Where Can You Find Information On Food And Supplement Labels Regarding Vitamin And Mineral Content?

The overview of nutrition labeling in the beginning of this chapter provides the historical context for the issues addressed by the Commission on Use of Dietary Reference Intakes in Nutrition Labeling in developing its recommendations on food reference values. Cardinal milestones are listed in Box 2-ane; a more than comprehensive give-and-take of the history of food labeling may be found elsewhere (e.g., Hutt, 1984, 1995; IOM, 1990). At the terminate of this chapter, information on consumer understanding of the label elements and the impacts of label content on consumer nutrient purchases are briefly described.

REFERENCE VALUES AND NUTRITION LABELING IN THE Us

The Early Years and Minimum Daily Requirements, 1906–1973

The federal government has had an essential and evolving role in assuring the integrity of the food supply. Government regulatory involvement in the food supply began with a focus on preventing fraud in the marketplace, expanded into preventing the sale of unsafe nutrient and, with the development of the science of diet, has assumed the part of protecting the integrity of the nutrient supply (Hutt, 1984). The Food and Drugs Act of 1906 (21 U.Due south.C. §1) was the first federal statute that broadly prohibited the misbranding or adulteration of food (Hutt, 1984). While it upgraded the safety and integrity of the entire food supply in the U.s., the constabulary lacked authority to establish standards of identity for item food products and to crave affirmative characterization declaration of information about the nutrition content of food products (Hutt, 1984, 1995). The Federal Meat Inspection Human action (21 UsC. §601), enacted on the same 24-hour interval equally the Food and Drugs Deed of 1906, too originated from concerns about adulteration, likewise as unsanitary weather.

The Federal Food, Drug and Corrective (FD&C) Deed of 1938 (21 U.S.C. §301) replaced the Food and Drugs Act of 1906. The FD&C Deed broadened the Nutrient and Drug Administration's (FDA) authority with regard to the nutrient content of food (Hutt, 1995), and information technology strengthened the prohibition against economical adulteration of food and authorized FDA to plant mandatory food standards. With regard to labeling, it prohibited false or misleading statements in food labeling, required any fake food to be labeled equally such, required affirmative labeling of food with particular information specified in the statute (name and accost of the manufacturer, net quantity of contents, name of the food, and argument of ingredients), authorized FDA to crave additional label information for special dietary food, and required that nutrient labels affirmatively reveal all facts cloth in calorie-free of whatever other representations fabricated for the product (Hutt, 1984, 1995).

Following enactment of the FD&C Act, FDA worked to implement a provision that authorized additional characterization data for nutrient for special dietary use (Hutt, 1995; IOM, 1990), and in 1941 information technology issued regulations governing the labeling of fortified food, vitamin and mineral supplements, and other explicit food categories (east.one thousand., infant formulas and hypoallergenic food) (IOM, 1990). These new regulations specified how the manufacturer should list ingredients if it chose to do so, but the regulations did not restrict the type or quantity of nutrients in a food that could be included, nor did they limit other claims that could exist made (IOM, 1990). For example, the regulations governing dietary supplements and fortified food required that the label include a announcement of the percentage of the "minimum daily requirements" for a vitamin or mineral for which a specific representation was made when consumed in a specified quantity during a flow of 1 solar day (Hutt, 1995). The Poultry Products Inspection Act of 1957 (21 United states of americaC. §451) and the Egg Products Inspection Act of 1970 (81 U.s.C. §1620) provided regulatory authority for poultry products and processed egg products to the U.S. Department of Agriculture (USDA). While misbranding and adulteration provisions were similar for meat, poultry, and egg products, the inspection and compliance framework differed. The Wholesome Meat Act of 1967 (21 U.S.C. §601) and the Wholesome Poultry Products Act of 1968 (21 U.S.C. §467a) incorporated additional provisions against cariosity and misbranding with greater enforcement authority for USDA.

U.S. Recommended Daily Intakes, 1970–1990

Early labeling policies were concerned primarily with maintaining the limerick of basic food products and discouraging the sale of processed substitutes on the assumption that traditionally formulated nutrient and meals prepared in the habitation would ensure healthy diets (IOM, 1990). The White House Conference on Food, Nutrition, and Health, convened by President Nixon in 1969, moved labeling policies to another plane. The conference focused on previously unrecognized malnutrition in Americans and included in its final report criticism of the manner in which FDA was regulating nutrient labeling and the need for improved characterization information to assist Americans make informed dietary choices to enhance nutrition (WHC, 1970).

By 1973 FDA had adopted several amendments to its regulations in follow-up to the White Firm Conference recommendations. Most important was its adoption of regulations governing nutrition labeling for packaged nutrient (IOM, 1990; Wodicka, 1973). The regulations applied to retail packaged food other than meat and poultry products. Diet labeling was required in a specified format and place on the nutrient label if the manufacturer of a food added a nutrient or made a diet claim for the production (IOM, 1990). The regulations required the same nutrition information if a manufacturer voluntarily chose to utilize nutrition labeling. It has been estimated that about one-half the food supply contained nutrition information under these requirements. These and other bug pertinent to the history of nutrition labeling in the 1970s through 1990 are well described by Hutt (1995) and in Diet Labeling: Problems and Directions for the 1990s (IOM, 1990).

In keeping with the concern nearly undernourishment in the United States, FDA officials wanted to ensure that consumers had sufficient information to enable them to select a diet that was acceptable in vitamins, minerals, and protein, while also curbing excessive consumption of these nutrients (IOM, 1990). Under the overall heading of "Nutrition Information," vitamins and minerals were described in terms of a pct of a single set of nutrient reference values chosen U.S. Recommended Daily Allowances (United states of america RDAs) per standard size serving (FDA, 1973). United states RDAs were established for 12 vitamins (vitamin A, vitamin C, thiamin, riboflavin, niacin, vitamin D, vitamin E, vitamin B_half-dozen, folic acrid, vitamin B₁₂, biotin, and pantothenic acrid), 7 minerals (calcium, iron, phosphorus, iodine, magnesium, zinc, and copper), and poly peptide (FDA, 1990b; IOM, 1990). Macronutrients were described in terms of weight and provided no percent information (Hutt, 1995). US RDAs were derived from the highest of the National Research Council's 1968 Recommended Dietary Allowances (RDAs) (NRC, 1968) for persons 4 years of age and older, excluding pregnant and lactating women. The exceptions were calcium and phosphorus, for which the highest values were not selected. Instead, the labeling values were based on the man requirements of approximately 1 g for calcium and on an equimolar basis for phosphorus. Other exceptions were the United states of america RDAs for copper, biotin, and pantothenic acrid. Although the scientific community recognized that these nutrients were essential for health, no RDAs had been established for them at that fourth dimension.

