Helen Lopez, MS 04.01.05
Navigating proper labeling rules for food products and dietary supplements can be difficult for many manufacturers, distributors and importers. That is why it is important for companies to remain current with the laws and regulations to avoid legal action. Product labeling really became a major focus in 1990 when the Nutrition Labeling and Education Act (NLEA) was enacted to require nutrition labeling for many foods so consumers could use that information to make healthier food choices. Since then, there have been labeling developments relevant to both dietary supplements and foods that warrant further discussion.
For conventional food labeling certain items must be disclosed. These include the product identity statement, the net quantity of contents, the identity of the manufacturer, packer or distributor, the ingredient list and the "nutrition facts panel." The product identity statement and the net quantity of contents (metric and inch-pound units) are displayed on the principal display panel (PDP). The PDP is the portion of the package predominantly seen by consumers. The ingredient list, the manufacturer or distributor, and nutrition labeling is placed on the information panel (located immediately to the right of the PDP). Ingredients are listed by their common or usual name, and listed in descending order by their predominance by weight. The signature line bears the name of the manufacturer, packer or distributor, to provide consumers with contact information should they have any questions or comments. Under the label's nutrition facts panel, manufacturers are required to include 14 nutrients. These nutrients (in the order in which they must appear) are: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron.
Starting January 1, 2006, trans fat labeling will go into effect as a requirement for manufacturers. This mandate was a result of human studies linking trans fat with coronary heart disease, and was prompted, in part, by a petition from the Center for Science in the Public Interest (CSPI). Trans fat will be listed in a separate line under saturated fat. Some dietary supplement labels must also list trans fat in the "supplement facts" panel when the product contains reportable amounts of trans fat (i.e., 0.5 grams).
Manufacturers will also have to identify major food allergens starting January 2006 as stipulated by the Food Allergen Labeling Consumer Protection Act (FALCPA), which was signed into law in August 2004. This legislation requires manufacturers to declare major food allergens on the labels of their products, including milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. Manufacturers will be required to identify major allergens by their common or usual name on the ingredient list, and use the word "contains" followed by the name of the major allergen printed at the end of the ingredient list or next to it. Manufacturers will also have to use a parenthetical statement to clarify technical ingredient terms (e.g., casein (milk)).
A product is deemed misbranded if the labeling is false or misleading. A product is also misbranded if it is offered for sale under the name of another food, if it is an imitation of another food and the label does not say "imitation," and if the package and the label do not have the required elements discussed above.
Foods exempt from labeling are those served for immediate consumption, medical foods (for people under the care of a physician), ready to eat foods (e.g., bakery items), foods shipped in bulk (as long as it is not for sale to consumers), plain coffee, tea, and some spices.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines a dietary supplement as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. A dietary ingredient can include vitamins, minerals, herbs, amino acids, enzymes and metabolites. Because dietary supplements fall under the "umbrella" of foods, the FDA is responsible for the oversight of these products; however, no approval is needed from the FDA prior to their introduction into commerce.
Exemptions to this are new dietary ingredients (NDIs). A NDI is a dietary ingredient not marketed in the U.S. prior to October 15, 1994 (see section 413(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 350b(c)). Premarket notification is required for a NDI 75 days prior to its introduction or delivery to the market. Manufacturers must include proof of safety to establish that the NDI will be reasonably expected to be safe. This enables the FDA to monitor NDIs, while at the same time allowing the FDA to protect consumers from unsafe products. Failure to comply with these requirements renders the product "adulterated" under section 402(f) of the FDCA (21 U.S.C. 342(f)).
Compliance requirements for conventional foods are generally applicable to dietary supplements. Dietary supplement ingredients and the amount per serving are listed in the "supplement facts" panel. Similar to the labels of conventional foods, nutrients that are most important to consumers must be listed. Botanicals should be listed by their common or usual name and the label should specify what part of the plant from which the ingredient was derived. When dietary ingredients are represented in a proprietary blend, only the total amount of the blend is stated. Dietary ingredients in a proprietary blend are also listed in order of predominance by weight. Further information on nutrition labeling of dietary supplements may be found in 21 CFR 101.36.
There are three types of claims that can be made on the labels of foods and dietary supplements: nutrient content claims, health claims, and structure/function claims.
Nutrient content claims are claims on a product that describe the level of a nutrient or dietary substance in the product. There are 12 terms related to nutrients: free, low, reduced, fewer, lean, high, less, more, extra lean, good source, light and healthy. Certain nutrient levels must be present in foods to use these terms. For example, in order for a product to be "sugar free," it must have less than 0.5 grams of sugar per reference amount and per labeled serving. Regulations on nutrient content claims can be found in 21 CFR 101.13.
