In this week’s blog our goal is to provide a bit of a tutorial on how to read the label on cosmetic products and dietary supplements.
Turning our attention first to cosmetic products, all aspects of labelling must adhere to guidelines set out by the FDA. These guidelines cover everything from the obvious (ingredients list) to the less obvious (type size). Let’s turn our attention to some of the most important aspects.
Labels (or the “Principal Display Panel” which is the fancy term used by the FDA) must be of a specific size and is dependent on the shape of the container. There should be two different labels if there is an outer container (eg. box) and an inner container (eg. bottle). On the outer container (or if it is a single container product), the label must contain the following information:
- Name of product
- Identity (eg. moisturizer)
- § 740.10 warning (this is for products whose safety has not been determined. The statement “Warning - The safety of this product has not been determined” must appear on the label in these cases. The safety of a cosmetic product may be considered sufficiently determined if qualified and experienced scientists can reasonably conclude from the chemical composition and available toxicological and other data that the product is not harmful to consumers under conditions of typical use (and reasonably potential conditions of misuse). If the safety of the product has not yet been established and the warning statement does not appear, the product will be considered as misbranded.
- Net quantity of contents (eg. weight or volume)
- Directions for safe use
- Warnings (all warning statements must appear prominently and conspicuously compared to other parts of the label so that they will likely be observed by consumers at purchase and use).
- Name and place of business
- Ingredients
- Any other required information
If there is an inner container, it should also be labelled with items 1,4,5,6,7 and 9 above. In the 1970’s, the labelling of ingredients in cosmetics was a rather contentious issue. Guidelines and regulations for ingredient labelling were proposed between 1972-1973, followed by years of legal challenges and it was not until 1977 that the requirement for ingredient labelling became effective. As a result, ingredients are now listed on cosmetic labels in decreasing order of predominance (eg. weight, volume), but there are a few exceptions to this rule. First, if the cosmetic is also a drug, the active drug ingredient must be labelled first, followed by the list of cosmetic ingredients. Second, any ingredients present at concentrations smaller than 1% may be recorded in any order following the ingredients present at greater than 1% are listed. Third, colour additives may be listed at the end of the list of non-colour additive ingredients. Finally, the name of an ingredient that has been accepted by FDA in accordance with established procedures as a trade secret does not need disclosure on the label. Instead, the phrase "and other ingredients" may be used at the end of the ingredient list.
And just like cosmetic products, the FDA also has guidelines and regulations for dietary supplement labels. We have already touched on a few of these in our previous blog about 5 things you probably didn’t know about dietary supplements, but we will expand on some of these and more here.
Five statements are required to appear on supplement containers and packages. They are:
- Identity (name/type of the supplement)
- The net quantity of contents (eg. weight, volume, number of tablets, capsules, gels etc.)
- Nutrition labelling (Supplement Facts)
- List of ingredients
- The name and place of business of the manufacturer, distributor or packer
The main label on the front of the container or package must contain the identity and the net quantity of contents. In our product, the identity is shown as a “dietary supplement” for “hair, skin and nails”, and there are 60 capsules in the container. If all of the 5 requirements are not placed on the front main label, they are to be placed on information panel labels located immediately to the right of the main label (as they are on our product when you rotate it clockwise right). Furthermore, brand names should not be overly prominent compared to the statement of identity (as brand names are not considered a statement of identity). Note how “Hair, Skin & Nails Vitamins” stands out.
The net quantity of contents statement advises consumers to the amount of dietary supplement that is in the container. The guidelines state that information is to be located within the bottom 30% of the main label and should also prominently displayed (as in our example).
The nutrition label for a dietary supplement is known as a "Supplement Facts" label. It is different from a Nutrition Facts label that you find on foods. A few important differences are that dietary ingredients without a recommended dietary intake (RDI) or dietary reference value (DRV) are required in the "Supplement Facts" label for dietary supplements but are not permitted to be listed in the "Nutrition Facts" panel for foods. Also, the source of a dietary ingredient may be stated in the "Supplement Facts" panel for dietary supplements, but not in "Nutrition Facts" for foods. Similarly, the part of the plant that provides the source of the dietary ingredient must be listed in "Supplement Facts" panel for dietary supplements but are not allowed in the "Nutrition Facts" label for foods.
