ICMAD Responds To Senate Proposal: Cosmetics Should Not Be Regulated Like Foods
This article was originally published in The Rose Sheet
Executive Summary
Small business advocate says the Senate Health Committee’s discussion draft – the Modernization of Cosmetics Regulation Act – would impose burdens on industry on par with requirements for foods. But while food products continue to pose significant risks, “no such record exists for the cosmetics industry,” the trade group asserts.
Draft cosmetics legislation up for Senate markup in April does not have the support of small business champion Independent Cosmetic Manufacturers and Distributors, which continues to advocate for a simpler, affordable update to regulations.
In March 15 comments to Senate Health, Education, Labor and Pensions Committee leadership, ICMAD President and CEO Pamela Busiek says HELP’s discussion draft released in February – the Modernization of Cosmetics Regulation Act – is a “significant departure from the current law.”
Moreover, it’s an unwarranted jump that would regulate cosmetics much like food products have been since the FDA Food Safety Modernization Act was enacted in 2011, she suggests.
“While there continues to be a record of significant health and safety risks presented to the general public from food borne illnesses (that still results in a significant number of deaths and hospitalizations), no such record exists for the cosmetics industry,” Busiek asserts.
The Senate Health discussion draft would authorize FDA to suspend cosmetic facility registrations if safety concerns arise and demand access to company safety records, similar to provisions in the FDA Food Safety Modernization Act.
From ICMAD’s perspective, sufficient regulatory modernization can be achieved by mandating industry participation in FDA’s now Voluntary Cosmetic Registration Program – which includes registration of manufacturing and/or packaging facilities and filing of product ingredient statements – and by requiring serious adverse event reporting.
“These new additions to the FDA laws would modernize the current cosmetic boundaries for companies of all sizes, protect the public and continue to allow the consumer access to the benefits of cosmetic products,” Busiek says.
Such changes also could be implemented without breaking FDA’s current budget, the trade group estimates.
Further, ICMAD maintains that robust federal preemption, aka national uniformity, is needed to “support a strong federal cosmetics program” without having it undermined by conflicting or additional state and local requirements around the country.
Preemption certainly would provide relief to ICMAD’s members, which range from startups to Mary Kay, Inc., and preemption also is a priority for the Personal Care Products Council, whose members similarly are challenged by a growing patchwork of state-level cosmetics laws.
The Senate committee’s discussion draft includes a placeholder for preemption, requesting feedback on the topic.
The MCRA does call for facility registration, product ingredient statements and serious adverse event reporting, in line with ICMAD’s proposed terms, but it goes considerably further. (Also see "Senate Health Committee Releases Cosmetics Reform Discussion Draft" - HBW Insight, 23 Feb, 2018.)
Notably, the bill seeks new powers for FDA that would authorize the agency to suspend facility registrations if safety concerns arise and demand access to company safety records, similar to provisions in the referenced foods legislation. (Also see "Think FDA Inspections Are Painful Now? These Could Be The Good Old Days" - HBW Insight, 24 May, 2017.)
Cosmetics companies also would have to attest to meeting a reasonable-certainty-of-no-harm standard and comply with good manufacturing practices developed by FDA via rulemaking.
The discussion draft closely mirrors the proposed Personal Care Products Safety Act, S. 1113, which ICMAD has steadfastly opposed, while also incorporating aspects of another bill on the table, the FDA Cosmetic Safety and Modernization Act, S. 2003. (Also see "Surprise Hatch Bill Lays Middle Ground For Cosmetic Regulatory Reform" - HBW Insight, 26 Oct, 2017.)
All told, the draft MCRA would impose “unnecessary and burdensome constraints” on industry, the trade group says.
ICMAD says it looks forward to continued work with lawmakers to modernize cosmetics regulations, “as we need to get this right.”
According to a February agenda statement, the Senate Health Committee intends to mark up cosmetics legislation, as well as OTC reform legislation, April 18, “and will work to get these measures passed by the full Senate this year.”
SPF Cosmetics A Case For Maintaining Status Quo?
Curiously, in the letter to Senate Health Chairman Lamar Alexander, R-Tenn., and Ranking Member Patty Murray, D-Wash., Busiek offers an example “where it was the cosmetics industry, and not the regulators, that were at the forefront of educating consumers.”
Ostensibly, the piece is included as further defense of the current oversight system for cosmetics, which ICMAD believes has succeeded overall in keeping consumers safe for some eight decades, and FDA’s largely hands-off role compared with its presence in other sectors.
ICMAD has expressed apprehension before about a more oppressive regime headed by an “activist FDA.” (Also see "ICMAD Clutches To House Cosmetics Bill Before Specter Of ‘Activist FDA’" - HBW Insight, 18 Jan, 2017.)
Busiek points to the rise of SPF-infused cosmetics, suggesting that the increasing prevalence of such products, and the protection they afford to consumers, are credits to industry. In fact, industry encountered resistance from FDA in its efforts to make UV-protective cosmetics widely available and educate the public on the importance of daily use, she suggests.
“When we first started this sun protection campaign, the FDA took serious issue with these daily-use products, stating that inclusion of sunscreens in non-beach products was ‘irrational,’ and threatened enforcement action if the industry continued to market these ‘irrational’ products,” the exec says.
Had the MCRA or comparable legislation been in place at that time, it’s doubtful that industry would have persevered in bringing SPF-containing cosmetics to market, according to Busiek.
She hazards that while FDA eventually came around to seeing things industry’s way, the agency would have been authorized to “forcibly remove” such products from circulation “without due process” – a risk industry likely would not have been willing to take.
FDA currently recommends that consumers use broad-spectrum sunscreens with SPFs of 15 or higher, “even on cloudy days,” and reapply frequently.
That said, the agency recently issued a call for contractor assistance, with the aim of conducting a clinical trial to better understand the absorption potential of sunscreen ingredients. In its solicitation, FDA cites concerns about increased exposure, including through daily use of SPF-infused cosmetics. (Also see "FDA To Try Its Hand At Sunscreen Absorption Study, A MUsT For TEA Sponsors" - HBW Insight, 16 Mar, 2018.)