Toxicity, Transparency & Sunscreen Regs Among Top “Rose Sheet” Topics In 2011

“The Rose Sheet” analyzes the stories that garnered the most reader interest and had the highest impact on the personal-care industry in 2011. The top topics include Johnson & Johnson’s reformulation of its baby-care products and the establishment of the Safe Cosmetics Alliance.

Personal-care stakeholders are keeping a close eye on how manufacturers, regulators and industry insiders are responding to allegations of ingredient toxicity and demands for greater transparency in product labeling, based on data from “The Rose Sheet” website.

FDA action against overreaching performance claims also drove readers’ interest in 2011, as well as developments in the sun-care sector surrounding FDA’s release of a final rule on sunscreen testing and labeling.

Additionally, data suggest that nanotechnology policy continues to concern industry stakeholders.

1. J&J Reformulates Under Pressure

In November, Johnson & Johnson announced its plan to remove quaternium-15 and other formaldehyde-releasing substances from its baby-care line within two years, and to minimize the presence of 1,4-dioxane by requiring suppliers to use “state-of-the-art” technologies to reduce traces of the contaminant.

The firm’s announcement came in prompt response to the release of a Campaign for Safe Cosmetics report – “Baby’s Tub Is Still Toxic” – alleging that J&J’s baby-care products continue to pose health risks to children more than two years after the public watchdog first identified suspected carcinogens in its formulas and petitioned the firm to eliminate them (Also see "J&J Plans Baby Shampoo Reformulation; CSC Claims “Victory”" - HBW Insight, 21 Nov, 2011.).

CSC championed J&J’s announcement as a hard-won victory for its cause.

However, J&J maintained the safety of its products, pointing out that formaldehyde is released in just “tiny amounts” by preservatives included in its formulas to guard against harmful bacteria. In fact, it said, a consumer is exposed to as much formaldehyde by eating an apple or pear, in which the substance occurs naturally, as he/she would be through use of a full bottle of baby shampoo.

Nevertheless, the firm said it would reformulate its products to cater to “changing consumer needs and values.” It noted that phthalates – which have been classified as potential endocrine disruptors, based largely on animal data – have already been eliminated from its baby-care products.

CSC indicated that it will continue to push for similar changes from other brands, including L’Oreal, Sesame Street and Gerber.

2. Stakeholders Form Safe Cosmetics Alliance

CSC’s science, or lack thereof, has come under attack on numerous occasions by the Personal Care Products Council, one member of the recently formed Safe Cosmetics Alliance.

Made up of personal-care stakeholders ranging from manufacturers and distributors to nail salon workers, the alliance operates under the banner “Sound Science for Safe Products” and aims to drum up support for legislation it says would “modernize” cosmetics regulations without compromising innovation or burdening industry unnecessarily (Also see "New Industry Alliance Aims To Drum Up Public Support, Emphasizing Safety" - HBW Insight, 26 Sep, 2011.).

The Independent Cosmetic Manufacturers and Distributors trade group joined the alliance as well. ICMAD looks to amplify its message and expand upon its tools and services to members in 2012, according to the association’s CEO and President Pam Busiek (Also see "New CEO Busiek Aims To Grow ICMAD’s Presence, Utility To Members" - HBW Insight, 2 Jan, 2012.).

3. Sunscreen Regs Cause A Stir

In 2011, FDA unveiled a final rule on sunscreen product testing and labeling. Under the rule, marketers of formulas that have not been shown to offer broad-spectrum protection and an SPF of 15 or higher must warn consumers that their products may not protect against cancer or premature skin aging (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 Jun, 2011.).

While not the long-awaited final monograph for over-the-counter sunscreen products – FDA says it is still evaluating other issues raised in comments on the proposed monograph – the final testing and labeling rule generated much buzz and some controversy.

The Council took issue with the rule’s labeling requirements for cosmetic products with built-in sunscreen protection. According to the trade group, the requirements are impractical for manufacturers of such products, which often come in petite packages with little surface room for labeling, and could compel firms to do away with the SPF component, making consumers more vulnerable to damaging sun exposure (Also see "FDA Should Grant Labeling Leeway For Cosmetics With SPF, Council Says" - HBW Insight, 19 Sep, 2011.).

Concerns also were raised among industry members by FDA’s contention in a notice of proposed rulemaking that spray sunscreens “lack a safety and efficacy record” and may require unique testing protocols to be demonstrated as suitable for consumer use (Also see "Spray Sunscreens Are Safe, Trade Groups Say; New Test Methods Not Needed" - HBW Insight, 24 Oct, 2011.).

Meanwhile, industry leaders are divided on the agency’s proposed cap on advertised sun-protection-factor values, which would restrict SPF claims to “50+”, with Procter & Gamble Co. coming out in support of the measure, while competitors J&J and Energizer believe the cap would be a disservice to the public (Also see "P&G Backs Proposed SPF Cap For Sunscreens, In Break From Rivals" - HBW Insight, 14 Nov, 2011.).

