Show me—don’t tell me. It’s a maxim of fiction writing and it’s something to keep in mind when formulating skin care products that do much more than moisturize the stratum corneum. After all, consumers can read labels that are chock full of exotic ingredients, view blogger reviews until they’re blue in the face or watch infomercial ad nauseam, but if they don’t see results when they look in the mirror, all that copy and all those promises mean nothing. Unfortunately, too many of today’s skin care products just don’t deliver on their promises, say some industry experts.

“We have so much knowledge to do good things for our skin,” observed Paolo Giacomoni, co-founder and chief technical officer of Élan Rose International, a new skin care company. “Yet, we incorporate a useless root of a tree—what does it mean?”

Other marketers agree.

“We don’t espouse clinical studies of magical ingredients —that’s hocus pocus,” insisted Frank Fanning, founder and CEO of Trilipiderm. “As we move forward, the consumer will demand functional products and we will deliver them.”

And consumers are seeing things in the mirror that they don’t like at an earlier age than ever. According to a recent study by Kline Group, anti-aging continues to be the leading skin care concern across all age groups in the US. Younger consumers are likely to use anti-aging products to prevent or delay signs of skin aging from showing.


Claims People Play

The show-don’t-tell concept might just work with regulators, too. The US Food and Drug Administration (FDA) is sending out more warning letters than a high school physics teacher at mid-marking period. After several years of relative quiet, FDA has turned up the heat on cosmetics companies large and small. 

According to industry experts at Arent Fox LLP, a Washington DC-based law firm, FDA appears to once again be trying to send a strong regulatory signal to industry in 2015 (similar to 2012) by issuing approximately 14 Warning Letters (WLs) to date.

“In 2012, FDA issued nine Warning Letters to cosmetics companies for objectionable skin care claims, particularly anti-aging claims,” recalled Georgia Ravitz, a partner with Arent Fox LLP.

According to Ravitz, the increase in WLs in 2015 can be attributed generally to several factors:

• FDA’s increasing enforcement capability over the past 5-6 years. FDA has been slowly increasing its enforcement staff at CFSAN as well as conducting more online research to review product claims and promotions online.
• Some companies continue to market their products with aggressive enforcement claims, which is drawing FDA’s attention to product claims it views as objectionable.
• FDA has been unable to get Congress to pass cosmetics reform legislation that would increase FDA regulation of the industry.  
• “Thus, FDA is using more active enforcement to try to keep industry in regulatory check,” she said.

More specifically, four of the WLs issued in 2015 were to companies for marketing “dermal fillers” that FDA deemed to be unapproved medical devices. So, 2015 has brought a new sub-area of enforcement in dermal fillers. Through October, 2015, WLs include: seven for skin-care claims; four for dermal fillers; one for an illegal color additive; one for antimicrobial contamination; and one for an illegal ingredient. 

“Thus, versus 2012, FDA’s warning letters for 2015 are more diversified as to the compliance issue—though seven letters relate to skin care claims,” observed Ravitz.

Looking back, FDA became more aggressive in 2012, when it issued 10 Warning Letters, including nine related to skin care claims, particularly anti-aging claims, recalled James H. Hartten, regulatory affairs analyst at Arent Fox. But 2012 was followed by two years, 2013 and 2014, in which FDA issued a total of three WLs, which is about average based on past practices.

“The 14 Warning Letters which have been issued to date in 2015 is a record number,” observed Hartten.

To avoid WLs, Arent Fox executives suggested that formulators create effective products, but don’t promote them for their anti-aging claims; i.e., let the product efficacy speak for itself.

“The majority of FDA Warning Letters are claims related, so avoiding use of aggressive structure function or therapeutic claims would clearly reduce the risk of FDA issuing a Warning Letter,” noted Ravitz. “Cosmetics companies should also limit importing cosmetics with aggressive labeling claims through US Ports of Entry, where they are subject to FDA scrutiny.”

According to the Arent Fox executives, the US has become a tougher market in which to promote anti-aging cosmetics with aggressive claims.

“This may be due more to the growth of FDA’s enforcement capabilities rather than existing regulations,” observed Ravitz. “For example, Canada and the EU both require cosmetics notification prior to marketing. Such notification is not required in the US.”

Ravitz noted too, that both Canadian and EU regulations restrict use of a greater number of ingredients in comparison to the US. 