The use of the highest values of the RDAs for well-nigh US RDAs grew out of business organisation nearly nutrient deficiencies in some segments of the population. Differences among the highest RDAs for the various age and gender groups were considered minor. The values for 19-to 35-year-old men were the highest and therefore were used for the reference values, with the exception of iron, where the RDA for women was selected. For nutrient targeted for children less than 4 years of age, the RDA for that age group was selected.

In the 1970s evidence emerged that suggested a function for nutrition in reducing the risk for several chronic diseases. In 1977 the Senate Select Committee on Nutrition and Human Needs published Dietary Goals for the U.s.a. (Senate Select Commission on Nutrition and Human Needs, 1977), which provided dietary recommendations to assist in maintaining health and reducing take a chance for chronic diseases, especially cardiovascular affliction. In response, in 1979 the Surgeon General issued a report on health promotion and disease prevention (DHEW, 1979), and in 1980 USDA and the Department of Wellness, Education, and Welfare issued the start edition of Dietary Guidelines for Americans (USDA/DHEW, 1980).

The final impetus for major changes in diet labeling regulations, including nutrient reference values, occurred in the late 1980s. In 1988 and so Surgeon General C. Everett Koop released The Surgeon General'southward Report on Nutrition and Health (DHHS, 1988). This report and the National Enquiry Council (NRC) report Nutrition and Health: Implications for Reducing Chronic Affliction Risk (NRC, 1989a) described significant links betwixt dietary patterns and chronic diseases. Also in 1989 NRC issued the tenth edition of Recommended Dietary Allowances (NRC, 1989b). To address concerns well-nigh the currency of nutrient information in food labeling, the U.S. Section of Health and Human Services and USDA asked the National Academy of Sciences to undertake a review of diet labeling. The study resulted in a study, Nutrition Labeling: Problems and Direc tions for the 1990s, which included numerous specific recommendations on all aspects of nutrition labeling, including label format and nutrient content (IOM, 1990).

Throughout this catamenia congressional and public business organization increased as FDA deportment on issues related to emerging new information on the human relationship between diet and health lagged behind expectations (Hutt, 1995). Recommendations were made to expand nutrition labeling to include additional macronutrients, to institute clear definitions for widely used nutrient descriptors, and to provide for disease claims in nutrition labeling. In July 1990 FDA published proposed regulations related to mandatory nutrition labeling on packaged nutrient, including a regulation that would establish new nutrient reference values for macronutrients, chosen Daily Reference Values (DRVs), and for vitamins and minerals, called Reference Daily Intakes (RDIs). The proposed RDIs were based on a population-average arroyo, that is, the adapted mean of the RDAs weighted co-ordinate to age groupings in the United States (FDA, 1990b). The use of reference values every bit part of nutrition labeling was intended to "assist consumers in interpreting information about the amount of a food present in a nutrient and in comparing the nutritional value of food products" and was part of FDA's efforts to "answer to changing nutrition information needs of consumers" (FDA, 1990b). In the proposed regulations FDA acknowledged questions about its authorisation to require nutrition labeling and tentatively concluded that the nutritional content of a nutrient is a textile fact and that a nutrient label is misleading if it fails to take diet data that would exist required nether the proposal. On Nov xviii, 1990, the Nutrition Labeling and Education Act (NLEA) (21 UsC. §343) was signed into law past President George H.W. Bush (Hutt, 1995). The passage of NLEA also served to ostend the say-so of FDA to require nutrition labeling (FDA, 1991).

Reference Daily Intakes and Daily Reference Values, 1990 and Beyond

The passage of NLEA began the current era of nutrition labeling. NLEA called for all packaged nutrient under FDA's jurisdiction to bear nutrition labeling. It also covered dietary supplements and included a strict timeline. The proposed regulations were to be released by November 8, 1991, and the final regulations were to be implemented past November 8, 1992 (Hutt, 1995).

As part of the implementation of NLEA, in Nov 1991 FDA republished the 1990 proposal on RDIs and DRVs (FDA, 1991). The 1991 proposal also addressed problems related to the mandatory condition of diet labeling and food content revision, with some modifications of the 1990 proposed regulation (FDA, 1991). Also in 1991 USDA's Food Safety and Inspection Service (FSIS) announced its commitment to improving harmonization with FDA on diet labeling (FSIS, 1991).

FDA once more proposed to replace the 1973 US RDAs with RDIs and to establish DRVs. The proposal included reference values for five life stage and gender groups that were to be used for nutrition labeling based on the increasingly complex RDAs (FDA, 1990a, 1991). The 5 groups were: infants (0–12 months), children less than 4 years of age (13–47 months), children and adults iv or more than years of age (excluding meaning women and lactating women), pregnant women, and lactating women. FDA proposed that the reference values for these groups be used in nutrition labeling for nutrient targeted to these groups. Because children 4 or more than years of historic period and adults were thought to generally eat the aforementioned food, FDA grouped them together to establish ane gear up of reference values to define the general population (FDA, 1990b). This approach thereby simplified nutrition labeling since it resulted in the listing of i column of nutrients on most food.

The proposal chosen for RDIs for protein and 26 vitamins and minerals for all 5 age groups. FDA likewise outlined the establishment of eight new DRVs for food components of increasing concern for Americans but for which there were no established RDAs: full fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, sodium, potassium, and poly peptide (FDA, 1990b).

The DRVs were based on discussions, recommendations, and guidelines presented in Diet and Health (NRC, 1989a) and The Surgeon General's Report on Nutrition and Health (DHHS, 1988). The proposal also indicated that the tenth edition of the Recommended Dietary Allowances (NRC, 1989b) provided a basis for reexamining electric current nutrient standards. Additionally, FDA's proposal cited a range of reports (Butrum et al., 1988; DHHS, 1988, 1989; Expert Panel on Population Strategies for Blood Cholesterol Reduction, 1990; LSRO, 1987; NRC, 1989a; USDA/DHHS, 1985) that provided a basis for expanding the required information on nutrition labeling to include information on nutrients and nutrient components that were associated with chance of chronic affliction (FDA, 1990b).

