Creating FDA Compliant Labels

Written by: | October 17, 2018 | Leave a Comment

To enter into the cosmetic market, it is important to create proper and compliant labels. The cosmetic label is usually the principal display panel of the product and needs to comply with labeling laws that the Food & Drug Administration (FDA) lays out.

The FDA standardizes cosmetic labeling laws under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). So we would like to give you some quick tips on following the basic rules of labeling. Please note that we always recommend that an attorney who is familiar with FDA rules performs a review of your labels, but we will try and guide you on the basics. For a more intensive understanding, please visit the FDA’s website here: https://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm

If a product will be exported then it must also follow international regulations which we can cover at another time.

Typical Issues While Creating Compliant Labels

Let’s start out with the 2 items that we find to be missing or listed incorrectly almost every time we review a customer’s labels, and then we will continue.

  • First is identifying the manufacturer or distributor AND how to reach them. This is often missing and absolutely required on the cosmetic label. So for example, although you don’t necessarily need to state who your manufacturer is, you must say “Manufactured for Your Brand Here” and then provide a full address or how to contact your own brand. We can make products for you but include your own business address on the label.
  • The second item we often find missing is the actual weight of the cosmetic in both standard and metric. The department of weights and measures requires these to be displayed on the label. One example is 2 oz (56.7 g) or 2 fl oz (59.14 ml). The net quantity of contents declaration must accurately reveal the quantity of cosmetic in the container in terms of weight, volume, measure, numerical count, or combinations of count and weight, volume or measure. Unless there is a firmly established, general consumer usage or trade custom to the contrary in your locale, the statement must be in terms of fluid measure if the cosmetic is liquid and in terms of weight if the cosmetic is solid, semi-solid, viscous, or a mixture of solid and liquid.
  • Not only must the ingredients be identified by a standardized name, but labels also require a mandated type size. Ingredients must be listed as 1/16″ OR 1/32″ (Labeling surface, less than 12 sq. in), while the contents must be listed as 1/16″ (PDP less than 5 sq. in.) OR 1/8″ (PDP 5-25 sq. in.) OR 3/16″ (PDP 25-100 sq. in.) and the warning statements must be listed as 1/16”

 What Are Cosmetics?

  • As defined in section 201(i) of the FD&C Act, a cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. In short, one may say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body such as a drug. If cosmetic claims, such as moisturizing, deodorizing, skin softening etc., are made on a label, the product is a cosmetic.

Required Warnings for Compliant Labels

  • Having mentioned the size of the warning on labels, only 2 categories that Essential Wholesale & Lab sells are required to have warnings. Please note that the FDA requires the warnings to be listed exactly as they are written in the 21 CFR 740 (please refer to the link from earlier).

 

  • The first is Feminine Deodorant Sprays. A feminine deodorant spray which, for the purpose of this regulation, is defined as “any spray deodorant product whose labeling represents or suggests that the product is for use in the female genital area or for use all over the body” must bear the caution stated below. The regulation further states that the use of the word “hygiene” or “hygienic” or similar words renders any such product misbranded. Caution–For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.

 

  • The other warning is for Foaming Detergent Bath Products. A foaming detergent bath product–also known as bubble bath product–is, for the purpose of this regulation, defined as “any product intended to be added to a bath for the purpose of producing foam that contains a surface-active agent serving as a detergent or foaming ingredient.” The caution stated below is required on the label of any foaming detergent bath product which is not clearly labeled as intended for use exclusively by adults. The following are two examples of label statements identifying a product as intended for use exclusively by adults: “Keep out of reach of children” and “For adult use only.” If the bubble bath product is intended for use by children, the phrase “Keep out of reach of children” may be expanded to further read “except under adult supervision.” The regulation further requires that the label “Shall bear adequate directions for safe use” of the product. Caution–Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.

 

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