“The combination of increased enforcement capability and FDA scrutiny at US Ports of Entry has become a more effective enforcement tool,” she added.

Will FDA’s attitude and activities surrounding anti-aging claims change any time soon? According to Hartten, FDA has been seeking to increase its regulation of the cosmetics industry via the passage and implementation of cosmetics reform legislation. 

“However, such recent attempts at enacting reform legislation have not been successful, as Congress is currently controlled by Republicans who generally oppose increasing industry regulations unless an urgent need exists,” he pointed out. “Looking forward, to the extent the Democrats can take back Congress, reform legislation would likely have a better chance of passage.”

FDA regulators aren’t the only guilty parties making life miserable for formulators. According to Giacomoni, too many products are formulated in ways that makes it difficult for actives to penetrate the stratum corneum to where they are needed. Instead, products must be formulated in such a way that favor molecule penetration.

“Chemists don’t know physical chemistry,” he charged. “They focus on the aesthetics.”

As a result, too many formulators come up with a combination of thickeners and emulsifiers that have a silky feel but leave no room for active ingredients, according to Giacomoni, who explained that the marketing team then steps in and demands a miracle claim. R&D responds by adding minute amounts of actives without making any changes to the formula.

“So, instead of deciding to build the cream around the active, they build a cream and throw in an active,” Giacomoni insisted. “This is the real difficulty in skin care because the formulator is pushed for good aesthetics.”


What’s Old Is New Again

One of the best ways to avoid the wrath of FDA, is to use widely-accepted ingredients that have been know for decades—if not centuries—according to one formulating expert.

“We’re finding new ways to infuse new life into old ingredients,” explained Shyam Gupta, president of Bioderm Research. “It takes so much time and money to bring a new ingredient to market. So, now, we’re looking at older ingredients, taking a closer look at their biochemistry and finding new applications for them.”

Of course, there are other ways to boost interest in older, established and often, less costly ingredients. One is to leave the ingredient alone and improve the delivery system; a move that may enable formulators to create products that use one ingredient to impart different benefits to different skin sites. For example, when left on the surface, aloe absorbs urea, but when it penetrates skin, it boosts collagen production, according to Gupta.


What’s New?

Few categories are more competitive than beauty. Each year, department store counters, drug store aisles and internet channels are filled with new products that promise to stem the tide of time, but rarely last more than a year or two on the market. The long odds haven’t deterred startups from entering the market and Happi chatted with several of them about their latest offerings.

Élan Rose International is the brainchild of co-founders Steve Alosio and Giacomoni, who met while working at Herbalife. The duo insists they know what works in skin care.

“We think there is an opportunity with science-based products,” explained Alosio, who serves as CEO. 

Trilipiderm got its start after the company founder and CEO Frank Fanning grew weary of his retirement (he had sold Sanncor Ingredients and tried his hand at retirement in Jackson, WY), and began itching for something to do. That itch may not have only been due to ambition, it may have had something to do with Jackson’s extremely dry climate. In any event, Fanning reassembled his team of chemists and introduced Trilipiderm via the internet in 2011. But he quickly learned that ROI wasn’t good through that channel and today, the brand is available through 350 retailers across the US.

The original product, an all-body moisture retention crème, combines meadowfoam and Abyssinian and jojoba oils with olive squalene and betasitosterol. According to the company, the formula reduces TEWL and improves tone, texture and elasticity of the skin. It also encourages collagen production, replaces lost sebum and helps remove wrinkles. The formula contains omega-3 and -6 essential fatty acids, too. 

“We tested the formula in Scottsdale and we’ve had a 90% ‘very satisfied’ approval rating from customers,” boasted Fanning. “The consumer has validated our products. When you get a 90% approval, you have a very good product.”

According to Fanning’s estimate, most products on the market get a 60-65% approval rating at best, and that’s what differentiates Trilipiderm from other products. That level of acceptance encouraged Trilipiderm to expand its offerings in 2014 with a Rehydrating Facial Créme that contains hyaluronic acid along with vitamins A, C, D and E. All of the ingredients are said to mimic skin cell structure and re-establish the skin’s natural barrier to water loss.

“We are using ingredients that are truly functional. We’re not formulating with ‘foo-foo’ dust,” he asserted. “Our whole philosophy is to understand skin cells and duplicate. We never formulate with co-enzyme Q-10, petrolatum or mineral oil.”