FDA also proposed to summate RDIs by using a population-adjusted mean of the relevant RDAs rather than the highest-of-the-high, population-coverage approach that was used to establish the US RDAs (FDA, 1990b, 1991). FDA proposed this new arroyo for several reasons. First, the use of a population average was thought to more appropriately meet the stated purpose of the RDIs, which was to serve as a full general nutrition labeling reference value. Second, it seemed logical non to use maximum values as the footing for reference values given the decreasing public health business concern with nutritional deficiencies. Third, FDA hoped that the selection of lower reference values would foster more than prudent fortification and conception of food consistent with its fortification policy (FDA, 1990b).

FDA as well suggested that the reference values should be listed under a single new term and proposed "Daily Value" (DV) for two reasons: (i) consistency with the NLEA management that information in nutrition labeling be presented in a manner that enabled consumers to empathize the significance of the information presented in the context of a total daily diet, and (2) consumer inquiry on the DV that indicated that the term was interpreted correctly (FDA, 1991).

Although there was back up for continued use of the RDAs equally the footing for reference values, use of the population-adapted mean met with resistance. The near ofttimes expressed concern near the approach was that information technology resulted in a value that was too low for at to the lowest degree one-half of the population and as such would pb to suboptimal nutrient intakes. The concern was partly expressed by passage of the Dietary Supplement Act of 1992 (DSA) (P.50. 102-571) that established a 1-year moratorium on implementation of NLEA with regard to dietary supplements and prohibited until November 1993 any diet labeling regulations that used recommended daily allowances or intake values for vitamins and minerals other than those currently in effect (Commission on Dietary Supplement Labels, 1997). It also prohibited FDA from promulgating regulations based on the RDAs any earlier than Nov 1993 (other than those specified in 21 C.F.R. 101.9 (c) (vii) (iv), i.due east., the U.s. RDAs) and prohibited implementation of NLEA for dietary supplements earlier than December 15, 1993 (21 UsC. §301).

In Jan 1993 FDA published its terminal regulations on nutrition labeling for conventional food. Considering of the moratorium in the DSA, the regulations retained the utilize of the highest value approach and the 1968 RDAs as nutrient reference values for vitamins and minerals for the age categories proposed (FDA, 1993c). In the preamble to the regulations, FDA indicated that it had planned to return to the population-coverage approach, acknowledging that the proposed arroyo lowered reference values for vitamins and minerals by an average of well-nigh 14 percentage compared with those that would accept been derived using the population-adjusted mean. The remaining differences were attributed to differences between the 1968 and 1989 RDAs (FDA, 1993c). The final regulations did alter the name of the US RDAs to RDIs for vitamins and minerals and established DRVs for sodium, potassium, and macronutrients. Once the moratorium was no longer in event, FDA proposed RDIs for nutrients that had non been included in the 1968 RDAs simply were in the 1989 edition (FDA, 1994). This led to concluding regulations in 1995 that established RDIs for vitamin K, selenium, manganese, chromium, molybdenum, and chloride (FDA, 1995). (Meet Appendix Table C-9 for the listing of reference values.)

With regard to the use and representation of a unified reference value for nutrition labeling, FDA explained that a unified reference value on the label was in response to the directive in the legislation that the data be conveyed to the public in a manner that enabled the public "to readily observe such data and comprehend its relative significance in the context of a total daily diet" (FDA, 1993a).

The preamble to the 1993 regulations explained that FDA had besides conducted focus group research with adults (Lewis and Yetley, 1992), called for boosted suggestions, and reviewed new consumer enquiry and comments regarding a term for the overall label reference value. FDA had earlier proposed using DVs, and it decided to retain the term and to utilise the percent DV (% DV) as the all-time representation for consumers: "FDA has carefully considered the arguments regarding percent displays simply finds no ground non to conclude that consumers will be able to employ per centum DV declarations more effectively than they would any other format tested" (FDA, 1993a). Wellness claims, food content claims, and structure/office claims were too addressed in implementing the NLEA regulations.

Current Condition of Nutrition Labeling

FDA and FSIS have regulatory oversight for ensuring that food labeling in the United states is authentic and not misleading. Each agency has responsibility for the labeling of different nutrient products in the food supply. FDA has jurisdiction over all food except that which contains 2 percent or more cooked or 3 percent or more raw meat (i.e., from livestock-cattle, sheep, swine, goats, and equine) or poultry (i.eastward., from domestic birds: chicken, turkey, ducks, geese, guineas, ratites, and squabs), and processed egg products, all of which are under the jurisdiction of FSIS. Although the products they regulate are subject to different laws, these agencies accept coordinated their approach to nutrition labeling in guild to maintain consistency.

Nutrition Labeling on FDA-Regulated Products

Under NLEA all packaged nutrient except those excepted in the Human activity¹ must take nutrition labeling. NLEA as well provides for voluntary nutrition information for fresh produce and seafood (21 U.s.C. §201). Specific food content "facts" in a mandatory order are required in the Nutrition Facts box, as are specific label design elements (come across Box 2-ii). The product content of other nutrients specified by FDA may exist voluntarily included in the box at the discretion of the manufacturer, but the order of the nutrients on the label must be maintained. If a manufacturer chooses to fortify a product with nutrients, and then the content of those nutrients also must exist included in the box. This is as well true for nutrients virtually which manufacturers make wellness or nutrient content claims. The mandatory food components in the Diet Facts box include those that scientists and wellness practitioners believed were important to the health of the American people based on the science available at the time NLEA was implemented.

BOX 2-ii

Sample U.S. Nutrition Facts Box. SOURCE: ONPLDS (2003a).

FDA specifies that the Diet Facts box include all nutrients presented as % DVs (with the exception of sugars, monounsaturated fatty acids, polyunsaturated fatty acids, and soluble and insoluble fiber for which DVs have not been established) with the amount in grams or milligrams also included for specific nutrients. The % DV for protein is required simply if a poly peptide claim is made for the product or when the product is intended for infants or children under 4 years of age. On most larger food packages the box besides must include a footnote that states that the % DVs are based on a 2,000-calorie diet. In addition it may include a statement of the calories provided per gram for fat, carbohydrate, and poly peptide. Serving sizes, calculation of % DVs, and Diet Facts box format modifications are regulated past FDA and FSIS in a consistent manner. (For boosted data about diet labeling, run into CFSAN, 2003b; FDA, 1993a, 1999b; OPPD, 2003a.)

