Skin Devices, ‘Hair-ceuticals’ Are Opportunities For Firms That Avoid Pitfalls

Growth opportunities exist for firms marketing home-use skin-care devices and cosmeceuticals in new categories such as hair care, but such products also can invite regulatory scrutiny for exceeding FDA’s definition of a cosmetic. Consulting with FDA on a premarket basis and crafting claims with attention to regulatory parameters can help firms stay in the agency’s good graces.

Market analysts identify advanced skin-care devices and “hair-ceuticals” as promising growth opportunities for beauty manufacturers, but firms innovating in those areas must be careful to stay within regulatory lines.

The success of skin-cleansing gadgets in recent years, led by L’Oreal S.A.’s Clarisonic brushes, has provided a platform for device expansion into new functionalities, including anti-aging, Euromonitor Beauty and Personal Care Analyst Nicole Tyrimou notes in a Jan. 28 blog post.

Clarisonic, picked up by L’Oreal in 2011, “has averaged 60% growth in the U.S. in the past five years,” according to Tyrimou. The line encompasses cleansing systems boasting varying speeds and features, as well as “the next generation of sonic technology” – the Opal Sonic Infuser, an anti-aging eye corrector priced at $185.

According to the brand’s website, the palm-sized Opal device delivers 200+ sonic movements per second to help reduce under-eye puffiness and dark circles “while maximizing the absorption of eye serums and wrinkle-reducing creams in a way that’s not possible with your finger alone.”

Meanwhile, Carol Cole Company’s NuFACE device range and the StriVectinLABS Facial Toner, marketed by the StriVectin skin-care brand owned by private equity firm Catterton Partners, rely on microcurrent technologies traditionally used in professional settings to provide anti-aging skin benefits.

“Like all muscles in the body, facial muscles need to be gently exercised to preserve the muscle mass and volume that define the shape of the face. The Facial Toner gently stimulates the nerves that control the major facial muscles for a younger looking appearance,” StriVectin says of the $199 device.

According to NuFACE, its mini facial toning device, also $199, “gently stimulates the larger surface areas of the face to provide a 5-minute facial lift.”

Johnson & Johnson’s Neutrogena division has gotten into the game at an entry price-point level with its Microdermabrasion System ($19.99), promising “softer, more luminous skin today and firmer, younger-looking skin over time.”

The system consists of a microdermabrasion applicator and single-use puffs “pre-dosed with ultra-fine crystals and mild purifiers for the perfect degree of gentle exfoliation,” Neutrogena says, adding that the massaging micro-vibrations boost surface cell turnover for rejuvenating effects.

At the upper end of the pricing spectrum, Tria Beauty, Inc.’s Age-Defying Laser ($495) is designed to “visibly restore the natural luminosity of your entire face and smooth hard-to-treat wrinkles for a more youthful, radiant and refreshed look in as little as 2 weeks” (Also see "Tria Beauty’s Age-Defying Laser Clears FDA, Aimed At Market In Early 2014" - HBW Insight, 4 Nov, 2013.).

Cosmetic Or Device? Exempt Or Non-Exempt?

Firms would be well-served to consult FDA before launching a skin-care device to market, particularly anti-aging technology, as the regulatory expectations for such products can hinge on subtle design and marketing details.

Tria’s laser, as well as the NuFACE and StriVectin offerings, are FDA-cleared as medical devices, according to the companies. FDA’s 510(k) premarket notification platform provides a pathway to market for medical devices deemed substantially equivalent to other technologies on the market – for example, skin-renewal systems used by doctors and aestheticians in medical offices or spas, many of which serve as models for home-use devices.

Clarisonic’s website indicates that its cleansing products are considered cosmetics and thus did not require notification to the agency. Estee Lauder Companies, Inc. and Procter & Gamble Co. are among competitors in the cleansing device category with their Clinique Sonic System Purifying Cleansing Brush and Olay ProX Microdermabrasion Plus Advanced Cleansing System, respectively (Also see "Lauder Launches Clinique Sonic Cleansing Brush, A “Skin Changer”" - HBW Insight, 7 Jul, 2014.).

General manual and motorized dermabrasion systems are Class I devices under the U.S. Food, Drug and Cosmetic Act and are exempt from premarket notification, like many other Class I and Class II devices. However, FDA notes in guidance on the subject that manufacturers could be subject to 510(k) requirements if their device has a unique indication, mode of action or abrasion substrate.

Asked about J&J/Neutrogena’s Microdermabrasion System, a company rep pointed to draft guidance issued Jan. 20 by FDA’s Center for Devices and Radiological Health, outlining the division’s “policy for low-risk devices,” specifically those “that promote a healthy lifestyle (general wellness products).”

In the proposed guidance, CDRH says it “does not intend to examine low-risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices.”

The center provides the example of a product intended to mechanically exfoliate the face, hands or feet to make skin smoother and softer. If described accordingly, marketing claims would not refer to a specific disease or medical condition, making them general wellness claims. Further, “the technology for exfoliating the face poses a low risk to the user’s safety as it does not penetrate the stratum corneum,” FDA says.

