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Regulatory Update: Regulation Time

Jeff Falk

Back to the January 2007 Issue

Regulations may appear as the bane of the industry—hoops to jump through, paperwork, red tape and man hours. However, the effect of regulation on consumer confidence that means so much to businesses and the industry as a whole should be considered.

A Google search for cosmetic regulations turns up information that is particularly alarming to one whose livelihood is tied to cosmetics and personal care products. Web sites of consumer interest groups and various agencies have put a dent in the warning bell with the force of their ring. Industry efforts to educate and inform customers regarding product safety often are ignored by these groups—to the detriment of consumers.

The tone taken on many of these sites are of Silkwood proportions, and the “facts” are not being reported by just anybody. Authoritative sources, in name at least, are providing information frightening enough to scare the rouge off the boldest consumer. However, these sources often are providing partial information.

According to a presentation made by Cosmetic, Toiletry, and Fragrance Association’s (CTFA) John Bailey and Elizabeth Anderson at the 2006 HBA conference, most consumers form an opinion based on the information they first see, and the information on these sites creates a false impression about cosmetic product safety.

On its site, the Cancer Prevention Coalition (CPC) states “Because of minimal regulation, products plainly dangerous to your health can be, and are being, sold.” Further, the coalition asserts that the FDA has found that “cosmetic manufacturers lack adequate data on safety tests and generally have refused to disclose the results of these tests.”

“Dangerous” ingredients have been used in cosmetics. However, the industry and regulatory bodies have not hidden the fact—the EU’s Dangerous Substances Directive, for example, is readily available. Classifying an ingredient as dangerous erroneously implies that it cannot be used safely, according to David Steinberg, former president of the Society of Cosmetic Chemists.

Illustrating both the power and shortcomings of the Internet, sites such as the aforementioned provide links to other sites that address specific ingredients/products or lend weight to their own argument—however, there are no links from the CPC site or others like it to the FDA, to CTFA, to Colipa, to ICMAD, to the EU or to any other industry source that directly and honestly addresses the issues of product safety.

Shadowboxing with proponents of out-of-date or unbalanced rhetoric does not win consumer confidence. Effective counter arguments constitute action: self regulation and innovative ways to best serve consumers across the scope of cosmetic and personal care products—and these ideas should not be limited to one facet of the industry.

As Carl Geffken, president of Carl Geffken Consultants, notes in the October 2005 issue of GCI magazine, ingredient disclosure is effective and advantageous in building consumer confidence. Geffken endorses the FDA’s Voluntary Cosmetic Registration Program (VCRP)—an online reporting system for cosmetic products on the market for individual consumer purchase—to provide strong ethical credibility to the industry regarding terms such as “safe use.” Colipa, too, has an online system for consumers to obtain ingredient information.

CTFA recently implemented its Consumer Commitment Code, which the organization noted as a top priority, and a consumer information Web site. The code has been developed to provide assurance of safety and transparency for government regulators. The site was designed to be the “definitive place to go for consumers seeking information about the science behind cosmetic products and ingredients.”

The Consumer Commitment Code, which will reinforce existing company safety practices and introduce some new practices, will go beyond the requirements of the law and highlight the pro-active and responsible approach to product safety supported by cosmetic companies. According to CTFA, it highlights the industry’s commitment to the health and safety of consumers.

“Outreach and education on the code has been provided to our members through workshops and direct communication,” stated the association. “We are also talking individually with member companies to provide assistance or guidance. Outreach to companies who are not members of CTFA will continue in 2007 as the program is implemented.”

The Consumer Commitment Code will be posted on CTFA’s Web site along with names of companies that have signed on to the code. Both CTFA and individual companies that sign onto the code will, according to CTFA, take on the responsibility of educating consumers about the code.

CTFA will make the appropriate announcements upon the site’s launch, and the site itself will be optimized to ensure that consumers looking for ingredient safety information are able to easily find that information.

