Nutricosmetics Pose Intriguing Possibilities For Brands That Hit Wall With Skin-Care Claims

Statements about collagen production, maintaining cellular integrity, addressing age spots, even shrinking wrinkles and treating noncystic acne – all are viable structure/function claims for nutricosmetics, assuming there's evidence to back them up. The Rose Sheet discusses the growing opportunity with regulatory and legal experts and provides an overview of the market at present.

A key challenge that cosmetic skin-care brands face in the US is that as soon as their offerings "do something," they run the risk of drawing FDA's attention and a warning letter for unapproved drug claims.

In a 2015 interview with the Rose Sheet, Katherine Giannamore of law firm Shehadeh Giannamore in Coral Gables, Fla., discussed the limitations on cosmetic claims that routinely frustrate her clients.

"What can be a problem is willingness to change something like 'Gets rid of wrinkles' to 'Minimizes the appearance of wrinkles,' because it can be wordy or less attractive. That's where we run into issues," she said. (Also see "Cosmetics That ‘Do Something’ A Regulatory Compliance Challenge" - HBW Insight, 31 Mar, 2015.)

FDA recognizes moisturization as a cosmetics claim, and the agency takes no issue with statements about making lines and wrinkles less noticeable simply by hydrating skin. Products that furnish such effects also are cosmetics, it says.

But in the competitive and highly lucrative anti-aging space, many brands are driven to promise their customers more.

FDA warning letters often follow. The agency issued around 30 of those last year to skin-care marketers, citing verboten structure/function claims about cellular regeneration, collagen production and wrinkle reduction, among others. (Also see "FDA Clampdown On Excessive Anti-Aging Claims May Lighten Up In 2017" - HBW Insight, 1 Dec, 2016.)

In the dietary supplement space, provided that you have substantiation, "You don't have to say, 'Reduces the appearance of wrinkles.' You can say, 'Reduces wrinkles' – sort of the golden goose, if you will, of cosmetics claims." – attorney Ivan Wasserman

But those are precisely the kinds of claims that are being attached to nutricosmetics, a growing class of products that could represent opportunity for beauty companies willing to pivot into new categories.

An FDA spokesperson noted in a July 19 email that "nutricosmetic" is not a defined term under the Federal Food, Drug and Cosmetic Act, much like "cosmeceutical," also applied to products that make a pretense of straddling product categories.

Dietary supplements, on the other hand, are defined by law – as ingestible products containing vitamins, herbs, amino acids or other "dietary ingredients" to add nutritional value to consumers' diet for enhanced health or reduced disease risk, per the Dietary Supplement Health and Education Act of 1994.

"Dietary supplements marketed with claims of cosmetic benefits are subject to the same regulations as any other product marketed as a dietary supplement," the FDA rep said.

There are privileges that come with being a dietary supplement as opposed to a cosmetic, albeit in exchange for heavier compliance burdens. (Also see "Supplement Industry Offers Cautionary Tale For Mandatory Cosmetic GMPs" - HBW Insight, 14 Apr, 2015.)

Among the perks is greater leeway in the area of benefit claims.

Ivan Wasserman, a partner at Amin Talati Upadhye who specializes in helping firms to navigate the regulatory landscape for health, wellness and beauty products, discussed the emerging nutricosmetics space in a July 26 interview with the Rose Sheet.

"The big benefit [of nutricosmetics] for a beauty company is that they can make structure/function claims, such as collagen production, wrinkle reduction. You don't have to say, 'Reduces the appearance of wrinkles.' You can say, 'Reduces wrinkles' – sort of the golden goose, if you will, of cosmetics claims," he said.

The attorney continued, "There's absolutely no reason why FDA would object to that. It's not a disease. The only way FDA can object to a dietary supplement structure/function claim, taking substantiation aside – so assuming there's proof – is if it's a claim to cure or treat disease. Wrinkles are not a disease."

A Look At The Marketplace

Generally speaking, the most visible nutricosmetic marketers aren't going quite that far with their anti-aging claims, but they are availing themselves of claims that might raise flags at FDA if used to promote a cosmetic.

Some of their products have the added bonus of being yummy, or advertisable as such.

Applied Nutrition sells a strawberry and kiwi-flavored Liquid Collagen Skin Revitalization supplement in conveniently quaffable tubes. The drink provides 4,000 mg of hydrolyzed collagen to "help replenish the body's supply of collagen," as well as biotin, "the essential super beauty nutrient," and a cocktail of antioxidants from super-fruit and green tea extracts, according to the company's website.

A 10-count pack retails for around $9 online.

ReVival Labs, LLC's youthH2O drink, in flavors including Blooming Apple, is described as "a proprietary blend of powerful superfoods and nutrients formulated through advanced science and innovation to stimulate, replenish, and reactivate youthful elements and nutrients in your body."

A one-month supply (15 bottles) can be purchased online for $28.99.

