E. Labeling for Dietary Supplements
TABLE 6. Checklist for Dietary Supplement Label
Main (“Principal Display”) Panel
|Side (“Information”) Panel||Elsewhere|
|✔ Statement of Identity- this is a phrase that identifies your product as a dietary supplement. It can simply be: “dietary supplement,” “herbal supplement,” “herbal dietary supplement,” or could be a phrase that replaces the word dietary with the name of the ingredient, for example, “ginseng supplement” or “holy basil herbal supplement.”||✔ Supplement Facts panel, if required (small and low volume businesses are exempt as long as no claims about a particular ingredient are made). Includes serving size, servings per container, and the names, quantities, and percent daily value of dietary ingredients in the product.||✔ Disclaimer for any health claims made: “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.”|
|✔ Net quantity of contents statement – indicates how many units are in the container. “100 capsules,” or “10 fl oz (285 mL).”||✔ Part of the plant used.||✔ Material safety information|
|✔ Name and place of business of the manufacturer, packer, or distributor|
| ✔ List of ingredients in
descending order of prominence
i. Principal Display Panel
Imagine your current label or your imagined future label—what is most prominent? You might be imagining a colorful rectangle featuring your logo, the name of the product, and some basic information—maybe the size or a catchy marketing phrase. This is what the FDA would call a “principal display panel,” the portion of the label that is most likely to be seen by the consumer. Most often, this would be the front of the package, but it could also be on the top of the packaging. Depending on the design of the packaging, you might have more than one. Even if multiple principal display panels exist, they must all have the same required information.
Obviously, you’ll have items you want on this most prominent panel of the label, but the FDA requires a few items, too. First, you will name your product and maybe include a company logo. There are no specific regulations on what you can and can’t name your product, but the overarching concern about not claiming your dietary supplement can cure, treat, mitigate, or prevent a disease holds true here, too. For example, Dr. Garber’s Natural Solutions produced a tincture made of fig tree, lime tree, and silver birch buds and called it “Depression Relief.” As the claims section of this guide makes clear, that is an impermissible drug claim as it insinuates the product will cure depression, a diagnosable condition. The FDA sent Dr. Garber’s warning letter. In response, the company renamed the product to the more innocuous “Mood Boost.”
1) Statement of Identity
Beyond the product’s name, you must identify the product as a specific type of supplement. You can simply call it a dietary or herbal supplement or enhance the word ‘supplement’ with one or more of the dietary ingredients in the product. This is the statement of identity, and it can’t be small or hidden. It must be in bold type, and its font size must be proportionate to the most prominent thing printed on the label. You’ve got to let this statement stand out. And, one last thing, the statement can’t be part of a quirky design—it must be oriented parallel to the package’s base.
2) Net Quantity of Contents Statement
The other requirement for this part of the label is to let the consumer know how much product is included in the package. This is called the net quantity of contents statement. Again, there are rules to make sure this statement is prominent, conspicuous, and easy to read—it must also be oriented parallel to the base of the container, proportionate to the size of the principal display panel (see the example below to see some of the exact measurements required), and the font color or type must be in distinct contrast to the background. You can’t squish this statement next to another printed line on the label, nor can you squish the words in the statement together. In fact, each letter must be no more than three times as high as it is wide.
As to the content of the net quantity statement- you can weigh the product and/or provide a numerical count. If you go with weight, you must include metric system measurements alongside the U.S. Customary System weights. Be careful not to include what are considered “qualifying phrases.” The FDA is wary of claims exaggerating the amount of product in a container. So, a statement such as “a full pound” or “jumbo quart” would not be allowed. Unless the principal display panel is less than 5 square inches, the net quantity statement must be in the lower 30% of the label.
This panel is also where you brand and advertise your product for the consumer walking down a supplement aisle, so you’ll want plenty of room for an eye-catching logo, a convincing product description, and a nice design.
ii. Information Panel
If you look at your product as a customer would, the principal display panel should be the first thing you see. Immediately to the right will be what the FDA calls the information panel. You must place three things on this panel:
- the Supplement Facts panel (if non-exempt),
- an ingredient list, and
- the name and place of your business.
