When companies plan to introduce new products into the U.S., they often place their focus on manufacturing and importing the goods. However, what companies need to realize is that labeling is an important component in the process as well.
The U.S. Food and Drug Administration (FDA) is the agency that governs the labeling of products such as food, dietary supplements, and cosmetics. Because a fine or regulatory action can be costly and time-consuming, it is important for businesses to carefully review the FDA labeling guidelines before distribution of their products.
Please note that, due to the vast amount of rules and regulations on the FDA website, this only provides a condensed overview and is not comprehensive. When creating labels for your products, please consult the links provided below or hire an attorney to review the labels for compliance. Also, be sure to note not only what information is required to be disclosed, but also the type specifications, such as the font, format, and how conspicuous the statements must be.
OVERVIEW ON LABELING
Labels refer to all labels and written, printed, or graphic matter on or accompanying a product, and include statements both on the outside and the inside of the packaging.
The label consists of the Principal Display Panel (PDP) and the Information Panel. The PDP is the front part of the packaging or the portion of the packaging that is most visible to the consumers. The Information Panel is the area directly to the right of the PDP, from the consumers’ viewpoint.
The Statement of Identity and the Net Quantity Statement must be located in the PDP. Other mandatory information must either go in the PDP or the Information Panel. If there is additional information a business would like to include, such information can be placed elsewhere on the package in the remaining space.
The packaging label for food must contain the following components: (1) the statement of identity; (2) net quantity statement; (3) manufacturer’s name and address, or distributor statement; (4) nutrition facts; and (5) the ingredients list.
The Statement of Identity is the name and form of the food product, but does not include the brand name or logo. The name of the food is determined either by law or regulation, by the “common or usual” name of the food, or by a clear description. This statement must be shown prominently.
The Net Quantity Statement is the amount of the product and it must be in weight, measure, or numeric counts. If the counter is weight or measure, the amount must be in both U.S. and metric versions.
The Manufacturer’s Name and Address must be listed on the package. If the name and address are not those of the manufacturer, the label must say “manufactured for…” or “distributed by…” The product’s country of origin is not required, unless the product is an imported food.
The Nutrition Facts section consists of three parts – the serving size, nutrients, and vitamins and minerals. Regarding the serving size, please consult the FDA website to determine the applicable serving size for the product. All food packaging must include information on calories, total fat, sodium, total carbohydrates, and protein in the Nutrients section, regardless of the amount present.
In the Ingredients List, the ingredients must be listed in descending order of predominance by weight. The label must also include information about common food allergens that are present in the product. A common food allergen is an ingredient that is one of the following eight foods or food groups or an ingredient that contains protein derived from one of them: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.
According to the FDA, cosmetics are those products “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.” Soap is specifically excluded from this category.
The packaging label for cosmetics must contain the following components: (1) the statement of identity; (2) net quantity statement; (3) manufacturer’s name and address, or distributor statement; (4) the ingredients list; (5) material facts; and (6) any warning or caution statements.
The Ingredients List format is similar to that of Food labels, with the ingredients listed by descending order of predominance. Furthermore, cosmetics that are also drugs must first identify the drug ingredients as “active ingredients” before proceeding to the cosmetic ingredients.
All Material Facts must be disclosed, such as directions for safe use if a cosmetic product has the potential to be misused.
If the safety of a cosmetic ingredient is not adequately substantiated, the product must contain a Warning Statement on the PDP stating, “Warning – The safety of this product has not been determined.” Other warning and caution statements are required whenever necessary or appropriate to prevent a health hazard that may be associated with the product, such as flammable cosmetics. These warnings must be prominent and conspicuous.
Dietary supplements include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet by increasing total dietary intake and concentrate, metabolite, constituent, extract or a combination of any ingredient listed above.
The packaging label for dietary supplements must contain the following components: (1) the statement of identity; (2) net quantity statement; (3) manufacturer’s name and address, or distributor statement; (4) the ingredients list; and (5) the Supplement Facts Panel.
The Supplement Facts Panel is the nutrition label for dietary supplements. Under that panel, you are required to list the names and quantities of dietary ingredients present in your product, the serving size, and the serving per container. For dietary supplements, the ingredients that are sources of dietary ingredients may be listed within the Supplement Facts panel, rather than in the Ingredients List.
Nutrient content claims are claims about the content of certain nutrients or substances in food, such as “fat free” or “good source of calcium.” Please note that all advertising cannot be false or misleading. Thus, nutrient content claims must be accurate.
Health claims refer to the relationship between an ingredient and the reduced risk of a disease or health-related condition. Such claims require significant scientific agreement and must be authorized by the FDA. On the other hand, a Structure/Function Claim, which describes the role of a substance intended to maintain the structure or function of the body, does not require pre-approval by the FDA. When making a disclaimer, please use the following language: “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.”
Again, please note that this guide is not comprehensive. For the full list of rules and regulations, please visit the FDA website.