Using an “FDA Disclaimer” on Cosmetics

Several people have asked me about FDA disclaimers they see on packaging, websites and promotional materials that say:

“This statement has not been evaluated by the Food and Drug Administration. This products is not intended to diagnose, treat, cure or prevent any disease.”

I’ve been asked if the same disclaimer can be used for claims made about cosmetics. The answer is “No!”

The regulations for what you can (and cannot) claim about cosmetics are clear. Putting a disclaimer that the statements “aren’t evaluated by the FDA” doesn’t exempt you from the regulations.

So When ARE These Disclaimer Statements Used?

The disclaimer statements are allowed (in very specific cases) on dietary supplements (vitamins, minerals, herbs, etc.). Of course, when it comes to the FDA, there are very, very, very detailed requirements on when the statements can be made and how the statement can be used in conjunction with claims made.

Before I go any further, let me say that I am NOT an expert in the labeling of food supplements. The information presented here is the result of a general look at the regulations, not a detailed study.

What I found was that, for dietary supplements, certain claims can be made that make a relationship between a nutrient (in a food supplement) to a disease or health-related condition.

Directly from the law:

(6) … a statement for a dietary supplement may be made if—

(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,

(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and

(C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.

21 USC 343(r)(6)

The FDA has clarified what substantiation is needed (per (B) above).

In addition, in order to make such claims with the disclaimer, the manufacturer must notify the FDA.

Directly from the regulations:

Certain types of statements for dietary supplements.

(a) (1) No later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403(r)(6) or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, that it has included such a statement on the label or in the labeling of its product. An original and two copies of this notification shall be submitted.

(2) The notification shall include the following:

(i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;

(ii) The text of the statement that is being made;

(iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and

(iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears.

21 CFR 101.93

My take on it is that these regulations were put in place to allow those making dietary supplements to explain what the nutritional benefits of taking the supplement are, and how they maintain a healthy well-being by preventing some sort of deficiency.

Disclaimers on Cosmetic Products

There is nothing in the regulations that allows for similar disclaimers to be made about any cosmetic product. Cosmetics are, by definition, applied TO the human body, and not ingested. They are meant to improve appearance and make one more beautiful—not to cure or treat any type of disease.

Placing the disclaimer (meant for dietary supplements!) on cosmetic products doesn’t alleviate the responsibility to follow the regulations for cosmetics and the claims that can (or cannot) be made for them.

There is, of course, nothing wrong with placing a statement on a cosmetic label, website or promotional materials that says that a person should see a doctor to address any health issues and shouldn’t self-diagnose or self-treat diseases or health issues. That would be completely up to you.

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Comments

19 responses to “Using an “FDA Disclaimer” on Cosmetics”

I have a few different products for my cosmetic line. And I would love to contact you to get a little help with my labeling if that is possible.

I offer a label review service (see this page). I can also do consulting. You can email me at hello@mariegale.com if you would like consulting and we can discuss what is needed.

I know it’s common to add vitamin E to cosmetics, but any idea how fda feels about adding vitamin d3 to a cream, if I make no claims & use its other name cholecalciferol? Thanks!

The FDA doesn’t regulate cosmetic ingredients (other than the fact that they cannot be adulterated or misbranded, and they must be safe).

Thank you,
I was able to reach to FDA and they said the same. the only way that is acceptable by FDA is to put the corrected IL sticker on top of the current one.

Can I use of the labels for the cosmetic product with a missing ingredient until use them all or for certain amount of time?

I haven’t seen anything that allows for incorrect ingredient declarations because the label is already printed. Sometimes, when a law changes, there is an allowance for companies to use up labels that don’t meet the new requirements, but I haven’t seen anywhere where that would apply because of a mistake or a change in the formulation.

I am just starting out. Crossing my t’s and dotting my i’s to put the horse before the cart as I get my company up and running. My start up product is a salt oil and essential oil combination to be distributed in bath water for a mi real bath. I know I cannot claim detoxing or other treatment values the essential oils or salts are thought to have as in not marketing a drug treatment, as a cosmetic can I label describe it as improving appearance of skin with cleansing and moisturizing or softening properties or by improving skin wording am I implying treatment (change) verses cosmetic (appearance)? I’d appreciate you feedback and thoughts.

So long as you stay within “improving appearance” (cleansing, moisturing, softening, etc.) then it is within the definition of a cosmetic. It’s when you get into claims that it will alter the function or structure of the body or “treat” physical issues that you run into the distinct possibility of the product becoming an unapproved new drug.

My product is a beauty and wellness essential oils fall under the food and drug dont they as I am using frankincense emu and olive oil as well as vitamin e t50 while not to be ingested it does have the ability to penetrate the human body and improve certain things what do I do lol

If your product is applied to the human body, then it is a cosmetic. Just label it according to the cosmetic labeling regulations and it will be fine. If you are making claims that it will alter the function or structure of the body, then it is an unapproved new drug. (NOT GOOD! That’s illegal.)

How about a moisturizer that may help fade stretch marks? I’m starting a business and want to add a body butter to help during pregnancy to hopefully prevent stretch marks, or after pregnancy to help them fade.

Something that moisturizes is a cosmetic. That is not really affecting the structure or function of the body, and it is improving appearance. Something that is intended to fade stretch marks IS intended to affect the structure (scar tissue) of the body. That puts it in the realm of an unapproved new drug. You could promote it as just a “tummy butter” without making any claims about stretch marks, just that it will make the tummy look and feel good (better).

Wow, I never thought about that disclaimer being used on cosmetics! Thank you for addressing this, Marie 🙂

this questions is also related to the other post about claims on cosmetic labels. So I thought I could ask it here since you mentioned what cosmetics are supposed to do. Can we then ” claim” on a hair product for example it makes your hair smoother to comb ? Or its appearance to be smoother by coating the hair cuticle? Isn’t that a claim? Or is it ok because its a claim that only makes your hair look more beautiful?

Honestly, I don’t know if the hair cuticle is considered part of the “function or structure of the body” since technically it’s not alive; like fingernails. Definitely you could make claims about what the product does to the APPEARANCE of the hair. I had 4 different conditioners in the bathroom and looked to see what they say: Pantene: Healthy-looking hair starts at a structural level; Your hair benefits from a daily dose of care to look its best; designed to leave hair shiny and healthy looking from root to tip; improves hair for manageability and strength against damage. Garnier Fructis: long-lasting frizz-control; penetrates to improve texture, moisturize and soften hair; smooths hair from root to tip. TRESemme: restores moisture to the most dehydrated hair; won’t weight hair down but will add much-needed hydration for the health looking, soft hair you crave. Nexxus: restore and maintain vital moisture, leaving hair looking and feeling touchably soft and vibrantly healthy; enhanced for an elevated level of moisturization; specially formulated… to provide nourishing moisture leaving hair luxuriously soft, manageable and full of lustre. I notice they all say healthy LOOKING hair and tout moisturizing the hair so its “more manageable” and LOOKS good. Shiny, softer, smooth, touchably soft, etc. Nothing mentioned about tangles or detangling, although in the directions all mention combing (with fingers or a wide-tooth comb) the product through the hair when applied.

If the products are vitamins to be ingested (eaten), then they fall under the regulations for nutritional supplements. Those regulations are quite different than the regulations for cosmetics (and the facility must be registered and approved by the FDA before making the products). If you are talking about a product that is applied to the hair and contains vitamins that might help the hair, then it is a cosmetic.