Food for human consumption: Food labeling Nutrient content claim healthy; sodium levels definition,
[Federal Register: September 29, 2005 (Volume 70, Number 188)]
[Rules and Regulations]
[Page 56828-56849]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se05-8]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 1991N-0384H and 1996P-0500] (formerly 91N-384H and 96P- 0500) RIN 910-AC49
Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term ``Healthy''
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim ``healthy.'' The agency is retaining the currently effective, less restrictive, ``first-tier'' sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the ``second-tier'' (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new ``healthy'' food products and risk substantially eliminating existing ``healthy'' products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term ``healthy'' will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the ``healthy'' regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for ``healthy'' into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.
DATES: This final rule is effective September 29, 2005.
FOR FURTHER INFORMATION CONTACT: Constance Henry, Center for Food Safety and Applied Nutrition (HFS-832), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.
SUPPLEMENTARY INFORMATION:
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Background
In the Federal Register of May 10, 1994 (59 FR 24232), FDA published a final rule amending Sec. 101.65 (21 CFR 101.65) to define the term ``healthy'' as an implied nutrient content claim under section 403(r) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)). The 1994 final rule defined criteria for use of the implied nutrient content claim ``healthy'' and its derivatives (e.g., ``health'' and ``healthful'') on individual foods, including raw, single-ingredient seafood and game meat, and on meal and main dish products. It also established two separate timeframes in which different criteria for sodium content would be effective for foods bearing a ``healthy'' claim (i.e., before January 1, 1998, and after January 1, 1998).
According to the 1994 final rule, before January 1, 1998, individual foods
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could bear the term ``healthy'' or a related term if the food contained no more than 480 mg of sodium (first-tier sodium level) per reference amount customarily consumed (RACC or reference amount), per labeled serving (LS) (serving size listed in the nutrition information panel of the packaged product), and if the reference amount was small (i.e., 30 grams (g) or less or 2 tablespoons or less), per 50 g (Sec. 101.65(d)(2)(ii)(A) and (d)(2)(ii)(B) and (d)(3)(ii)(A) and (d)(3)(ii)(B)). After January 1, 1998, an individual food could bear the term ``healthy'' or a related term if it contained 360 mg or less of sodium (second-tier sodium level) per reference amount, per labeled serving and per 50 g if the reference amount was small (Sec. 101.65(d)(2)(ii)(C) and (d)(3)(ii)(C)). The agency derived this 360 mg sodium level by applying a 25 percent reduction to the original sodium disclosure level of 480 mg for individual foods (59 FR 24232 at 24240).\1\
\1\ Under Sec. 101.13(h)(1) (21 CFR 101.13(h)(1)), individual foods bearing a nutrient content claim and containing more than 480 mg sodium per reference amount, per labeled serving or per 50 g (if the reference amount is small--i.e., 30 g or less or 2 tablespoons or less), must bear a label statement referring consumers to information about the amount of sodium in the food. Such disclosure statements are required when a food contains more than a certain amount of total fat, saturated fat, sodium, or cholesterol and that food bears a nutrient content claim. (See section 403(r)(2)(B) of the act.) The agency developed disclosure levels based on dietary guidelines, and taking into account the significance of the food in the total daily diet, based on daily reference values for total fat, saturated fat, cholesterol, and sodium (58 FR 2302 at 2307, January 6, 1993).
Similarly, before January 1, 1998, meal and main dish products could bear the term ``healthy'' or a related term if they contained no more than 600 mg of sodium (first-tier sodium level) per labeled serving (Sec. 101.65(d)(4)(ii)(A)), and after January 1, 1998, no more than 480 mg of sodium per labeled serving (second-tier sodium level) (Sec. 101.65(d)(4)(ii)(B)). The agency selected the 480 mg sodium level because it was low enough to assist consumers in meeting dietary goals, while simultaneously giving consumers who eat such foods the flexibility to consume other foods whose sodium content is not restricted; because there were many individual foods and meal-type products on the market that contained less than 600 mg of sodium; and because comments suggesting other levels did not provide supporting data (59 FR 24232 at 24240). Higher levels of sodium were rejected in the 1994 final rule (59 FR 24232 at 24239) because the agency determined that higher levels would not be useful to consumers wanting to use foods labeled as ``healthy'' to limit their sodium intake in order to achieve current dietary recommendations.
