Regulation of Fragrances According to the US FDA: An Outline

Regulation of Fragrances According to the US FDA: An Outline

Fragrances are a combination of chemicals that render a pleasant scent to perfumes and colognes. Cosmetics and personal care products like makeup products, moisturizers, and shampoos contain fragrances. An attractive fragrance makes the product more appealing to the consumer and enhances the user experience. Fragrances also influence buying behavior and give a competitive edge to the product.

The US FDA classifies fragrances according to their intended use. Fragrance products can be categorized as Drugs, Cosmetics, or both. Products that claim therapeutic benefits are drugs. For example, a product promising to soothe headaches or relieve muscle pains is classified as a drug. If a product is intended to be applied to a person’s body to make them more attractive, it is categorized as a cosmetic. In this way, perfumes, colognes, and aftershaves are considered cosmetics according to the US FDA.

Manufacturers also use fragrances to mask unpleasant odors in a formulation. Cosmetic products that are labeled ‘unscented’ may also contain fragrance ingredients. Such products do not have a noticeable scent.

Before entering the US market, fragrance ingredients should comply with the US FDA requirements for cosmetic ingredients. Although exempt from the US FDA approval before entering the market, fragrances and fragrance ingredients must adhere to labeling regulations and ensure consumer well-being during usage. To be marketed in the USA, a cosmetic or a personal care product containing fragrances should contain a list of ingredients. In most cases, the ingredients are listed individually.

Fragrance and flavor formulae are complex mixtures of natural and synthetic chemical ingredients and may be considered ‘trade secrets’ by cosmetic manufacturers. On that account, fragrances and flavor ingredients can be listed as ‘Fragrance’ or ‘Flavor’ as per the US FDA.

Cosmetic manufacturers and brand owners have a legal responsibility for ensuring appropriate labeling for the safety of consumers. To avoid legal repercussions and product recalls in the US market, it becomes vital to adhere to Regulatory guidelines laid down by the US FDA. Reach out to a cosmetic Regulatory expert like Freyr to achieve compliance.

Stay updated. Stay informed. Stay compliant.