If you want to and can fit any of this required information on your most prominent, branded label, it does not have to be repeated on the information panel. Do not include extras, like a UPC code, on this panel or between the principal display and information panels.
1) Supplement Facts Panel
Small or low-volume businesses that do not make any nutrient or health claims about their botanical products are not required to have a “Supplement Facts” panel. The definitions of both small and low-volume businesses are rather generous. A producer will qualify as a small business if they gross less than $500,000 total direct-to-consumer sales or less than $50,000 in food sales direct to consumers. A low-volume business is defined as one that sells less than 100,000 units annually and employs less than 100 full-time equivalent employees. Low-volume businesses must file an annual notification with the FDA. Wholesalers also have an exemption from adding the Supplement Facts panel.
If your business doesn’t fit those exemptions, you must include a Supplement Facts panel in your Information panel. Remember, any health claim or nutrition information on your label will also trigger the need for the Supplement Facts panel.
A Supplement Facts panel is the corollary to the Nutrition Facts panel on food packaging. Except here, the botanical and its source are prominently displayed. And, if nutrients (e.g., carbohydrates and fats) aren’t present in measurable amounts, they do not have to be listed. If no vitamins or minerals are added, and no claims about them are made, they do not have to be listed either. This creates a simple, clean Supplement Facts panel highlighting your botanical ingredients. In contrast, Nutrition Facts panels on food packaging require an exclusive list of mandatory nutrients, vitamins, and minerals that cannot include botanicals.
And, if you were to compare Supplement Facts panels for botanical products to those for synthetic vitamins, minerals, and amino acids, you’ll find that they are much less complex. However, it will come as no surprise that there are still strict rules on placement, wording, font size, and content. See Figures 1 & 2 for examples of a Supplement Facts panel.
Figure 1. Supplement Facts Panel for a Ginseng Herbal Supplement Label
Figure 2. Supplement Facts Panel for A Proprietary Blend
The required elements of the Supplement Facts statement are:
- serving size,
- number of servings per container, and
- a list of the names and quantities of dietary ingredients in the product.
Take a moment to look at the Figures above and identify each of these elements, paying attention to how they are expressed and where they are in relation to all the other information presented.
The serving size for your product is based on the maximum recommended intake based on a single instance of ingestion. If the recommendation is 1-3 capsules multiple times a day, the serving size would be 3 capsules. If the recommendation were 1-3 capsules once a day, the serving size again would be 3 capsules. If the recommendation were 2 capsules daily, the serving size would be 2 capsules. Absent a recommendation, the serving size would be a single unit of the product in whatever form makes the most sense—tablet, capsule, packet, tablespoon, or other form. You must label this portion of the statement “serving size—” you cannot alter this phrase.
SERVINGS PER CONTAINER
The “servings per container” portion of the statement can be omitted only if listing it here would repeat the exact information from the net quantity of contents statement. If the serving size is two, then the servings per container would differ from the net quantity of contents statement, and both statements would need to be present.
NAMES AND QUANTITIES OF DIETARY INGREDIENTS
For the ingredient list, how you identify each ingredient should reflect the standardized names in the Herbs of Commerce, a publication by the American Herbal Products Association. Follow the name with the part of the plant from which the botanical is derived unless it is an algae-derived product. Name the part of the plant in English. The plant’s Latin name is only required if the botanical is unavailable in the Herbs of Commerce reference. The Latin name should come before the plant source.
Most likely, the botanical will not have a recommended daily reference value from which a percentage of daily value (% DV) would need to be calculated. In this case, you simply refer to a footnoted “Daily Value Not Established” with an asterisk or other symbol, as shown above in Figures 1&2.
Typically, botanical products won’t have nutrients (e.g., calories, fats, cholesterol, sodium, sugars, carbohydrates, protein, fibers) in the measurable amounts required to include in the Supplement Facts statement. There are limited cases in which dietary ingredients with a reference daily intake or daily reference value must be added to the supplement facts panel.
