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Labeling Claims—Untangling the Rules

By: David C. Steinberg
Posted: September 3, 2009, from the September 2009 issue of GCI Magazine.

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Another labeling trend is highlighting the origins of ingredients by using terms like vegetable, natural, organic or certified organic. Some marketers further emphasize these origins by inserting an asterisk (*) within the ingredients declaration to call attention to materials in the product that are of a certain origin.

Free-from Claims

To this author, nothing is more damaging to the personal care industry than using free on the product label or in its advertising—unless it’s the selling price. The first time that marketers discovered they could sell more of a product by promoting what it does not contain was in the early 1980s, when PABA-free became the term du jour for sunscreens.

The number of sunscreens that actually used PABA, or aminobenzoic acid (the correct U.S. drug name), were few because it was a poor sunscreen active that was too water-soluble and oil-insoluble; it also stained fabrics and required application at least 30 minuntes before sun exposure to work. On the positive side, it is found in nature—Health Canada still lists it as a permitted natural health product active—and for about 25 years, it was the only UV filter universally allowed. The sunscreen used at that time had an INCI designation of octyl dimethyl PABA. When the first U.S. sunscreen rules were published in 1978, this was the most popular UV filter in use. Marketers were allowed to claim that products containing octyl dimethyl PABA contained PABA, although these are different chemicals. The biblical saying “People who live by the sword, die by the sword” came true when marketers of the potential competition for Padimate O, octyl methoxycinnamate (OMC, also known as octinoxate) began claiming PABA-free on product labels, inferring that something was wrong with PABA. This carried over to Padimate O and led to a domination of the sunscreen market by OMC, as well as the near disappearance of Padimate O from the market.

The labeling of sunscreens as PABA-free became almost automatic and the FDA addressed this in its 1993 proposed rules stating that PABA is not the correct ingredient name.3 In addition, the FDA noted that PABA was a safe and effective Category I sunscreen; however, the PABA-free labeling still inferred it was not. In the 1999 Final Monograph, the FDA allowed the claim for Aminobenzoic acid (PABA)-free but as of yet, to this author’s knowledge, no sunscreens have been marked with this claim.

Since the PABA-free claim worked, marketers began using other negative claims: oil-free, silicone-free, fragrance-free, chemical-free, phthalate-free, preservative-free and, the latest, paraben-free. The approach is always the same: our products are safer than our competitors’, which contain “unsafe” ingredients.

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