Some women also do dermaplaning.”

Dr. Friedman also agreed with the importance of protecting the environment and the minimal impact the ban will have on products.

“I’m all for putting appropriate measures in place to prevent inappropriate exposures and damage to the natural setting. That said, I’m also for preserving the scientific method.”

Taking microbead-containing products off the shelf is not a life-altering process, Dr. Friedman said, noting that he doesn’t usually even recommend such products for patients. However, it will be expensive for the industry as it adapts to the microbead ban – and the money that will be spent is money that could have been applied to initiatives and efforts that may have had a bigger impact, he added.

“What frustrates me is that no opportunity was given to improve the technology,” he said, explaining that nano- and microparticles could be augmented to prevent them from entering the water system. For example, surface modifications applied to the microbeads could be used to increase aggregation under specific environmental conditions, and thereby prevent filtration failure. “There was a missed opportunity to engage industry and scientists alike to better understand how materials at this scale behave and how they can be manipulated for good,” he maintained.

“The ban opens the door to adversely impact more important technology that could be life altering. Now, we have an uphill battle.”

Dr. Friedman, Dr. Kurrasch, and Dr. Wesley reported having no relevant disclosures.

sworcester@frontlinemedcom.com

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