For example, some dried herbs will have over 0.5 grams of carbohydrates per serving, which is the threshold for listing them on the Supplement Facts panel. Often, it will still be below 1 gram per serving. In this case, your label would read “<1 gram.” Anytime you have to declare a nutrient (fat, saturated fat, carbohydrate, dietary fiber, protein, or added sugars), you must refer to a footnoted “Percent Daily Values are based on a 2,000 calorie diet” with a symbol that is distinct from any other footnoted material.
You do not have to include vitamins and minerals that are naturally occurring in your botanical. However, this rule changes if you claim any vitamin or mineral in your botanical product. In that case, you would need to list the vitamin or mineral you referred to and its % DV based on the DRV. For example, if you were to make a claim about the benefits of Vitamin C in a rose hip product, you would then be required to declare the amount of Vitamin C in your product.
When calculating the amounts of the botanicals listed in the Supplement Facts panel, you list the weight of the actual botanical in the product, not the weight of the source ingredient. The weight you record is the amount per serving or unit. So, weigh each capsule or teaspoonful. Or, if the recommended serving is 2 capsules, you could instead use the product’s weight in two capsules. If you list a vitamin and mineral with an FDA-approved RDI or DRV, you must use the units of measurement given in those recommendations. Otherwise, use what unit of measurement makes the most sense.
The amounts of dietary ingredients you intentionally add must 100% accurately show the volume or weight, save for acceptable deviation attributable to the analytical method used. If not accurate, your product could be determined to be misbranded, a serious violation of the law. However, if you declare a naturally occurring dietary ingredient, those must be present at only 80% of the declared value. Let’s return to the example above. If you were to add rose hips and make a claim about the benefits of Vitamin C in the rose hip product, then you would, as stated above, be required to declare the amount of Vitamin C in your product. Vitamin C occurs naturally in rose hips, so it must be present at (at least) 80% of the declared value. On the other hand, if someone were to add synthetic or isolated vitamin C, they would be subject to the 100% rule.
The format of the Supplement Facts panel must strictly adhere to the format shown above. There is very little flexibility in the wording or placement of any of this information. Even the thin and thick lines you see in Figures 1 and 2 are prescribed in the regulations. All text must be black; the background can be a color other than white but must be neutral. Typically, the smallest font size allowed is 6 point. Helvetica font is not required but is a suggested font as it is easy to read, and the letters are adequately separated.
If your product is a proprietary blend, then you must list the net weight of the blend and each ingredient in descending order of weight. See Figure 2 above for an example.
In cases where the Supplement Facts panel is required, the ingredient list must be located directly below it. If there is insufficient space, it can be directly adjacent to the Supplement Facts panel and to its right. You must call this list “Ingredients” unless some ingredient sources (i.e., plant parts) were identified in the Supplement Facts panel. In that case, you would call this list “Other ingredients.” You must also include non-dietary ingredients, such as binders, artificial sweeteners, colors, or fillers.
Note in Figure 1 that this label includes the name of the botanical and its source in the Supplement Facts panel, so it is not required to include it in the list of ingredients. Thus, the list of ingredients is called “Other ingredients” and references the materials that make up the capsules themselves.
NAME AND ADDRESS OF BUSINESS
The name and address of the business printed on the container can be that of the manufacturer, packer, or distributor. Depending on your business model, that could be your business or another business with whom you are partnering. Indicate which role the business listed plays unless the business listed is the only business handling this product before market.
Typically, the name and address must include the street address, city, State, and zip code. The street address may be omitted if the street address is shown in a current city directory or telephone directory. Having the address available on a website is not a suitable substitute.
If you have ingredients imported from another country, you must clearly indicate the country of origin of the ingredient or material used (including the container).
F. Labeling for Cosmetics
If you are making lotions, lip balms, salves, or other similar items, you are likely making cosmetics. The legal cosmetic definition is a product that is intended to be rubbed, poured, sprinkled, or sprayed on or otherwise applied for cleansing, beautifying, promoting attractiveness or altering appearance. Furthermore, cosmetics exert a physical, not physiological, effect on the body.
Special Regulation for Soaps
Notice the definition above does include ‘cleansing’ in its intended uses. Nevertheless, soap is often not regulated as a cosmetic. Whether a soap is a cosmetic depends on the physical process by which the product is made, and the way the manufacturer describes their product on the label and in marketing.
