Through October, 2015, FDA Warning Letters include seven for skin-care claims by Happi

15 December 2015

Today’s active skin care ingredients provide a host of benefits to the skin – By Tom Branna , Editorial Director – Published December 2, 2015

Claims People Play

The show-don’t-tell concept might just work with regulators, too. The US Food and Drug Administration (FDA) is sending out more warning letters than a high school physics teacher at mid-marking period. After several years of relative quiet, FDA has turned up the heat on cosmetics companies large and small.According to industry experts at Arent Fox LLP, a Washington DC-based law firm, FDA appears to once again be trying to send a strong regulatory signal to industry in 2015 (similar to 2012) by issuing approximately 14 Warning Letters (WLs) to date.

“In 2012, FDA issued nine Warning Letters to cosmetics companies for objectionable skin care claims, particularly anti-aging claims,” recalled Georgia Ravitz, a partner with Arent Fox LLP.

According to Ravitz, the increase in WLs in 2015 can be attributed generally to several factors:

  • FDA’s increasing enforcement capability over the past 5-6 years. FDA has been slowly increasing its enforcement staff at CFSAN as well as conducting more online research to review product claims and promotions online.
  • Some companies continue to market their products with aggressive enforcement claims, which is drawing FDA’s attention to product claims it views as objectionable.
  • FDA has been unable to get Congress to pass cosmetics reform legislation that would increase FDA regulation of the industry.
  • “Thus, FDA is using more active enforcement to try to keep industry in regulatory check,” she said.
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