Material Facts
Part of the purpose of the label of a product is to make it possible for the consumer to make a value comparisons1 about the product. Can they use it? How valuable is it to them? Is it worth the cost? Is it better or worse than a similar product? The information they use to make those decisions are material facts.
Material Facts: Factual information which is significant or influential, especially when affecting a person’s decision-making.
Illegal Cosmetic
A cosmetic product that fails to provide material facts is considered misleading.2 If the label of a cosmetic product is false or misleading in any specific, the cosmetic is misbranded.3 Introducing a misbranded cosmetic into interstate commerce (offering it for sale) is prohibited4 and could be subject to penalties.5
Required Facts on Cosmetics
Some material facts are required by law or regulations, such as:
- Product Identity (what it is)
- Net contents
- Business name and address
- Ingredient declaration
- Warning statements
Each of these items on the label provides material facts which the consumer needs in order to make value comparisons and an informed decision on whether or not to purchase the product.
Recommended Facts on Cosmetic Products
In addition to the required information, some material facts are specifically recommended by the FDA:
- Hazardous substances labeling
- Alpha hydroxy acid warning statements
- Beta hydroxy acid warning statements
These facts should be included on the label when appropriate and failure to include them is considered misleading.
Product Specific Material Facts
If there is some particular consequence, particularly an unexpected one, of using a product in the usual and customary way or as directed on the label, then that would be a material fact. The consumer needs to know what that consequence is in order to decide if they want to buy the product.
What would be a material fact depends on the product itself and who it is being marketed to. They often take the form of cautions or warnings.
In deciding what information might be a material fact for your product, look at what you would tell a friend or family member when giving them the product to use.
1 15 USC 1451 – Fair Packaging and Labeling Act
2 21 CFR 1.21 – Failure to reveal material facts
3 21 USC 362(a) – Misbranded Cosmetics
4 21 USC 331(a) – Prohibited acts
5 21 USC 333(a)(1) – Penalties