Soaps made in the ‘traditional’ way by combining fats or oils and an alkali, such as lye, are regulated in their own category by the Consumer Product Safety Commission (CPSC) rather than the FDA. The CPSC does not have specific regulations on labeling soaps except requiring cautionary labeling if the product meets the definition of “hazardous substance.” This is not common and is usually reserved for products like strong degreasing soaps that could cause eye irritation.
However, many products today are not ‘true soaps,’ and instead contain synthetic detergents. These products might be marketed as ‘soap,’ but aren’t true soaps for regulatory purposes. In fact, if any synthetic detergents are included as ingredients, the product is a cosmetic and regulated by the FDA. To be a ‘true soap’ in the regulatory sense, the product must be composed of mainly alkali salts of fatty acids.
Furthermore, how a producer describes the product can change who regulates it! If a soap claims to do more than cleanse, i.e., to moisturize, deodorize, make the user smell nice, or soften the skin as well as cleanse, then the soap will be regulated as a cosmetic. Be cautious about the soap claims you make because it can be easy to stumble into drug-regulation territory. Any product that claims it is antibacterial, or can merely kill germs, or can treat skin conditions (e.g., acne, eczema) will be classified as a drug and need pre-market approval as well as all other regulatory conditions that drugs trigger.
Cosmetic products that don’t fall under the regulatory definition of a ‘true soap’ can still use the word ‘soap’ on the label and must follow all the rules that apply to cosmetics.
Review FDA’s Guide, “ Is it a Cosmetic, a Drug, or Both? (Or Is It Soap)? ” for further guidance.
i. Cosmetic Principal Display Panel
1) Name of Product
The name of your product is up to you! There aren’t specific regulations on what you can and cannot call your product. However, you wouldn’t want to name your product, for example, “Eczema Cure Miracle,” or anything that would insinuate that your product was a drug and not a cosmetic. Your name and logo can be larger in font size than the following required information but must be in reasonable proportion to the required components of the PDP.
2) Statement of Identity
You must state what your product is, separate from the name of your product. You can use the common or usual name of the product, a descriptive name, or, if the nature of the cosmetic is obvious, a fanciful name or illustration. This statement must be in bold type and sized in reasonable proportion to the part of the label that is most prominent (usually the name of the product). The statement must be oriented parallel to the base of the product.
3) Net Quantity Statement
Net Quantity Statements tell the consumer how much of the product is in the container. How you measure and construct the net quantity statement depends on the type of product—is it liquid or not? See the chart below for more guidance and some examples of these statements.
Table 7. Net Quantity Statement Guidance
*Measure at 68 F
Sometimes, in larger quantities, you need to make a dual declaration. Meaning, if your product is more than one pound but less than 4, then you first say the total amount in ounces, followed in parenthesis by the number of pounds and ounces or by the number of pounds and fraction thereof. For example, “Net Wt. 24 oz. (1-1/2 lb.)”.
Similarly, liquids measuring more than a pint, but less than a gallon must be declared in fluid ounces, followed in parenthesis by the number of quarts, pints and ounces or by the fractions of the quart or pint. For example, “56 fl. oz. (1 qt. 1 pt. 8 fl. oz.)” or “56 fl. oz. (1-3/4 qt.)” or “56 fl. oz. (1 qt. 1-1/2 pt.)”. Fractions can be expressed as decimals of no more than two significant numbers.
The net contents statement must appear in the bottom 30% of the container unless the PDP is 5 square inches or less. This statement must be separated from anything else on the label by at least twice the width of the letter ‘N.’ The aspect ratio cannot exceed 3:1. The type size is determined by the area of the PDP. If the PDP is 5 square inches or less, the type size must be at least 1/16”. If 5-25 square inches, 1/8”; if 25-100 square inches, then 3/16”; and finally, if greater than 100 square inches, ¼”.
If the entire package of the cosmetic contains less than ¼ av. Oz. or 1.8 fl. Oz., then the cosmetic is exempt from a net quantity of contents declaration.
4) Warning Statement
“Warning – The Safety of this product has not been determined.”
