'Natural' Oral Care Settlements Signal Risk For Ingredients Despite Regulatory Void

Colgate's Tom's of Maine and Hello Products separately agree to revise "natural" labeling and marketing for toothpastes containing sodium lauryl sulfate and xylitol to settle lawsuits alleging deception. Mary Kay also faces a class action for its Obsessively Natural Kids 100% Natural Toothpaste.

Federal court settlements should give pause to oral care product firms about using sodium lauryl sulfate and xylitol in products labeled and marketed as "natural," even as FDA hedges on whether it will conduct a rulemaking on use of the term in product labeling.

Colgate-Palmolive Co.'s Tom's of Maine division received final approval in January for a deal with a Florida consumer who challenged the brand's natural labeling on toothpaste products in a proposed class action filed in 2014 in US District Court for the Southern District of Florida.

The complaint alleged the consumer was duped into paying a premium for Tom's products based on their natural positioning, even though they contain "heavily chemically processed" ingredients, including SLS and xylitol.

Tom's admits no wrongdoing in the settlement but commits $4.5m to refunding consumers for natural product purchases across its portfolio – including deodorant/antiperspirant, sunscreen, body wash, shampoo, lip care and other items outside of toothpaste – between March 25, 2009 and Sept. 23, 2015.

The brand also will update product labels and make related changes to its website, according to its notice.

ONHA Shies Away From Natural Seal

Uncertainty about using natural to describe an entire product prompts the Organic & Natural Health Association against introducing a natural certification seal. It recommends using the term only to describe specific attributes of products in marketing and promotional materials.

Organic & Natural Health instead supports the work on Organic 3.0 led by the International Federation of Organic Agriculture Movements International to make organic the leading innovation towards sustainability in agriculture and healthy products for consumers. The association on Feb. 1 said its research showed a majority of consumers do not differentiate between natural and organic and expect that products labeled natural also are organic.

The direction of the Tom's case may have been influenced by separate litigation regarding natural oral care claims – Procter & Gamble Co.'s suit against Hello Products LLC, alluded to in the complaint against Tom's.

P&G alleged in a 2014 filing in federal court New York's Southern District that labeling and advertising for Hello Anticavity Toothpaste misrepresented the product as "99% natural" and a uniquely natural alternative to competing products, including Crest Cavity Protection.

According to P&G, such claims are bogus because "a significant proportion of the ingredients in Hello Paste are extensively and chemically processed."

P&G cited SLS, xylitol and sorbitol among the "at least 50%" of ingredients in Hello Paste that undergo processing. Further, it noted that the Happy paste contains sodium fluoride, but the product's primary display panel does not identify it as a fluoride-infused formula in accordance with FDA regulations.

In a settlement reached in June, Hello will stop claiming its toothpaste is 99% natural or "more natural than Crest," and discontinue the phrase "chemistry, not chemicals," which it also used in the context of its natural marketing. Hello also will update the front panel of its product packaging to indicate the presence of fluoride.

The complaint against Tom's states that P&G, "an industry leader in oral hygiene products, acknowledged that xylitol and SLS are not natural products" in its claims against Hello.

Kiss My Face Obsessively Targeted

Kiss My Face LLC in December was hit with a proposed class action alleging its Obsessively Natural Kids' 100% Natural Toothpaste is deceptively labeled and marketed due to the brand's use of glycerin, "a non-natural, highly chemically and industrially processed ingredient."

The complaint was filed in New York's Southern District by consumers who purchased the Kiss My Face toothpaste in the 50 US states and the District of Columbia where laws are established to protect consumers from false advertising and "unfair, deceptive, fraudulent and unconscionable trade and business practices."

According to the Personal Care Products Council, glycerin is a sugar alcohol that serves personal care manufacturers as a humectant, skin protectant or viscosity-decreasing agent, with known uses in skin, hair and oral-care products, among others.

It is the most frequently used cosmetic ingredient after water, based on information provided to FDA by industry through the Voluntary Cosmetic Reporting Program, PCPC says.

The trade group notes glycerin can be synthesized or obtained from natural sources. The two forms are chemically identical, and long-term laboratory studies indicate that the body processes synthetically derived glycerin the same way it handles naturally derived glycerin, according to PCPC's consumer-facing website.

In contrast, plaintiffs in the Kiss My Face suit assert that glycerin is "a synthetic, factory-produced texturizer that is created by complex processing and does not occur in nature."

They seek an injunction, compensation for costs and damages for economic losses.

Kiss My Face is no stranger to litigation contesting its labeling and marketing claims, though cases settled in previous years have focused on the truthfulness of the brand's organic claims.

In 2011, the Gardiner, N.Y.-based company agreed in a settlement with the Center for Environmental Health to dispense with its organic claims or increase the organic content in named products to comply with the California Organic Production Act (Also see "Brands Settle With CEH, Will Make “Organic” Products COPA-Compliant" - HBW Insight, 12 Dec, 2011.).

Kiss My Face settled in 2013 with a consumer who filed suit against the company in California federal court for alleged organic deception, seeking class certification. Among products named in the suit were Obsessively Organic offerings (Also see "Suit Challenging Kiss My Face Organic Claims May Proceed – Calif. Court" - HBW Insight, 7 Oct, 2013.).

The firm's experience in federal courts speaks to the challenges and risks companies assume in marketing cosmetic products as either natural or organic.

Meanwhile, FDA in November FDA announced a docket for comments on “natural” labeling dietary supplements and other food products on questions including whether a public health concern will emerge if the agency does not substantially expand its regulation of use of the term. The agency was clear in the notice that the information gathering is not automatically a preliminary step toward a rulemaking (Also see "FDA Compelled To Test ‘Natural’ Climate But Hedges On Rulemaking Forecast" - Pink Sheet, 16 Nov, 2015.).