5 Point Checklist – Are Your Labels FDA Compliant?

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You might have noticed that we mention claims, compliance, and the FDA and Truth in Labeling quite frequently, but it’s with good reason. The FDA has increased its pursuit of cosmetic companies breaking rules and laws, so below is a 5-point checklist to help you on the road to FDA compliance.

Need to know: FDA Monitors Cosmetics

All cosmetics marketed in the United States, whether they are manufactured in the US or are imported from abroad, are monitored and regulated by the Food and Drug Administration (FDA) under the authority of Federal Food, Drug, and Cosmetic (FD&C) Act and the Fair Packaging and Labeling (FP&L) Act.

The Federal Food, Drug, and Cosmetic (FD&C) Act is a set of laws passed by Congress in 1938 for the safety of food, drugs, medical devices, and cosmetics.

The Fair Packaging and Labeling (FP&L) Act was enacted specifically to protect consumers from unsafe or deceptively labeled or packaged products by prohibiting interstate commerce of adulterated or misbranded cosmetics (as well as food and drug devices).

As part of their mission, the FDA also monitors the marketing of cosmetic products to ensure they – cosmetic products — are not improperly labeled or marketed as an actual medicine or drug. This means that any claims that are made to treat or “cure” a condition, illness, or symptom must be backed up by clinical testing and trials—most cosmetics avoid this — and it must be made in an Over-the-Counter drug manufacturing facility, not a cosmetic manufacturing facility.

The FDA has the right to tour any cosmetic manufacturing facility without warning to perform an inspection. They can both issue warnings and assess fees. Also, they monitor websites and other marketing materials to ensure you remain compliant with regards to claims and labeling. In this too, they can either issue a public letter of warning or pursue fines or both. And these fines can run into the millions of dollars, even for relatively small companies.

This type of activity has recently increased, especially with the rise of the CBD (cannabidiol) skincare market which has traditionally been laden with medical claims. Additionally, federal lawmakers are looking to tighten the regulatory framework the cosmetics industry and in August of 2018, launched a review into the safety and manufacturing practices and standards of the cosmetics industry, and taking a detailed look at the entire segment.

We want to avoid any issues that may arise with the FDA, and we have made compliance a chief tenet of our business. While we are not FDA attorneys* and cannot provide specific legal advice, we do have a 5-point checklist we use with clients in our contract manufacturing side of the business to help flag any issues that might not meet FDA guidelines.

The 5-Point Checklist for FDA Compliant Labels

 

1 – Is your ingredient deck correct on your packaging?

  • Are all ingredients listed in full and in the correct order?
    • Per the FDA regulation 21 CFR 701.3, the declaration of ingredients except for trade secret ingredients like flavor and fragrance, are to be listed in descending order of predominance. So in other words, the highest percentage to the lowest percentage. Everything under 1% can be listed in any order. There are a few exceptions to this rule and you can read more here on the FDA website.
    • Here’s an example from our Bamboo Face & Body Polish: Water, Bamboo Stem Extract, Decyl Glucoside, Cocamidopropyl Betaine, Roman Chamomile Distillate, *Lavender Distillate, *Jojoba Oil, Rosehip Seed Oil, Glycerin, Hydrolyzed Wheat Protein, *Alcohol, *Oat Straw Extract, *White Willow Bark Extract, *Aloe Vera Powder, ProVitamin B5, Vitamin E, Xanthan Gum, Tetrasodium Glutamate Diacetate, Phenoxyethanol (*Certified Organic).
  • Is the ingredient deck on the outward most component of the product? Is it legible?
    • Typically it is on the primary package (what is holding the actual product, such as a bottle) unless there is a secondary package, i.e., a retail box, and then the ingredient deck must be on the retail box. In the United States, you only need to list the common name – as we did above — but if you’re selling internationally, you’ll need to include the INCI.
    • For example, our Seabuckthorn Berry Oil shows both the common and the INCI on ingredient deck: Hippophae Rhamnoides (Seabuckthorn) Berry Extract.
  • There are specific guidelines about typeface size, readability, etc., as part of the regulation as well.  From the FDA website:
    • Prominence: The declaration must appear with prominence and conspicuousness so that it is likely to be read and understood (read with ease) by ordinary individuals under normal conditions of purchase. The letters must not be obscured by design, vignettes, background or crowding.
    • Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange, decorative or sculptured surfaces) is less than 12 square inches. The type size consisting of upper and lower case letters is determined by the height of the lower case letter “o”.

