SUNSCREENS
Who's Protecting Us?
In 1978 FDA announced that it would begin developing comprehensive standards for sunscreen safety and effectiveness. Twenty-nine years later the Agency has yet to issue final regulations, but instead encourages manufacturers to follow draft guidelines that the Agency has delayed finalizing at the behest of the sunscreen industry. As a result, sunscreen manufacturers in the U.S. are free to market products that aren't necessarily proven to protect people from the sun, and to use marketing claims with no mandatory testing to back them up.
In response to FDA's failure to set mandatory standards for sunscreen, citizens have filed nine class-action, false-advertising lawsuits in California; a state Attorneys General has petitioned the Agency to set standards; and six Senators have written FDA, urging the Agency to finalize sunscreen regulations to protect the public from skin cancer. None of these actions have spurred FDA to finalize its guidance into enforceable standards. In the meantime, consumers are left to wonder which of the hundreds of sunscreens on the market are the safest and most effective.
FDA's inaction has led to a diverse range of problems:
- Many products don't protect from UVA damage. Despite evidence on the hazards of deeply penetrating UVA radiation, which may cause skin cancer and is linked to skin damage and aging, FDA has failed to approve effective UVA filters that are in widespread use in other countries. In the U.S. the most common UVA filter is Avebenzone, a chemical that breaks down in the sun and quickens the breakdown of other common sunscreen ingredients with which it is used. The EU has approved at least two UVA filters now in common use in the EU that are more effective than Avobenzone. Companies applied years ago for approval to use these ingredients in the U.S., but FDA has failed to act. In the meantime, some companies are adding these EU sunscreens to U.S. products as "inactive ingredients," to give consumers extra sun protection without violating over-the-counter drug laws that require approval for "active ingredients" listed on products, which must all be FDA-approved.
- Questionable product claims are widespread. FDA's draft sunscreen standards detail claims that the agency considers misleading and indicative of a misbranded product. Because FDA has failed to finalize these standards, manufacturers in the meantime are making unsubstantiated claims on products. We found claims ranging from "all day protection" and "mild as water" to "blocks all harmful rays," "total protection," and "waterproof." None of these claims are possible when it comes to sunscreen.
- Some products oversell their UVB (sunburn) protection. Few people realize that while a sunscreen with an SPF of 50 provides some additional protection relative to an SPF 30 product, particularly for sun hazards other than sunburn, it washes off just as rapidly as lower SPF counterparts, and needs to be reapplied just as often. Sunscreens with these high SPF ratings can give consumers a false sense of security. The FDA has proposed limiting SPF numbers to 30+ to avoid misleading consumers but hasn't finalized this requirement.
Federal regulations for over-the-counter drugs like sunscreens give FDA the authority to enforce draft regulations if they choose to do so (21 Code of Federal Regulations 330.13). In the case of sunscreen, they haven't. While each sunscreen chemical must be manufactured according to specifications in an FDA document called the chemical's "monograph," this monograph is limited in scope, and does not cover important public health issues like protection from UVA radiation, nor does it protect consumers against the rampant, misleading claims used on products. Currently, sunscreen products are required to protect consumers from only one of the many health hazards linked to sun exposure (sunburn).
Sunscreens — drugs or cosmetics, industry's choice. The personal care product industry's options are wide open for incorporating suncreens into products. The Food and Drug Administration (FDA) regulates products containing sunscreen active ingredients under the Food, Drug and Cosmetics Act (FDCA). But how exactly these products are regulated, however, depends more on what is written on the box than what's in the box (Shaath 2005):
- If a product bears a claim about sunburn protection or prevention, the product is regulated as a drug.
- If a product contains a sunscreen active ingredient but does not claim to protect against or prevent sunburn, the product is regulated as a cosmetic.
- If a product bears both sunburn protection/prevention claims and cosmetic claims, the product is regulated both as a drug and as a cosmetic.
The issue of how sunscreens are regulated by the FDA is important because, at least in theory, drugs are much more strictly regulated than cosmetics.
In September of 2005, the FDA responded to an EWG petition by affirming its inability to effectively enforce a requirement that a warning label be posted on cosmetics that have not been substantiated for safety (EWG 2005). The FDA noted that the FDCA "contains no provision that requires demonstration to FDA of the safety of ingredients of cosmetic products... prior to marketing the product" and "does not authorize FDA to order a recall for a defective or possibly harmful cosmetic product."
What this means is that cosmetics manufacturers could legally take a sunscreen active ingredient that was denied FDA approval due to safety concerns and put it into a cosmetic or personal care product — as long as the manufacturer made no claim about that product's ability to prevent sunburn. This concern is not as far-fetched as it might seem, given that sunscreen actives are not uncommonly used to add or protect cosmetic color and are found in many personal care products not marketed as sunscreens.
