5 Point Checklist – Are Your Labels FDA Compliant?

Over the past few years 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. Looking for more information? We have another blog on this topic! 

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.

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.

• 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.

• 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/jar/tottle/tube. A 2 oz container will hold 2 fluid ounces of pure water, based on the fact that the specific gravity of water is 1. Your container will hold less product if the specific gravity of the product is more than 1. For example, a 2 oz jar might only hold 1 net oz of powder, whereas it might hold 2.5 oz of cream. And a 1 oz bottle might hold 1.75 fl oz of toner. You will need to fill your jar and weigh it to get the actual fill weight for a net ounce label, or for your fluid ounce label, you will want a volume fill by using a volumetric beaker or cylinder. 

• 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, toners, serums, washes. 

• 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.

• “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.