On December 13, 1996, FDA received a petition from ConAgra, Inc., (the petitioner) requesting that the agency amend Sec. 101.65(d) to ``eliminate the sliding scale sodium requirement for foods labeled `healthy' by eliminating the entire second tier levels of 360 mg sodium for individual foods and 480 mg sodium for meals and main dishes'' (FDA Docket No. 96P-0500/CP1, p. 3). As an alternative, the petitioner requested that the January 1, 1998, effective date for the second-tier sodium levels be delayed until such time as food technology ``catches up'' with FDA's goal of reducing the sodium content of foods and there is a better understanding of the relationship between sodium and hypertension.
FDA responded to ConAgra's petition in the Federal Register of April 1, 1997 (62 FR 15390), by announcing a partial stay of the second-tier sodium levels in Sec. 101.65(d)(2)(ii)(C) and (d)(4)(ii)(B) until January 1, 2000. The stay was intended to allow time for FDA to reevaluate the second-tier sodium levels based on the data contained in the petition and any additional data that the agency might receive; to conduct any necessary rulemaking; and to give industry an opportunity to respond to the rule or to any changes in the rule that might result from the agency's reevaluation.
On December 30, 1997 (62 FR 67771), FDA published an advance notice of proposed rulemaking (ANPRM) announcing that it was considering whether to initiate rulemaking to reevaluate and possibly amend the implied nutrient content claims regulations pertaining to the use of the term ``healthy'' (the 1997 AMPRM).
In the Federal Register of March 16, 1999 (64 FR 12886), FDA published a final rule extending the partial stay of the second-tier sodium requirements in Sec. 101.65 until January 1, 2003. The agency noted that it took this action to provide time for the following: (1) FDA to reevaluate the supporting and opposing information received in response to the ConAgra petition, (2) the agency to conduct any necessary rulemaking on the sodium limits for the term ``healthy,'' and (3) companies to respond to any changes that may result from agency rulemaking. On May 8, 2002 (67 FR 30795), FDA issued another final rule to extend the partial stay of the second tier sodium requirements in Sec. 101.65 until January 1, 2006.
While the partial stay was pending, the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) jointly published the ``Dietary Guidelines for Americans 2000'' (Ref. 1). This report provides recommendations for nutrition and dietary guidelines for the general public and suggests a diet with moderate sodium intake, not exceeding 2,400 mg per day. The health concerns relating to high salt intake are high blood pressure and loss of calcium from bones, which may lead to risk of osteoporosis and bone fractures (Ref. 1).
On February 20, 2003, FDA published a proposed rule (68 FR 8163) to amend the ``healthy'' regulation by retaining the current, less restrictive first-tier sodium level of 600 mg for meals and main dish products while permitting the more restrictive second-tier level of 360 mg for individual foods to take effect when the partial stay expired (the 2003 proposed rule). The agency also proposed to revise the regulatory text for the definition of ``healthy'' to clarify the scope and meaning of the regulation and to convert the nutrient content requirements for ``healthy'' to a more readable table-based format, consistent with the Presidential Memorandum instructing Federal agencies to use plain language.
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Summary of the Final Rule
As proposed, this final rule amends the ``healthy'' definition in Sec. 101.65(d) by eliminating the second-tier, more restrictive sodium requirement (480 mg) for meal and main dish products, which had been stayed until January 1, 2006. The final rule also eliminates the second-tier sodium requirement for individual foods instead of allowing it to go into effect on January 1, 2006, as proposed. Consequently, neither second-tier sodium requirement will take effect when the stay expires on January 1, 2006, and the sodium requirements for products labeled as ``healthy'' will remain at the current first-tier levels of 600 mg of sodium for meal and main dish products and 480 mg of sodium for individual food products. As proposed, the final rule also revises the regulatory text for the definition of ``healthy'' to clarify the scope and meaning of the regulation and to convert the nutrient content requirements for ``healthy'' to a more readable table-based format.