“These efforts form another important part of our public-private partnership working to ensure consumer safety and provide FDA with the information needed to effectively do its job,” stated CTFA. “We have been meeting with FDA’s Office of Cosmetics and Colors to discuss the Code and how FDA can expect to use it, commencing in January 2007 when companies sign on. The industry already ensures product safety, while the code will provide FDA with a voluntary mechanism to verify and confirm specific safety concerns under specified circumstances.”

But is it enough to register ingredients or cite the CTFA or Colipa system or EU’s Dangerous Substances Directive? Action can’t end there, because that, on its own, does not reach the consumer. The VCRP, for example, cannot be used to market a product or be cited as an FDA endorsement of a product. However, there may be long-term benefits in simply marketing the existence of these online databases.

Suncreens: A Regulatory Hot Spot

In June 2006, Colipa announced that European, U.S., Japanese and South African cosmetic industry associations signed the International Sun Protection Factor Test Method. SPF, according to Colipa’s press statement, has become key in consumers’ choice of personal sun care products. Colipa sees the recently adopted method “as the basis for a harmonized way for companies to substantiate claims on sun protection products worldwide.” The new method is being implemented to assure consumers that the same testing standard has been applied regardless of which country the products were purchased and that SPF claims can be substantiated. In the U.S., manufacturers still must comply with the FDA-mandated method.

According to David Steinberg, former president of the Society of Cosmetic Chemists, however, SPF is not an accurate test. An SPF level of 15 can measure anywhere from 12–18 and an SPF of 30+, the maximum claim allowed by the FDA, could mean a level of protection from 31–100. In the November 2006 issue of Cosmetics & Toiletries magazine, Steinberg demonstrates that only a marginal increase in protection is provided as SPF numbers increase. An SPF level of 15, for example, filters out 93.3% of UV exposure while an SPF of 18 filters out 94.4%; SPF 30, 96.7%; and SPF 45, 97.8%; etc.

Even if consumers get and understand the message that SPF testing has become standardized globally, it is likely that many consumers don’t understand SPF ratings, the marginal increases in protection as the SPF number increases and, more importantly, how to apply sunscreen to effectively protect themselves. As sun protection attributes are being touted in an increasing number of products, the prospect of truly protecting one’s self may actually be more confusing and less effective than ever.

“The real problem with consumer use of sunscreens is the fact that usually not enough is applied,” said Steinberg. “Adequate protection clearly requires application of enough product (usually dictated by the clinical SPF testing protocol) and clear directions for use,” said Carl Geffken, president of Carl Geffken Consultants. “Directions should identify both quantity and repeat application parameters, especially when swimming or sweating after exercising.”

When reading about the challenges and regulatory issues in sun care, it is clear that R&D and ingredient suppliers are on the front line in facing testing and labeling challenges. Steinberg notes that most formulations are developed two years before a product launch, so it makes sense that chemists are the de facto vanguard. However, it does not preclude other segments of the industry from playing an immediate and effective role in helping consumers use sunscreen correctly.

“Consumer education about product use could advisably go beyond the specific mandatory labeling of products in the required directions for OTC drug products,” said Geffken. “For example, marketers can provide a very responsible perspective by reminding consumers to seek advice from a skin care professional to understand the necessity of higher SPF value and greater protection required for certain skin types and for children. The idea of measured dose delivery systems can be a benefit for consumers to assure adequate application and protection with sun products. This concept is, of course, best for beach products rather than for face makeup. The question about adequacy of use and the appropriate instructions for use must not be confused by failure to consider the type of sun protection provided by different categories, such as incidental makeup with SPF versus true beach products.”

Because sun care products play such an important role in consumer safety, the continued proliferation of new sunscreen ingredients, technologies and products is inevitable, and regulatory scrutiny and debate over these products is sure to remain. For example, in May 2006, a citizen’s petition was filed with the FDA requesting that nanomaterial sunscreens be considered as new drugs and be removed from the market.

Better informed consumers will ease the growing pains of advancing technologies. Knowledgeable consumers may also facilitate additional advancements and improvements. According to Steinberg, getting consumers to use the required amount of sunscreens, for example, may force chemists to make better sunscreens and formulations that are less greasy and dry better.

Back to the January 2007 Issue