The FDA guidelines often read with such gray area that I myself find it confusing and often frustrating to read through even after almost 15 years experience in the business!. With the busy holiday season just around the corner, this seemed like a super time to go back over the FDA website to help our customers understand what is needed in body care labeling.
Good manufacturing practices are essential when creating and packaging Cosmetics & Soaps. Often times the gray area I talked about above comes from knowing the difference. Is it soap? Is it a cosmetic? Is it a drug or maybe it's a combination hybrid?! This has been very confusing over the years and this should help clarify this, or that is my hope at least.
True soap is NOT included in regulations by the FDA but rather the Consumer Product Safety Commission: http://www.cpsc.gov/ Over the years this has been a STRONG debate in the world of hand crafted soaps and cosmetics. I actually recently got confirmation on what IS needed on a soap label and what truly defines it as soap directly from the CPSC. This is copied and pasted from a response they emailed to me:
I stand by my long time belief that "MOST" melt and pour soap is still considered a cosmetic and thus requires labeling per the FDA guidelines. If you look at a list of standard ingredients for melt and pour soap, you find that they are primarily comprised of detergents and other chemical ingredients and not fats (vegetable oils, animal fats like lard etc.) and alkalis (potassium or sodium hydroxide) or the product of mixing a fat and an alkali like sodium cocoate = soap created by the combination of sodium hydroxide and coconut oil. This is a list of a pretty basic melt and pour soap:
Glycerin, Propylene Glycol, Sodium Stearate, Sodium Laureth Sulfate, Sorbitol, Cocos Nucifera (Coconut) Oil, Sodium Myristate, Triethanolamine, Sodium Laurate, Sodium Cocoate, Water.
Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States
From the Cosmetic Labeling Manual
Cosmetics That Are Also Drugs
Adulterated or Misbranded Cosmetics
Declaration of Ingredients
Law Enforcement Authority
Cosmetic claims are a big thing as well. This outlines more what you can and can not say about your product. THIS IS VERY IMPORTANT! This is copied and pasted directly from the FDA website page:
April 25, 2006; updated January 23, 2012
- its labeling is false or misleading
- its label fails to provide required information
- its required label information is not properly displayed
- its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362]
Does FDA pre-approve cosmetic product labeling?
Some labeling terms you should know
- Labeling. This term refers to all labels and other written, printed, or graphic matter on or accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C. 321(m)].
- Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR 701.10].
- Information Panel.
Generally, this term refers to a panel other than the PDP that can
accommodate label information where the consumer is likely to see it.
Since the information must be prominent and conspicuous [21 CFR
701.2(a)(2)], the bottom of the package is generally not acceptable for
placement of required information, such as the cosmetic ingredient
Is it permitted to label cosmetics "FDA Approved"?
What about therapeutic claims?
How should products be labeled if they are both drugs and cosmetics?
What languages are acceptable?
What labeling information is required?
- An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
- Name and place of business. This may be the manufacturer, packer, or distributor. [21 CFR 701.12].
- Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." [21 CFR 701.12].
- Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 740]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. Flammable cosmetics are an example.
- Ingredients. If the product is marketed on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. As an alternative, when cosmetics are distributed on a mail-order basis, the package mailed to the consumer may contain readily visible instructions for locating the ingredient declaration, such as in a product catalog (currently interpreted as including a website), or instructions for requesting a copy of the ingredient declaration. Mail-order distributors must respond promptly to such requests [21 CFR 701.3(r)]. Remember, if the product is also an OTC drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.
Happy Cosmetics, Soap and Candle Making!