However, there is a caveat: “If the product exfoliates the skin to enhance the delivery of a topically applied product containing one or more active pharmaceutical ingredients through the stratum corneum, the product would present inherent risks to the user’s safety because of its invasive nature.” Such products would not qualify as low-risk devices for general wellness, according to the agency.

A recent warning letter issued to Dermapen, LLC, cited for its Dermapen micro-needling skin dermabrasion device, provides an illustration. The device raised safety concerns at FDA due to its mechanism of action that “creates micro-injuries to the skin, stimulating new collagen production” (Also see "FDA Monitoring Market For Devices More Medical Than Beauty" - HBW Insight, 3 Feb, 2015.).

Room For Global Growth

For companies that can ensure compliance, home-use skin-care devices represent a market primed for continued growth. Tyrimou points out that consumers in developed economies, particularly in the U.S., increasingly see such products as affordable alternatives to professional skin-care treatments.

She cites Japan, South Korea and Hong Kong as markets outside of the U.S. with “the strongest potential for skin-care devices due to local consumers’ affinity with both skin care and electronic devices.”

Promising emerging markets include China, Indonesia and Thailand where rapid growth in the premium anti-aging space signals opportunity for home-use devices, the analyst suggests.

“However, much of their success will depend on marketing activities that raise awareness and education about the technology behind products as well as high-efficacy claims, both of which are vital for convincing consumers to invest in these products,” she says.

In research released in 2014, Kline & Company also underscored the need for increased device awareness to maximize market potential, noting that consumers who have used at-home beauty devices report high satisfaction, while those who have not tried such products list “Didn’t know about them” as a leading reason (Also see "Home Beauty Devices Likely To Satisfy ... If Consumers Knew About Them" - HBW Insight, 9 Jun, 2014.).

In a Jan. 29 white paper authored by Datamonitor Consumer’s Jamie Mills, the associate analyst cites “smarter” skin care, particularly “the expansion of devices with more complex functions,” among six emerging innovation opportunities in personal care.

Mills refers firms to the developing market for “predictive” devices or diagnostics designed to complement and optimize consumers’ skin-care regimens.

“The beauty devices space is rapidly expanding, and there is a growing shift in innovation towards devices which provide a holistic approach to meet users’ skin-care requirements. Designing devices to analyze and predict future needs through skin diagnostics will appeal to the growing demand for individualized beauty consumption experiences,” she says.

Datamonitor points to OKU, a soon-to-launch device from mySkin Inc. that connects to users’ smartphones and analyzes skin needs by scanning below the surface, serving as a “personal skin coach,” according to mySkin (Also see "iPhone-Connected OKU ‘Sees Below Skin’s Surface’ To Assess Health" - HBW Insight, 22 Jan, 2015.).

Nearly a third of global consumers do not currently use beauty devices but would consider using them in the future, according to Datamonitor survey findings.

Cosmeceuticals Enter New Categories

Mills notes that consumers have escalating expectations for beauty products and their performance, “no longer seeking to just maintain their appearance,” but rather, “searching for products which can improve, enhance and cure specific concerns.”

Datamonitor research indicates that 28% of global consumers believe reducing or curing visible imperfections is the greatest benefit of using beauty or grooming products.

Industry has answered with the development of “pharma-inspired beauty solutions designed to ‘cure’ perceived beauty flaws and enhance appearance beyond the skin-care space,” often referred to as cosmeceuticals, Mills says.

Movement in this direction represents regulatory challenges for cosmetics firms, however, as FDA does not recognize the term “cosmeceutical,” and products that do more than improve appearance exceed the regulatory definition of a cosmetic.

In the agency’s eyes, pure cosmetic products with drug-like benefits – in terms of curing or treating diseases or affecting body structure or function – do not exist. Such items are subject to drug compliance requirements, even if they also fit the definition for cosmetics under the Federal Food, Drug and Cosmetic Act.

FDA stresses the point in its recent warning letter to Dermapen, whose cosmeceuticals marketed as healing skin, stimulating immune defense and promoting collagen production are drugs, the agency asserts, a position consistent with warnings issued to other cosmetics firms in recent years (Also see "‘Revolution’ Quelled? FDA Warns Firm For ReLuma Stem-Cell Claims" - HBW Insight, 3 Dec, 2014.).

As marketers innovate to meet evolving consumer demand and craft claims to drive uptake in an increasingly competitive market, avoiding regulatory scrutiny with cosmeceuticals could prove a delicate balancing act. However, opportunity does exist for companies that can pull it off.

According to Mills, cosmeceuticals are “becoming more rapidly established in categories such as hair care,” and “more granular beauty concerns such as lash, brow, and nail quality all represent areas for growth.”

The analyst cites Elizabeth Arden Inc.’s Prevage Clinical Lash + Brow Enhancing Serum as a noteworthy entry in the segment (Also see "New Launches Propel Arden In Q1; Restaged Elizabeth Arden Rolling Out" - HBW Insight, 12 Nov, 2012.).

Priced at $100, the serum contains a triple peptide complex, as well as vitamins, botanicals and lash conditioners, “support[ing] the natural lash cycle so they look lush, healthy and revitalized – and eyes appear younger than ever.”