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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.

Little is more confusing to marketers and 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?”

Ingredient Listings

The rules for ingredient listings are fairly simple and straightforward. For instance, only INCI names are allowed on 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?

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 U.S. Pharmacopeia, 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.

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 U.S. 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. A product that features vitamin E, for example, must list the chemical name tocopherol in the ingredient declaration since listing it as vitamin E could mislead consumers by giving the impression that it offers a nutrient or health benefit. In fact, vitamin E typically is added as an antioxidant to prevent the chemical deterioration of the product.2 On the other hand, the FDA does not object to stating that the product contains vitamins outside of the ingredient listing.

Since the FDA has not taken action against these infractions, some companies believe they can list ingredients in impermissible ways without consequence. However, many countries enforce the rules, especially during customs inspections, and this can delay a product from reaching the market. This also may occur when foreign goods are shipped into the U.S.

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