Cosmetic Labeling Regulations
By Karen Weaver
Marketing plays a strong role in cosmetic product development, and advertising can sometimes overshadow more perfunctory labeling elements. While a relatively high degree of variation is permitted on cosmetic product labels, the U.S. Food and Drug Administration (FDA) has set forth a clear mandate of label requirements. This article addresses these requirements and offers a quick reference guide to cosmetic labeling.
The FDA does mandate certain labeling requirements. A product label must bear (1) a statement of identity, (2) the name and address of the product manufacturer, packer or distributor, (3) net quantity, (4) an ingredient declaration, and (5) warnings regarding health hazards. There is a small container exemption for the above-listed labeling requirements. Under this exemption, the required label elements are (1) the name and address of the product manufacturer, packer or distributor, (2) the net quantity, and (3) an ingredient list (which may appear on leaflets or displays).
The type appearing on a product label must also meet size requirements. Ingredients must appear in 1/16th inch type size, unless then label area measures less than 12 square inches. In that case, the type size for the ingredient listing is 1/32nd inch. The net contents declaration must appear on the principal display panel (the area of the label that would face a consumer when placed on a shelf). Its type size requirements are (1) if the principal display panel (PDP) is less than 5 sq. in.: 1/16th inch, (2) if the PDP is 5 to 25 sq. in.: 1/8th inch, and (3) if the PDP is 25 to 100 sq. in: 3/16th inch. All warnings must appear in 1/16th inch type. All other type appearing on the label must be reasonably related to the panel size.
The statement of identity must appear on the PDP in bold type and oriented parallel to the package base. The descriptor used as the statement of identity must be clear and obvious. It must be either (1) the common or usual name, i.e. “mascara”, (2) an appropriate descriptive name, i.e. “shower gel”, (3) a fanciful name, i.e. “Bertha’s Beautifying Blend”, as long as the nature of the product is obvious, or (4) an illustration or vignette of the intended use, i.e. a picture of a man shaving.
The manufacturer, packer or distributor must list its name and address on the product label. The actual corporate name, or the name used to conduct business must appear. Standard abbreviations such as “Inc.”, “Co.”, or “Ltd.” may be used. If the packer or distributor name and address are listed, then “Manufactured for” or “Distributed by” must precede the company name. The street address, city, state and zip code must be listed, unless the company can be found in the current telephone directory. If so, then the street address may be omitted. Do not use the company’s website address in lieu of the street, city, state and zip code.
The net quantity of contents must be displayed in terms of weight, measure or count. Avoid decimals or fractions. Dual statements comprised of weight and count are permissible. Metric measure is allowed, but it must appear in addition to avoirdupois pound and ounce, or U.S. gallons, quarts, pints and ounce measuring units. If the quantity of product can be measured by weight, then “Net Weight” must precede the quantity statement. If the quantity of product is measured by count or liquid units, then “Net” or “Net Contents” may appear, but is a voluntary declaration.
The ingredient declaration must be printed conspicuously on the label. Ingredient listings must use nomenclature found in the International Cosmetic Ingredient Dictionary and Handbook published by the Cosmetic Toiletries and Fragrance Association (CTFA). Manufacturers that use ingredients not found in the CTFA publication in their formulations must certify that the ingredients are safe for their intended use. Ingredients must appear in descending order of predominance by weight, but may be grouped into three categories. These categories are: (1) ingredients that are other than color additives and are present in the formulation at concentrations less than one percent, (2) ingredients that are other than color additives and are present in the formulation at concentrations greater than one percent, and (3) color additives. Individual ingredients must be listed in descending order within each group. Often a formulation will comprise a core group of ingredients, and vary only as to color additive. In this case, a label may use “May Contain” or “Or” to delineate the range of color additives that may be present in the product. There is no requirement to identify the individual fragrance or flavor used in cosmetic products, although “fragrance”, “natural flavor”, “artificial flavor” or “natural and artificial flavors” must appear in the ingredient listing. Incidental ingredients do not need to be declared if they have no technical or functional effect in the cosmetic product.