Instead, Trilipiderm’s combination of ingredients work synergistically to deliver better results than what they would on their own. Fanning’s goal is to establish Trilipiderm as a science-based company that solves skin problems.

“Dry skin is a major problem, not just in Wyoming but across the country,” he insisted. “It will become more acute with environmental and health issues.”

Procter & Gamble researchers have been big fans of niacin for years (see Happi, January 2015); in fact, company executives like the vitamin so much, that they signed an agreement with ChromaDex Corp., which makes proprietary health, wellness and nutritional ingredients. Under terms of the agreement, ChromaDex will provide P&G exclusivity to its new proprietary ingredient for use in P&G branded products.

ChromaDex’s portfolio includes Niagen nicotinamide riboside, and according to reports, the accord stipulates that ChromaDex will become an exclusive supplier to P&G if stable forms of Niagen can be developed. Niagen nicotinamide riboside may be a cornerstone to developing solutions to delay or reverse the effects of aging, obesity and disease, according to ChromaDex.

In August, ChromaDex Corp. announced results of the first controlled human clinical study on the use of the Niagen nicotinamide riboside (NR) at 4th Federation of American Societies for Experimental Biology (FASEB) Science Research Conference on NAD+ Metabolism and Signaling.

Charles Brenner, PhD, a key member of the ChromaDex Scientific Advisory Board, presented an oral platform talk on “How Nicotinamide Riboside Promotes Weight Loss.” In addition, Dr. Brenner, Frank Jaksch, Dr. Ryan Dellinger, and their co-workers presented a poster entitled, “Dose-Dependent Elevation of the Blood NAD Metabolome by NR in Healthy Human Beings.” The oral presentation and poster presented data that indicate that single doses of Niagen NR can elevate the co-enzyme NAD+ in the blood by as much as 2.7-fold.

Niagen is supported by five patents issued and several pending, with patent rights acquired from Dartmouth College, Cornell University and Washington University, according to ChromaDex.

In addition to functioning as a cofactor, NAD+ is required for the function of sirtuins, key target enzymes in healthy aging.

P&G will make an undisclosed up-front payment to ChromaDex as well as other payments based on achievement of various milestones, according to ChromaDex.

The health problems associated with a lack of niacin are well known to the medical community. Pellagra is a disease characterized by dermatitis and other health maladies. It occurs as a result of niacin deficiency. Secondary pellagra occurs when there is enough niacin in the diet but something prevents its absorption and processing. According to Giacomoni, vitamin B3 is the most important vitamin for skin and a key ingredient in Élan Rose products.

“B3 improves energy and DNA repair,” he insisted.

Chestnut extract is another primary active in the Élan Rose lineup. According to Giacomoni, chestnut extract activates the natural exfoliation process to polish the skin to hide imperfections.

“Most exfoliants are acids, but consumers need to apply these products around the eye, which is not good with acid products,” he explained. “The chestnut extract goes around the eye area with no problem. It actives trypsin and overnight you have incredible results.”


A Limited Offer…for Now

Initial product offerings from Élan Rose International are limited to Wake Up Beautiful, a night serum and Hello Sunshine!, a day cream. Other active ingredients in the Wake Up Beautiful formula include gorgonian extract, which is said to sooth and heal skin and melatonin to strengthen it. The Hello Sunshine! formula also contains gorgonian extract, along with vitamin E to protect the structure of the epidermis and 7-dehydrocholesterol to activate the endogenous anti-stress system, according to the company.

Both formulas deliver on the company’s five-point must system to improve softness, smoothness, glow, radiance and luminosity. In clinical lab tests all subjects reported dramatic and rapid improvement to their skin.

Despite these promising results, the Élan Rose executives kept the initial product offerings to just two SKUs.

“Our brand is focused on the aging gracefully message,” explained Alosio. “Our customers want strong science not fads.”

Still, depending on the success of this initial launch, plans are in the works to add an anti-acne formula and a skin lightener.

For now, Élan Rose International formulas are only available online, but Alosio has plans to expand via the direct sales route (which he describes as the original social network), to give the company the best opportunity to explain Élan Rose International’s philosophy and the benefits of its products. Alosio expects to build the business in Asia too, primarily Korea, Singapore, Malaysia and Indonesia.