Since drugs are supposed to be verified as safe and effective by the FDA before they can be sold, consumers might feel a bit relieved thinking that at least the products they buy that are marketed as providing sunburn protection are seeing strict government oversight. Unfortunately, for the most part, this isn't true.
Two regulatory mechanisms, both essentially moot. The FDA uses two different systems to regulate all over-the-counter (OTC) drugs, including sunscreens. The first, called the new drug application (NDA) system, is what consumers typically think of when they imagine how FDA regulates drugs. Under this system, a manufacturer submits a lengthy application to the agency that includes clinical data on the drug's safety and effectiveness, information describing its manufacturing process, proposed labeling language, and a check for almost $900,000 (Shaath 2005; FDA 2006a). The FDA reviews the application and approves the application if the agency believes the data shows the drug to be both safe and effective.
As consumers have learned over the past several years, the system is by no means fool-proof: Vioxx and several other prescription drugs approved by FDA through the NDA system have been yanked from commerce after they were found to be health hazards. Yet this system is far more strict and extensive than the system we have in place to regulate the marketing of new industrial chemicals — which requires no actual safety testing to gain government approval. It is also far more strict and extensive than the system used to regulate the vast majority of over-the-counter drugs.
Under the NDA system, if the FDA approves a manufacturer's new drug, the manufacturer may market that particular drug formulation, but may not make any changes to product formulation, manufacturing process, labeling language, etc. without explicit FDA approval (Shaath 2005). But manufacturers of over-the-counter drugs have a cheaper, faster, more flexible alternative to marketing their products: the OTC monograph system.
Under this second regulatory system created in 1972, FDA publishes a detailed monograph for each particular OTC therapeutic product category that describes, among other things: (1) what active ingredients are permitted for use, in what concentrations, and in what combinations; (2) warning information that must be included on the label; (3) what claims are allowed/prohibited for marketing products; (4) and specific testing procedures, where applicable (Shaath 2005).
Products marketed under the OTC monograph system do not need FDA approval, but must simply be registered (for free) with the agency. Regulatory compliance is determined simply by whether the products are adhering to the monograph's guidelines. Manufacturers may use any inactive ingredients they choose, as long as they are considered safe and do not interfere with the effectiveness of the active ingredients (Shaath 2005). As such, these products are only minimally scrutinized by FDA.
Given that the NDA system is costly, slow, restrictive, provides no guarantees for manufacturers, and is not required by the FDA for OTC products, it should not come as a surprise that it has not been popular with sunscreen manufacturers. Since sunscreens first came on the market, in fact, it has only yielded approval for two new ingredients used in sunscreen formulations — Avobenzone in 1988 and Ecamsule (Mexoryl SX) in 2006 — and a handful of specific products (FDA 1996; Shaath 2007).
In theory, sunscreen manufacturers that were not marketing their products under the NDA system would be bound by the OTC monograph guidelines, thereby ensuring mandatory safety and effectiveness standards for this important and widely used class of over-the-counter drugs. But despite the fact that the FDA has been working on the sunscreen monograph for almost 30 years, the agency still has nothing more than a set of unenforceable recommendations when it comes to what manufacturers can put in their sunscreens and what claims they can make about them (FDA 2006b).
Still no mandatory safety standards for sunscreens after 29 years. In 1978 the FDA announced that it was going to create an OTC monograph for sunscreens. Fifteen years later, in 1993, the agency finally published its first set of tentative guidelines, but within a year reopened the administrative record to discuss outstanding issues surrounding UVA protection claims and testing methods. Over the next few years the document underwent various revisions, including deleting several active ingredients that manufacturers appeared to have little interest in actually using, and adding a couple of others that the agency deemed safe and effective (Shaath 2005; FDA 2006b).
In 1999, the agency issued its final monograph for sunscreens with rules set to take effect in May, 2001. The monograph, as one would hope after a 20-year lag time, contained extensive and detailed regulations. It contained a list of 16 allowed sunscreen active ingredients, what combinations they could be used in without diminishing safety or effectiveness, and their maximum acceptable concentrations. It required manufacturers to do sun protection factor (SPF) testing for UVB radiation and provided a standardized methodology for this testing as well as standard methods to determine sunscreens' water resistant properties. The monograph also outlawed a variety of misleading terms and claims commonly used by manufacturers in the marketing of sunscreens, capped the SPF ratings at "30+," and set forth specific language to be used for warnings and directions printed on the package (FDA 1999).