On its website, youthH2O lists benefits including:

• "Glowing, Firmer, Smoother Skin"
• "Stimulate Skin Collagen"
• "Help Prevent Wrinkles"
• "Protect Skin from Environmental Damage"
• "Healthy, Strong, Luscious Hair"
• "Healthy Strong Nails"

According to the company, the "breakthrough fountain of youth" also provides "immunity support," another claim FDA has targeted in warnings to topical skin-care brands.

Perricone MD similarly says its Skin & Total Body Supplements – $155 for 60 packets – support a healthy immune system, as well as "normal growth of hair and nails" and "normal skin health."

NeoCell Corporation, which touts itself as "American's No. 1 collagen brand," promotes its line of supplements as helping to maintain a healthy collagen matrix in skin as it ages.

The company explains in online marketing materials: "By supplementing with NeoCell products, additional collagen peptides are introduced into the extracellular fluid. The molecular receptors of the worker cells are 'turned on' more frequently, thus continuing the regeneration cycle at a healthy rate and rebuilding the collagen matrix more quickly."

For $54, consumers can pick up a month's supply of Murad, LLC's Hydro-Glow Dietary Supplements, featuring N-acetyl D-glucosamine, which "acts as a 'building block' for structural molecules such as hyaluronic acid and collagen, helping improve skin firmness and creating a reservoir of moisture within cells to boost hydration and support healthy cellular functions."

Murad targets the product to consumers interested in "visibly minimizing lines and wrinkles."

In a 2000 final rule, FDA clarified that in the context of dietary supplement structure/function claims, "mild conditions commonly associated with particular stages of life or normal physiological processes will not be considered diseases," listing wrinkles, hair loss associated with aging and noncystic acne as examples.

Alternatively, Dermal Repair Complex from Beverly Hills MD is formulated "to stop the skin breakdown that comes with age."

The supplement – $58 for one bottle – contains methylsulfonylmethane (MSM) to "strengthen collagen strands from deep inside skin for a firmer, more toned look," as well as vitamin B to "increase cell turnover for a constantly renewed and energized complexion," among other potent ingredients, the company says.

The product also contains hydrolyzed collagen, a common denominator for many offerings in the nutricosmetics space.

Global supplier Gelita AG says its ingestible Verisol Bioactive Collagen Peptides ingredient, "specially optimized for beauty applications," has been linked to significantly higher skin elasticity (up to 15%) in clinical testing.

In another study of more than 100 women ages 45 to 65, oral administration of Verisol led to significantly reduced wrinkles and significantly higher skin procollagen concentration, according to the Germany-based firm's website.

It also cites cellulite and nail health/growth benefits backed by study results.

"Verisol has enormous potential in the growing market of beauty and skin-improvement supplements, addressing skin issues from the inside-out. The use of collagen in cosmetics is already common for women – what's new on the Western market is its stimulatory effect after oral intake," Gelita notes.

"In Japan … which leads the way in the field of beauty care, foodstuffs containing collagen are already well established. This trend is also expected to spread quickly in Europe and the USA," it says.

Non-Disease Claims: Liver Spots, Hair Loss, Even Acne?

It's unclear whether the majority of nutricosmetic marketers have robust scientific data to support their claims.

FDA explains on its website that it does not preapprove structure/function claims on dietary supplements, but manufacturers must have evidence substantiating such claims as truthful and not misleading.

In addition, they must submit a notification with the text of the claim to the agency within 30 days after marketing a product with the claim.

If the claim is used on supplement labeling, the label also must bear a disclaimer that FDA has not evaluated the claim and that the product is not intended to "diagnose, treat, cure or prevent any disease."

FDA specifically cites "Antioxidants maintain cell integrity" as a structure/function claim that may be used for dietary supplements, assuming that it can be supported.

According to Wasserman, "FDA is very, very rarely challenging dietary supplement – or cosmetics companies for that matter – on the adequacy of scientific evidence to support claims. It's not an area that they get into often."

However, the agency does intervene frequently in cases where claims identify products, in its view, as unapproved drugs.

On its website, FDA states that "if a product is intended, for example, to remove wrinkles or increase the skin's production of collagen, it's a drug or a medical device." It makes no mention of dietary supplements.

According to a June 2017 report from Coherent Market Insights, the global nutricosmetics market reached $5bn in 2016 and is projected to surpass $13.4bn by 2025.

But in a final rule issued in 2000, FDA clarified that in the context of dietary supplement structure/function claims, "mild conditions commonly associated with particular stages of life or normal physiological processes will not be considered diseases."

Thus, claims about those conditions do not require prior authorization from the agency as health claims or premarket approval as drug claims, the agency says.

FDA includes a list of conditions in the rule about which structure/function claims could be made. Wrinkles and "other signs of aging on the skin, e.g., liver spots, spider veins," as well as hair loss associated with aging and noncystic acne, all appear on the list.