Health claims express or imply a relationship between a food or a dietary supplement ingredient to a disease or health related condition. Examples of approved health claims include calcium and osteoporosis, folic acid and neural tube defects, and dietary lipids and cancer. A petition must be filed with the FDA for all health claims. The petition must characterize the ingredient's ability to "reduce the risk of disease"-it cannot make any claims about treating diseases. Within 90 days of the date of filing for a health claim, the FDA will either deny the petition or inform the petitioner that a proposed regulation will be published in the Federal Register.
Structure/function claims describe the effect of a substance on the structure or function of the body. The statement "fiber maintains bowel regularity" is one example. If a structure/function claim is made, a disclaimer stating that the FDA has not evaluated the claim must be included on the product label. The product must also state that it is not intended to "diagnose, treat, cure or prevent any disease." Manufacturers are also required to submit a notification to the FDA no later than 30 days after the product is marketed.
In November of 2004, the FDA issued a guidance document for dietary supplement claim substantiation. The guidance document indicated that manufacturers would have to show "competent and reliable scientific evidence" to support their claims. The document also addressed the amount, type and quality of evidence that the FDA suggests for substantiating a claim. A general consensus on claim substantiation has yet to be reached.
There are several upcoming topics of interest to manufacturers. These include changes to the nutrition facts panel, health claims relating to obesity and carbohydrate claims. The FDA's Obesity Working Group has made recommendations to the FDA in an effort to battle obesity in the U.S. One recommendation is to enhance the way "calories" are displayed on the nutrition facts panel (e.g., increasing font size).
The regulations on serving sizes may also change to avoid consumer confusion. For example, an additional column on the nutrition facts panel might be required to list the quantitative amounts for the whole package for products that can be eaten in a single sitting.
Health claims relating to obesity will be considered by the FDA on certain foods that meet the definition of "reduced" or "low" calorie. In response to petitions from the industry, the FDA is also planning to define terms such as "low carbohydrate," "reduced carbohydrate" and "carbohydrate free."NW
About the author: Helen Lopez, M.S., is a Research Associate at Burdock Group (a food science and regulatory consulting company with offices in Washington, D.C. and Vero Beach, FL). In 2002, Ms. Lopez received her Master of Science degree in Aquaculture from the University of Tasmania, Australia. She received her Bachelor of Science degree in Marine Biology from Florida Atlantic University. Ms. Lopez is a specialist in food and dietary supplement labeling, scientific data retrieval and exposure assessment analysis at Burdock Group. She may be contacted at hlopez@burdockgroup.com or by calling 1-888-6-BURDOCK.
Conventional Food Labeling
For conventional food labeling certain items must be disclosed. These include the product identity statement, the net quantity of contents, the identity of the manufacturer, packer or distributor, the ingredient list and the "nutrition facts panel." The product identity statement and the net quantity of contents (metric and inch-pound units) are displayed on the principal display panel (PDP). The PDP is the portion of the package predominantly seen by consumers. The ingredient list, the manufacturer or distributor, and nutrition labeling is placed on the information panel (located immediately to the right of the PDP). Ingredients are listed by their common or usual name, and listed in descending order by their predominance by weight. The signature line bears the name of the manufacturer, packer or distributor, to provide consumers with contact information should they have any questions or comments. Under the label's nutrition facts panel, manufacturers are required to include 14 nutrients. These nutrients (in the order in which they must appear) are: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron.
Starting January 1, 2006, trans fat labeling will go into effect as a requirement for manufacturers. This mandate was a result of human studies linking trans fat with coronary heart disease, and was prompted, in part, by a petition from the Center for Science in the Public Interest (CSPI). Trans fat will be listed in a separate line under saturated fat. Some dietary supplement labels must also list trans fat in the "supplement facts" panel when the product contains reportable amounts of trans fat (i.e., 0.5 grams).
Manufacturers will also have to identify major food allergens starting January 2006 as stipulated by the Food Allergen Labeling Consumer Protection Act (FALCPA), which was signed into law in August 2004. This legislation requires manufacturers to declare major food allergens on the labels of their products, including milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. Manufacturers will be required to identify major allergens by their common or usual name on the ingredient list, and use the word "contains" followed by the name of the major allergen printed at the end of the ingredient list or next to it. Manufacturers will also have to use a parenthetical statement to clarify technical ingredient terms (e.g., casein (milk)).
A product is deemed misbranded if the labeling is false or misleading. A product is also misbranded if it is offered for sale under the name of another food, if it is an imitation of another food and the label does not say "imitation," and if the package and the label do not have the required elements discussed above.
Foods exempt from labeling are those served for immediate consumption, medical foods (for people under the care of a physician), ready to eat foods (e.g., bakery items), foods shipped in bulk (as long as it is not for sale to consumers), plain coffee, tea, and some spices.