Yet these regulations never came into force. In June of 2000 the FDA delayed the effective date of the final sunscreen monograph to December, 2002 in response to a petition from the cosmetic industry trade association, the Cosmetic, Toiletry and Fragrance Association (CTFA) (FDA 2000). And then a year before the new effective date, the FDA stayed its sunscreen regulations indefinitely. At issue was the fact that the FDA monograph set out rules to ensure that sunscreens claiming to protect consumers from UVB radiation were actually doing their job, but ignored the question of UVA protection entirely. At the time, the agency stated that it would develop UVA testing methods and guidance and expected the new effective date would be no later than January of 2005. Yet by mid-2007, the FDA still had not issued a final monograph. Meanwhile, the vast majority of sunscreens are being marketed in what the Connecticut Attorney General has called a "marketing Wild West" in which "sunscreen makers can make claims that are unproven and untrue" (Blumenthal 2006).
Misleading claims on sunscreen packaging persist due to FDA inaction. FDA's inaction on sunscreen regulation has prompted action by various state and federal representatives. For example, a fiscal year 2006 agriculture appropriations bill called for the FDA to finalize its sunscreen rules by June of 2006 (Castle 2007). A month after that deadline passed, Connecticut Attorney General Richard Blumental wrote to the FDA urging them to implement and upgrade their sunscreen rules, pointing out that current regulations "fail to prevent false and misleading claims" (Blumenthal 2006). In March of 2007, Delaware Congressmen Mike Castle called for the FDA to require sunscreens to protect people from both UVA and UVB radiation, noting that the European Union already had similar regulations (Castle 2007). In May, six senators followed suit with an almost identical letter to the FDA (Dodd 2007). Unfortunately, all these efforts have so far been to no avail.
Meanwhile, many misleading claims and statements persist on sunscreen packaging:
- Manufacturers market sunscreens with SPFs as high as 50, giving the impression that these products provide much greater protection than sunscreens with an SPF of 30. In reality, a product with an SPF of 50 only gives about 1.3% more protection than one with an SPF of 30 (FDA 1999).
- Claims such as "waterproof," "blocks all harmful rays," and "provides all day protection" are common, but untrue and misleading. Such claims would be banned under the FDA's delayed rules, as would the term "sunblock" which can give consumers the false impression that they are being shielded from all of the sun's harmful effects (FDA 1999; Blumenthal 2006).
- Manufacturers often market sunscreens as providing "UVA and UVB protection," yet tell reveal nothing about how much UVA protection they are actually getting. Consumers are left to assume that the SPF ratings on "broad-spectrum" products apply to both UVA and UVB protection, when they actually only apply to a sunscreen's ability to filter out UVB rays only (Blumenthal 2006; AP 2006).
Such rampant misrepresentations have even resulted in legal action. In May of 1997, for example, the Federal Trade Commission (FTC) brought a complaint against Schering-Polugh Healthcare Products, the makers of Coppertone. The FTC alleged that in magazine, television and radio ads the company "represented, directly or by implication, that it ha[d] conducted tests demonstrating that a single application of Coppertone Kids provides six hours of protection from the sun for children engaged in sustained vigorous activity in and out of the water," when in fact Schering-Plough had not conducted such tests (FTC 1997).
In 2006, nine coordinated class action lawsuits were filed in California Superior Court against five major sunscreen manufacturers, including the makers of Banana Boat, Bullfrog, Coppertone, Hawaiian Tropic, and Neutrogena. The lawsuits allege systematic fraud, false advertising, and misleading claims, with one even calling sunscreen the "snake oil of the 21st century" (AP 2006).
These issues are not simply questions of semantics. Behind all of the calls for truth in advertising is the fact that millions of people make decisions every day about how long they are going to spend in the sun based on comfort and perceived level of risk. Since sunscreens are very effective at shielding the skin from sunburn-producing UVB rays, people are able to stay in the sun longer without suffering immediate consequences. But this increased sun exposure may actually increase people's risk of skin cancer over the long-term since harmful UVA radiation is still coming though unnoticed. This problem is only compounded if people believe that their sunscreen is actually protecting them from all of the sun's harmful rays by wearing sunscreen, when this is far from the case.
US lags behind other major countries in sunscreen regulations. While the US has no mandatory regulations for sunscreens, and lacks even unenforceable guidelines when it comes to UVA protection claims, other industrialized nations have extensive rules and regulations. Some highlights include:
- Required tests for UVB claims. In Australia, the European Union, and Japan any SPF claims must be substantiated by an approved testing method (Shaath 2005).