In 1999 FDA proposed to amend its regulations to require that the Diet Facts box include information near trans fatty acids in a food (FDA, 1999a). In July 2003 FDA published final regulations with this mandate (FDA, 2003b). The regulations as well apply to dietary supplement labeling. The regulations specify that the gram amount of trans fatty acids exist listed in the box immediately beneath the line for saturated fat acids. Particularly pertinent to this study, the regulations specify that the new line does not require a % DV for trans fatty acids and withdrew the earlier proposal (FDA, 1999a) that the trans fatty acid line take a footnote stating "Intake of trans fat should be as depression as possible." The regulations, constructive Jan 1, 2006, are a issue of research and public comments reviewed by FDA that documented the link between consuming diets high in trans fatty acids and increased serum low-density lipoprotein cholesterol, a adventure factor for coronary heart illness.

Other FDA-Regulated Label Elements Related to or Dependent on DVs

Other nutrition information, such as ingredient lists, structure/ function claims, nutrient content claims, and health claims, that is found on food labels outside the Nutrition Facts box as well is relevant to a word of reference nutrient values. Nutrient products that contain more one ingredient must list these ingredients on the package. FDA has provided manufacturers with regulations near how the ingredient list must appear on the bundle and which ingredients must be listed (21 C.F.R. 101.4). Ingredient lists are of import label elements because they enable consumers to place sources of the nutrients, and they can be used to compare products for the presence or absence of ingredients. Claims about the structure and office of a nutrient have historically appeared on labels of conventional food and dietary supplements, also as on drug labels. (For more information on structure/role claims, see ONPLDS, 2003b.)

Nutrient content claims² are FDA-regulated statements on food packages that characterize the level of a food in a food, such as "complimentary," "high," and "low." These claims are based on the amounts of the nutrient in the nutrient item, and FDA specifies the package wording and allowable synonyms (FDA, 1993b). With few exceptions, a nutrient content merits can be made only if there is a DV identified for that nutrient and if FDA has established, by regulation, the criteria a nutrient must meet to list the merits.

A wellness meritsⁱⁱⁱ on a food parcel is a statement of a scientifically demonstrated relationship between a food substance (defined by law as a specific food or component of nutrient) and a affliction or health-related status. Some of the criteria for health claims are dependent on reference values for nutrition labeling because a food must meet the criteria for a sure food content level based on the DV in order to be eligible for the health merits. For example, the food needs to contain, without fortification, 10 per centum or more of the DV for at least one of 6 nutrients (dietary supplements excepted): vitamin A, vitamin C, iron, calcium, protein, and cobweb.

The wording of health claims is advisedly delineated past FDA and requires that the relationship between the food component and the risk of a disease or health-related condition is stated in a fashion that does not imply direct causation. FDA has approved 14 health claims that may be used on packaging, and new claims may exist added to the list. (For more information on current claims, encounter CFSAN, 2003a.)

Wellness claims must be authorized by FDA prior to their use in nutrient labeling. There are several methods for obtaining authorization. First, FDA reviews scientific prove supporting a proposed wellness claim in response to a wellness merits petition. When FDA finds that the evidence satisfies the significant scientific agreement validity standard prescribed under NLEA, the bureau issues a regulation authorizing apply of the health claim. Second, under the Food and Drug Assistants Modernization Act of 1997 (P.Fifty. 105-115), if a scientific torso of the U.S. government or the National Academies has published an authoritative statement virtually the relationship betwixt a food and a disease or health-related condition, that argument may serve as the ground for authorizing the use of a health merits. In such a situation, a manufacturer submits to FDA a notification of its intent to use a wellness claim based on the authoritative statement. Barring an objection by FDA, claims based on administrative statements get authorized 120 days after submission of the notification. Tertiary, when FDA'due south evaluation of scientific bear witness supporting a petitioned wellness claim concludes that the bachelor evidence does non meet the meaning scientific agreement standard, but that there is some credible evidence in back up of the health claim, FDA will consider permitting a "qualified" health claim that includes appropriate qualifying linguistic communication to explain the level of scientific proof that the claim is truthful. In blessing a qualified health merits, FDA issues a letter stating that it will consider its "exercise of enforcement discretion" in permitting a qualified claim nether prescribed conditions although the wellness merits has not been authorized by a regulation. FDA first considered permitting the use of qualified health claims for dietary supplements and conventional nutrient in response to a court decision⁴ that was based on First Amendment commercial complimentary spoken language considerations for dietary supplement labeling.

More recently FDA issued guidance on the review process for qualified health claims as part of its initiative on Consumer Health Information for Better Nutrition. The guidance included an interim method to systematically evaluate and rank the scientific evidence for qualified wellness claims (FDA, 2003c). While health claims are not addressed in this written report, the committee's recommendations may inform the process of developing health claims in then far every bit they chronicle to reference nutrient values.

Dietary Supplement⁵ Labeling

NLEA covered dietary supplements, simply every bit described earlier, DSA prohibited implementation of NLEA for dietary supplements earlier than December xv, 1993. Thus the 1993 nutrition labeling regulations did not accost labeling of dietary supplements. Nevertheless, as part of the implementation of the Dietary Supplement Health and Education Deed of 1994 (DSHEA) (21 U.S.C. §401(q)(v)), in 1997 FDA issued final regulations requiring that a Supplement Facts box appear on all dietary supplements constructive in 1999 (FDA, 1997). The Supplement Facts box (see Box 2-3) is modeled after the Diet Fact box and is similarly regulated in content and format. It must include amounts and % DV of the same nutrients that are required on nutrition labeling of conventional nutrient if the nutrients are present in the supplement and the amounts of other dietary ingredients included. These other dietary ingredients must exist identified by their common or usual proper noun and, in some cases for botanicals, by their Latin binomial name and specific plant office, if applicable.⁶ Proprietary blends may be listed past weight of the total blend, and the serving size must be clearly stated within the box. Nutrients for which there are established DVs must exist listed first, followed by a horizontal line that separates these nutrients from nutrients and other ingredients for which there are no DVs (east.g., botanicals).