Establishing and substantiating the safety of cosmetics is a burden placed on the shoulders of the manufacturer. If a cosmetic hasn’t been tested for safety, then the warning shown above is required to be included on the label. It is up to the manufacturer to adequately substantiate that the cosmetic has been shown to be safe by qualified experts. Existing toxicological test data can be sued to substantiate, or new testing. Even if the safety of each ingredient in a cosmetic has been substantiated, that does not mean that the specific formula (i.e., combination) has been, and further testing might need to be completed. If not, the warning shown above must be on the label. This is FDA’s compromise position, as they don’t go so far as to require companies to test their products before market or require pre-market approval by any federal agency.
The warning, if required, must be in lettering no less than 1/16” in height. See also warnings that are required to be placed on the information panel.
ii. Cosmetic Information Panel
1) Name and Place of Business
The name and address listed on the product must be the name of the manufacturer, packer, or distributor. if the name listed is not that of the manufacturer, then the business listed must be identified with appropriate language, such as “manufactured for…” or “Distributed by…”
The name given must be the corporate name. The business address must include the street address, name of the city and state, and the zip code. Neither a post office box or website address is adequate for this labeling requirement.
There are some specific cosmetics that require more detailed warnings than the warning described for the PDP. The most likely to be relevant to botanical producers are foaming detergent bath products.
In the case of these products, producers can do one of two things. They can clearly label the product as intended only for use by adults. This can be accomplished by writing on the label “Keep out of reach of children” or “For adult use only” or “keep out of reach of children except under adult supervision.” The other option, if the product is not clearly labeled as intended for use exclusively by adults, is to include this warning on the label:
“Caution—Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.”
3) Ingredient Declarations
Ingredients must be declared in descending order of predominance except ingredients present at a concentration less than 1% may be listed in any order after listing all the ingredients that are present at greater than 1%.
Font size for the ingredient declaration cannot be less than 1/16” in height, unless the total available surface area for the IP is less than 12 square inches. In that case the font size can be reduced down to 1/32”.
As you are listing ingredients, you want to make sure you are using the standardized name for each ingredient. You’ll need to identify your ingredients by how they are described in the following sources. You must start with the first in this list and then move down the list in order. Only if the ingredient is not listed in the first XX options can you move on to selecting its name from common descriptions.
1. The name established in the cosmetic regulations. These are all chemical formulations, and the list is short. Here is a link.
2. Cosmetic, toiletry and Fragrance Association, Inc. Cosmetic Ingredient Dictionary, 2nd Ed., 1977 (the 3rd edition and 1985’s Supplement have not yet been recognized by the FDA, but can be consulted and no regulatory action will be taken if products are labeled according to those editions)
3. United States Pharmacopeia, 19th Ed., 1975, and Second Supplement to the USP XIX and NF XIV, 1976.
4. National Formulary, 14th Ed., 1975, and Second Supplement to the USP XIX and NF XIV, 1976. 5. Food Chemicals Codes, 2d Ed., 1972; First Supplement, 1974 and Second Supplement, 1975. 6. USAN and the USP dictionary of drug names, USAN 1975, 1961-1975 cumulative list. 7. The name generally recognized by consumers (common name), or
8. The chemical or other technical name or description.
iii. Regulated Words for Cosmetics
Words that compare amounts or quantities can stray into regulated territory. A cosmetic label can only say “economy size” if the business offers at least two packaged sizes of the same brand. Only one can be ‘economy size,’ and to be so it must be priced so that the unit price of the package is at least 5% lower than that of the package not labeled ‘economy.’
It is considered deceptive to exaggerate the cosmetics’ quantity. Therefore, a cosmetic cannot be labeled as a “giant pint” or a “full quart.” These statements are meaningless and insinuate that there is more product than in other cosmetics measuring the same. Do not make these claims.
If you were to want to say on your label the number of applications or linear measure of the product, you may, but this must be displayed on the principal display panel. Therefore, you could add to the PDP a statement indicating each package contains “six applications.”
Action Steps for the Botanical Producer
The Action Steps for this chapter are:
- Make a mock-up of your proposed (or current) label and have a peer review the label with you after reading this guide. Are there potential issues? Do you need professional advice before going to market?
- Change your current or proposed botanical product labels so that they comply with relevant rules and regulations.