Marketing And Labeling Requirements

Understanding FDA regulations pertaining to the marketing and labeling of lotions, skincare products and cosmetics will enable salon operators to provide a higher level of service to customers and serve as responsible representatives of the indoor tanning industry.

It’s typical for tanning salons to offer various lines of lotions, skincare products and cosmetics. Many products claim to improve skin in a number of ways by moisturizing, diminishing wrinkles, increasing firmness, improving skin tone and reducing cellulite, etc. Due to the variety of claims made by manufacturers and their products’ often complex mechanisms of action, it is reasonable for consumers to question whether a product is categorized as a cosmetic or a drug— and why.

The Food and Drug Administration (FDA) set forth the Food, Drug, and Cosmetic Act (FD&C Act), which defines cosmetics and drugs by their intended use. Cosmetics are defined as, “articles intended 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.” These products include moisturizers, fingernail polish, makeup, hair color, shampoos, deodorants, bath oils, mouthwashes, etc.

A product is considered a drug if its intended use is to treat or prevent disease or otherwise affect the structure or function of the body. The FD&C Act legally defines drugs as, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and as, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Simply put, drug claims state the product alters the physiology or function of any part of the human body. Conversely, cosmetics do not claim to cause a physiological effect on the body.

A product can be both a drug and a cosmetic when it has more than one intended use. For example, shampoo typically would be categorized as a cosmetic due to its cleansing function, which does not have a physiological effect. However, an anti-dandruff shampoo formula would be considered a drug because of its intended use to treat dandruff. Other examples of products that are both cosmetics and drugs are fluoride toothpaste and cosmetics that contain sunscreen ingredients. Although the term “cosmeceutical” has become a common industry term loosely defined as a cosmetic with pharmaceutical properties. This term is not recognized by the FD&C Act and has no legal meaning.

The laws and regulations applying to the marketing of products are governed by their categorization as a cosmetic or drug. Requirements overseeing the sale of cosmetics are less stringent than regulations enforced by FDA pertaining to drugs.

According to the FD&C Act, cosmetics and cosmetic ingredients—with the exception of food dyes and select prohibited substances—do not required approval prior to being sold. Typically, these products are regulated by FDA upon their introduction into the marketplace.

Unlike cosmetics, drugs either must receive pre-market approval by FDA or conform to final regulations specifying conditions whereby they are recognized as safe and effective and not misbranded.

There are two general categories for FDA drug claim approval. The first applies to all products within a given class of over-the-counter (OTC) products. The FDA issues a monograph on the class, and OTC products can be marketed with drug claims that adhere to the restrictions set forth in the monograph. For example, any antifungal product containing an effective level of an active ingredient approved in the OTC anti-fungal monograph can make the claim “cures athlete’s foot.” This is an approved efficacy claim based on the proven effect of the active ingredient.

The second category for FDA drug claim approval is for claims that do not fall within an approved OTC monograph. These are approved (or not approved) only after an extensive review by the FDA. If a company wishes to make a drug claim for a product beyond the claims approved in the monograph for that product category, it must submit an Investigative New Drug application. After an exhaustive clinical study the FDA will review the claim and determine whether it is approved for marketing purposes.

While less stringent than drug regulations, important cosmetics regulations do exist, including the Fair Packaging and Labeling Act that requires an ingredient declaration on cosmetic products sold to consumers. Regulations require product ingredients to be listed in descending order, classified by quantity. These regulations apply only to retail products intended for home use. Non-retail samples and products used only by beauticians in salons and spas must state the distributor, include relevant warning statements, and list product quantities.

There also are differences in registration, good manufacturing practice (GMP) requirements, and labeling requirements for cosmetics and drugs. It is mandatory that manufacturers of drugs register their facilities and products with the FDA. However, it is voluntary for cosmetic manufacturers to register products with the Voluntary Cosmetic Registration Program (VCPR).

There are no regulations governing the specific GMP guidelines for cosmetics, but the law is very strict with the GMP requirements for drugs. Labeling requirements also differ— cosmetics must be labeled according to cosmetic labeling regulations; OTC drugs must be labeled according to their regulations; and products that are both a cosmetic and an OTC drug must have labeling that fulfils both requirements.

Companies manufacturing cosmetics are not required to conduct safety testing or substantiate performance claims. If safety has not been shown, the product must have a label stating, “WARNING: The safety of this product has not been determined.”

If a cosmetic makes a therapeutic claim, it is regulated both as a cosmetic and a drug, and must meet the legal requirements for both. Chemicals that make the product effective are required to be listed first on the label as active ingredients, followed by the cosmetic ingredients in descending order.

When a product claims to be both a drug and cosmetic it must be proven scientifically safe and effective, and must validate its claims. When such regulations are not met, FDA considers the product misbranded.