With every New Year come the New Year’s resolutions. Besides the old standbys to lose weight, eat better, exercise more, and reduce stress, how about a new one this year? Review your product labels to make sure they are compliant with the regulations! Eliminate the stress you might have from wondering whether your products would get quarantined if the FDA (or some other officious government agency) decided to check your labels or inspect your premises.
It doesn’t take much to check and see if they are compliant. If they aren’t, well, then at least you will know what to do about it and can schedule in the time necessary to take care of it.
Here’s what to look for:
Identity of the Product
Is the product identity clearly stated on the front of the package?
The product identity is what the product IS. The consumer should be able to tell what the product is so they know if it’s what they want to purchase. It is important, especially if your product might be confused with something else such as a lotion bar that looks like soap, or a bath fizzy that looks like a cupcake. It only needs one or two words to establish the product identity on the label.
Net Contents
Are the net contents on the front?
The net contents (that is, how much product is actually in the package?) must go on the front of the package. For anything except the smallest packages (under 2 oz usually), the net contents needs to be parallel to the bottom of the package, and within the bottom 30% of the front.
It may be tempting to put on the side or back because it looks better, but the net contents are required to be on the front.
Is the net contents in the right measurement?
For solid or semi-solid products, the net contents should be stated in avoirdupois (weight) ounces and grams (g). Both US and metric are required.
For liquid products, the net contents should be stated in fluid ounces (volume) and milliliters (mL).
Is the net contents accurate?
Keep in mind that if a bottle or jar is said to be a certain number of ounces (a four ounce jar, for example), it will hold four ounces by VOLUME, but how much it holds by WEIGHT depends upon what’s inside it. A fluffy cream, a lotion or a whipped soap will weigh less; salt or sugar scrubs may weigh more. Don’t assume! Measure the actual weight and put that on the label.
Where products have a variation in the weight because of the way the soap is cut or the bottle/jar is filled, weigh or measure! You can put a lower amount on the label than is actually in the package, but not more than is actually in the package. Be as accurate as possible.
Is the net contents text large enough?
For most products, the text of the net contents must be 1/8″ high. That’s WAY bigger than you would probably like or expect.
Different fonts have different heights; even when they are the same “font size!” Print out the label text and actually measure it with a good ruler.
If the text is in upper and lowercase (such as “Net Wt.” or “Net Contents”), then measure the height of the lower case “o.” Keep in mind that when the lower case “o” is 1/8 inch high, the capital letters are usually 1/4 inch high. That’s pretty big!
If the text is in upper case only (i.e. NET WT or FL OZ), measure the height of the upper case “L”.
If you don’t have enough room, using all upper case will keep the size down somewhat. You can also use “condensed” text (taller and skinnier), but it can’t be more than 3 times as tall as it is wide.
Business Name and Address
Is the business name and address on the label?
The business name and address is required on the label. It is normally placed on the back, sides, or bottom (not usually on the front).
Is the legal business name used?
The business name to put on the label is the LEGAL business name. Unless you have filed a “doing business as” or are registered as a partnership, corporation or LLC with your state, the business name is your personal name. Generally, it’s the same name that is on your bank account.
Is the physical business address used?
The address should be the physical address where business is conducted. Even if you get your mail at a PO Box or a mailbox service, the business isn’t conducted inside that little box. It’s at a physical address, and that’s what needs to go on the label.
The city, state and zip code are always required. The street address may be omitted if it is listed online. See my post on Street Address – Your Choices for additional info on what does and doesn’t qualify.
Ingredient Declaration (Cosmetics Only)
Are the ingredients included?
Ingredients listings are required on all cosmetic products. Cosmetics include any products that are are applied to the human body to cleanse, beautify, or make more attractive (lotions, creams, bubble bath, bath fizzies, nail polish, shampoo, soap, hair products, make-up, etc.)
Are the components of blended ingredients listed individually?
Where a blended ingredient has been used to manufacture your product, each of its component ingredients must be listed individually in the ingredient declaration. For example, a lotion base, a preservative blend, or a blended color additive would need the ingredients listed individually. Your supplier should be able to provide you with a list of the ingredients in their blended products.
Are the ingredients listed in the right order?
List ingredients in descending order of predominance. That is, the ingredient with the highest amount goes first, then the one with the second highest amount, etc. If you are using a blended ingredient, check with the supplier to determine how to accurately place the component ingredients in your total list.
As an alternative, you can list all ingredients present at more than 1% in descending order of predominance, followed by all the ingredients present at 1% or less, which can then be listed in any order. Using this alternate form of listing ingredients, color additives can go at the end of the list, regardless of amount.
Are the ingredients named correctly?
Ingredients should be listed by their standardized cosmetic ingredient name (the “INCI” name). So, for example, baking soda is listed as Sodium Bicarbonate, epsom salts are listed as Magnesium Sulfate, and lye is listed as Sodium Hydroxide or Potassium Hydroxide (as applicable).
[US ONLY] Botanical ingredient names (that is anything that comes from a plant) should be listed by the common English name. This is true even though the standardized international requirements are for the Latin name to be used. If you want, you may include the Latin name in parenthesis. Example: Lavender Oil or Lavender (Lavandula angustifolia) Oil.
Is the ingredient declaration text large enough?
The text of the ingredient declaration must be at least 1/16″ high, measuring the lower case “o” for upper and lower case text, or measuring the upper case “L” for all upper case text. As with the net contents, you can save some room using all uppercase text, especially if it is slightly condensed.
If the total surface area of the package is less than 12 square inches, then you can reduce the text size to 1/32″ in height. As an example, a typical bar of soap that is 3.5″ x 2″ x 1″ (about 5 ounces) has a total surface area of 25 square inches (which counts the front, back, top, bottom and sides).
Color Additives (Cosmetics Only)
Have you used approved color additives?
Only color additives that have been approved by the FDA for use in cosmetics may be included in a cosmetic product. When a cosmetic product contains a color additive that is not approved, it is considered an adulterated product and is illegal to be sold in the US.
Are any color additives used approved for this type of product?
Some color additives are approved for use in cosmetics, but with limitations. For example, some color additives can be used generally, some are limited to external use, and some may not be used around the eyes. Any product that uses a color additive that isn’t approved for that use (for example, using a color additive in eye make-up that is not approved for eye area use) causes the product to be considered adulterated and therefore illegal to be sold.
In Closing
Now the New Year is just getting started and you’re working on those New Year’s Resolutions, take a moment to look over your labels and make sure they are A-okay for 2019.
Shameless plug!
To really be able to create your own labels that comply with the regulations, get my book from Amazon and use it.
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