BOX 2-3

Sample U.Southward. Supplement Facts Box. Other ingredients: Gelatin, lactose, magnesium stearate, microcrystalline cellulose, FD&C yellow No. 6, propylene glycol, propylparaben, and sodium benzoate. SOURCE: 21 C.F.R. 101.36, subpart C.

The box must land that % DVs have not been established for these latter ingredients and must signal these ingredients clearly with an asterisk. The ingredients used in the manufacturing process (e.chiliad., excipients, fillers, binders, flavors), a clear statement of identity, the net quantity of the contents, the manufacturer contact information, and any label claims must exist located exterior the Supplement Facts box. Source ingredients (e.grand., calcium carbonate as the source of calcium) may exist listed parenthetically within the Supplement Facts box following the dietary ingredient or in the ingredient listing that appears outside and below the box.

Dietary supplements may include three categories of claims on the label exterior the Supplement Facts box. Under the same regulations that apply to conventional nutrient labels, dietary supplement labels may include food content claims and wellness claims. Dietary supplements as well may comprise statements of nutritional support, including construction/function claims (21 U.S.C. §343(r)(6)). This category of characterization statement may claim or draw the role of a food or dietary ingredient intended to affect the structure or function of the human trunk or its full general well-beingness. As with structure/function claims for conventional nutrient, the manufacturer is responsible for the accuracy and truthfulness of structure/ function claims for dietary supplements. FDA has statutory authorisation to have action against any false or misleading claims. FDA, by law, does not require prior blessing of the wording of the claim. As a result of DSHEA, dietary supplement manufacturers notify FDA within 30 days after the commencement utilise of a structure/part claim (referred to besides as a nutritional back up statement). All construction/ function claims used on a dietary supplement characterization must be accompanied by the disclaimer that FDA has not evaluated the claim and that the ingredient or product is non intended to "diagnose, care for, cure, or prevent any disease." (For additional information on construction/role claims, see FDA, 2000.)

Nutrition Labeling of FSIS-Regulated Products

NLEA required that FDA implement regulations for food labeling, merely it did not address the labeling of meat and poultry products nether FSIS jurisdiction. FSIS, nonetheless, coordinated efforts with FDA and issued regulations that were based on its existing statutes and were designed to be as consequent as possible with FDA regulations (FSIS, 1993a, 1993b; Keystone Center, 1996). FSIS requires that meat and poultry products bear eight required labeling features: (1) mutual or usual name of the food, (2) if fabricated from two or more than ingredients, a statement of ingredients listed, by common or usual name, in descending order of predominance by weight, (3) an accurate statement of the quantity of contents, (4) the name and place of business of the manufacturer, packer, or distributor, (five) an inspection fable with the establishment number for the establishment where the product was made, (6) nutrition labeling unless an exemption exists, (seven) a handling argument if the product is not shelf stable, and (viii) safe handling instructions if the meat or poultry component of the product is not ready to eat (9 C.F.R. 317.2 9, 381 subpart N).

Under the Federal Meat Inspection Act (21 United statesC. §601), the Poultry Products Inspection Act (21 United states of americaC. §451), and the Egg Products Inspection Act (81 U.s.C. §1620), FSIS conducts a "prior characterization blessing organisation" for meat, poultry, and egg products. These Acts and their implementing regulations provide for sure exemption from USDA jurisdiction (e.g., products prepared for human consumption that contain meat or poultry ingredients in relatively small proportions or are not considered by consumers to be products of the meat or poultry industry).^vii

FSIS has over 80 food standards of identity for the meat and poultry products it regulates. For example, specific definitions be that underlie what can be identified equally "ham with natural juices" or "ham with water added." FSIS also regulates the new employ and labeling of food ingredients as they relate to FSIS standards of identity. Additionally, FSIS regulates claims and special statements on labeling, including creature production claims (eastward.thousand., "no added hormones"), processing statements (e.g., "treated for pathogen control"), and descriptive terms (e.g., "fresh"). FDA also has regulations governing utilise of the term "fresh."

FSIS has promulgated regulations for the labeling of nutrient content claims on meat and poultry products (nine C.F.R. 317 subpart B, 381 subpart Y). These regulations are similar to those issued past FDA. FSIS has no regulations for the labeling of health claims, only it permits the voluntary labeling of health claims on meat, poultry, and egg products provided the claims are labeled in accordance with FDA'southward regulations. Thus, the committee'south guiding principles and recommendations will every bit apply to FSIS-regulated food. (See OPPD, 2003b, for data about the prior approval of product labels and labeling terminology for meat, poultry, and egg products as regulated past FSIS.)

REFERENCE VALUES AND NUTRITION LABELING IN CANADA

Historical Overview

In Canada the Food and Drugs Human action (R.S. 1985, c. F27) is the main federal statute governing the labeling of nutrient. The Act applies to all food sold in Canada at all levels of commerce. Regulations made under the Act comprehend ingredient listing, nutrition labeling, and all types of claims.

Until 1988 when nutrition labeling guidelines were introduced, regulations pertaining to the proclamation of nutrients in food were largely intended to control claims. They were put in place over a 40-year period, and for the purposes of labeling they distinguished between added and naturally occurring vitamins and minerals. Amounts of added vitamins and minerals were required to be declared in absolute amounts per 100 chiliad of food whenever one or more was added to a food. For the nearly part, the labeling of absolute amounts of naturally occurring vitamins and minerals was not permitted; a food containing minimum levels of one or more of 9 nutrients in a reasonable daily intake could only be described every bit a "adept" or "excellent" source of the nutrient. With few exceptions, declaration of the free energy value and of single nutrients other than naturally occurring vitamins and minerals was permitted. Declaration of protein was permitted if it was grouped with a declaration of carbohydrate and fat content and all were expressed in grams per 100 thou. Sodium and potassium had to be declared together in milligrams per 100 g. Nutrition labeling was only required for food for special dietary uses and for nutrient containing intense (artificial) sweeteners. Energy value, protein, carbohydrate, and fatty, each expressed both per 100 1000 and per unit of measurement of ready-to-serve food, were required to exist listed (Canada, 1988a).