As discussed in section III of this document, this action is being taken as a result of comments from a variety of stakeholders urging FDA to eliminate the more restrictive sodium requirements for individual foods as well as for meal and main dish products. The comments documented substantial technical difficulties in
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finding suitable alternatives for sodium and demonstrated the lack of consumer acceptance of certain ``healthy'' products made with salt substitutes and/or lower sodium. Comments from both industry and consumer advocates support the conclusion that implementing the second- tier sodium requirements would risk substantially eliminating existing ``healthy'' products from the marketplace because of unattainable nutrient requirements or undesirable and, thus, unmarketable flavor profiles. As a result of these comments, FDA has concluded that it can best serve the public health by continuing to permit products that meet the first-tier sodium level to be labeled as ``healthy,'' and thereby ensure the continued availability of foods that consumers can rely on to help them follow dietary guidelines not only for controlling sodium but also for limiting total fat, saturated fat, and cholesterol and consuming adequate amounts of important nutrients such as fiber, protein, and key vitamins and minerals.
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Summary of Comments from the Proposed Rule
FDA received a total of 18 responses, each containing one or more comments, to the 2003 proposed rule. Of these comments, 5 were about topics other than the nutrient content claim ``healthy'' and are not considered here because they are outside the scope of this rulemaking. The remaining comments were from consumers, industry, a trade association, health and nutrition scientists and organizations, and consumer groups. The majority of the comments took the view that the more restrictive second-tier requirements for both the meal and main dish category and individual foods category should be revoked. The comments are discussed in detail in this section of the document.
To make it easier to identify comments and FDA's responses to the comments, the word ``Comment'' will appear in parentheses before the description of the comment, and the word ``Response'' will appear in parentheses before FDA's response. FDA has also numbered each comment to make it easier to identify a particular comment. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted.
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Sodium and Hypertension
(Comment 1) Several comments agreed that there is a problem with high blood pressure in the United States, citing statistics showing that 40 million people in this country are hypertensive and that an additional 45 million people are prehypertensive. Most of these comments further agreed that excess sodium in the diet is a primary cause of the incidence of high blood pressure in the United States. Comments pointed out that for two decades the National Institutes of Health's (NIH) National Heart Lung and Blood Institute (NHLBI) has recommended that Americans cut back on their sodium consumption while eating a diet high in fruits and vegetables, low-fat dairy products and limited in saturated and total fat (the DASH diet). Some comments, including comments from a consumer advocacy group and health advocacy groups, stated that it was indisputable that reducing sodium would lower blood pressure.
One comment maintained that there was no evidence that restricting sodium consumption will result in improved cardiovascular health outcomes. This comment criticized FDA's reliance on studies examining the intermediate variables associated with salt intake, such as changes in blood pressure, maintaining that the agency should instead focus on whether restricting sodium consumption will result in improved cardiovascular health outcomes. According to this comment, none of the nine studies reported since 1995 that examined health outcomes associated with reduced dietary sodium showed a benefit to the general population in terms of health outcomes such as reduced incidence of heart attacks and strokes; in fact, some studies actually found a connection between low sodium diets and adverse health outcomes, i.e., a greater incidence of heart attacks. Another comment pointed out that too little sodium can actually be harmful, especially for people with low blood pressure and those living in hot climates. A few of the comments suggested that the NIH/NHLBI study ``Dietary Approaches to Stop Hypertension--Sodium,'' known as the DASH-Sodium study, should be examined more closely before the agency comes to any conclusion about the need to reduce sodium in foods.\2\ As discussed in detail under comment 2 of this document, one comment questioned the accuracy and objectivity of this study, whose reported conclusions were that both hypertensive and nonhypertensive individuals can lower blood pressure by reducing dietary sodium.