2 – Do you have the right net quantity of contents on your label?

  • You never want to overstate the amount of product in a package, so it is better to give a slightly lower number that is in the package so you stay at the lower part of the margin of error.Your fill weight is not necessarily going to match the size of your bottle. A 2 oz cosmo will hold 2 fluid ounces. But a 2 oz jar will not hold 2 net ounces of powder. You will need to fill your jar and weigh it to get the actual fill weight for a net ounce label.
  • The term “net” and “net contents” is optional for fluids but required for weight. Net is used for products that are more solid than liquid. Think powders, scrubs, very thick creams, balms, and deodorant sticks.
    • Net Weight 1 OZ / 30 gm
    • 1 oz. net wt. / 30 gm
  • The term “fluid” (“fl”) is required to distinguish liquid ounces. Think oils, lotions, serums, washes. For a 1 oz bottle of serum, you must list:
    • 1.0 FL OZ / 30 ml
    • Net Contents 1.0 FL OZ (30 ml)

3 – Are you making claims?

  • The FDA guideline is very clear: A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic. If a product claims to accomplish these deeds through physiological activity or by changing the structure of the skin, it is also a drug and must follow the guidelines for a drug. A product can be both a drug and a cosmetic, and the drug guidelines apply.
  • This can’t hardly be stated enough and is one of the most frustrating things about making cosmetics you truly believe in that have produced great results. If there is any type of condition you’re referencing—be it irritated skin, acne, eczema, or age spots—stop and reword it. Talk about unhappy skin, oily teenage skin, or signs of maturing skin. Have a miracle product that makes wrinkles disappear? Reword! This is why you so frequently hear “minimizes the appearance of fine lines and wrinkles”. Tip-toeing and creative wording become key.
  • It takes a while to learn the myriad words that are not allowed, so be patient and ask trusted advisers or professionals what word works or doesn’t when it comes to staying FDA compliant. We steer clear of the word “renew” but have found “rejuvenate” to work. Avoid “heal” and opt instead for “balancing” or “restorative”. These words sound weaker than claim words, and they are, but this is simply how you must do business without further licensing in the cosmetic world.
  • Avoid using 100% natural or All Natural as you can be sued for misleading your customers if just one tiny partial % of an ingredient is shown to be synthetic or lab-created or processed in such a way that a non-natural trace is left.
  • Pro-tip: Managing your ‘claim’ vocabulary goes well beyond your label. Any marketing materials, emails, training, videos, ads, and social media posts are also to be ‘claim free’ as they are used to market your product and influence consumers.

4 – Are you using defined terms you shouldn’t be?

  • Promoting your product as ‘organic’ anything without the official USDA Certified Organic seal and certification is a big no-no.  And although you see a lot of bottles out there with ‘organic cleanser’ on the front panel, without the USDA Cert. Organic symbol, know that this is actually violating the law.  The exception is that you can write “X% organic content” on the back panel (but not the front) and you can’t say ‘made with X% organic content” because “Made With” is a defined term for certified organic products made with 70% organic material. Learn more about organic certification in general here, and how to get certified. If you’re already an Essential customer we’ll do our best to help guide you through the certification process
  • “Made in the USA”, even using a flag icon, is a no-no-, too, unless every ingredient in your product is from the US. So yes, the products you buy from us are ‘made’ here in Oregon, they don’t meet the “Made in the USA” unless every ingredient comes from the US. You can say something like “Manufactured in the US of ingredients sourced from around the globe,” but to give the impression your products are “American Made” when it doesn’t meet the definition, is against the guidelines.
  • Cruelty-free logos or images – like the Leaping Bunny or PETA’s rabbit face icon – are regulated and you must be an approved member or certified organization to use them.  If you don’t have the correct credentials, consider using different images or words to imply your products were never tested on animals.
  • Vegan is not regulated but you’ll want to be sure you are actually fully vegan — there’s no such thing as 95% vegan (and, yes, we’ve seen this on a label before).  Tricky ingredients like beeswax, honey, goats milk, and silk will disqualify you.

