FDA rules say a cosmetic is sometimes just a cosmetic – and sometimes a “drug”

To paraphrase Freud, sometimes a cosmetic is just a cosmetic – and sometimes it’s a drug…. Which is it—drug or cosmetic?

The answer, FDA says, depends on intended use.

Cosmetics v. Drugs

In Cosmetics and U.S. Law, FDA repeats the definitions of cosmetics as drugs.

Cosmetics: “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.” Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Drugs: “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.”

Over-the-counter (OTC) drugs are drugs that can be purchased without a doctor’s prescription.

For OTC drugs, FDA has monographs (rules) under which the drugs are generally recognized as safe and effective, and not misbranded. These rules are established on a class-by-class basis (for example, fluoride dentifrices, cough suppressants, and antihistamines). OTC drugs must meet the requirements of the appropriate class once that rule is published as a final regulation.

Sometimes when a manufacturer comes to our firm for regulatory review of its product, it takes creativity—for example, the product might possibly fit into an OTC monograph if a critical ingredient is added.

If an OTC drug does not meet the requirements of the appropriate final rule, it is considered a misbranded drug and a “new drug.” A “new drug” must have an approved New Drug Application (NDA) before it may be introduced into interstate commerce. In addition, drug manufacturers must comply with Good Manufacturing Practice regulations.

Both a Cosmetic and a Drug

Some products qualify as both cosmetics and OTC drugs. The product could have two intended uses, such as a shampoo (cosmetic) that has an anti-dandruff (drug) intended use.

Other examples include: toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.

There are over 30,000 marketed OTC drug products.

As FDA notes in Drug Applications for Over-the-Counter (OTC) Drugs, FDA reviews the active ingredients and the labeling of therapeutic classes of drugs (such as analgesics or antacids), and as mentioned, maintains OTC drug monographs.

Color Additives

One of the hidden issues is whether a particular ingredient in a product meant as a cosmetic, is a color additive. Color additives must be approved for their intended use, and sometimes, certified for purity in FDA labs.

Cosmetics Regulation

While drugs require premarket approval for safety and efficacy, there is no such requirement for cosmetics.

However, companies must market products that are safe.

Companies also must have backup substantiation for the claims they are making. The Federal Trade Commission (FTC) has overlapping jurisdiction with FDA over advertising, and will initiate an enforcement action if the claims are false and misleading, or, if there is no reasonable scientific basis for a claim.

Claims such as “dermatologist tested” or “clinically proven” will be carefully scrutinized to be sure they are substantiated. Qualifying language must be included to limit claims based on the evidence shown by studies.

FDA maintains a Voluntary Cosmetic Registration Program (VCRP) for cosmetic manufacturers. In this way, manufacturers can get notified by FDA of any problem with their ingredients prior to entering the market.

Like dietary supplements, cosmetics are subject to extensive FDA labeling rules. Fortunately, FDA provides an overview of labeling regulations, as well as a Cosmetics Labeling Manual.

Cosmeceutical, by the way, is a made-up word that has no legal significance – but it sounds like something you might want to be when you grow up.

Contact our FDA legal team for counsel regarding legal and regulatory issues relating to dietary supplements, nutraceuticals, cosmeuticals, cosmetics, OTC drugs, homeopathic remedies, or medical devices (including mobile medical apps).

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Michael H Cohen Healthcare & FDA Lawyers

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