\2\ The primary objective of the DASH-Sodium trial was to test the effects of two dietary patterns (a control diet and the DASH diet) and three sodium intake levels on blood pressure in adult men and women with blood pressure higher than optimal or at stage 1 hypertension (systolic 120-159 (millimeters of mercury (mm Hg) and diastolic 80-95 mm Hg). The DASH diet is rich in fruits, vegetables, and low fat dairy products and reduced in saturated and total fat. Consequently, it is rich in potassium, magnesium, and calcium.
Other comments expressed concern about the lack of scientific data to support changes in the sodium level for ``healthy,'' stating that the commenters were not aware of any studies showing improved health outcomes with reductions of 120 mg of sodium for individual foods. Another comment stated that the commenter was not aware of any scientific research since 1997 that increased concerns about the sodium content of foods or that showed a need for a 25 percent reduction in sodium to ensure consumer health. Still other comments suggested that before making its decision, the agency should await the outcome of the Institute of Medicine (IOM), National Academy of Science's (NAS) report on Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate (The Electrolyte Report) (Ref. 2), possible revisions of the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid, as well as the DASH-Sodium study, in the hope that examination of the issue through these deliberative processes would shed more light on the matter.
(Response) The effects of sodium on blood pressure are well documented. The IOM has recently completed its in-depth evaluation of a variety of electrolytes and established dietary reference intakes (DRI's) for these nutrients. The other scientific studies and evaluations mentioned in comments (the DASH-Sodium study and revisions of the Dietary Guidelines for Americans, 2000 and Food Guide Pyramid) have also been completed. The IOM's most recent evaluation of the role of sodium is summed up in its 2004 report (The Electrolyte Report) (Ref. 2). The Summary section of the Sodium and Chloride chapter of the Electrolyte Report states in part:
The major adverse effect of increased sodium chloride intake is elevated blood pressure, which has been shown to be an etiologically related risk factor for cardiovascular and renal diseases. On average, blood pressure rises progressively with increased sodium chloride intake. The dose-dependent rise in blood pressure appears to occur throughout the spectrum of sodium intake. However, the relationship is non-linear in that blood pressure response to changes in sodium intake is greater at sodium intakes below 2.3 g (100 mmol) per day than above this level. The strongest dose- response evidence comes from those clinical trials that specifically examined the effects of at least 3 levels of sodium intake on blood pressure. The range of sodium intake in these studies
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varied from 0.23 g (10 mmol) per day to 34.5 g (1,500 mmol) per day. Several trials included sodium intake levels close to 1.5 g (65 mmol) per day and 2.3 g/day (100 mmol/day).
While blood pressure, on average, rises with increased sodium intake, there is well recognized heterogeneity in the blood pressure response to changes in sodium chloride intake. Individuals with hypertension, diabetes, and chronic kidney diseases, as well as older-age persons and African Americans, tend to be more sensitive to the blood pressure raising effects of sodium chloride intake than their counterparts. Genetic factors also influence the blood pressure response to sodium chloride. There is considerable evidence that salt sensitivity is modifiable. The rise in blood pressure from increased sodium chloride intake is blunted in the setting of a diet high in potassium or that is low in fat, and rich in minerals; nonetheless, a dose-response relationship between sodium intake and blood pressure still persists. In non-hypertensive individuals, a reduced salt intake can decrease the risk of developing hypertension (typically defined as a systolic blood pressure >= 140 mm Hg or a diastolic blood pressure >= 90 mm Hg).
