Office of Planning
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4219
Silver Spring, MD 20993
Re: Environmental Working Group's Comments on Food and Drug Administration Draft FY 2011-2015 Strategic Priorities Document
Docket No. FDA–2010-N-0506
The Environmental Working Group (EWG) submits the following response to the U.S. Food and Drug Administration's (FDA) request for comments on its FY 2011-2015 Strategic Priorities Document (Strategic Document). EWG is a non-partisan, non-profit organization dedicated to using the power of information to protect public health and the environment. EWG provides useful resources such as the Skin Deep Cosmetic Safety Database to consumers and advocates policies that promote conservation and mitigate public health risks.
EWG supports as a general matter FDA's effort to tackle the "unprecedented" public health challenges of the 21st Century. EWG also applauds FDA for making advances in regulatory science a top priority as it tries to build a stronger, more effective agency. That said, EWG strongly urges FDA to give more attention to cosmetics safety as it prepares its five-year strategic plan.
The U.S. cosmetics industry netted roughly $50 billion in revenue last year as consumers stocked bathrooms and medicine cabinets with products meant to improve health and beauty. Most Americans assume that their cosmetics are safe, but many of those products can cause serious adverse reactions such as allergies and asthma attacks.1 Additionally, many cosmetics products contain ingredients that build up in people's bodies over time – including dozens of chemicals linked by scientists to health problems such as cancer and hormone disruption.2
Consider, for example, the ongoing controversy over Brazilian Blowout, a hair-straightening product claimed to be "formaldehyde-free" even though test samples found "significant levels" of the chemical.3 Stylists who use the product are coming forward to report "ill effects, such as headaches, nosebleeds, burning eyes and respiratory problems," potentially caused by the formaldehyde ingredient.4 These events not only reinforce EWG's health concerns about cosmetics, but also illustrate how manufacturers might possibly misrepresent the safety and effectiveness of their products.
EWG recognizes that FDA has less authority to regulate cosmetics than drugs or medical devices. Nevertheless, FDA can take important steps to mitigate health risks associated with cosmetics and remain within the bounds of its statutory authority. Consequently, EWG believes that FDA should amend the Strategic Document to reflect the recommendations below as it positions itself for a "new era."
- Specifically, EWG proposes that FDA
- dedicate scientific resources to determine the safety of nanotechnology used in cosmetics;
- study and develop a more uniform way of compiling statistics on adverse reactions to cosmetics products; and lastly,
- better educate consumers about the safety and effectiveness of cosmetics and consider ways to improve product labeling accordingly.
A.) Scientific Study of Nanotechnology Used in Cosmetics
On page 5 of the Strategic Document, FDA writes:
Over the next five years, FDA will create and execute a strategic plan for expanding and modernizing the field of regulatory science within the agency… The agency charged with judging the safety and efficacy of drugs and other medical products… must possess a scientific capability equal to that task and become engaged in the mission-critical fields of applied research, including... nanotechnology... In that spirit, FDA has already begun identifying strategies to recruit and retain outstanding scientists and will work collaboratively with other agencies, industry, and academia to define and advance science in high-priority areas critical to the health of individuals...
Comment. EWG asks that FDA amend the above-mentioned text to read as follows: "The agency charged with judging the safety and efficacy of drugs and other medical products, as well as the safety of cosmetics products, must possess a scientific capability equal to that task and become engaged in the mission-critical fields of applied research, including… nanotechnology…"
As EWG reported in 2006, industry now routinely uses nano-scale ingredients in cosmetics despite the fact that they "[‘]have chemical or physical properties that are different from those of their larger counterparts,' including ‘increased chemical and biological activity."5 Although groups such as the Personal Care Products Council maintain that size does not matter, EWG notes that there is a dearth of "published data from… scientific studies" addressing questions about nanotechnology safety.6 For those reasons, EWG believes that FDA has a real opportunity over the next five years to fill the research gap with nanotechnology data not only about drugs and medical devices, but also cosmetics. Likewise, FDA might require that cosmetics manufacturers designate nano-ingredients as such on their product labeling given how little we know about the long-term effects of exposure to them. By taking those steps, FDA will be in a better position in the 21st century to protect Americans who increasingly are exposed to nano-sized ingredients found in a host of consumer products.
B.) Statistics on Adverse Reactions to Cosmetics
Part III of the Strategic Document presents a broad list of "long-term objectives" that covers everything from establishing effective tobacco regulation to promoting healthy dietary practices and nutrition.
