The Regulations Concerning Cosmetics & Over-the-Counter Products


Cosmetics and over-the-counter (OTC) certification regulations differ greatly, so it is essential to understand the differences.

The world is forever changing, as is the ISO 22716:2007 certification for cosmetic and OTC product manufacturers. You need to know the options available to support cosmetic and OTC products.

What are cosmetic and OTC products?


Cosmetic products

The Federal Food, Drug and Cosmetic Act (FD&C Act) defines cosmetics by their intended use as articles 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”.

Products include skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors and deodorants, as well as any substance used in a cosmetic product.

OTC drug products

The FD&C Act defines drugs, in part, by their intended use as articles for “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”.

Cosmetics and drugs

Some products meet both definitions. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because it cleanses the hair while an anti-dandruff treatment is a drug because it treats dandruff. Consequently, an anti-dandruff shampoo is a cosmetic and drug.

Among other cosmetic/drug combinations are fluoride toothpastes, antiperspirant deodorants and moisturizers, and makeup marketed with sun-protection claims. Such products must comply with both cosmetic and drug requirements.


The FD&C Act does not recognize cosmeceuticals, which are purported to have bioactive ingredients with medicinal benefits. A product can be a drug, cosmetic or combination of both, but the term “cosmeceutical” has no meaning in law.

What’s the difference in regulatory requirements?


Approval requirements

Under the FD&C Act, cosmetic products and ingredients, excluding color additives, do not require FDA approval before they enter the market.

Generally, drugs must either receive premarket approval by the FDA through the New Drug Application process or conform to a “monograph” for a drug category, as established by the FDA’s OTC Drug Review.

Registration requirements

The FDA maintains the Voluntary Cosmetic Registration Program for cosmetic establishments and formulations. As this is voluntary, the FD&C Act does not require organizations to register themselves or list product formulations.

In contrast, drug firms must register their establishments and drug products with the FDA.

Labeling requirements

A cosmetic product must be labeled according to cosmetic labeling regulations while OTC drugs must be labeled according to OTC drug regulations, including Drug Facts labeling.

Products that are both OTC drugs and cosmetics must display OTC drug/cosmetic labeling.

Soap vs. cleanser

Not every product marketed as soap meets the FDA’s definition of the term. The FDA interprets “soap” to only apply when the bulk of the product’s nonvolatile matter consists of an alkali salt of fatty acids and the detergent properties are due to the alkali-fatty acid compounds, as well as the product is labeled, sold and represented as soap.

Cleanser as a cosmetic

If a product intended to cleanse the body does not meet all soap criteria, it is either a cosmetic or drug.

Cleanser as a drug

If a product consists of detergents or primarily alkali salts of fatty acids, and is for cleansing and curing, treating or preventing disease, or to affect the structure or any function of the body, it is regulated as a drug, or drug and cosmetic.

Good manufacturing practice requirements

Good manufacturing practice (GMP) is vital in helping to assure that your cosmetic products are neither adulterated nor misbranded. However, while the FDA has guidelines for cosmetic GMP, no regulations outline specific GMP requirements for cosmetics.

In contrast, the law requires strict GMP adherence for drugs. There are also regulations specifying minimum current GMP requirements for drugs. Failure to follow GMP requirements causes a drug to be adulterated.

Impact on ISO 22716:2007 certification scopes

This international standard provides guidelines for producing, controlling, storing and shipping cosmetic products.

Based on ISO 22716:2007, the scope statements for this certification may contain cosmetic and personal care products, but they may not contain OTC or household products.

Our beautifying services

SGS can review the differences between and regulatory requirements of cosmetic and OTC products. We can help you understand the removal of OTC products from the ISO 22716 scope statements, as well as review the options that cover the products.

Our experts can help with World Health Organization (WHO) GMP certification for OTC products, as well as addendum auditing and reporting that covers 21 CFR Parts 210/211 without certification, to prepare you for an FDA inspection of OTC products. We can also support ISO 9001:2015 certification for household products, as well as auditing and reporting that covers general quality management system requirements, to ensure you are ready for customer audits for household products.



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