Cosmetic Claims and Required Approval

Recently there has been some discussion online (in a Facebook Group) as a result of a report of a conversation with someone from the FDA. The report was that this FDA representative said that if you wanted to use the word “moisturizing” to describe a soap, then your recipe would need to be submitted and evaluated for its composition of moisturizing properties. This FDA person also said that the term “lip balm” is regulated by the FDA as a drug.

I have absolutely no reason doubt that the person reporting this conversation reported it accurately. She was, in fact, doing her due dilligence in checking with the FDA to understand the rules and regulations.

The problem is that FDA staff are human, and may not be completely versed in all the applicable regulations when confronted with a question from the public. I doubt they intentionally give out wrong information, but it’s happened in the past, I expect it will happen in the future, and it’s likely that it happened in this instance. It’s generally better to understand the regulations by referring to the actual regulations, or at least to the written material the FDA provides as it has been vetted and double checked for accuracy.

So, here are a few documents to take a look at when evaluating the accuracy of the information provided by someone at the FDA in this case:

Finding the Actual Laws, Regulations & Interpretations

There are several different sets of laws and regulations applicable to cosmetics (including soap), food and drugs.  The most applicable ones are the Food, Drug and Cosmetic Act and the regulations that implement it.  I strongly recommend that you read at least the regulations concerning cosmetics.

Food, Drug and Cosmetic Act

The Food, Drug and Cosmetic Act is the act that was approved by Congress (in 1938 and subsequently updated).  It is the “law”.  The full text of the FD&C Act is on the FDA website.  Chapter VI deals with cosmetics, but Chapters I and II have definitions that are applicable.

The FD&C Act is in the US Code, Title 21, Chapter 9. To find the full content on the U.S. Government Printing Office site (www.gpo.gov) search “21 USC site:gpo.gov”.  Any of the pages should take you to the main Title 21 page, then scroll down, opening up sub-sections as needed, to get to the right link for the text.

Regulations

Once an Act is appoved by Congress and passed into law, it is implemented into action in the form of regulations. To get regulations approved, they must be generally proposed and submitted for public comment in the Federal Register.  Once interested particies have a chance to comment (either in writing to the FDA or in hearings, if any are held), the FDA finalizes the regulations (taking into account all the comments).  Once finalized, they are published in the Federal Register and incorporated into the US Code of Federal Regulations.

Regulations covering the implementation of the Food, Drug and Cosmetic Act (as well as some others) that apply to Cosmetics are covered in Code of Federal Regulations, Subchapter G, Parts 700 – 740.  The full text is available on the US GPO site (search 21 CFR 700 site: gpo.gov).  They are also available on the FDA website: Regulations Related to Cosmetics.

There are also regulations that apply to over-the-counter (OTC) drugs.  Some of those regulations include the details on different types of OTC drugs, including 21 CFR 347 , titled “Skin Protectant Drug Products for Over-The-Counter Human Use,” available here.

Interpretations

The laws and regulations are, as we all know, sometimes hard to read.  The FDA has worked hard, including recently updating their website, to make the information available in human-readable form. You can assume that the information that is posted on the FDA website has been vetted, checked and double-checked for accuracy and that it correctly reflects the actual regulations and laws.  Even so, what you are required to follow are the actual existing regulations and laws … regardless of what’s written on the FDA website (or anywhere else).  The only exception seems to be in the area of some policy decisions or interpretations (such as the fact that the required “common name” has been interpreted to mean the common English name, not the Latin bi-nomial). Usually those decisions or interpretations are made in response to a Citizen Petition or in materials published in the Federal Register and/or on the FDA website.

Specifics on the Discussion

So now that you know where to find the official information, let’s take a look at what the FDA representative told the soaper when she called.

1. Using the word “moisturizing” to can’t used to describe a soap.

How does the law define a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. [Source: Is It a Cosmetic, a Drug or Both? (Or is it Soap?)]

So, “moisturizers” are a type of cosmetic.

What about soap, then?

How FDA defines “soap”

Not every product marketed as soap meets FDA’s definition of the term. FDA interprets the term “soap” to apply only when

  • the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
  • the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.
If a cleanser does not meet all of these criteria…

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
If a product

  • consists of detergents, or
  • primarily of alkali salts of fatty acids, and
  • is intended not only for cleansing but also for other cosmetic uses,

it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin. [Source: Is It a Cosmetic, a Drug or Both? (Or is it Soap?)]

