9.5: Regulation of Cosmetics

You might be surprised to learn that the FDA has regulatory oversight over cosmetics. You may be even more surprised to know that this oversight is largely self-regulated! The FDA acts with hazardous products – but the remainder of the control is by the companies themselves. The other area the FDA does scrutinize heavily is misbranding. Many companies have recently moved to market their cosmetics with drug language – such as "anti-aging cream." https://www.fda.gov/cosmetics

Figure \(\PageIndex{1}\): Regulation of cosmetics, such as the multicolored eye-shadow pallet shown here, are governed by the FDA. Image public domain.

Some of the areas the FDA looks at when considering cosmetics is:

• regulations and policy governing the safety of cosmetic ingredients and finished products
• regulations, policy, and other activities dealing with proper labeling of cosmetics
• regulatory and research programs to address possible health risks associated with chemical or biological contaminants
• post-market surveillance and related compliance activities ✓ industry outreach and consumer education

As with foods, the complexity of the cosmetic industry and the technologies and ingredients used in the production of cosmetics is overwhelming. A global cosmetics industry has increased the calls for safety oversight since products and components enter the U.S. from many countries with different regulatory and safety standards. Some of the current areas of focus for cosmetics include:

1. microbiological contaminants
2. chemical contaminants
3. drug vs. cosmetic products
4. use of nanoscale materials as ingredients
5. botanical ingredients
6. alternatives to animal testing

What is a Cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) define cosmetics 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" (FDA.gov). Lipstick, nail polish, moisturizers all are examples of cosmetics that would meet this definition.

The FDA excludes “soap” as a cosmetic – but this is a complicated and tricky topic. Soaps that are composed of fat and alkali (ex. Vegetable oil and lye) are not regulated at all by the FDA – but rather are under the purview of the Consumer Product Safety Commission. Soap that is advertised to cleanse, or beautify in any way, is regulated as a cosmetic. Moreover, soap that has a treatment claim, such as an anti-bacterial soap, is a drug! Whew!

Is it a Cosmetic, Drug, or Both?

One of the biggest issues with cosmetics is determining Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Whether a product is a cosmetic or drug primarily depends on its intended use. Different laws (above) come into play, depending on the use of the product. A product can be considered both a cosmetic and a drug when it is used to diagnose or treat a disease or disorder and to beautify. An excellent example of this would be dandruff shampoo – it is used to both clean the hair as well as treat a disorder. Ultimately, which regulations apply to depend on labeling and marketing.

Law & Regulations of Cosmetics

Many laws and regulations on the regulations of cosmetics. To learn more, click on the law below!

• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act
• Regulations Related to Cosmetics, Title 21, Code of Federal Regulations
• Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded
• Prohibited & Restricted Ingredients
• Color Additives Permitted for Use in Cosmetics
• FDA Authority Over Cosmetics
• View More Resources on Laws & Regulations

Good Manufacturing Practice for Cosmetics

The FDA provides CGMPs for cosmetic products – however, there are no requirements in the FD&C Act for cosmetic products to be manufactured under CGMPs. Many legislative attempts have been made to change this, but so far, none has passed. The industry does provide many of its manufacturing guidelines; some follow the international Guidance’s provided in ISO 22716.

Adulteration of Cosmetics

One of the FDA enforcement areas is of facility and product inspection. Specifically, the FDA is looking for:

1. A poisonous or deleterious substance that may injure the customer under regular use
2. Filthy, putrid or decomposed substance (including microorganism contamination)
3. Packaging under unsanitary conditions
4. The container is composed of a poisonous or deleterious substance
5. The product contains an unsafe (or unapproved) color additive
6. Any outlawed ingredient (ex. Mercury, lead, zirconium, chlorofluorocarbons)
7. Prohibited cattle material (brain, skull, spinal cord)

FDA's Enforcement Tools for Food and Cosmetic Products

For food and cosmetics, the FDA focuses on:

• inspection of establishments
• collection and analysis of samples
• monitoring of imports
• monitoring of adverse event reports and consumer complaints
• premarket review (e.g., food and color additives)
• notification programs (e.g., food contact substances, infant formula)
• regulations/agreements (e.g., memoranda of understanding)
• determine the health effects of food and cosmetic contaminants
• determine the effects of processing on food composition and allergenicity
• determine the health effects of dietary factors
• determine skin penetration of cosmetic ingredients and contaminants