4. FDA Targets Drug-Like Cosmetic Claims

FDA demonstrated in 2011 that it will continue to take action against companies whose cosmetic products and/or marketing impinge on drug territory.

In March of last year, the agency issued a warning letter to San Antonio, Texas-based JabaLabs, LLC for claims on websites selling the firm’s StemCellin Intensive Emulsion, among other anti-aging skin-care products (Also see "FDA Warns JabaLabs About Drug Claims For Anti-Aging Cosmetics" - HBW Insight, 21 Mar, 2011.).

According to the regulator, JabaLabs claims such as “Lose your wrinkles! without painful injections” and “Delays deterioration of essential skin cells” cast the firm’s offerings as products affecting the structure or function of the human body, making them drugs that would require premarket approval.

One month later, [Lifetech Resources LLC] received a warning letter citing online claims and testimonials for its eyelash and eyebrow enhancement brands RapidLash, NeuLash and NeuveauBrow (Also see "FDA’s Warning To Lash-Growth Firm Shows Risks In Third-Party Claims" - HBW Insight, 2 May, 2011.).

Third-party testimonials included “After eight weeks my lashes were curlier, darker, longer and thicker than before,” suggesting performance benefits beyond beautification, FDA said. The agency also zeroed in on the products’ active ingredient, a prostaglandin analog related to bimatoprost, which Allergan uses in its Latisse drug to treat “inadequate” eyelashes.

The year’s most publicized warning letter in the cosmetics sector was that to [GIB LLC], maker of the Brazilian Blowout hair-straightening system. According to FDA, the product was adulterated and misbranded because it contained potentially hazardous levels of methylene glycol, which converts to formaldehyde when heated as part of the hair-smoothing process, and because it was labeled as “formaldehyde-free.”

5. Fragrance Firms Debate Ingredient Disclosure

With cosmetic ingredients increasingly coming under fire – whether formaldehyde releasers in baby products and hair straighteners, prostaglandin analogs in eyelash enhancers or ever-controversial phthalates –labeling transparency has become a hot-button issue in the personal-care marketplace.

For fragrance makers and suppliers, the issue is particularly salient. Under current federal regulations, marketers can simply list “fragrance” on product labeling without breaking a scent down into its myriad components. Because of this, as noted by FDA on its website, “the consumer will not be able to determine from the ingredient declaration if phthalates are present in a fragrance,” for example.

The Environmental Working Group and other CSC members are lobbying Congress to require full disclosure, backed by research which they say identifies “secret” toxins in fragrances from celebrity names and popular consumer brands. The Safe Cosmetics Act of 2011 includes a provision for mandatory disclosure of fragrance components (Also see "Safe Cosmetics Act Would Remedy “Broken Regulatory System,” Says CFSC" - HBW Insight, 4 Jul, 2011.).

In 2011, fragrance stakeholders debated the merits and drawbacks of full disclosure.

The International Fragrance Association, which has launched animated videos on its website and YouTube to raise public awareness, maintains that fragrance recipes are sacred trade secrets that must be protected for the good of competition and the overall health of the market (Also see "IFRA Videos Designed To Educate, Feel Out Public On Ingredient Disclosure" - HBW Insight, 2 Jan, 2012.).

On the other hand, at the 2011 annual meeting of IFRA’s scientific arm, the Research Institute for Fragrance Materials, an industry consultant argued that firms have much to gain by disclosing fragrance ingredients and little to lose, given the ease of reverse-engineering fragrances with today’s technology. Regardless, he opined, regulations mandating full disclosure are inevitable (Also see "Fighting Ingredient Disclosure Is Losing Battle, Consultant Suggests At RIFM Meeting" - HBW Insight, 14 Nov, 2011.).

6. Regulators Refine Nanotech Approach

Nanotechnology – the use and manipulation of materials on the billionths-of-a-meter scale, where matter can exhibit novel properties – is increasingly making its way into personal care and other consumer-goods markets, and regulators are at work on strategies for ensuring public safety.

At their fifth meeting, held in Paris in summer 2011, regulators from the U.S., Canada, Europe and Japan accepted a report from a joint working group holding that nanomaterials should be taken into consideration for special regulatory attention when present in final product formulations, not at earlier stages in the development process (Also see "Nanomaterials Should Be Measured In Final Product Formulations – ICCR Report" - HBW Insight, 7 Nov, 2011.).

That position is likely well-received by manufacturers of sunscreens and other personal-care products that contain larger clusters of nano-sized materials, which likely do not pose the same penetration risks that the molecules might independently.

In a June 2011 guidance, FDA steered clear of rigidly defining the nanotech realm, which the National Nanotechnology Initiative has placed squarely between 1 nanometer and 100 nm. Instead, the agency urged firms to evaluate materials more in terms of properties, focusing on behavior that could distinguish a microscale material from its macroscale counterpart (Also see "FDA Takes “Property”-Based Approach To Nanotech, Raises Roof To 1 Micron" - HBW Insight, 20 Jun, 2011.).