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Nutricosmetics Pose Intriguing Possibilities for Brands That Hit Wall with Skin-Care Claims RYAN NELSON [email protected]

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Nutricosmetics Pose Intriguing Possibilities for Brands That Hit Wall with Skin-Care Claims RYAN NELSON Ryan.Nelson@Informa.Com Rose Sheet Pharma intelligence rose.pharmamedtechbi.com August 2017 informa Nutricosmetics Pose Intriguing Possibilities For Brands That Hit Wall With Skin-Care Claims RYAN NELSON [email protected] key challenge that cosmetic skin- care brands face in the US is that A as soon as their offerings “do some- thing,” they run the risk of drawing FDA’s attention and a warning letter for unap- proved drug claims. In a 2015 interview with the Rose Sheet, Katherine Giannamore of law firm Sheha- deh Giannamore in Coral Gables, Fla., dis- cussed 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” - Rose In the dietary supplement space, provided that you Sheet, 31 Mar, 2015.) FDA recognizes moisturization as a cos- have substantiation, “You don’t have to say, ‘Reduces the metics claim, and the agency takes no issue appearance of wrinkles.’ You can say, ‘Reduces wrinkles’ – with statements about making lines and wrinkles less noticeable simply by hydrat- sort of the golden goose, if you will, of cosmetics claims.” ing skin. Products that furnish such effects also are cosmetics, it says. – attorney Ivan Wasserman But in the competitive and highly lucra- tive anti-aging space, many brands are driv- en to promise their customers more. resent opportunity for beauty companies value to consumers’ diet for enhanced health FDA warning letters often follow. The agen- willing to pivot into new categories. or reduced disease risk, per the Dietary Sup- cy issued around 30 of those last year to skin- An FDA spokesperson noted in a July 19 plement Health and Education Act of 1994. care marketers, citing verboten structure/ email that “nutricosmetic” is not a defined “Dietary supplements marketed with function claims about cellular regeneration, term under the Federal Food, Drug and Cos- claims of cosmetic benefits are subject to collagen production and wrinkle reduction, metic Act, much like “cosmeceutical,” also the same regulations as any other product among others. (Also see “FDA Clampdown On applied to products that make a pretense of marketed as a dietary supplement,” the FDA Excessive Anti-Aging Claims May Lighten Up In straddling product categories. rep said. 2017” - Rose Sheet, 1 Dec, 2016.) Dietary supplements, on the other hand, There are privileges that come with be- But those are precisely the kinds of claims are defined by law – as ingestible products ing a dietary supplement as opposed to a that are being attached to nutricosmetics, containing vitamins, herbs, amino acids or cosmetic, albeit in exchange for heavier a growing class of products that could rep- other “dietary ingredients” to add nutritional compliance burdens. (Also see “Supplement CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF ROSE SHEET AND TAN SHEET Exploring Opportunities in the Natural Beauty Market SUPPLYSIDE WORKSHOP Tuesday, September 26 | 1:30-4:30pm SPEAKERS Xuesong Li Director Consumers are seeking natural solutions for every Kline & Company aspect of their lives, and the personal care segment is no exception. Join experts to learn about the trends and innovation driving the personal care market; unique active ingredients and whitespace opportunities; formulation consideration for both external and internal uses; and the Ryan Nelson Managing Editor – Rose Sheet importance of understanding the complex, and different, Informa – Pharma Intelligence regulations in the personal care market. • Explore the global landscape for cosmetic actives, including new ingredients and trends impacting the growth of the personal care sector. Perry Romanowski • Understand the clinical research and formula- Vice President Element 44 Inc tion considerations in working with natural active ingredients. • Discover the challenges in the regulatory arena for cosmetic and personal care products. Paula Simpson REGISTER NOW: http://bit.ly/2uXLznQ Principal Nutribloom Consulting Rose Sheet Pharma intelligence | Rose Sheet Pharma intelligence | AUGUST 2017 Our selection of Rose Sheet content from the past month includes some of our most-viewed articles online and editors’ picks of top issues across the cosmetics and dietary supplement sectors. Please visit rose.pharmamedtechbi.com for full access to our comprehensive, up-to-the-minute news coverage and analysis. ■ ■ ■ ■ ■ COSMETICS COVER Nutricosmetics Pose Intriguing Possibilities For Brands That Hit Wall With Skin-Care Claims 6 Care2 Petitions Top Beauty Firms To Call ‘Anti-Aging’ Products … Something