5 – Do you have the correct contact information on the back panel?

  • The FDA regulations say you must include a way for your customers to contact you.
    • The words: “manufactured for” or “distributed by” (Brand Name)
    • You must also provide your contact details, including full company name, city, state, and website. If you do not have a website, you must provide the full street address and phone number so consumers may contact you if issues arise.

 

There are so many detailed regulations around FDA compliance, including dozens more we have not covered here. Instead, we’ve addressed the most common issues we see with our customer labels, so take the time, in the beginning, to get the labels right.

Let us know if you have other concerns or comments about FDA regulations, or how you handle them in your own business.

 

* We always recommend you work with FDA, FTC, and FP&L qualified attorneys to help you navigate the complexities of cosmetic compliance. If you are selling outside of the United States, finding and working closely with a qualified attorney who knows the country or countries you are exporting to is critical to remaining compliant across your entire sales channel.
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2 years ago

This is a great and helpful article. Thank you so much!

Bonnie Parry
2 years ago

What about botanical perfumes and candles? I’m confused on how they are labeled.

Lori
2 years ago

This article was well written- so easy to understand. I appreciate the arrangement and the way you put this in ‘everyday’ speech for ‘us’ the general public, to understand!
Thank you for an excellent informational on cosmetic rules, Take Care!

Jennifer S.
1 year ago

I have come back to this article several times. It is SO helpful. One question that I still have is regarding #5. I’m a small lotions & potions company and doing everything myself. So I am curious what is needed regarding the “manufactured for” or “distributed by” statement? I currently just have “Made in (city, state) by (brand name) and am wondering if that might suffice. Any thoughts? And/or is just “Made in (city, state)” enough since the brand name is on the front of the label. THANKS.

Admin
1 year ago
Reply to  Jennifer S.

Hi Jennifer,

We included the “Manufactured for” statement in this blog post to help customers that are using us to manufacture their products. If you are making everything yourself then you do not need to include this statement on your label. What you currently have – Made in (city, state) by (brand name) – should suffice. The safest bet is to include more info rather than less. Now I do have to write a disclaimer and tell you that we are not legal experts nor can we give legal advice.

I hope this helps 🙂

-Brandon

Jennifer S.
1 year ago
Reply to  Brandon Paul

Of course you’re not legal experts! And yes this helps. Thanks!

1 year ago

This article is a super help to all of us in the cosmetics industry. Thank you so much. It still amazes me to go into major retailers and see cosmetics (lotions and potions especially) without any of the required labeling.

Mariah Samaniego
1 year ago

Thanks for the information. It definitely made things clear for me to move forward with my product labeling.

Anne
1 year ago

Excellent article

1 year ago

Really helpful and informative, thanks.

1 year ago

Thank you for this helpfull article.

liz
1 year ago

Well if a person using your stock formula on their label they must put manufactured by,
( Your Company name ) or can they put distributed by: (their Company name) or not.
your thoughts on this.

Maria Cruz
1 year ago

What if I just buy a lotion BASE from your company then I add other things, e.g, essential oils, other actives, etc., can I safely say in the label that the product is manufactured by my company or by Essential Wholesale FOR MY company? The finished product will not be the same as the starting base.
Thanks for your time.

Admin
1 year ago
Reply to  Maria Cruz

Hi Maria! Brandon from EWL here.

Firstly, you never have to say that Essential made the product, you can simply say “Manufactured for XYZ Cosmetics”. If you are altering it you are safe to simply use your own company name.

And of course I need to add the disclaimer that we are not legal experts, and it is best to verify this with someone who is.

