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Understanding Diluent [Food and Drugs]: Legal Insights and Applications
Definition & meaning
A diluent is a substance that is mixed with a color additive to enhance its usability in food, drugs, cosmetics, or for coloring the human body. While it does not have coloring properties itself, a diluent can serve additional functions, such as sweetening, flavoring, emulsifying, or stabilizing the mixture. This term is defined under the regulations set forth by the Food and Drug Administration (FDA).
Table of content
Legal use & context
The term diluent is primarily used in the context of food and drug regulations. It is relevant in legal practices surrounding food safety, pharmaceutical regulations, and cosmetic safety. Legal professionals may encounter this term when dealing with compliance issues related to the use of color additives in products. Users can manage some aspects of compliance with the help of legal templates available through US Legal Forms, which are drafted by qualified attorneys.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: In a food product, a diluent like water or oil may be used to dilute a color additive to achieve the desired hue without altering the flavor or texture of the food.
Example 2: In cosmetics, a diluent such as glycerin may be mixed with a color additive to ensure even application and stability of the product. (hypothetical example)
Relevant laws & statutes
The definition of diluent and its use in color additives is primarily governed by the Federal Food, Drug, and Cosmetic Act, along with regulations outlined in 21 CFR 70.3(m). These regulations detail the requirements for color additives in food, drugs, and cosmetics.
Comparison with related terms
Term
Definition
Key Differences
Diluent
A substance mixed with a color additive to facilitate its use.
Does not have coloring properties; serves functional purposes.
Color Additive
A substance used to impart color to food, drugs, or cosmetics.
Has inherent coloring properties; used to change appearance.
Common misunderstandings
What to do if this term applies to you
If you are involved in the production or regulation of food, drugs, or cosmetics, ensure that any diluents used comply with FDA regulations. Consider using US Legal Forms to access templates for compliance documentation. If your situation is complex, it may be beneficial to consult with a legal professional for tailored advice.
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