- Required tests for UVA claims. Since 1996 in Japan, sunscreens that claim to protect against UVA radiation have been required to test for and rate the degree of this protection on a standardized three-tiered scale; a product that is rated "PA+++" screens out more UVA rays than a product that is rated "PA+". In Australia, a sunscreen can only claim to have "broad spectrum" protection if it passes the appropriate government-mandated test (Shaath 2005)
- Required tests for active ingredient safety. Sunscreen manufacturers in the European Union, Australia and Japan may only use active ingredients that appear on these countries' respective approved lists. To get a new ingredient on the approved list requires most or all (depending on the country in question) of the following tests: acute, subacute, and chronic toxicity, carcinogenicity, reproductive effects, skin irritation and sensitization, phototoxicity and photosensitization, eye irritation, genotoxicity, endocrine disruption, photostability, and interaction potential with other sunscreen active ingredients (Shaath 2005).
- Required tests for non-active ingredient safety. Before a new non-active ingredient can be used in sunscreens in Australia, manufacturers must subject it to at least three — and up to six — different toxicity and absorption tests (Shaath 2005).
- Required tests for water-resistance claims. In Australia, a sunscreen can only be labeled as "water resistant" if it passes the appropriate government-mandated test. The maximum claimable resistance depends on the sunscreen's SPF, but ultimately cannot exceed 4 hours (Shaath 2005).
Other countries have also been far ahead of the United States when it comes to considering the safety of nanoscale materials in sunscreens. The European Union's Scientific Committee on Cosmetics denied approval for micronized zinc oxide as a sunscreen in 2003, citing a lack of data on skin absorption and inhalation, and studies showing the ingredient to be potentially toxic in the presence of light (SCCNP 2003; SCCP 2005). The FDA, on the other hand, accepted zinc oxide as a new sunscreen active when it published its revised monograph in 1999, but didn't consider the safety of the nanoscale forms of the ingredient. In contrast to zinc oxide, the European Union opinion on micronized titanium dioxide is favorable, given a review of studies that indicates little penetration through the skin (SCCNFP 2000). EWG research has identified nearly 9,800 products containing nano-scale ingredients or ingredients that may contain a nano-scale fraction, but there is no assurance that these ingredients are actually safe (EWG 2006).
References
AP. 2006. Sunscreen makers sued for misleading claims; popular brands exaggerate their effectiveness, nine lawsuits charge. Associated Press April 24, 2006.
Blumenthal R. 2006. Connecticut Attorney General's Office Press Release: Attorney General Says Sunscreen Labeling Rules Fail To Prevent False Claims, Urges FDA To Update, Enforce Regulations. July 7, 2006.
Castle M. 2007. Press Release: Castle Urges FDA to Upgrade Sunscreen Standard to Protect All Americans from Harmful Rays Leading to Skin Cancer.
Dodd and Reed, Hillary Clinton (D-NY), Joe Biden (D-DE), Tom Carper (D-DE), and Bernie Sanders (I-VT). Dodd C. 2007. Press Release: Dodd, Reed Lead Fight Against Skin Cancer; Request Higher Standard's for FDA's sunscreen labeling. (Letter to FDA from Senators.
EWG. 2005. Consumer Update Ñ FDA admits inability to ensure the safety of personal care products http://skindeep.ewg.org/research/fdafails.php: Environmental Working Group.
EWG. 2006. A Survey of Ingredients in 25,000 Personal Care Products Reveals Widespread Use of Nano-Scale Materials, Not Assessed for Safety, in Everyday Products. Comments to U.S. Food and Drug Administration. : Environmental Working Group. Available at http://ewg.org/issues/cosmetics/20061010/comments.php.
FDA. 1996. Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph. Federal Register 61(180): 48645-48655.
FDA. 1999. Final Rule for Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register: U. S. Food and Drug Administration, 27666.
FDA. 2000. Summary: Cosmetics Harmonization and International Cooperation (CHIC) Meeting; Washington, D.C.; May 8-9, 2000. Available: http://www.cfsan.fda.gov/~dms/cos-ch00.html.
FDA. 2006a. Prescription Drug User Fee Rates for Fiscal Year 2007. Federal Register 71(148): 43780-43784.
FDA. 2006b. Monograph History. Available: www.fda.gov/cder/Offices/OTC/Monograph_history_sunscreen.pdf [accessed May 31 2007].
FTC. 1997. Federal Trade Commission complaint against Schering-Plough Healthcare Products, Inc. May 16, 1997. Docket No. C-3741.
SCCNFP. 2000. Opinion concerning Titanium Dioxide. Opinion: European Commission — The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers.
SCCNP. 2003. Opinion concerning zinc oxide.The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers. Adopted by the SCCNFP during the 24th plenary meeting of 24-25 June 2003. OLIPCA n S 76.
SCCP. 2005. Statement on zinc oxide used in sunscreen. The Scientific Committee on Consumer Products. Adopted by the SCCP during the 5th plenary meeting of 20 September 2005.
Shaath N. 2007. The Encyclopedia of UV Filters: Allured Publishing.
Shaath NA. 2005. Sunscreens. In: Sunscreens: Regulation and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.
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