Dietary Supplement Labeling
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines a dietary supplement as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. A dietary ingredient can include vitamins, minerals, herbs, amino acids, enzymes and metabolites. Because dietary supplements fall under the "umbrella" of foods, the FDA is responsible for the oversight of these products; however, no approval is needed from the FDA prior to their introduction into commerce.
Exemptions to this are new dietary ingredients (NDIs). A NDI is a dietary ingredient not marketed in the U.S. prior to October 15, 1994 (see section 413(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 350b(c)). Premarket notification is required for a NDI 75 days prior to its introduction or delivery to the market. Manufacturers must include proof of safety to establish that the NDI will be reasonably expected to be safe. This enables the FDA to monitor NDIs, while at the same time allowing the FDA to protect consumers from unsafe products. Failure to comply with these requirements renders the product "adulterated" under section 402(f) of the FDCA (21 U.S.C. 342(f)).
Compliance requirements for conventional foods are generally applicable to dietary supplements. Dietary supplement ingredients and the amount per serving are listed in the "supplement facts" panel. Similar to the labels of conventional foods, nutrients that are most important to consumers must be listed. Botanicals should be listed by their common or usual name and the label should specify what part of the plant from which the ingredient was derived. When dietary ingredients are represented in a proprietary blend, only the total amount of the blend is stated. Dietary ingredients in a proprietary blend are also listed in order of predominance by weight. Further information on nutrition labeling of dietary supplements may be found in 21 CFR 101.36.
A Claims Overview
There are three types of claims that can be made on the labels of foods and dietary supplements: nutrient content claims, health claims, and structure/function claims.
Nutrient content claims are claims on a product that describe the level of a nutrient or dietary substance in the product. There are 12 terms related to nutrients: free, low, reduced, fewer, lean, high, less, more, extra lean, good source, light and healthy. Certain nutrient levels must be present in foods to use these terms. For example, in order for a product to be "sugar free," it must have less than 0.5 grams of sugar per reference amount and per labeled serving. Regulations on nutrient content claims can be found in 21 CFR 101.13.
Health claims express or imply a relationship between a food or a dietary supplement ingredient to a disease or health related condition. Examples of approved health claims include calcium and osteoporosis, folic acid and neural tube defects, and dietary lipids and cancer. A petition must be filed with the FDA for all health claims. The petition must characterize the ingredient's ability to "reduce the risk of disease"-it cannot make any claims about treating diseases. Within 90 days of the date of filing for a health claim, the FDA will either deny the petition or inform the petitioner that a proposed regulation will be published in the Federal Register.
Structure/function claims describe the effect of a substance on the structure or function of the body. The statement "fiber maintains bowel regularity" is one example. If a structure/function claim is made, a disclaimer stating that the FDA has not evaluated the claim must be included on the product label. The product must also state that it is not intended to "diagnose, treat, cure or prevent any disease." Manufacturers are also required to submit a notification to the FDA no later than 30 days after the product is marketed.
In November of 2004, the FDA issued a guidance document for dietary supplement claim substantiation. The guidance document indicated that manufacturers would have to show "competent and reliable scientific evidence" to support their claims. The document also addressed the amount, type and quality of evidence that the FDA suggests for substantiating a claim. A general consensus on claim substantiation has yet to be reached.
On the Horizon
There are several upcoming topics of interest to manufacturers. These include changes to the nutrition facts panel, health claims relating to obesity and carbohydrate claims. The FDA's Obesity Working Group has made recommendations to the FDA in an effort to battle obesity in the U.S. One recommendation is to enhance the way "calories" are displayed on the nutrition facts panel (e.g., increasing font size).
The regulations on serving sizes may also change to avoid consumer confusion. For example, an additional column on the nutrition facts panel might be required to list the quantitative amounts for the whole package for products that can be eaten in a single sitting.
Health claims relating to obesity will be considered by the FDA on certain foods that meet the definition of "reduced" or "low" calorie. In response to petitions from the industry, the FDA is also planning to define terms such as "low carbohydrate," "reduced carbohydrate" and "carbohydrate free."NW
About the author: Helen Lopez, M.S., is a Research Associate at Burdock Group (a food science and regulatory consulting company with offices in Washington, D.C. and Vero Beach, FL). In 2002, Ms. Lopez received her Master of Science degree in Aquaculture from the University of Tasmania, Australia. She received her Bachelor of Science degree in Marine Biology from Florida Atlantic University. Ms. Lopez is a specialist in food and dietary supplement labeling, scientific data retrieval and exposure assessment analysis at Burdock Group. She may be contacted at hlopez@burdockgroup.com or by calling 1-888-6-BURDOCK.
