FDA Clampdown On Excessive Anti-Aging Claims May Lighten Up In 2017
This article was originally published in The Rose Sheet
Executive Summary
FDA issued close to 30 warning letters to cosmetics firms in 2016 for unapproved drug claims as part of “a project for reviewing product labels and websites for drug claims related to anti-aging.” That initiative may be winding down, if it hasn’t already, but the agency is playing its cards close to its vest going into the new year.
Cosmetic skin-care marketers may be able to breathe easier in 2017, with FDA potentially shifting its focus away from anti-aging claims that identify products as unapproved drugs.
The agency issued upwards of 30 warning letters in 2016 to companies for excessive anti-aging claims related to skin diseases or body structure/function effects, including statements about acne, eczema and psoriasis treatment and collagen-building, hyperpigmentation and anti-inflammatory benefits.
In an October letter to Sen. Lamar Alexander, R-Tenn., FDA’s Dayle Cristinzio, acting associate commissioner for legislation, attributed the uptick in warnings, compared with previous years, to “a project for reviewing product labels and websites for drug claims related to anti-aging.” (Also see "FDA Divulges Cosmetics Enforcement Data, Notes Hair Loss As ‘Serious’ AE" - HBW Insight, 3 Nov, 2016.)
She indicated that the project launched in late 2015, when the agency warned Cosmetic Dermatology, Inc. and Episciences, Inc., for example, for claims on their respective dr. brandt and epionce skin-care lines. (Also see "FDA's Naughty List This Holiday Season Includes Doctor Skin-Care Brands" - HBW Insight, 16 Dec, 2015.)
The initiative then carried over into 2016 with an unprecedented number of warning letters targeting skin-care players on an almost monthly basis through the end of October.
If the project was a year-long undertaking, it should be drawing to a close if it hasn’t already. Notably, FDA issued no such warning letters in November.
FDA isn’t sharing its enforcement plans for 2017, but a spokesperson cautioned that “companies and individuals who manufacture and market cosmetics remain responsible for ensuring that their products are in compliance with all requirements of the laws we enforce.”
FDA was cagey about whether it will be focusing resources elsewhere in the new year, turning its attention to different types of cosmetic claims or compliance concerns for instance.
In a Nov. 30 email, a spokesperson for the agency’s food and cosmetics programs stated, “As a law enforcement agency, FDA does not announce in advance its intention to pursue enforcement action or its priorities for doing so.”
FDA has noted that it generally strives to strike a balance in its enforcement work between its statutory responsibilities and the resources available to it, which are always strained and particularly limited in the area of cosmetics.
Even it’s not a formal priority, the agency likely will continue to issue periodic warning letters to cosmetics firms as reminders of the limitations on claims, as dictated by the “cosmetic” definition enshrined in the Federal Food, Drug and Cosmetic Act.
It could just be that the pace of such activities in 2017 is closer to that seen in years prior to 2016.
FDA may decide to zero in on claims made by large industry leaders in its warning letter program going forward or otherwise tailor its actions to send messages to the industry at large with minimal resource expenditure.
EAS Consulting’s John Bailey, who directed FDA’s cosmetics program in the 1990s and served as the Personal Care Products Council’s chief scientist through July of 2011, has noted this approach taken by the agency in the past. (Also see "Rash Of FDA Warning Letters Raises Questions For Cosmetics Industry" - HBW Insight, 22 Oct, 2012.)
L’Oreal S.A., for example, was warned for overreaching claims in 2012 and again in February 2015. The former instance put industry on notice about use of gene- and stem cell-related claims, an issue FDA went on to highlight repeatedly in warning letters to smaller companies in 2016. (Also see "FDA Warns Lancome For Gene/Stem-Cell Claims: A Signal To Marketplace?" - HBW Insight, 17 Sep, 2012.)
There could be some backsliding if FDA lays off the sector in 2017. Claims about reducing fine lines and wrinkles, rather than merely improving their appearance, may begin to crop up again, for example.
Overall, however, FDA may have served its purpose with the 2016 ramp-up. In June, the Advertising Self-Regulatory Council’s President and CEO Lee Peeler said the organization has seen anti-aging claims “muted,” likely on account of increased regulatory activity. (Also see "NAD: Anti-Aging Claims ‘Muted A Bit,’ But Vigilance Remains High" - HBW Insight, 28 Jun, 2016.)
Of course there is no guarantee that FDA warning letters to cosmetics firms will let up in the new year. While no November warnings have posted to the agency’s site yet – which occurs when companies acknowledge their receipt of the notices – there were no warning letters issued in January, February or April of this year either.
It could simply be a holiday season lull that industry is seeing now. In any event, cosmetics firms should continue to exercise caution in crafting and promoting their product claims.
The FDA rep emphasized that “companies and individuals who manufacture and market cosmetics remain responsible for ensuring that their products are in compliance with all requirements of the laws we enforce.”