FDA creates guidelines for small and homemade cosmetics businesses via Cosmetics Design

5 December 2015

By Simon Pitman –  03-Dec-2015 –

The FDA has created a webpage outlining its guidelines for smaller and homemade cosmetic players in an effort to regulate this niche but fast growing area.

The FDA page, titled “Small Businesses & Homemade Cosmetics: Fact Sheet, outlines 15 commonly asked questions about this category, with responses that specify what regulatory responsibilities these kind of businesses have to incorporate into their practices.

Here is a sample of some of the first three of the 15 points raised in the fact sheet, which provide some of the most far-reaching recommendations:

Does FDA regulate cosmetics?

Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetics Act. Under this law, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. Any color additives they contain must be approved for the intended use, and some must be from batches certified in FDA’s own labs. Packaging and labeling must not be deceptive. If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products. If your cosmetics are marketed to consumers on a retail basis, such as in stores, or by mail order (including online), or by personal sales representatives (for example, door-to-door sales), they also must meet ingredient labeling requirements under the Fair Packaging and Labeling Act.

Do I need to have my cosmetic products or ingredients approved by FDA?

The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly labeled. With the exception of color additives and ingredients that are prohibited or restricted by FDA regulations, you may use any ingredient in your cosmetic, as long as it does not cause the product to be adulterated in any way. You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them. Remember, however, that not all “personal care products” are regulated as cosmetics under U.S. law. For example, some are regulated as drugs. If your product is a drug under U.S. law, it must meet the requirements for drugs, such as premarket approval.

How do I know if my products are regulated as cosmetics, and not as drugs or some other product category?

A product’s intended use is determined by factors such as claims made for the product, consumer expectations, and certain ingredients. A product is a cosmetic if it is intended for uses such as cleansing the human body, making a person more attractive, or changing a person’s appearance.

Here are some examples of products marketed as cosmetics:

  • Makeup
  • Moisturizers
  • Hair dyes,
  • permanent waves,
  • straighteners, and removers Perfumes and colognes
  • Nail care products

Homemade and artisanal cosmetics a small but growing niche

Demand for this kind of products has mainly risen out of the popularity of natural and organic products, with the burgeoning farmer’s markets and online sales proving to be amongst the biggest distribution networks for such products. Likewise, there is also a growing trend for do-it-yourself cosmetics, with a growing online community geared towards helping individuals create cosmetics at home for their own personal use. Although there are no specific figures for these kind of businesses because their size makes them hard to track, consumers who want to avoid harsh chemicals and preservatives feel that ‘artisanal’ products that provide a more holistic and natural approach to personal care and beauty routines.

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