Less than 1% of cosmetic products imported into the U.S. are inspected due to limited resources, a Food and Drug Administration official recently warned in a letter to a top House Democrat, pushing for better regulation of the industry.
Anna Abram, an FDA deputy commissioner, said in a letter to Rep. Frank Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Committee, which oversees the FDA, that of the 2.9 million "lines," or categories, of cosmetic products imported to the U.S. in fiscal 2016, just 9,871 were inspected at a time when cosmetics imports are increasing by significant numbers. Of those physical inspections, issues were found with 1,474 different product lines, representing 15% of the imported cosmetic products.
The letter came in response to a congressional inquiry late last year calling for data on the types of personal care products imported each year, as well as the number of imports inspected and found to be unsafe.
"Not only is the volume of cosmetic imports quite significant, but many different countries and manufacturers export cosmetics to the United States," Abram wrote in her June 30 letter. "FDA has limited resources to examine imported cosmetics."
The 2.9 million categories of cosmetics that were imported to the U.S. in fiscal 2016 through the FDA import process represents a significant increase over imports of cosmetics five years ago, which totaled 2.1 million lines in fiscal 2011, according to the agency.
Abram noted that although cosmetic imports are by volume one of the larger import categories, FDA's cosmetic examination program is one of its smallest. The New York Times, which first reported on the FDA letter Aug. 2, noted in the report that the agency has the equivalent of six full-time inspectors to handle cosmetics imports.
Despite roughly 29,000 foreign companies identified as cosmetics importers to the U.S., few have registered with FDA through its Voluntary Cosmetic Registration Program for cosmetic manufacturers, packers, and distributors. The program currently does not require that companies register with the agency.
Pallone is hoping to change that.
In September 2016, Pallone and Rep. Leonard Lance, R-N.J., introduced bipartisan draft legislation that would give the FDA more power to regulate cosmetics imports. Their draft bill would strengthen the FDA's authority to recall potentially dangerous cosmetic products as well as $20.6 million in annual allocation for enforcement.
"The fact that less than one percent of cosmetics imported into this country are physically examined is startling," Pallone said in an Aug. 2 statement. "Congress must give FDA the authority and resources necessary to ensure the safety of cosmetics and personal care products, whether they are produced domestically or abroad."
The Personal Care Products Council, a cosmetics industry group whose member companies include L'Oréal SA, The Estée Lauder Cos. Inc. and Clinique, said it supports increased funding to better regulate cosmetics and personal care products. In an Aug. 4 statement, Group President and CEO Lezlee Westine said consumer safety is a top priority, and one that can only be achieved by a modernized regulatory system.
"Despite the very strong safety record of cosmetic products, the Council and its member companies believe more can be done to ensure that FDA has the appropriate authority and resources to regulate our products in the 21st century," Westine said.
Lisa Powers, a spokeswoman for the council, said in a statement emailed to S&P Global Market Intelligence that "we do support providing FDA with additional authority over cosmetics."
"However, we note that current FDA authority over imports is already extensive," she added.
This struggle with limited resources comes as the lines of cosmetic imports have doubled over the past decade, and countries including China and Mexico have increased their exports of cosmetic products to the U.S. by 79% and 61% respectively over the past five years. China leads the pack in cosmetic imports turned away by the U.S., followed by India, South Korea, and Canada, according to the FDA.
Although the majority of lipstick, eyeliner, nail polish, face powder and tattoo ink coming to the U.S. meets import standards, the FDA currently has seven public cosmetics import alerts, which include illegal color additives, unsafe chemical substances, and microbial contamination. Of the 364 confiscated products subject to lab testing in 2016, 20% resulted in adverse findings.
In her letter, Abram gave examples of issues that have been found in confiscated products, including skin whitening creams that contain high levels of mercury, eyeliners containing heavy metal content and cosmetic kits found to have high levels of certain types of bacteria.