“Our biggest competitors are Mary Kay and Amway, not to mention smaller local companies,” he acknowledged. “But there are a lot of opportunities. Skin care is a huge market and every consumer is always looking for something new.”

Its parent company, Valeant, has drawn the ire of FDA in the ethical pharmaceutical sector, but that hasn’t stopped Strivectin from improving existing formulas in recent months. Strivectin Advanced Retinol Intensive Night Moisturizer is said to be stronger and faster at promoting hydration and visible skin firmness than its predecessor.

Like other companies, Strivectin is harnessing the power of B3, in this case to convert retinol into retinoic acid. According to the company, its NIA-114 molecule is one of the most effective forms of vitamin B3 compared to niacinamide. The formula also contains retinol to improve surface cell turnover; copper tripeptides to help revitalize and protect skin; hyaluronic acid to hydrate, improve the skin barrier and replenish skin; and shea butter to promote elasticity to visibly firm and hydrate skin. After four weeks of use, 94% of test subjects reported an improvement in smoothness, 88% had an improvement in hydration, and 83% reported improvement in firmness and radiance. The formula retails for $112 for a 50ml tube.

That hero ingredient, NIA-114, can be found in Strivectin’s new Advanced Retinol Pore Refiner, too. The formula also contains marine exopolysaccharide to smooth and soften skin texture, oligosaccharides to reduce sebum production, and ginger root extract and bisabolol to reduce the appearance of redness and blotchiness.

The daily moisturizing lotion reportedly reduces pore size by 50%. The company said after four weeks, 96% of test subjects felt their skin was smoother and softer, 93% felt pores were tighter, 89% saw an improvement in the appearance of enlarged pores and felt skin was firmer; and 85% felt skin was more hydrated. A 50ml tube retails for $99.

Of course, all of this technology is useless if the consumer doesn’t use the products correctly and make changes to their lifestyle.
“I’ll speak with a 55-year-old woman who wants a facial treatment and wants to see things happen immediately,” said Amos Lavian, founder of Dermelect Cosmeceuticals. “I tell her if you’ve been in the sun for 25 years it won’t happen in 25 days.”
Women have to use the products and adjust their lifestyle, according to Lavian.

“You can’t stay up until 3am every day eating Snickers! But all kidding aside, we try to provide customers with the tools that they need to achieve their goals.”

But they must be reasonable goals.

“At 60, you won’t look like Kylie Jenner,” Lavian noted.

Next month, Dermelect Cosmeceuticals will roll out two products on its website, www.dermelect.com that do more than color lips. Both the 4-in-1 Smooth Lip Solution and Smooth + Plump Lipstick contain ingredients such as keratin peptide and hyaluronic acid, along with vitamins A, C and E.

“We are making waves and are on a lot of people’s radar,” Lavian insisted. “When I started the company, I wanted to bring a no-nonsense approach to skin care. I didn’t want to fleece the consumer with a $1,000 skin preparation.”


To Your Health!

Obviously, cosmetics should never be confused with pharmaceuticals. But one pharma company is eyeing the OTC topical treatment space. BioPharmX, based in Menlo Park, CA, recently introduced a hydrophilic form of minocycline that, company officials maintain, is more effective than other topical acne treatments. The product, BPX-01, is billed as the first and only stable hydrophilic topical gel with fully solubilized minocycline. Minocycline, an antibacterial and anti-inflammatory medicine, is the most commonly prescribed acne treatment because it has a lower resistance rate than other antibiotics. No stable form of hydrophilic topical minocycline is currently commercially available.

Anja Krammer, the company’s co-founder and president, told Happi that BioPharmX is monitoring the direct-to-consumer category. Prescription acne products are a $3 billion market, compared to $750 million for OTC products, so it makes sense to focus initial efforts in the prescription space.

“We are building a direct to consumer business,” she added. “Benzoyl peroxide, retinoids, we are looking at all of them.”

In fact, Krammer expects BioPharmX to enter the OTC space in 2018.

Regardless of prohibitive costs or regulations, the active ingredient arena will remain viable for years to come, say industry experts.
“The opportunities for new products and new ingredients is tremendous; we have not even come close to exhausting this area,” observed Gupta of Bioderm Research. “During the next 10 years, the segment will double from where it is today.”

That’s great news for aging Millennials, marketers and raw material suppliers, too.