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By: David C. Steinberg, Steinberg & Associates
Posted: July 30, 2009, from the August 2009 issue of Cosmetics & Toiletries.
Little is more confusing to marketers and cosmetic formulators than product claims regulations. Questions regarding the rules commonly arise, including: What proof is needed? Who decides what can be claimed? What’s the penalty? and Who regulates the claims? When speaking with various governments about cosmetic regulations, I jokingly refer to Steinberg’s First Rule of Regulation: Do not promulgate regulations that you do not have the resources or ability to enforce completely. Why? Because without uniform enforcement, companies do not know which rules to follow or what they can get away with—they always seem to be chasing a competitor that is making prohibited claims without any repercussions. The mentality is, “If they can do it, why can’t I?”
The rules for ingredient listings are fairly simple and straightforward; for instance, only INCI names are allowed on cosmetic product labels. However, without enforcement of the rules, companies are listing all sorts of claims in their ingredient statements. The question is, do consumers read the ingredient listings, or are cosmetic chemists the only ones reading them?
One major labeling infraction is the use of an adjective to describe water, such as purified, deionized, natural, spring, etc. Of these errors, purified water is the most common. Purified water is the drug name for water, as defined in the US Pharmacopoeia, and may only be listed on the labels of drugs that do not make cosmetic claims. Purified water on the product label is automatically considered a drug claim, yet many companies do this without repercussions.
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1. Cosmetic Product Manufacturers (2/95), available at: www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074952.htm (Accessed Jun 15, 2009)
2. FDA Cosmetics Handbook (1994) p13, available at www.mlmlaw.com/library/guides/fda/Coshdbok.htm(Accessed Jun 15, 2009) 3. Federal Register vol. 58 no. 90 (May 12, 1993) p 28208
4. www.Cosmeticsdesign-europe.com (Mar 13, 2009)
5. Guidelines for Cosmetic Advertising and Labeling Claims, available at www.hc-sc.gc.ca/cps-spc/alt_formats/hecs-sesc/pdf/pubs/indust/cosmet/guidelines-ld-eng.pdf (Accessed Jun 10, 2009)
The word vitamin is another advertising claim that is prohibited on cosmetic ingredient labels. Companies often list the correct INCI designation but parenthetically add “vitamin A, C, E, etc.” after the INCI name. The US Food and Drug Administration (FDA) considers vitamins as separate from cosmetic ingredients1 as they are not recognized as providing health benefits in the cosmetic product.