Cheers!
-Brandon

Leah Flournoy
1 year ago
Reply to  Brandon Paul

Hi, WHAT a helpful article, thank you! For clarity, if I buy your base, add my own fragrance and say… a bit of Mango Butter, these 2 items only, am I legal to use just my own company name or, “Manufactured for My Company?”

Michele
1 year ago

Can I put “made with” and list some of your ingredients from the RTL products on my front label?
And do you your suggested label sizes go all the way around the container or is there space to put an ingredient label

Admin
1 year ago
Reply to  Michele

Hi Michele!

Brandon from EWL here. You should be fine saying “made with” followed by some of the ingredients you would like to feature. Just make sure you have all of the ingredients listed somewhere on the label. In the United States, you only need to list the common name – as we did above — but if you’re selling internationally, you’ll need to include the INCI.

Our suggested label sizes go all the way around the container. If using our suggested sizes you would not have room for an additional label.

And of course I need to add the disclaimer that we are not legal experts, and it is best to verify this with someone who is.

Cheers!
-Brandon

Bri
1 year ago

This is very helpful! Do you know (beyond including Latin names) if Europe and the UK have different labeling requirements?

Michele Freitas
1 year ago

Does this apply to handmade soap also?

Admin
1 year ago

Hi Michele! Great question.

Brandon from EWL here.

It depends on the ingredients you use to make your soap.

According to the Consumer Product Safety Commission (CPSC):

…many “soaps” on the market today are, in fact, not just soap. They are cleansers, detergents, or other types of products regulated as a cosmetic or a drug by the Food and Drug Administration (FDA).

The FDA’s regulations address three conditions:

1. What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.

2. What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. However, the word “soap” can be used on the label.

3. How it’s intended to be used: To be regulated as soap, the product must be labeled and marketed for use as soap only. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as kill germs, or treat skin conditions, such as acne or eczema, it’s a drug. Again, the word “soap” can be used on the label.

To answer your question:

These labeling guidelines DO apply to your handmade soap if it is a cleanser, detergent, or other type of product regulated as a cosmetic or drug by the FDA.

These labeling guidelines DO NOT apply to your handmade soap if it falls under the FDA’s regulatory definition of “soap”. In this case you would need to refer to the CPSC’s soap regulations.

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].

I hope this helps!

I recommend reading these articles if you want to do some additional digging:

Let me know if you have any more questions. We are here to support you and help you succeed 🙂

Cheers!
-Brandon

Admin
1 year ago

Hello Bri!

Brandon from EWL here.

We primarily focus on the United States market, so we don’t have up to date resources on EU regulation.

I did a quick google search for “cosmetic labeling eu” and I found some helpful articles that outline the differences between cosmetic label regulations in the US vs EU.

Yes, the EU has different requirements, so you’ll definitely want to do a bit of your own research.

Let me know if you have any more questions!

Cheers!
-Brandon

YD
1 year ago

Hi! I was wondering if you could tell me whether it is OK to put the ingredients on the bottom of the bottle of room mists for example vs on the front or back of the prominent label? Same question for bath salts or sugar scrub. Thank you!

Admin
1 year ago
Reply to  YD

Hi YD!

Brandon from EWL here.

As per the FDA’s 21 CFR 701.3(b) and (p):

…Prominence: The declaration must appear with prominence and conspicuousness so that it is likely to be read and understood (read with ease) by ordinary individuals under normal conditions of purchase. The letters must not be obscured by design, vignettes, background or crowding. Type Size: Not less than 1/16 inch in height. It may be not less than 1/32 inch in height if the total surface area available to bear labeling (which excludes bottom, shoulder, neck, flange, decorative or sculptured surfaces) is less than 12 square inches. The type size consisting of upper and lower case letters is determined by the height of the lower case letter “o”…”

So with that said, you can put underneath the container if it is legible. Hope that helps (-:

Let me know if you have any more questions.

Cheers!
-Brandon

10 months ago

Great site, thanks so much for posting