FDA begins first inquiry of lightly regulated cosmetics industry

A study at the U.S National Library of Medicine found that Benzophenone, also known as Oxybenzone, a product that is commonly used in sunscreens as a UV absorber and in lip balm, can lead to the proliferation of human breast cancer cells in the laboratory. Johnson & Johnson’s Safety and Care commitment site disclosed using the chemical, but cited a 2015 U.S. Department of Health and Human Services National Toxicology Program that concluded that “within normal use levels” oxybenzone does not have an effect on human hormone levels. Hawaii recently passed legislation that banned companies from selling sunscreen on the island that included oxybenzone and octinoxate, however, health concerns were not the reason: the state was concerned about harmful effect on its marine environment and coral reefs to which the chemical has been linked.

Kimberly Berger, research scientist at the Center for Environmental Research and Children’s Health at UC Berkeley, said that the average teenage girl uses 14 personal-care products a day. “We have a responsibility to study these chemicals in these cosmetics to find out if any of them are harmful to us and to make that information available to the public.” Berger said many labels don’t list the actual chemical names of artificial fragrances, instead calling them “fragrance” or “parfum.”

The WEN headlines led a team of Northwestern University researchers to review an FDA database of complaints made between 2004 and 2016. The FDA received, on average, 396 cosmetic-related complaints per year, but there were big increases in 2015 and 2016, mostly due to WEN. Hair-care products, skin-care products and tattoos were responsible for the majority of complaints. Personal cleanliness products, hair care and hair-coloring products were associated with serious health problems.

The Northwestern research team wrote in a 2017 JAMA Internal Medicine article, “Better cosmetic surveillance is needed given their ubiquity and lack of a premarket approval pathway. Unlike devices, pharmaceuticals, and dietary supplements, cosmetic manufacturers have no legal obligation to forward adverse events to the FDA.”

Driven largely by the rising number of health-conscious consumers and the demand for clean label products, demand for products that are free from synthetic fragrances, preservatives, parabens, petrochemicals and harsh cleaners such as sodium lauryl sulfate has seen a huge uptick over the past few years. As a result, the global natural and organic beauty market has been exploding. According to a June report released by market research firm Grand View Research, the global organic personal care market is projected to reach $25.11 billion by 2025, up from $12.9 billion in 2017. Rising R&D expenditure to introduce improved plant and animal extracts into various products is expected to promote the demand for organic personal-care products over the forecast period, said the report. It also stated that regulations encouraging the use of organic materials in the personal-care industry are likely to propel market growth.

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