Else 8 Rep. Pallone Seeks Answers In Tween Makeup Asbestos Controversy 10 Just For Men’s Hair-Dye Marketing Amounts To Civil Rights Violation – Plaintiff 11 Cosmetics Europe Reflects On WC10, Alternative Testing Landscape 12 European Agencies Readying Draft Guidance For Identifying Endocrine Disruptors 13 EU WORKING GROUP: Cosmetics Should Be ‘Free From’ Denigrating Ingredient Claims DIETARY SUPPLEMENTS 15 Supplement, Drug Co-Packaging Potential Could Be Clipped In FDA Proposed Rule 17 Independent Pharmacies Stock Growth Opportunities In Health, Wellness And Beauty Aisles 19 Love Seated As Utah’s Next Supplement Industry Champion In Congress 20 PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN 22 Sale To Icahn Off Table, Herbalife Tenders $600m Share Repurchase 23 Supplement Industry Investment Continues On Swander Pace Contract Manufacturing Move 24 Vitamin Shoppe Turnaround Tools Include Auto-Delivery, Price-Matching 26 Glutamine Claim Class Action Against GNC Gets Wide Berth For Relevant Studies LEADERSHIP CORPORATE SALES ADVERTISING DESIGN SUPERVISOR Phil Jarvis, Richard Faint John Lucas, Elissa Langer Christopher Keeling Gayle Rembold Furbert MANAGING EDITOR EXECUTIVE EDITOR EDITORIAL OFFICE Ryan Nelson Malcolm Spicer 52 Vanderbilt Avenue, 11th Floor SENIOR REPORTER SENIOR REPORTER New York, NY 10017 Lauren Nardella Eileen Francis phone 240-221-4500, fax 240-221-2561 CUSTOMER CARE 1-888-670-8900 or 1-908-547-2200 © 2017 Informa Business Intelligence, Inc., an Informa company. All rights reserved. No part of this publication may be reproduced in any form or incorporated into any fax 646-666-9878 information retrieval system without the written permission of the copyright owner. [email protected] 3 | Rose Sheet | August 2017 © Informa UK Ltd 2017 COSMETICS CONTINUED FROM COVER body’s supply of collagen,” as well as biotin, ing materials: “By supplementing with Neo- Industry Offers Cautionary Tale For Mandato- “the essential super beauty nutrient,” and Cell products, additional collagen peptides ry Cosmetic GMPs” - Rose Sheet, 14 Apr, 2015.) a cocktail of antioxidants from super-fruit are introduced into the extracellular fluid. Among the perks is greater leeway in the and green tea extracts, according to the The molecular receptors of the worker cells area of benefit claims. company’s website. are ‘turned on’ more frequently, thus con- Ivan Wasserman, a partner at Amin Talati A 10-count pack retails for around $9 tinuing the regeneration cycle at a healthy Upadhye who specializes in helping firms online. rate and rebuilding the collagen matrix to navigate the regulatory landscape for ReVival Labs, LLC’s youthH2O drink, in fla- more quickly.” health, wellness and beauty products, dis- vors including Blooming Apple, is described For $54, consumers can pick up a month’s cussed the emerging nutricosmetics space as “a proprietary blend of powerful super- supply of Murad, LLC’s Hydro-Glow Dietary in a July 26 interview with the Rose Sheet. foods and nutrients formulated through Supplements, featuring N-acetyl D-glucos- “The big benefit [of nutricosmetics] for advanced science and innovation to stimu- amine, which “acts as a ‘building block’ for a beauty company is that they can make late, replenish, and reactivate youthful ele- structural molecules such as hyaluronic structure/function claims, such as collagen ments and nutrients in your body.” acid and collagen, helping improve skin production, wrinkle reduction. You don’t A one-month supply (15 bottles) can be firmness and creating a reservoir of mois- have to say, ‘Reduces the appearance of purchased online for $28.99. ture within cells to boost hydration and wrinkles.’ You can say, ‘Reduces wrinkles’ – On its website, youthH2O lists benefits support healthy cellular functions.” sort of the golden goose, if you will, of cos- including: Murad targets the product to consumers metics claims,” he said. • “Glowing, Firmer, Smoother Skin” interested in “visibly minimizing lines and The attorney continued, “There’s abso- wrinkles.” • “Stimulate Skin Collagen” lutely no reason why FDA would object to Alternatively, Dermal Repair Complex that. It’s not a disease. The only way FDA can • “Help Prevent Wrinkles” from Beverly Hills MD is formulated “to stop object to a dietary supplement structure/ • “Protect Skin from Environmental the skin breakdown that comes with age.” function claim, taking substantiation aside Damage” The supplement – $58 for one bottle – – so assuming there’s proof – is if it’s a claim • “Healthy, Strong, Luscious Hair” contains methylsulfonylmethane (MSM) to cure or treat disease. Wrinkles are not a to “strengthen collagen strands from deep • “Healthy Strong Nails” disease.” inside skin for a firmer, more toned look,”
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