The adverse effects of higher levels of sodium intake on blood pressure provide the scientific rationale for setting the Tolerable Upper Intake Level (UL). Because the relationship between sodium intake and blood pressure is progressive and continuous without an apparent threshold, it is difficult to precisely set a UL, especially because other environmental factors (weight, exercise, potassium intake, dietary pattern and alcohol intake) and genetic factors also affect blood pressure. For adults, a UL of 2.3 g (100 mmol) per day is set. In dose-response trials, this level was commonly the next level above the AI [Adequate Intake] that was tested. It should be noted that the UL is not a recommended intake and, as with other ULs, there is no benefit to consuming levels above the AI. Among certain groups of individuals who are most sensitive to the blood pressure effects of increased sodium intake (e.g., older persons, African Americans, and individuals with hypertension, diabetes, or chronic kidney disease), their UL may well be lower. These groups also experience an especially high incidence of blood pressure-related cardiovascular disease. * * *
It is well-recognized that the current intake of sodium for most individuals in the United States and Canada greatly exceeds both the AI and UL. (The Electrolyte Report, pp. 270-272 (footnote omitted).)
The IOM also looked at cardiovascular disease and high blood pressure. Page 323 of the Electrolyte Report states that ``[d]ata from numerous observational studies provide persuasive evidence of the direct relationship between blood pressure and cardiovascular disease,'' citing a recent meta-analysis (Lewington et al., 2002) of 60 prospective observational studies with almost 1 million enrolled adults. Individuals with preexisting vascular disease were excluded. With 12.7 million person years of followup and the total number of deaths at 122,716, about half of the deaths in these studies occurred as a result of cardiovascular disease (11,960 deaths from stroke, 34,283 from ischemic heart disease, and 10,092 deaths from other vascular causes). The IOM further commented (pp. 324-325):
[S]troke mortality progressively increased with systolic blood pressure * * * and diastolic blood pressure * * * in each decade of life. Similar patterns were evident for mortality from ischemic heart disease and from other vascular diseases. In analyses that involved time-dependent correction for regression-dilution bias, there were strong, direct relationships between blood pressure and each type of vascular mortality. Importantly, there was no evidence of a blood pressure threshold--that is, vascular mortality increased throughout the range of blood pressures, in both non-hypertensive and hypertensive individuals.
The IOM also looked at the effects of reduced sodium intake on blood pressure using evidence from intervention studies in both nonhypertensive and hypertensive individuals (page 329). Although the studies differed in size (500 persons), duration (range 3 days to 3 years), extent of sodium reductions, background diet (e.g., intake of potassium), study quality and documentation, the studies provided relatively consistent evidence that a reduced intake of sodium lowers blood pressure in both hypertensive and nonhypertensive adults. In these intervention trials, the extent of blood pressure reduction from a lower intake of sodium in hypertensive participants was more pronounced than that observed in nonhypertensive participants. (See The Electrolyte Report, Tables 6-12 and 6-13.)
The NIH/NHLBI DASH-Sodium study tested the effects of two dietary patterns (a control diet and the DASH diet described previously) and three sodium intake levels on blood pressure in adult men and women with blood pressure higher than optimal or at stage 1 hypertension. The overall blood pressure range for the study was systolic 120-159 mm Hg and diastolic 80-95 mm Hg. The reported conclusions of the DASH-Sodium study were that both hypertensive and nonhypertensive individuals can lower blood pressure by reducing dietary sodium. These conclusions were generally consistent with those of the other intervention studies, showing a connection between reduced sodium intake and lowered blood pressure in both hypertensive and nonhypertensive subjects, with a greater effect observed in the hypertensive subjects.
The IOM considered the DASH-Sodium trial in the Electrolyte Report, which describes the results of the subgroup analysis as follows:
On the control diet, significant blood pressure reduction was evident in each subgroup. Reduced sodium intake led to greater systolic blood pressure reduction in individuals with hypertension compared with those classified as non-hypertensive, African Americans compared with non-African Americans, and older individuals (> 45 years old compared with those Producers increase the sodium level to 480 mg for the 25 percent of ``healthy'' meals and main dishes that are currently below 480 mg of sodium.
Producers reduce the sodium level to 480 mg for 56 percent of ``healthy'' meals and main dishes (37.5 percent with no loss of taste, 19 percent with some loss of taste).
