5- Point Checklist – Are Your Labels FDA Compliant?
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 Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the authority of these two laws.
The FD&C Act was enacted by Congress 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 “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.
- Is your ingredient deck correct on your packaging?
- Are all ingredients are 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”.
- Do you have the right size 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. In the US you must include both the “Imperial” weight or fluid ounces, AND metric. So for a 1 oz bottle of serum, you must list 1.0 FL OZ / 30 ml or 1.0 FL OZ (30 ml). For a net weight, you would list this as 1 Net oz / 30 gm.
- When using imperial (pounds, ounces) you need to ensure the “fluid” versus “net” is used correctly. The fluid indicator is used for liquid products. Think oils, lotions, serums, washes. Net is used for products are more solid than liquid. Think powders, scrubs, very thick creams, balms, and deodorant sticks.
- 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. So you will need to fill your jar and weigh it to get the actual fill weight for a net ounce label.
- Am I 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 hardly be stated enough, and is one of the most frustrating things about making cosmetics you truly believe in and 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 advisors or professionals what word works or doesn’t when it comes to getting and 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 have to 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.
- Am I using defined terms I 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 here. 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 – 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.
- Do I 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.
- The FDA regulations say you must include a way for your customers to contact you.
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.