Nutrition labeling guidelines were introduced in Canada in 1988, along with amendments to the Food and Drug Regulations, concluding a process that was started in 1983. The organization was voluntary, with a few exceptions. The Guidelines on Diet Labelling (Canada, 1989) governed format, nutrient content information (core list and optional nutrients), and a declaration of serving size. Once practical, the nutrient declaration had to comply with the amended regulations (Canada, 1988b), which stipulated nomenclature, units of measurement, and expression on a per serving basis. Nether the overall heading of "Nutrition Information," amounts of vitamins and minerals were required to exist expressed in terms of a per centum of a single set of nutrient reference values, Recommended Daily Intakes, per serving of stated size (Canada, 1986). Amounts of macronutrients were expressed in terms of weight; no percent data was provided.

The process begun in 1983 had proposed criteria for rating the nutrient content of nutrient based on two reference standards: a food density index (NDI) and the pct of a blended Recommended Nutrient Intake (RNI) derived from the Recommended Nutrient Intakes for Canadians (Canada, 1983a, 1983b). A reference set of RNIs expressed per megajoule (RNI/MJ) was derived by dividing the RNI for each historic period and gender grouping by the average energy requirements of that group. When the RNIs were not based on energy and the nutrient to energy ratios were not constant among groups (e.g., iron and vitamin C), the highest RNI/MJ was selected. The NDI was the amount of the food per MJ in the food divided by the RNI/MJ. To arrive at the blended RNI, a demographic average energy intake was adamant and the RNI/ MJ was multiplied by this number. Minimum levels for both the NDI and the composite RNI were required for claims. Relating all the RNIs to energy was criticized and the proposal was not pursued.

In 1986 Health Canada decided to set Recommended Daily Intakes for nutrition labeling using the highest RNI from 1983 for each nutrient for each age and gender grouping, omitting supplemental needs for pregnancy and lactation (Canada, 1986). Thus the values chosen were those for nineteen- to 24-year-old males (except for fe, for which the value was that of women of childbearing age). Recommended Daily Intakes were established for eleven vitamins (vitamin A, vitamin D, vitamin E, vitamin C, thiamin, riboflavin, niacin, vitamin B₆, folacin, vitamin B₁₂, and pantothenic acid) and 6 minerals (calcium, iron, phosphorus, iodide, magnesium, and zinc). The Guidelines on Nutrition Labelling (Canada, 1989) specified the minimum nutrient content information, the label format, and the serving size information that would constitute nutrition labeling for food sold in Canada.

In 1996 Canada published its national activeness plan on nutrition, Nutrition for Health: An Agenda for Action (Joint Steering Committee, 1996). This report identified important strategies for Canadians to reduce wellness risks and supported the need for improving the usefulness of nutrition labeling, increasing its availability, and broadening public education on its use. In June 2001 Wellness Canada undertook a terminal consultation on proposals to improve diet information on prepackaged food labels, including nutrition labeling. On December 12, 2002, the Canadian government issued "Regulations Amending the Nutrient and Drug Regulations (Diet Labeling, Nutrient Content Claims and Health Claims" (Canada, 2003). The new regulations mandate nutrition labeling on well-nigh prepackaged food, update and consolidate permitted nutrient content claims, and introduce a new regulatory framework and process for diet-related wellness claims. While companies marketing nutrient in Canada may brainstorm to follow the new regulations immediately, they have until December 12, 2005, to bring their labels into compliance with the new regulations. Small businesses, defined equally having less than $1 one thousand thousand in sales, will not have to be in compliance until December 2007 (Canada, 2003).

Current Status of Nutrition Labeling

Wellness Canada and the Canadian Food Inspection Agency (CFIA) oversee the regulatory procedure of food labeling in Canada. Health Canada is responsible for setting health and condom standards and for developing food labeling policies related to health and nutrition under the Food and Drugs Act. CFIA is responsible for administering other nutrient labeling policies and enforcing all food labeling regulations.

The new regulations require a Nutrition Facts table that is modeled afterward the Nutrition Facts box used in the United States (see Box 2-4). Similar to the Usa, the Canadian Diet Facts table will be a requirement on almost packaged food, but some nutrient products are exempted (due east.thousand., fresh fruits and vegetables; raw, single-ingredient meat and poultry, except when ground; fish and seafood; food prepared in retail establishments and individual portions prepared for immediate consumption; and alcoholic beverages).

BOX 2-4

Sample of Canada'due south Nutrition Facts Table. SOURCE: Canada (2003).

The Canadian Nutrition Facts table includes calories and thirteen nutrients in a specified gild (meet Box two-4). Recommendations from and discussions with Canadian consumers, scientists, and wellness professionals led to the selection of the 13 nutrients (Canada, 2003). The required nutrients in the Nutrition Facts table are identical to those required in the United states, including a statement on trans fat, with the exception that the new Canadian table does not require a list for "calories from fat." Other nutrients from a permitted list may exist included in the table at the discretion of the manufacturer, simply the specified guild of the nutrients must be maintained. Food data with the exception of that for cholesterol must be expressed in terms of % DV, and, in the example of macronutrients, sodium, and potassium, in grams and milligrams based on a serving of stated size. The % DVs for fat, cholesterol, carbohydrate, fiber, sodium, and potassium are based on Reference Standards that are identical to the DRVs used in the United states. Since the RDIs for vitamins and minerals used in the United States are based largely on the 1968 RDAs, it was decided to retain the Canadian Recommended Daily Intakes, which are based on the 1983 RNIs, until further guidance is received from the Found of Medicine on the establishment of reference values for nutrition labeling.

The Canadian regulations require trans fat to be incorporated with saturated fat in the same % DV, with the % DV for the sum of saturated and trans fats being 20 g based on 10 percent of free energy with a ii,000-calorie dietary energy reference value. Expression of a % DV was considered important to assist consumers in agreement the relative significance of the amount of these nutrients in a food. The % DV for cholesterol is optional. There is no % DV for poly peptide because protein intakes in Canada were not considered to be a public health business. Explanatory footnotes related to the DV are similar to those used in the U.s.a. and may exist included in the Diet Facts tabular array. The graphic elements of the Nutrition Facts tabular array are tightly regulated to ensure the use of a consistent and legible format. The Canadian regulations, unlike those of the United States, do non include specific regulations to define the serving size except in the case of single-serving containers. Guidelines for establishing serving sizes are provided in CFIA'southward Guide to Nutrient Labelling and Advert (CFIA, 2001). Reference Amounts, a specific quantity of a type of food unremarkably eaten by an individual at 1 sitting, serve as the basis for composition criteria for claims and are regulated.