So, if you have a soap that meets the FDA’s definition of soap (primarily alkali salts of fatty acids), you can’t say it’s moisturizing and still treat it as “soap” exempt from the FDA. It becomes a cosmetic and is regulated as a cosmetic as soon as a claim for “moisturizing” is attached to the soap product.

There’s nothing illegal or wrong about making a “moisturizing” claim for a soap product … it just causes the soap to be regulated as a cosmetic under the FDA, rather than as a typical consumer commodity under the Consumer Product Safety Commission.

2. A “moisturizing” soap is a cosmetic and must be sent to the agency for evaluation and approval

As noted above, it’s true that a soap that claims to be moisturizing is a cosmetic.  However …

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. [Source: Is It a Cosmetic, a Drug or Both? (Or is it Soap?)]

In the US, cosmetics do not require approval, nor do their ingredients.

This is not true in other countries, some of which require that cosmetic claims be documented and/or that the formulations are reviewed or approved for safety, usually by an external third party. In addition, most other countries (and some US states) require that cosmetic products be registered with the appropriate agency, such registration also requiring a list of ingredients (although, as noted, not all countries require an actual evaluation of the recipe or ingredients).

FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations.
Cosmetic products and ingredients do not require FDA approval before they go on the market, with one exception: color additives (other than coal tar hair dyes.) Cosmetics must be safe for their intended use and properly labeled. [Source: Is it Really FDA Approved?]

Again, cosmetic products do not require the approval of the FDA before being marketed.

Is it permitted to label cosmetics “FDA Approved”?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. [Source: Labeling Regulations: Overview of Labeling Requirements]

In fact, you may NOT say that your product is “FDA Approved” (since the FDA doesn’t approve cosmetics).

“Lip Balm” is a Drug Claim

In the regulations covering the class of OTC drugs called “skin protectants,” the term “lip balm” is one of the acceptable names for a skin protectant product. In order to qualify as a “skin protectant” the product must meet all the specifications in 21 CFR 347, Skin Protectant Drug Products for Over-The-Counter Human Use. That includes meeting the requirements for the active ingredients, and correct labeling. From the regulations (only the sections pertinent to lip products are quoted):

Sec. 347.50 Labeling of skin protectant drug products.

(a) Statement of identity . The labeling of the product contains the established name of the drug, if any, and identifies the product with one or more of the following:

(2) For any product formulated as a lip protectant . “Skin protectant,” “lip protectant,” or “lip balm” (optional, may add dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”).

(b) Indications. The labeling of the product states, under the heading “Uses,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used […with some restrictions in regulation]

(2) For products containing [list of specific ingredients] The labeling states (optional: “helps prevent and”) “temporarily protects” (optional: “and helps relieve”) (optional: “chafed,”) “chapped or cracked skin” (optional: “and lips”). This statement may be followed by the optional statement: “helps” (optional: “prevent and”) “protect from the drying effects of wind and cold weather”. (If both statements are used, each is preceded by a bullet.)

(ii) For products formulated as a lip protectant. The labeling states (optional: “helps prevent and”) “temporarily protects” (optional: “and helps relieve”) (optional: “chafed,”) “chapped or cracked lips”. This statement may be followed by the optional statement: “helps” (optional: “prevent and”) “protect from the drying effects of wind and cold weather”. (If both statements are used, each is preceded by a bullet.)[Source: 21 CRF Sec. 347.50]

For a lip protection product to be compliant with the skin protection monograph, it must be identified as a “skin protectant,” “lip protectant,” or “lip balm”. (347.50 (a)(2) above).

It must state, under the heading of “Uses” (primary phrases in bold; optional phrases are in red):

  • Helps prevent and temporarily protects and helps relieve chafed chapped or cracked skin and lips.
  • Helps prevent and protect from drying effects of wind and cold weather  (this statement is optional)

As with “moisturizing” causing a product to become a cosmetic, use of the claims listed above cause a product to become a skin protectant (and thus a drug, albeit an OTC drug).  All drug manufacturers must register with the FDA and comply with good manufacturing practices [Source: Is It a Cosmetic, a Drug or Both? (Or is it Soap?)]

The issue of calling a product a “lip balm” when these claims are NOT made has come up several times.  I did veryify with the FDA that a product may be identified as a “lip balm” and sold as a cosmetic, providing no skin protectant claims are made.  [See: More on Lip Balm]

More resources

For more information, check out some of these pages on the FDA website:

Also take some time to cruise around the cosmetics section of the FDA website for other information you might find useful.

Comments

  1. You know the regulations are confusing if the people answering the phone don’t even know them! Don’t they all have a copy of your book on their desks?! 😉

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