Labeling Claims

By: David C. Steinberg, Steinberg & Associates

Posted: July 30, 2009, from the August 2009 issue of Cosmetics & Toiletries.

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In March 2009, the UK Cosmetic, Toiletry and Perfumery Association (CTPA) advised members against labeling products as being free-from certain ingredients.⁴ Advertising Standards Canada has gone even further, allowing such claims to be made but under limited conditions, including:

• Manufacturers must supply proof that the ingredient was in their product but has since been removed completely; even trace amounts of the chemical are not allowed.
• This claim may only be made for up to one year; and
• Claims may also state that the product never contained a material if the statement is true. For example, phrasing such as, “This product naturally never contained automobile tires,” would be acceptable.

Drug vs. Cosmetic Claims
In the United States, the FDA makes the distinction between drugs and cosmetics principally by the product’s promoted intent. If the claim indicates a product to have drug-like effects, that product will be regulated as a drug. This ruling based on intent is subjective and leads many companies to “push the envelope”—that is, to make stronger drug-like claims until the FDA issues a warning letter; then they pull back.

Health Canada, on the other hand, publishes a list of claims that it considers to be unacceptable for cosmetics but permissible for drugs, as well as a list of acceptable cosmetic claims with some examples. All claims must be true, verifiable and accurate. The group recently revised its “Guidelines for Cosmetic Advertising and Labeling Claims.”⁵ These guidelines are broken into three categories of substrate, product and claim type, with sub-categories listed for each (see Categories for Advertising and Labeling Claims).

European Union
The 7th Amendment to the Cosmetic Directive, under Article 7a part (g), states that one must have “proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product.” In relation to this, as part of the product information package, companies are required to list an EU address that the Competent Authorities may contact in order to inspect evidence of the claims made.

Going further with labeling requirements, the 8th Amendment, known as a recast since it changes the Cosmetic Directive to Cosmetic Regulations, has been approved but at press time had not yet been published in the Official Journal of the European Union. It states that:

• Names, trademarks, pictures and other signs should not be used to imply that products have characteristics or functions that they do not have;
• The commission will adopt a list of common criteria for claims that may be used for cosmetic products. Three years after the Cosmetic Regulations are implemented (approximately 2012), the commission will submit to the Parliament and Council a report regarding the use of claims on the basis of common criteria; and
• The “responsible person” (a new provision within the regulations) may allow the fact that no animal tests have been carried out by the manufacturer or ingredient suppliers to comply with this regulation.