Compliance with these FDA-enforced laws is not something to take lightly. It requires much work and it serves an essential purpose. Labeling products properly helps consumers make informed decisions when buying products. Lawful labeling also helps protect people from falling prey to deceptive marketing practices and health risks.
Spa professionals may never need to create product labels. However, understanding the labeling laws that apply to products can be beneficial. After all, the more informed and confident professionals are about the quality and integrity of the products used, the better professionals can feel when providing treatments to clients.
Take a high-level look at some of the labeling rules that apply to spa products. Please note that the information in this article merely touches on some of the labeling laws. For extensive details about the regulations, visit the FDA’s website at fda.gov/cosmetics/labeling.
OUTER CONTAINER LABEL REQUIREMENTS
The labeling on outer containers has two panels: a principal display panel and an information panel.
Principal Display Panel
The principal display panel is the part of a retail product’s label that is most prominently displayed. It must have the following elements:
- Name of the product – the product name must be: expressed as the common (usual) name, a descriptive name, a fanciful name (if it is obvious what the product is), or an illustration. It should be shown in bold type in a reasonable size and positioned parallel to the product’s base.
- A warning disclaimer – If the manufacturer has not proven the product’s ingredients and finished product are safe, the panel must display the following message: “Warning – The safety of this product has not been determined.”
- Net quantity of contents – The label’s disclosure of the amount of product in the container must accurately reveal the weight, volume, measure, numerical count, or a combination of these things.
- Product consistency – With some exceptions, this must typically be in terms of fluid measure — at 68 degrees Fahrenheit (20 degrees Celsius) — if the product is liquid. If the product is solid or semi-solid, it must be in terms of weight.
The information panel on the outer container is where a product’s ingredients and instructions for use are typically found. It must include:
- Name and place of business – The information label needs to provide the name of the manufacturer, packer, or distributor and that business’s street address, city, state, and ZIP code. If either the packer or distributor is shared, the label must have wording similar to “Manufactured for…” or “Distributed by…”
- Directions for safe use – These must appear if a consumer could face harm if they use the product incorrectly.
- Warnings and caution statements – If a product poses any health hazard risk, its label must have a warning statement. That warning must appear prominently on the package so consumers do not miss it.
- Ingredient declaration – Generally, product ingredients must appear in descending order of prominence.
INNER CONTAINER LABEL REQUIREMENTS
The label of the inner container (which directly holds the product) must disclose the following information: directions for safe use, warnings and caution statements, name and place of business, and net quantity of contents.
If the product is displayed for sale without the outer container, the inner container label must include the same information as the outer container because, in that case, it essentially serves as the outer container.
LABEL SIZE, DESIGN, AND LANGUAGE REQUIREMENTS
The laws also apply to the size, design, and language of product labels. The intent of the rules is to ensure consumers can easily read the information.
For example, the principal display panel must be large enough to provide enough space for all label information. On a rectangular package, the principal display panel label must cover one entire side. On a cylindrical package, the label’s size must be at least 40 percent of the height and circumference of the package. For any other shape, the principal display panel size must be at least 40 percent of the total container surface area (excluding top, bottom, neck, shoulder, and flanges). With decorative or "boudoir-type" containers (such as compacts or pill boxes) and those that contain a quarter ounce or less of the product, a tear-away tag, tape, or card affixed to the container may serve as the label.
As for the relationship between the text and its background on labels, there must be enough contrast between them so the label information is readable. Also, design elements should not hide or disguise the required label information.
The FDA enforces language rules for labels, too. All labeling must be in the English language, except those products distributed only in Puerto Rico or a territory where English is not the primary language.
PRODUCT SAFETY TESTING AND WARNING STATEMENTS
The FD&C Act and FPLA work together to help ensure consumer safety when using cosmetic products.
For a product to be considered safe, experts with scientific training and experience must have assessed the ingredients, chemical composition, test and toxicological data, and other information to have concluded the product will not cause harm to consumers.
Even when the safety of each ingredient has been substantiated, some toxicological testing must usually be carried out on the formulated product to assure it is safe in that form.
If a spa product or its ingredients pose any health hazards, its label needs to display a warning statement. If it does not include that disclosure, the FDA will consider it misbranded under the FD&C Act.
Warning statements must appear prominently in bold type — no less than one-sixteenth of an inch in height — on the label, so they do not get lost among other words and design elements. It is key to position it so that consumers will see it and likely read it when purchasing and using the product.
For products such as cosmetic aerosols, feminine deodorant sprays, and bubble bath, more specific warning statement rules apply.
FAIR PACKAGING REQUIREMENTS
Under the FPLA, labels must give consumers accurate information about how much of a product is within the packaging. This is meant to help buyers make comparisons with other products as they make purchase decisions. The label must not falsely represent the amount of product the consumer is getting.
Also, labels must not mislead consumers by making false claims about what the product will do for them. According to the FD&C Act, cosmetics’ intended use is to be “rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body” for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”
When claiming a spa product will treat or prevent disease (or somehow affect the structure of or enhance the function of the body), the FDA may consider the product a drug rather than a cosmetic, which leads to far more strict regulations.
