Cosmetic or Drug? Regulatory Basics and FDA Monographs

Updated: Sep 6, 2019

When working in the cosmetics industry, a common question preceding any conversation about a product is whether it is a cosmetic or over-the-counter (OTC) drug. These are two separate regulatory classifications that have a broad impact on the product life cycle.


It is a distinction that is typically unnoticed by consumers, but very important to company operations. Drugs have more oversight by the government and therefore more rules and restrictions. Large companies have entire departments dedicated to regulatory affairs due to the complexity and ever-changing nature of the laws around the world. Different countries have different legal requirements for product registrations, labeling, and ingredients.


Today, I'd like to keep it relatively simple and focus on the distinction between cosmetics and drugs. I will focus on the United States, where the cosmetic industry is regulated by the Food and Drug Administration (FDA). The definitions below are from the Federal Food, Drug, and Cosmetic Act of 1938 which established the FDA as a regulatory body.


Legal Definitions


Cosmetic

The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.


Drug

The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).


If you're like me, you probably struggle with legalese, but the inclusion of the word "sprinkled" makes me smile. To help clarify, I've indicated in bold the sections that matter most. The main distinction is that cosmetics are altering appearance and drugs are treating disease or affecting the body's structure or function. This is why it's a bit complicated. Two identical formulations could be regulated differently based on the claims on the package. This is why your favorite wrinkle cream says "reduces the appearance of fine lines" and not "reduces fine lines."


FDA Monographs

The most common over-the-counter drugs sold by cosmetics companies are called "monograph" drugs. This is different from monograms, or the southern tradition of putting your initials on everything you own. If an ingredient is under monograph, that means that the FDA has already determined it is safe and has issued a guidance about the dosage of the ingredient allowed in formula as well as the claims you can make. Monographs are available on the FDA website. They are broken down by product function and list all the different ingredients that can be used for that function. For example, the monograph for anti-acne products lists 40 ingredients. There are monographs for sunscreen, antiperspirant, skin protectants, and more. You can find the full list on the FDA website. The FDA even has a frequently asked questions page. If you are having a hard time falling asleep at night and want to read about government regulations, check it out.


Overall, monographs simplify the FDA's job because every company doesn't need to go through an approval process for every OTC product launch if it is covered by an existing monograph. Companies are required to follow the guidance in the monograph and label the OTC product with a drug facts box. I've included an example of a drug facts box below. As a consumer, you are probably familiar with seeing this on everything ranging from cold medication to sunscreen.

Drug Facts Box Example from https://www.fda.gov/drugs/resources-you/over-counter-medicine-label-take-look

Active Ingredients and Claims

As you can see in the drug facts box above, the top row lists the active ingredient. To close the loop, for OTC monograph drugs, this is the ingredient that is covered by the monograph. For an anti-acne face wash, it may be 2% of salicylic acid. One interesting point about the active ingredient and the monograph is that just because you are using 2% salicylic acid in your formula, the product is not necessarily an OTC drug. If you are making anti-acne claims about your product that are contained in the monograph, then you need to treat your product as an OTC drug. However, if you are not making any anti-acne claims, your product is a cosmetic.


A word of warning for a savvy consumer, if you are avoiding a specific active ingredient, make sure you check the entire ingredient list! Just because it's not listed as an active ingredient doesn't mean that it's not included in the formula. For more ingredient information, refer back to my prior post Ingredients 101.


Thanks for joining me today! I hope you learned a bit about government regulations and feel more confident in the distinction between OTC monograph drugs that contain active ingredients and cosmetic products. If you have any additional questions, please let me know below!

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