Required information in the Supplement Facts label includes the names and quantities of dietary ingredients present in the supplement, the "Serving Size" as well as "Servings Per Container". In our case, we show the serving size is 2 capsules. Our container contains 60 capsules making 30 servings per container. Dietary ingredients refer to entries such as Vitamin A or Vitamin C etc. The sources of these vitamins, for example retinyl palmitate or ascorbic acid, are simply considered as ingredients and also need to be listed.
Supplement facts must list total calories, calories from fat, saturated fat, total fat, cholesterol, total carbohydrate, sodium, dietary fiber, protein, sugars, vitamin A, vitamin C, iron, and calcium when they are present in measurable amounts (where a measurable amount is that which exceeds the amount that is declared as "zero" in the nutrition label of conventional foods). From our Supplement Facts label, you can immediately note that our supplements are fat- and sugar-free. Other vitamins or minerals are only required when they are added to the product for purposes of supplementation, or if a claim is made about them.
Those ingredients that have no RDIs or DRVs must be listed if present in the supplement and identified as such by use of a symbol in the column for "% Daily Value" that refers to a footnote stipulating "Daily Value Not Established." We have 5 such ingredients (hyaluronic acid, l-proline, l-lysine, l-methionine and bamboo stem and leaf extract) whose “% Daily Value” is listed as a * referring to the statement on our product “Daily Value not established”. And while the amounts per serving may be listed for those ingredients with RDI’s, they must be listed for those ingredients that do not. Ingredients that are not dietary ingredients, but used as, for example, binders, fillers or excipients must be included in the ingredient statement. In our case, these are hypromellose, rice flour, rice hull concentrate and magnesium stearate. These will be listed in predominance by weight.
And what about order? Is there a convention similar to cosmetic products? Indeed there is! Dietary ingredients that have RDI’s must be listed in the same order as found in conventional food labels, except that vitamins, minerals and electrolytes are categorized together resulting in the following order: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, and potassium – just like they are ordered on our label (at least for those present in our product).
Also note that for ingredients that are specifically added to the supplement, they must contain 100% of the volume or weight declared for that ingredient on the label within analytical errors. Products that contain less than this amount are considered misbranded. However, there is a slight exception to this rule. Dietary ingredients provided by naturally occurring ingredients must be present to 80% of the declared value. For example, if you add synthetically made vitamin C to a supplement product, it needs to be present to 100% of the declared value. However, if you added rose hips as the source of the vitamin C declared, the vitamin C content need only be within 80% of the declared value since rose hips are a naturally occurring ingredient.
Structure/function claims describe the role of an ingredient in supporting or maintaining the function or structure of body elements. These need no authorization from the FDA. The manufacturer must also have sufficient evidence that the statement is indeed truthful and not misleading. Another requirement for structure/function claims is that the following disclaimer must appear on the product: "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". In our container, you will find the statement: “Our vitamin supplement is a commitment to reflect the true beauty from within. Our formula uses a unique combination of vitamins, minerals, and amino acids to rebuild a promote optimal cell production to enhance hair, skin and nails”. This last sentence is a great example of a structure/function claim, which is why the FDA stipulated disclaimer statement appears directly below it.
Take Away Message
This week’s blog aimed to teach you about how to read the label on cosmetic products and dietary supplements. It is quite a bit longer than are usual blogs so thank you for hanging in there and getting this far. Hopefully, you can now appreciate how regulated labelling of these types of products is, and how much effort needs to go into producing proper labels that abide by FDA guidelines. You can also learn a lot from looking closely at the labels in the same manner that you might for your groceries. Are there hidden ingredients like sugars? Is there only a one-week supply in the bottle you just paid a fortune for? And finally, if a company’s attention to detail is lacking in their label content, doesn’t it give you a bit of a hint and perhaps pause for thought about their attention to detail in other aspects of their day-to-day operation?