Such allowances could pose intriguing possibilities for cosmetics companies, which often are warned for claims about treating dark spots or acne of any sort, not to mention wrinkles. (Also see "FDA Warning Cites Ageless Derma's Anti-Wrinkle, Brightening Claims" - HBW Insight, 9 May, 2016.)

Murad seems to have capitalized on the opportunity with its $50 Pure Skin Clarifying Dietary Supplement for "acne-prone skin." The product provides "the nutrients needed to support the body's natural defense against blemish-producing toxins," helping to reduce blemishes and prevent breakouts, the company says.

Along with the disclosures normally required for supplement structure/function claims, Murad specifies with a footnote on its website that by "acne-prone skin," it means skin afflicted by non-cystic acne.

Substantiate Claims Or Roll The Dice

George Burdock, president of safety and regulatory consulting firm Burdock Group, emphasized the importance of claims substantiation in a July 26 exchange with the Rose Sheet.

For nutricosmetics, "you could probably say something like ingestion of gelatin can produce harder fingernails … but you would still have to generate clinical test data to show harder fingernails following ingestion of gelatin."

Similarly, he said, "'maintaining cell integrity' or 'collagen building' are structure/function claims" permitted for dietary supplements, "but you still must have data to support your claim if FDA comes knocking at your door."

Asked if FDA has pressed companies to produce evidence for beauty-related structure/function claims on dietary supplements, Burdock said he's not aware of any examples – "but FDA certainly has the power to do so."

Wasserman noted that even if non-disease nutricosmetic claims aren't a priority for FDA in its enforcement work, US-based advertising regulatory authorities do have an eye out for overreaching claims on nutricosmetic products. (Also see "Is 'Moisturol' Up For Grabs? NBC's Faux Nutricosmetic May Be Worth Reconsidering" - HBW Insight, 4 Aug, 2017.)

The National Advertising Division has come down on nutricosmetic brands for inadequately supported claims about anti-aging skin-care effects and hair growth, and has gotten the Federal Trade Commission involved in cases of noncompliance. (Also see "NAD Tugs On FTC's Sleeve Again About New Nordic Supplement Claims" - HBW Insight, 21 Mar, 2016.)

However, it also has made clear – notably in a case examining Irwin Naturals' advertising for its Doctor Developed Clear Pure Complexion dietary supplement – that firms can highlight benefits supported by ingredient studies, as long as they tie such claims to the ingredients in their product rather than the product itself. (Also see "In Brief" - HBW Insight, 19 Mar, 2012.)

"NAD noted that although the Dietary Supplement Health and Education Act (DSHEA) allows 'structure function' claims – accompanied by required language – both the Federal Trade Commission and NAD require that all advertising claims relating to a product’s impact on human health be supported by competent and reliable scientific evidence," NAD explained in its 2012 Irwin decision.

"When making an express claim of product performance, an advertiser must be able to demonstrate that its product, as formulated for sale, actively performs the function promised or provides the benefit claimed in the advertisement," the Advertising Self-Regulatory Council unit concluded, advising Irwin only to limit its claims accordingly.

Global Nutricosmetics To Top $13bn By 2025

For companies that effectively navigate the potential regulatory pitfalls, nutricosmetics could be a rewarding venture – in the US and especially overseas.

According to a June 2017 report from Coherent Market Insights, the global nutricosmetics market reached $5bn in 2016 and is projected to surpass $13.4bn by 2025.

The segment's growth reflects increased interest among consumers in beauty, grooming and premature skin-aging prevention. Meanwhile, the busy lifestyle of the swelling urban population makes vitamins and ready-to-drink beverages popular choices for personal care on the go, Coherent suggests.

The global market research and consulting firm, which is headquartered in India with an office in Seattle, says Europe accounted for more than 34% of overall nutricosmetics revenue in 2016 and will continue to dominate the scene through 2025.

Analysts attribute slower uptake of nutricosmetics in the US to American consumers' fixation on quick fixes, which poses challenges for products designed to impart benefits only after weeks and even months of use. (Also see "Nutricosmetics In U.S. On The Rise; Savvy Marketing Could Spur Uptake" - HBW Insight, 26 Nov, 2012.)

Whereas topical lotions and creams at least look and feel like they're acting on skin immediately, the "beauty from within" concept is counterintuitive to many US consumers, and it's been suggested that scientific evidence has been lacking in the past for such offerings.

But marketers have been working on their clinical science to shore up consumer confidence in ingestible products, and research in recent years has indicated that younger consumers in particular may be receptive to nutricosmetics and the promise of beauty from within. (Also see "Nutricosmetics Firms’ Science, Innovation May Win Over “Trusting” Youth" - HBW Insight, 3 Oct, 2014.)

According to Coherent, the North American nutricosmetics market also will register "significant" growth over the forecast period, with "lucrative" opportunities for players in the region.