Only nutrition labeling that complies with the regulations may appear on food labels in Canada, and the information must exist presented in both English language and French like other mandatory labeling information. Considering other countries' nutrition labeling does not meet the Canadian requirements, they cannot be used on nutrient sold in Canada.

The new regulations permit specifically defined nutrient content claims that are similar to, but have slightly dissimilar definitions than, those allowed in the Us. Prior to passage of the new regulations, health claims were not permitted on food labels in Canada. Now claims associated with four diet and health relationships are permitted: sodium and potassium and their clan with blood force per unit area, calcium and vitamin D and their clan with osteoporosis, saturated fat and trans fat and their association with centre affliction, and vegetables and fruit and their association with some types of cancer. The regulations stipulate the prescribed wording for the permitted claims. 1 criterion for health claims is based on another reference value, the Weighted Recommended Food Intake (WRNI). WRNI became part of the regulations in 1996 (Canada, 1996). A food must contain at least 10 percent of the WRNI for i vitamin or mineral per reference amount and per serving of stated size in order to exist eligible for claims related to claret pressure and middle disease. The WRNIs are the demographic averages of RNIs published in 1990 (Canada, 1990) and are considered to represent the nutritional needs of the full population because they are weighted co-ordinate to the age and gender distribution of the Canadian population.

CONSUMER Agreement AND Apply OF Diet LABELING

Consumer Research on Nutrition Labeling in the United states of america

The history of consumer research on nutrition labeling of food parallels the evolution of nutrient labeling legislation in the United States, with the temporal pattern of inquiry focused effectually pregnant proposed changes in label format or content. For example, FDA undertook extensive research in the 1970s, which contributed to the current concepts about nutrition labeling, including the use of percentage The states RDA (FDA, 1972), and at that place was research conducted just earlier and subsequently the 1993 regulations implementing NLEA (FDA, 1993a). Overall however, inquiry to track the continuing evolution of consumer-employ patterns of food labeling has been express.

The Context of Research on Current Nutrition Labeling

The implementing regulations for NLEA explained that nutrition data on the label was to help consumers in maintaining healthy dietary practices and was to be conveyed in a way that enabled the public "to readily observe and encompass such information and to understand its relative significance in the context of a total daily diet" (FDA, 1993a). Thus it was designed to serve equally a tool to allow consumers to compare similar products and to understand the contribution of an individual food to the diet—not for planning the overall structure of the diet (FDA, 1991, 1993a).

The development of a label to meet these objectives required extensive testing and included experimental studies, shopping mall-intercept interviews, and focus groups (FDA, 1993a; Geiger, 2001; Geiger et al., 1991; Levy et al., 1992; Lewis and Yetley, 1992). No single pattern consistently performed best as measured by correct estimation of the data and consumer format preferences (Levy et al., 1992). Experimental studies constitute that the % DV helped consumers to make judgments virtually whether different nutrient products were high or low in a particular nutrient and to put individual food products into the context of a total diet. Without the % DV, consumers could not interpret metric values correctly and made inaccurate judgments most individual products (Geiger, 2002; Levy et al., 1996).

Trends in the Use and Understanding of the Nutrition Facts Box

Both FDA and the Food Marketing Found (FMI) periodically track label employ. FMI surveys signal that in 1992, half of U.S. developed consumers said they used nutrition labeling when buying a food for the first time (FMI, 1993). The number rose to about 60 percent past 1995, and and so dropped nigh to baseline (FMI, 1997). About half of consumers continue to report using nutrition labeling for first-time purchases (FMI, 2001). Estimates from the FDA Food Characterization Utilize and Nutrition Education Surveys (FLUNES) conducted in spring 1994 and fall 1995 indicated that about half of adult consumers reported using the food label to make a food product option in the two weeks before the interview (Derby, 2002).

Data from FLUNES also showed that over 50 per centum of consumers used the Nutrition Facts box to make a summary judgment of the overall nutritional quality of a food (Derby, 2002). The most notable increase in the mode the new label was used was to determine how loftier or low a product was in a particular nutrient, especially fat (Derby, 2002). The percentage of consumers who checked fat information rose steadily from 1992 to a high of 83 percent in 1995 (Derby, 2002; FMI, 1992, 1995), simply dropped back to lxx percent by 1997 (FMI, 1997). Overall, fat content was the factor that influenced purchase decisions in both directions, merely the percent of shoppers who identified fat every bit the factor that led them to choose a specific product declined (FMI, 1997).

The second most common use of the Nutrition Facts box was for information about the calorie content of food. In 1992, 51 pct of consumers said that they always or almost e'er checked calories (FMI, 1992). By 1997 however, that figure had dropped to 33 percent of characterization readers (FMI, 1997), but calories were nonetheless listed among the top three pieces of data sought past 80 per centum of label readers.

Consumers use the Nutrition Facts box, and specifically the % DV, to ostend a claim on the front of a product and to make production-specific judgments (FDA, 1995; Geiger et al., 1991). In full general consumers continue to report that they employ nutrition labeling to brand purchase decisions, more frequently to avoid, rather than to purchase, a specific item (FMI, 1997).

Satisfaction with the Characterization

In the 1994 FMI survey (FMI, 1994), two-thirds of shoppers who had seen the new Diet Facts box said it was clearer and more understandable than the sometime box. Kristal and coworkers (1998) reported that significantly fewer people found the characterization to exist disruptive, burdensome, and hard to read afterwards the new format was introduced, but 70 percent of those studied, particularly older and less well-educated individuals, however wanted the label to be easier to understand. The main barrier to use of nutrition labeling as reported by Kristal and coworkers (1998) was lack of involvement. In a 1995–1996 study, Levy and coworkers (2000) found that the majority of subjects could not define % DV, did not find it useful for assessing the fatty content of a product, and did non know how to utilise it appropriately to select a diet low in fat. Hrovat and colleagues (1994) likewise reported that 56 percent of 200 volunteers in a small pilot study did not correctly use the % DV, merely the researchers acknowledged limitations in the study design.

