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Study highlights rise in consumer complaints to FDA

By Simon Pitman+

12-Jul-2017
Last updated on 13-Jul-2017 at 18:40 GMT2017-07-13T18:40:38Z

Study highlights rise in consumer complaints to FDA

A new study by Northwestern University highlights how the number of complaints to the FDA relating to cosmetic and personal care products more than doubled between 2015 and 2016.

Hair care products were the biggest offender, according to the Northwestern Medicine study published in the JAMA Internal Medicine journal, but it also outlines a wide range of adverse reactions from the complete spectrum of products, including skin care and in particular products with a high level of active ingredients. 

The authors of the study also underlined how, despite this spike in complaints, FDA regulations relating to the cosmetics and personal care area still do not require product pre-approval, which means that this higher risk to consumers will still have limited consequences.

FDA needs more authority on the issue

The team behind the study believes that the FDA should have more authority to tackle the problem, a point that is emphasized in the study report.

"The FDA has much less authority to recall cosmetics from the market in stark contrast to drugs or medical devices. It’s harder for the FDA to get harmful cosmetics off the shelves,” said corresponding author Dr. Steve Xu, a resident physician in dermatology at Northwestern University Feinberg School of Medicine.

Xu went on to point out that even though around 5,000 events relating to cosmetics and personal care were reported to the FDA between 2004 and 2016, this is likely to be a small fraction of the actual number as most such cases will go unreported. 

Better data is key to solving the problem

The team believes its findings also underscore the need for more accountability and better data.

“This is a $430 billion-a-year global industry with millions of products on the market,” Xu said.

“But we are only getting, on average, between 200 and 400 adverse events per year. That represents significant under-reporting. If we want more public safety and to keep dangerous products off the market, the first step is the make sure we have reasonably good data. The key point of our results is we don’t have it.”

Underlining this point, the team also points to the fact that in 2014, the FDA received 127 complaints about scalp irritation caused by Guthy Renker's Wen cleansing conditioner by Chaz Dean. 

Further investigation by the FDA then unearthed that the manufacturer had received over 20,000 complaints relating to scalp irritation and even alopecia.

Active ingredients put spotlight on cosmeceuticals

The team also puts the active ingredients found in cosmeceuticals under the spotlight, stating that although the category was not specifically studied, it did see evidence of a growing problem. 

“Although not explicitly studied, this cosmetic product class is becoming a growing problem,” Xu said.

“Many of these products are really making drug-like claims but are skirting the FDA approval pathway by presenting themselves as a cosmetic. At the very best, these products are making unsubstantiated marketing claims for products that may or may not work. At the very worst, there are actual drug components in these products that can cause real harm.”

Moving forward Xu believe's the team's findings may help raise awareness of Dianne Feinstein's (D-CA) Personal Care Products Safety Act, which proposes tighter regulation of products.

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