Under FPLA rules, cosmetic product ingredients only need to appear on the label of the outer container of products sold on a retail basis. Therefore, ingredient declarations do not apply to spa products used professionally at resorts, salons, and spas, nor do they apply to free samples.
When labeling is required, ingredients must appear individually in decreasing order of their prominence within the formulation. In other words, the ingredient found most prominently in a product will appear first and the ingredient found in the least amount will be last.
Ingredients must be shown by their “common or usual names,” but Latin or other foreign names may appear in parentheses after the common name. For example, “Coconut (Cocos Nucifera) oil. Some exceptions to the descending order rule exist.
- If the cosmetic is also considered a drug, its active drug ingredients must appear before the cosmetic ingredients. The label should then show “Active Ingredients” (drug ingredients) first, followed by “Other Ingredients” (cosmetic ingredients).
- Ingredients that have a concentration that does not exceed one percent can be listed in any order after more prominent ingredients.
- Color additives, of any concentration, can appear in any order after other ingredients.
- If the FDA has accepted the name of an ingredient as a trade secret, the manufacturer does not have to specifically reveal it on the label.
Any ingredient that serves as a fragrance or flavor should be listed in descending order of predominance in the product. It should appear as its true name or as “fragrance,” “flavor,” or “flavor and fragrance” if it serves as both.
TRADE SECRET INGREDIENTS
A trade secret ingredient is one that gives a product manufacturer a competitive advantage. It is often what makes a product unique. Specific ingredients deemed a trade secret by the FDA do not have to be divulged because doing so would make it possible for competitors to copy a product, thereby hurting the company that developed it. Instead, trade secret ingredients may appear as “Other Ingredients” at the end of the label’s ingredient declaration.
PRODUCTS THE FDA CONSIDERS “COSMETICS” AND “DRUGS”
Some products classify as both cosmetics and drugs. As mentioned earlier, cosmetic products have the intended use of cleansing or enhancing beauty. Drugs, according to the FD&C Act, are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” If the FDA considers a product both a cosmetic and a drug, its labeling must meet the requirements for both.
When a product has two intended uses, it might be considered both a cosmetic and a drug. An anti-dandruff shampoo is a good example. It has the cosmetic purpose of cleansing the hair and the drug purpose of treating dandruff. Other cosmetic/drug combinations include toothpaste with fluoride, deodorants with antiperspirant ingredients, and makeup or moisturizers that claim they protect skin from the sun.
Cosmeceuticals is a common term tossed about in the industry to refer to products that have medicinal benefits, but the FD&C Act does not consider it a valid term and it has no meaning under the law. Products are either cosmetics, drugs, or both — and will need to follow all applicable labeling laws.
INTENDED USE OF A PRODUCT
The intended use of a product determines how the FDA will classify it. Here are some ways intended use becomes established:
- Claims about the product – Whether on the product’s label, in advertisements, on a website, or in other promotional collateral, a cosmetic product may be considered a drug if certain claims are made about it. If a company promotes its product as one that will treat or prevent disease or somehow affect the functions or structure of the human body, the FDA may deem the product a drug. Claims that a product will reduce cellulite, restore hair growth, regenerate cells, or influence pigment production of melanin are examples of those that might tip the scales toward classification as a drug.
- Consumer perception – Why the consumer is buying the product and what it is expected to do can also affect whether the product will be considered a drug and cosmetic. The product's reputation in the market typically influences this.
- Ingredients in the product – If any ingredient in the product has a well-known therapeutic use (fluoride in toothpaste, for example), it might result in the FDA considering it a drug. This rings true for essential oils. If marketed for its aromatic qualities and promoting attractiveness, it fits the description of a cosmetic. However, if marketed to have certain aromatherapy benefits (like helping to induce sleep or quit smoking), it would fit the definition of a drug. Likewise, if massage oil is claimed to relieve muscle pain in addition to doing its part to lubricate skin and smell nice, it will qualify as both a drug and cosmetic.
HOW LABELING REQUIREMENTS DIFFER FOR COSMETICS AND DRUGS
While cosmetic products and ingredients (other than color additives) do not require FDA approval before going to market, products considered drugs do. They either need premarket approval through the New Drug Application (NDA) process or fit the conditions approved for the particular drug category they fall into (as established by the FDA’s Over-the-Counter Drug Review).
Regarding label requirements, cosmetics that are also drugs must display the active drug ingredients before listing cosmetic ingredients.
HOW TO HELP CLIENTS UNDERSTAND PRODUCT LABELS
Although most clients will not have an overwhelming interest in the intricacies of products’ labels, occasionally skin care professionals will need to field questions about the products being used in treatments or being sold on a retail basis. In addition to circling back to this article for the basics about product labeling, being educated on the nuances of the specific products being used helps. Know what they contain, learn about the characteristics of the ingredients, make certain everyone knows how to use them properly, and be aware of any potential adverse reactions or side effects. Spa product manufacturers should be expected to answer questions about their products so those using them will have all the information they need and feel confident using them.
Guests look to spa professionals for an exceptional spa experience, as well as expertise in the products used in treatments and sold to them for use at home. Having a working knowledge of product labels is necessary to answer questions and provide guidance.