The Impact of the Diet Facts Box on Diet Quality

Since 1973 the Nutrition Facts box or its equivalent has provided consumers with the reliable, objective nutrient composition of the production, the ability to compare products and, increasingly, the ability to place them in the context of a total daily diet. Several studies have attempted to address the larger question of whether the use of nutrition labeling information contributes to overall diet quality. Kreuter and colleagues (1997) found that characterization users had diets lower in fat and higher in fruits and vegetables than nonusers. In a population-based study in Washington Land that was conducted between 1995 and 1996 and in which 80 percent of residents reported reading nutrition data on packaged nutrient, at that place was a meaning association betwixt label reading and fat intake (Neuhouser et al., 1999). Levy and colleagues (2000), however, found a relationship between reported regular apply of the label and fat consumption, only no clan between understanding of the label and fat consumption. Regardless of an individual's income, Perez-Escamilla and Haldeman (2002) found characterization utilise to exist associated with college scores on the Healthy Eating Index, a measure of diet quality based on the Food Guide Pyramid (Kennedy et al., 1995). In this study those who were more flush merely did non use labels were equally likely as less flush nonusers to have a low Salubrious Eating Index.

One study provided data about how label apply predicted dietary intake. Kristal and coworkers (2001) compared data collected in Washington State in 1995–1996 and followed-upwardly in 1997–1998. They institute that fat intake decreased by approximately 2 percent of calories (from 32 percent to 30 percentage) and was strongly associated with the use of food labels. Reductions were greater amidst women, older persons, persons who were well educated, and those in the later stages of eating a low-fat diet.

Several studies accept explored the use of nutrition labeling information past women with type 2 diabetes mellitus (Miller and Dark-brown, 1999; Miller et al., 1997, 1999). In one study, participants reported frequent employ of the Nutrition Facts box, only comprehension of label information was poor (Miller and Brown, 1999). An intervention to teach a similar grouping of women to use the characterization resulted in a significant increase in their ability to employ the food label every bit compared with the control group (Miller et al., 1999).

Consumer Research on Nutrition Labeling in Canada

In 1999 a study for Wellness Canada evaluated consumer attitudes and behaviors related to nutrition labeling prior to the policy review (Joint Steering Committee, 1996). A representative sample of 1,331 adults 18 years of historic period and older was drawn from all ten provinces and stratified for location (urban or rural), age, gender, and didactics. One subsample included persons who followed a special nutrition related to heart illness or diabetes or who shopped for a person on a special diet. Over forty percent reported that nutrition-related information on the food label is "extremely" or "very" important in making purchase decisions; less than ten per centum regarded it as "not of import at all." Women and persons with a university education or with the highest income level were more probable to exist influenced by nutrition labeling. The data perceived as near useful was food content, especially fat (46 percent). Over 80 per centum reported that they understood the nutrition information on labels "fairly" or "very well."

Frequency of using the Nutrition Information Panel (NIP), in use at that time, likewise was assessed. Respondents who had previously indicated that they referred to the NIP "ofttimes" or "sometimes" were led through the possible uses of the NIP. Table 2-ane displays the total of "oftentimes" and "sometimes" responses to each selection. The results demonstrated few meaningful differences betwixt groups by gender, age, education level, or income.

Table 2-1

Utilise of the Diet Data Panel in Canada.

In this study various formats of nutrition labeling were presented. For macronutrients and micronutrients respondents preferred information presented as both bodily amounts and % Recommended Daily Intake. However, less than one-half understood % Recommended Daily Intake before educational intervention. Over one-half of users said that nutrition labeling influenced their decision to purchase a product; there were no age or gender differences.

Within the context of the history, current status, and employ of diet labeling in the Us and Canada described in this chapter, the commission developed the guiding principles presented in Chapter 5. The next chapter provides an overview of fortification and provides the groundwork for the guidance the commission presents in Chapter half-dozen.

1

The nutrient products specified past NLEA every bit exempt from food labeling include: food served for firsthand consumption, gear up-to-swallow nutrient not for immediate consumption that can be eaten when carried abroad, majority-shipped food not for sale to consumers, medical food, food of no nutritional significance, nutrient produced by small businesses (annual sales of not more than than $500,000 if nutrient is offered for sale or sales of food less than $50,000), and depression-volume food products (fewer than 100,000 units of a production sold annually in the United states of america and less than 100 full-time equivalent employees of the house).

2

NLEA permits the use of label claims that characterize the level of a food in a food made in accord with FDA's authorizing regulations.

3

According to NLEA, information technology describes "the relationship between a nutrient of the type required in the label or labeling of a food … and a disease or wellness related condition and the significance of each such nutrient in affecting such affliction or health related status" (21 U.s.a.C. § 343(r)(3)(B)(ii)).

4

Pearson v. Shalala 164 F.3d 650 (D.C. Cir. 1999).

5

Dietary supplements, as defined past DSHEA, include products (other than tobacco) intended to supplement the diet that comport or comprise one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical; an amino acid; a dietary substance used to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above. A dietary supplement must exist intended for ingestion in the form of a capsule, powder, soft gel, or gel cap, or, if not in one of those forms, is not represented as a conventional food or as a sole detail of a meal or the diet (21 UsaC. §321(ff).

vi

In a direct concluding dominion FDA (2003a) amended its regulation on botanical ingredients in dietary supplements to incorporate the utilize of the latest (year 2000) editions of two books that serve every bit references for botanical nomenclature. The current regulation cites by reference Herbs of Commerce (Foster, 1992) and the International Code of Botanical Nomenclature (Tokyo Code) (Grueter et al., 1994). This rule likewise includes statutory changes in the definition of ginseng and other changes with regard to labeling botanicals. This terminal rule is effective January 1, 2006, if FDA receives no significant adverse comments during the comment period.

7

More often than not, FSIS has determined by policy that the "relatively small proportions" of livestock ingredients are: 3 percentage or less raw meat; less than 2 per centum cooked meat or other portions of the carcass; or 30 percent or less fat, tallow or meat extract, alone or in combination. In the instance of poultry, the relatively small proportions are: less than 2 percent cooked poultry meat; less than ten percent cooked poultry skins, giblets, or fat, separately; or less than 10 percent cooked poultry skins, giblets, fat, and poultry meat (express to less than ii per centum) in whatever combination (9 C.F.R. Office 381.fifteen(a)). These percentages are computed on the ground of the moist cooked chicken in the ready-to-serve product when prepared co-ordinate to the directions on the consumer package.

Source: https://www.ncbi.nlm.nih.gov/books/NBK208873/

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