Comment. In keeping with other concerns, EWG believes that FDA should add a sub-section in Part III titled "Promote Public Health by Advancing Cosmetics Safety." Under the added sub-section, EWG recommends that FDA make it a priority to study and develop a more uniform method of compiling statistics on adverse reactions to cosmetics products. EWG is aware that consumers and companies can submit voluntary reports to FDA regarding "serious adverse events" resulting from cosmetics,7 but that information remains largely unavailable to the public. Furthermore, other sources of cosmetics injury statistics are hardly as uniform or comprehensive. Thus, EWG calls on FDA to find new ways to encourage information sharing not only among FDA, consumers and companies, but also among hospitals, physicians, insurance companies and trial attorneys. With more comprehensive data, FDA could more easily identify safety risks associated with cosmetics products such as those made by Brazilian Blowout (discussed above).
C.) Consumer Education Efforts Regarding Cosmetics Claims
On page 15 of the Strategic Document FDA states that it intends to give American consumers the information they need to "make healthier choices about the food they eat," since reducing "the chronic disease burden…[d]epends, in large part, on consumers having the knowledge to make wise food choices." Similarly, FDA states on Page 29 that with regard to tobacco regulations, it intends to "develop a communication and public education strategy to address the public health risks of tobacco products."
Comment. EWG urges FDA to build on those consumer education goals by also making it priority to educate consumers about what to look for when trying to purchase safe cosmetics. For example, EWG calls on FDA to provide consumers with more information about the safety and effectiveness of anti-aging skin care products. Revenue from anti-aging products will amount to nearly $7 billion in 20108 – a figure that has grown by more than 10 percent annually since 2000.9 Some of that growth can be attributed to increased demand from aging Baby Boomers. However, it can also be explained by consumer confusion resulting from aggressive claims made about anti-aging products "in combination with [their] drug-like appearance."10 Today, many consumers assume that FDA regulates such products in the same way it does drugs, and so they believe anti-aging products are free of "possible risks and side effects."11 By educating consumers with those perceptions in mind, FDA can help them to buy cosmetics with a better understanding of their risks and benefits. At the same time, FDA might want to audit labeling and marketing claims made by cosmetics manufacturers to make the education initiative more comprehensive. Over the longer term, FDA should also seek ways to improve labeling of cosmetics products to the extent permitted under FDA's statutory authority.
EWG sincerely appreciates the opportunity to comment on FDA's ambitious five-year strategic plan. EWG acknowledges the daunting challenges FDA must address as it enters a new era. That said, EWG has high hopes that FDA will give cosmetics safety the attention it deserves given the growth of the industry and the concerns raised above.
Thomas Cluderay, Stabile Law Fellow
Environmental Working Group
1436 U. Street, Suite 100, NW
Washington DC 20009
1 E.g., Magnus Lindberg, et al., Clinical Report: Are Adverse Skin Reactions to Cosmetics Underestimated in the Clinical Assessment of Contact Dermatitis? A Prospective Study Among 1075 Patients Attending Swedish Patch Test Clinics, 84 Acta Derm Venereol 291 (2004); see also McBride v. Detroit, 2007 U.S. Dist. LEXIS 87391, *1 (E.D. Mich. Nov. 25, 2008) (plaintiff experienced "scratchy throat, coughing, and severe headaches"); Weber v. Infinity Broadcasting Corp., 2005 U.S. Dist. LEXIS 40724, at *1 (E.D. Mich. Dec. 14, 2005) (plaintiff with sensitivity to chemicals developed serious allergic reaction to perfume used by co-workers); Paula Kurtzweil, Hair Relaxers Destroyed After Consumers Complain – Products Sold by World Rio Corp, FDA Consumer, March 1996, http://findarticles.com/p/articles/mi_m1370/is_n2_v30/ai_18175443/.
3 Andrea Canning, et al., Brazilian Blowout Hair-Straightening Product Under Fire, ABC News, Oct. 1, 2010, http://abcnews.go.com/GMA/Consumer/brazilian-blowout-hair-straightening-....
4 Alene Dawson, Brazilian Blowout Might Be Dangerous to Your Health, Baltimore Sun, Oct. 13, 2010, http://articles.baltimoresun.com/2010-10-13/news/la-ig-1010-beauty-brazi....
6 Int'l Risk Governance Council, Risk Governance of Nanotechnology Applications in Food and Cosmetics 5 (2008), http://www.nanowerk.com/nanotechnology/reports/reportpdf/report125.pdf.
7 FDA, Reporting Serious Problems to FDA, http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (last visited Oct. 25, 2010).
8 Victoria Farren, Removing the Wrinkle in Cosmetics and Drug Regulation: A Notice Rating System and Education Proposal for Anti-Aging Cosmeceuticals, 16 Elder L.J. 375, 376 (2009).
9 LaToyah Burke, Advances in Skin Care: Prestige and Mass Brands Must Now Compete with Dermatologist-Inspired Treatments, HAPPI, Dec. 1, 2006, http://www.happi.com/articles/2006/12/advances-in-skin-care.
10 Farren, supra note 8, at 380.
11 Id. at 388.