Compliance Corner: What You Need To Know About Claims On Your Labels

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Compliance and Product Claims on Labels

There are many important factors to consider when composing labels for your product, among the most critical being, the claims you intend to make. One always has to be able to offer substantiation for one’s claims, and Government agencies such as the FDA can be very particular about what claims can and can’t be made. Perhaps the most significant claims related issue is the distinction between cosmetics and drugs.

 

The Difference Between Cosmetics and Drugs

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)].

 

Every claim you consider making in the marketing of your cosmetic product must remain within these boundaries. If your product’s labeling suggests it does anything more than cleansing, beautifying, promoting attractiveness, or altering the appearance, it is likely that you are making a claim that will cause your product to be classified by the FDA as an unapproved drug.

 

The FD&C Act defines drugs, in part, by their intended use, as

 

…articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals [FD&C Act, sec. 201(g)(1)].

 

If your product’s labeling suggests the product “cures,” “mitigates,” “treats” or “prevents” anything, it is likely that you are making a drug claim. Note that common problems such as acne, dermatitis, eczema, psoriasis, dandruff, bacterial, viral, fungal and parasitic infections, allergies, depression, anxiety, baldness, obesity, hyperactivity, insomnia, disordered memory, inflammation, pain, etc. are all technically diseases or symptoms of diseases. Any cosmetic product marketed to cure, mitigate, treat or prevent any of these, or any other diseases or symptoms of disease, is likely to be classified by the FDA as an unapproved drug and the FDA will require you to remove any drug claims from your labeling.

 

Understanding Intended to Affect

What is meant by “intended to affect the structure of the body” and how does that differ from the action of a cosmetic? Remember that a cosmetic cleanses, beautifies, promotes attractiveness, or alters the appearance. A cosmetic only affects the way we look. A product that claims to promote “radiant skin with a youthful appearance” is a cosmetic. However, a product that claims to “eliminate fine lines, wrinkles and sagging”, thereby affecting the structure of the skin, is a drug. A beautifying crème is a cosmetic. Anti-wrinkle, or anti-sagging claims are likely to cause your cosmetic to be classified by the FDA as an unapproved drug.

 

What is meant by “intended to affect any function of the body”? A product that moisturizes the outer layer of the skin is a cosmetic. A product that was intended to stimulate the sebaceous glands to produce oil, thereby affecting the bodily function, would be a drug.

 

Including “Intended Use” on Your Label

We referenced “intended use” in the marketing of both cosmetics and drugs. What does this mean? Intended use may be established in a number of ways. The following are some examples:

  • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Products that claim to restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin or regenerate cells establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body.
  • Consumer perception, which may be established through the product’s reputation, means asking why the consumer is buying it and what the consumer expects it to do.
  • Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

 

How the FDA Classifies OTC Products

Under the FD&C Act, cosmetic products and ingredients, do not require FDA approval before they go on the market. Drugs must receive premarket approval by the FDA through the New Drug Application (NDA) process, or conform to a “monograph” for a particular drug category. Monographs are established by the FDA’s Over-the-Counter (OTC) Drug Review, and specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded.

 

There are many benefits to using natural products. Nevertheless, without testing the efficacy of the ingredients, the FDA will not allow brands to make drug claims on their product.

 

For example, the FDA has published a monograph, available online, for topical acne products. The monograph details exactly which chemical concentrations are effective to treat acne. To market an acne treatment, it must be manufactured in strict accord with the FDA monograph using their approved ingredients at their predetermined proportions. Any deviation will cause the FDA to classify your product as an unapproved drug.

 

Note, the FDA does not recognize lavender oil as an anti-acne agent. It does not matter how many hundreds, or thousands, of peer-reviewed clinical trials, demonstrate the efficacy of lavender oil in the treatment of acne. Lavender oil is not included in the FDA’s monograph for topical acne products. Should you choose to market a coconut oil-based lotion with 3% lavender oil as an “acne treatment” the FDA will classify the product as a misbranded unapproved drug. The lotion with lavender is a cosmetic, not a drug, and it can only be marketed as a cosmetic.

 

Putting it All Together: Labeling and Marketing

The information you include in your label and marketing must adhere to FDA regulations. When you promote your product online, at a festival, or using a Point of Sale promotion in a retail store or spa, you will want to observe the same guidelines as you would for your label. In other words, be careful what you claim.

