Hatch's Cosmetics Bill Trades Recall Authority For New 'Adulterated' Language

Attorney Angela Diesch says the draft FDA Cosmetic Safety and Modernization Act would lower the burden of proof FDA faces in federal courts when taking action against products it deems dangerous. She views the provision as another compromise between antecedent bills proposed in the House and Senate.

FDA still would not be able to order a cosmetic recall under the proposed FDA Cosmetic Safety and Modernization Act, but the agency could have an easier time securing court orders to halt the sale of hazardous products, according to attorney Angela Diesch.

Diesch, managing partner at Diesch Forrest APC, practices in the Sacramento, Calif. area, representing cosmetics companies in class action litigation and advising firms on regulatory compliance issues under California and federal law, among other roles.

In a Nov. 7 email exchange with the Rose Sheet, the attorney offered her take on a standout provision in the draft FCSMA, introduced by Sen. Orrin Hatch, R-Utah, in late October. (Also see "Surprise Hatch Bill Lays Middle Ground For Cosmetic Regulatory Reform" - HBW Insight, 26 Oct, 2017.)

"In court, the FDA bears the burden of proof that the subject cosmetic is in fact adulterated. As currently worded, if FDA cannot identify the specific substance that causes the alleged harm, it's difficult, if not impossible, for FDA to meet that burden."

The bill, S. 2003, would amend language in the Federal Food, Drug and Cosmetic Act related to adulterated cosmetics (Section 601(a)), specifying that "a cosmetic may be adulterated regardless of whether it is known which particular substance or substances may render the cosmetic injurious."

Cosmetics that are adulterated, or formulated in a manner that makes them injurious to users, cannot be marketed in the US under the FDCA. However, Diesch noted that under the current regulatory framework, FDA cannot stop the sale of such products without a court order.

"In court, the FDA bears the burden of proof that the subject cosmetic is in fact adulterated," the attorney explained. "As currently worded, if FDA cannot identify the specific substance that causes the alleged harm, it's difficult, if not impossible, for FDA to meet that burden."

It begs the question of whether WEN Cleaning Conditioners, for example – linked in recent years to more than 20,000 known adverse events, including severe hair loss – would still be available for sale in the US if the legal threshold for FDA action against adulterated cosmetics were lowered.

Despite an investigation of at least three years and intense pressure from NGOs and lawmakers, FDA still says it has been unable to determine the cause of reported adverse reactions to WEN. (Also see "FDA To Congressman Pallone: Probe Into WEN Conditioner AEs Continues" - HBW Insight, 6 Jul, 2016.)

Consequently, "we are unable to determine that the product does not comply with the law," the agency says on its website.

Diesch believes the adulterated cosmetic provision in Hatch's proposed FCSMA is likely a response to FDA safety investigations that have failed to deliver in the eyes of policymakers and consumer advocacy groups.

She noted that under current law companies must ensure that cosmetics are safe before placing them on the market, but neither the law nor FDA dictates testing that must be performed. Informal FDA guidelines allow flexibility in safety substantiation approaches, including the use of safety data on individual ingredients and products with similar formulations rather than toxicological testing on finished products themselves.

In some cases, ingredient data may not reliably predict the safety of overall products – i.e., "the synergistic effect of a finished product may be unknown," Diesch said.

And even if FDA could demand access to companies' safety substantiation records – which it cannot under current law and still could not under the FCSMA – the information may not help in pinpointing causative agents for reported AEs if it consists solely or largely of ingredient safety findings.

"This new [adulterated cosmetic] language would arguably permit the FDA to obtain court ordered relief even where a toxicological assessment of the individual ingredients would not render the finished product adulterated, but where the finished product has been shown to be injurious," Diesch said.

Generally, "it lowers the bar for the FDA to the point that the FDA would need only show the product is injurious to consumers when used under the conditions of use prescribed by the product labeling."

EAS Consulting Group's John Bailey, who served previously as director of FDA's cosmetics office, suggested in a Nov. 6 email that the adulterated cosmetic provision in the FCSMA may have been sought by FDA's legal staff to alleviate difficulties the agency has encountered in its cosmetics enforcement work.

He is skeptical, however, that the revised language would make an appreciable difference. (Also see "Former FDA Cosmetics Director Weighs In On Senator Hatch's Draft FCSMA" - HBW Insight, 8 Nov, 2017.)

Diesch sees the proposed change as another compromise – similar to other features of the FCSMA – between the Personal Care Products Safety Act, S. 1113, and Cosmetic Modernization Amendments of 2017, H.R. 575, insofar as it does not grant FDA recall authority like the former would, but goes beyond the latter by lowering the agency's burden of proof in legal actions seeking injunctive relief.

Big and small industry trade groups have expressed optimism about Hatch's proposal, while the Environmental Working Group shows no signs of budging in its steadfast support of the PCPSA. (Also see "ICMAD Stands By House Cosmetics Bill, But May Be Ready To Negotiate" - HBW Insight, 31 Oct, 2017.)

Diesch blogs on cosmetics legal issues at cosmeticsandthelaw.com.