Rep. Pallone Galvanized By FDA's 'Troubling Overview' Of Cosmetic Imports

FDA physically inspected less than 1% of the 2.9m cosmetic imports that reached the US in fiscal 2016, according to a letter from the agency released by Congressman Frank Pallone. The ranking member of the House Energy and Commerce Committee says he's aiming for a hearing in September on his bipartisan proposal to increase FDA's authority over the cosmetics sector.

Rep. Frank Pallone, D-N.J., is banging the drum for cosmetics oversight reform after receiving a "troubling overview" from FDA of the cosmetic imports situation in the US.

In a June 30 letter to Pallone, FDA said its inspectors physically examined just 9,871 of the 2.9m cosmetic imports that arrived at US ports in fiscal 2016 from 181 declared countries of origin, or roughly 0.3%.

Of those, 1,474, or roughly 15%, had adverse findings. Lab testing led to adverse findings for 73 of 364 imports, a rate of around 20%, according to the agency.

Adverse findings include labeling violations, use of illegal color additives and/or microbial contamination, FDA explains.

FDA’s letter “should serve as a wake-up call to Congress to act,” Pallone says.

The letter, signed by Anna Abram, deputy commissioner for policy, planning, legislation and analysis, notes that "cosmetic imports, by volume, are one of FDA's larger categories of imports … yet the agency's cosmetics program is one of its smallest."

She continues, "Not only is the volume of cosmetic imports quite significant, but many different countries and manufacturers export cosmetics to the United States."

By a large margin, imports from China were the most problematic last year, Abram says.

If it weren't already clear, she adds, "FDA has limited resources to examine imported cosmetics."

Abram does note that FDA uses a risk-based screening tool in its electronic review of all imports to focus its inspection and sampling resources on products with the potential for the greatest impact on public health.

But cosmetic exports to the US have doubled over the past decade and have been steadily and substantially climbing over the past five years, the FDA official says. In particular, imports from China, Mexico and Canada escalated during that period, by 79%, 61% and 60%, respectively.

The letter from FDA came in response to an inquiry from Pallone in December 2016 regarding cosmetic imports and the agency's related inspection activities and findings.

“The fact that less than 1 percent of cosmetics imported into this country are physically examined is startling, and should serve as a wake-up call to Congress to act,” Pallone asserts in an Aug. 2 release. “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 congressman has demonstrated an active interest in cosmetics safety issues in recent years, probing for example into FDA's investigation of WEN Cleansing Conditioners, which led to an agency response obtained by the Rose Sheet last July through a Freedom of Information Act request. (Also see "FDA To Congressman Pallone: Probe Into WEN Conditioner AEs Continues" - HBW Insight, 6 Jul, 2016.)

Pallone also released a discussion draft bill in September 2016, developed with Rep. Leonard Lance, R-N.J., which sought to beef up FDA's oversight powers and impose new responsibilities on cosmetics manufacturers, generally in line with provisions in the Personal Care Products Safety Act in the Senate. (Also see "Pallone Proposes House Companion To PCPSA; Will 2017 Be The Year For Reform?" - HBW Insight, 14 Sep, 2016.)

The latter bill, S.1113, was reintroduced in May by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine. (Also see "Cosmetics Reform Bill Relaunches In Senate, Sending Stakeholders To Familiar Corners" - HBW Insight, 12 May, 2017.)

Both the PCPSA and Pallone's proposal would require companies marketing cosmetics in the US to register their facilities with FDA, providing the agency with greater insight into the manufacturer landscape, domestic and foreign.

Abram notes in her letter that “very few” of the approximately 29,000 known companies that manufacture or export cosmetics that reach the US from abroad have registered voluntarily with FDA.

The cosmetics reform bills also would establish a user fee system to help fund FDA's regulatory and enforcement activities with $20.6m targeted in its first year. The added resources likely would be used in part to give the agency's import inspection program a boost.

A staffer in Pallone's office said the congressman, who serves as ranking member of the House Energy and Commerce Committee, is aiming for a September hearing on his proposal.

However, he also suggests in his release that provisions to strengthen cosmetics product regulation "should be considered as a part of a proposal to create a new user fee program for over-the-counter drug products that is being developed by FDA, industry, the Energy and Commerce Committee and the Senate HELP Committee." (Also see "OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft" - HBW Insight, 30 May, 2017.)

A discussion draft bill unveiled in May, authored by Sens. Johnny Isakson, R-Ga., and Bob Casey, D-Pa., proposes two tracks for proposing changes to OTC drug product monographs and targets $22m to $34m in annual user fees from OTC manufacturers. (Also see "OTC Monograph Reform Proposal Offers Two-Tier Approach" - HBW Insight, 30 May, 2017.)