 

As always if you have any questions or comments, please let us know. We appreciate your interest and invite you to share this article if it was helpful to you.

 

 

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V
5 years ago

Thank you for this, super helpful!

5 years ago

Thank you for all the great information the label thing is BIG!

4 years ago

Hi Steven,
I just read the compliance information after I had already done the labels. The information does not contain any claims of the product, however, in the ingredients it says Vibrational Remedies, and Quantum information, because I put some drops of Bach Flower Remedies and energize the gels, which are actually only energy with no substance other than some drops of brandy as a preserver and crystals on the outside of the jars.
Would it be wrong to have done it in that way? Is it possible that the FDA does not approve the product because of this? And being a cosmetic, do I need to send the product somewhere to be approved?
Thank you very much,
Carina

Mike Gividen
3 years ago

I am exploring a new product based on an old formula… It contains essential oils… Is it permissible to discuss the anti microbial and anti bacterial benefits of certain essential oils that are common ingredients in otc topical applications? For example, camphor, eucalyptus, thyme oil and menthol are all used in various topical products that have FDA approval… If I used those ingredients is it not permissible to say “relief of”, “promotes healing”, “helps reduce”, “use for” or similar type claims?

Thanks

Kathy
3 years ago

Hi Teeneke Barresi,

Your information is so informative . So much that I felt compelled to respond, something I’ve never done.

Having said that, It appears that you are very established in your business.

Although I haven’t gone public nor have I published a FaceBook business account as I’m still ironing out some minor details. In addition, im doing most of the work mysel, which can be Overy, yet very rewarding. Even though, I’m excited to announce KaDell Essentials (since May 2017), I’ve been making Natural body & skin care products and I’m loving it!

It would be greatly appreciated if you could offer any advice/networking :
~ Which websites builder did you decided to use, if any. I’m torn between Wix and GoDaddy? I like them both.
~ I’ve decided to do my labels myself. However, know I’m not sure if that was the best option? Did you do your own labels or did you have your labels pre-made?
~My orders are made to order. Therefore, I’m searching the worldwide web to see how can I utilize pics without plagiarism as long as I give credit to the person the picture belongs to.

Right now I’m doing just a little more than breaking even. Family and friends seem to love my products. However, it’s time to go online (not sure which one) to get some feedback from others I do not know. This way I can change what I need to change and grow.

I hope I’m not being intrusive and I hope you believe in sharing the knowledge as do I. Hence, I’m ready to take my business to the next step. Any advice/information you are willing to provide would be greatly appreciated. Also, I’m hoping to have my business published on a website within the next month.

To conclude, it’s always good to see women owning there own business. I wish you continued success.
So thank yo soooo much for your time,

Kathy P., MS, BSW
KaDell Essentials
Kadellessentials@gmail.com

3 years ago
Reply to  Kathy

Google free stock images to avoid plagiarism

2 years ago

I like this website so much, saved to my bookmarks.

2 years ago

I am a new start up and was reading online that for any cosmetic a big no no is naming your product after only one ingredient (ie. ” Jojoba lotion” since it has coconut and other ingredients.

Admin
2 years ago
Reply to  lauren wolf

Hi Lauren, we have not encountered this issue in any compliance area or with any organization, as long as you clearly list all the ingredients in the appropriate spot on the packaging. In general we find that referencing a key ingredient is a great way to highlight its functions in a product, and often remove any confusion. For example, including the word “Charcoal” in our Charcoal Creme Mask immediately indicated why it is a black/dark gray color and that it has purifying properties. This naming trend is also used by almost all of the large cosmetics companies, so I would feel comfortable using it in that way. Thank you for your question!

Paula Price
1 year ago

What ingredients are in the laundry soap?

Admin
1 year ago
Reply to  Paula Price

Borax, Baking Soda, Sodium Carbonate, Epsom Salt, Sea Salt

Melissa Beccles
1 year ago

I would like to order products like hand sanitizer, lotions, and creams can my logo be put on the front? Also will you put the ingredients on the back?? Can I have an example of pricing for that???

Admin
3 months ago

Hi Melissa!

We can fill and label products for you, but we do not print our design labels here.

What you can do is have your labels printed and mailed to our warehouse, where we can apply them to your packaging for you.

Please email our customer support team and they can assist you 🙂 info@ewlnatural.com

Warmest regards,
-Brandon