Much variation is permitted within the ingredient declaration due to the common practice of copycat formulas. Grouping ingredients within the categories makes it more difficult to reverse engineer the formula. Another was to protect a formula is through petitioning the FDA for trade secret status. A trade secret is any formula, patter, device or compilation of information which is used in one’s business and which gives it an opportunity to obtain an advantage over competitors who do not know or use it. The FDA will grant such a petition if it finds that listing the ingredient would reveal a trade secret. The voluntary filing of a Cosmetic Formulation or Raw Material Composition Statement (FDA Form 2512 or 2513) must accompany a submission to the FDA for trade secret status. A statement of the factual and legal grounds justifying the trade secret and a statement of prior non-disclosure must also be included. The FDA may also request that the company submit additional data. When determining prior non-disclosure, consider the following factors. Is the information publicly known? Was there prior public disclosure by either the petitioner or in reportable literature? Were measures taken to guard the secrecy? Does the information have value? What is the importance of the ingredient to the product? What is the product’s profitability and expected future market performance? What effort and financial resources has the company expended? Can the information be readily acquired or duplicated? If ultimately the FDA grants the trade secret petition, the company benefits in that certain ingredients may be exempted from appearing on the label and be replaced with the phrase “and other ingredients” at the end of the ingredient list.
The FDA mandates that certain product categories bear verbatim warning statements. These product categories are bubble bath products, coal tar based hair dyes and suntanning products. Self-pressurized containers must also bear a specified warning statement.
All of the required label elements must be prominently placed on a product label. They must be conspicuous enough for an ordinary individual to read and understand them under customary conditions or purchase and use. All required and voluntary elements must appear in English, although dual language labels are permitted as long as one is a fully translated version into English. Often dual language labels appear on products to impart an international flavor. Product does not actually have to be exported to the associated foreign language speaking country. If product is to be shipped exclusively into Puerto Rico, then the label may appear only in Spanish.
The FDA does not require manufacturers or distributors of cosmetics to test the products for safety. However, the agency does strongly urge toxicological or other safety testing. A manufacturer’s or distributor’s product liability insurance carrier may require proof of product safety prior to issuing the insurance certificate. While the FDA does not require product safety testing, it does require the label statement: “Warning – The safety of this product has not been determined.” if safety is not adequately substantiated by the manufacturer prior to marketing the product.
Certain common label claims may be made voluntarily. The “fragrance free” claim may appear if no fragrances have been added or if a masking agent has been added to hide the scents from other ingredients. “Hypoallergenic” may appear if the formulated ingredients have a minimum potential for causing allergic reactions. One or more studies involving a physician must be completed before the “Ophthalmologist Tested” or “Dermatologist Tested” claims may be made. “Not tested on animals” may appear on a product label if the final product, and not individual ingredients, was not tested on animals.
Some cosmetic products benefit from the use of tamper or child resistant packaging. Tamper resistant packaging deters malicious adulteration of the product and is governed by the Federal Anti-Tampering Act. The FDA mandates that liquid oral hygiene and vaginal products bear tamper resistant packaging (TRP). TRP has an indicator or a barrier to entry that provides visible evidence of packaging breach or removal. The product label must identify the type and location of the tamper resistant feature. The feature itself must be distinctive by design or by identifying characteristic. Examples of TRP are pressure sensitive seals, neck bands, fully sealed plastic sleeves or shrink wrap product overlays. Child resistant packaging is used to prevent or mitigate injury to children. It is governed by the Poison Prevention Packaging Act. Nail care products are primarily affected by this requirement. Child resistant packaging (CRP) applies to household substances determined to be responsible for serious injury or illness to children due to a child’s ability to gain access to the product. CRP must meet criteria developed by the Consumer Product Safety Commission. Such packaging typically requires two-handed or other dual functionality when opening the package.
The above article briefly discusses the tedious yet required elements of a cosmetic product label. However, this is merely an overview and should not be considered a substitute for legal review of your label. Please bear in mind that there are many variations to label design that can incorporate required elements while maintaining a product’s individuality. Once the basic template is in place, creative and ingenious marketing takes over.
Please contact us if you need additional information or assistance regarding cosmetic or regulatory matters.
A version of this article was published in GCI Magazine, www.thecosmeticsite.com.