Producers either drop ``healthy'' from the label or cease producing 19 percent of all ``healthy'' meals and main dishes.
In this scenario, consumers respond to the loss of taste and disappearance of products by switching choices within the ``claims'' segment of the market, which includes ``healthy'' and similar meals and main dishes. They switch with equal probability to any one of the three brands in the ``claims'' segment, which means that one-third will switch to another ``healthy'' branded product and two-thirds will switch to products outside the ``healthy'' brand. The market share loss of the ``healthy'' brand is therefore 25 percent of its market, or two- thirds of the 37.5 percent of the market that experiences loss of taste, or disappearance of products. This is 11.3 percent of the total ``claims'' market. The average sodium intake implied by the market activity in this scenario under option 1 is 566 mg per meal.
Scenario 6b: Combined Total Response to Option 2b. We assume that producers will reformulate most, but not all, of the ``healthy'' products to the first-tier limit. We believe producers of ``healthy'' products will choose to position themselves as a slightly lower sodium alternative in this market, as they are currently positioned, but reformulate to increase sodium to improve taste. Because of improved taste, these producers increase their market share by 10 percent under this scenario, so the average sodium intake under the proposed amendment would be 588 mg per meal.
The difference between scenarios 6a and 6b gives us the difference in average sodium consumption between option 2b and option 1, the baseline. This amount, 22 mg sodium per meal, is the best estimate of the ``sodium cost'' of option 2b.
FDA's technical memorandum (Ref. 15) repeats the basic parts of this analysis for a second sample of products from the Web sites of a producer of ``healthy'' products and a ``claims'' segment producer, which we performed as a stress test\13\ of the first sample conclusions. The result from this different sample of meal products is quite close to the 22 mg ``sodium cost'' calculated in scenario 6 of table 2 of this document.
\13\ A stress test is performed to see if the model results hold using a different data sample.
According to our analysis, the sodium increase under option 2b would be insubstantial. Almost all studies linking sodium's influence on hypertension, coronary heart disease, and stroke consider the effect of a change in sodium consumption two orders of magnitude larger than these changes. A 100 millimole (mmol) (2,300 mg) difference per day is typical in both clinical and epidemiological studies; these studies do not address the relative dose-response relationship of the small sodium intake differences found in the scenarios. Even if the effect were linear (i.e., even if the health risk associated with the mg change per day in sodium under option 2b were a simple percentage of the 2,300 mg risk), the total statistical lives saved by implementing the second- tier sodium level for meals and main dishes would be less than 1 under the total effects calculation in table 2 of this document and in the results of the second sample (Ref. 15). Since FDA does not assume a linear health response to sodium intake, however, the agency concludes that the health effects from this low level of sodium increase are negligible.
Benefits of Option 2b. In the analysis of market data for the 2003 proposed rule, FDA identified 148 meals and main dishes labeled ``healthy'' among 10 brands (see 68 FR 8163 at 8169). Under option 1 (no amendment to the current rule), manufacturers would have to reformulate their products (meals and main dishes in this case) to meet the second-tier sodium level when the stay expires. Reformulation costs would be the lower limit of the cost to society of the current rule. If producers could reformulate perfectly, without altering any property other than sodium content, then reformulation would be the total cost of option 1. But if they could not
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replicate the desirable characteristics of their product, consumers would also suffer the utility loss of a market with fewer meal choices.
In the product samples used for the scenario analyses regarding the cost of the second-tier sodium level for meals and main dishes, a significant percentage (around 75 percent in the store-based sample and 50 percent in the Web site sample) of the major ``healthy'' producer's products were above the second-tier sodium levels. If this sample represents the market as a whole, then approximately 74 to 111 products would need to reduce their sodium to meet the second-tier level. In estimating the total effects of the second-tier sodium level on meals and main dishes, we assumed that 56 percent, or 83 of the 148 products on the market (see scenario 6a in table 2 of this document), would be reformulated.
Preliminary testing costs incurred in the first stage of reformulation--according to comments on the ANPRM received from a frozen meal ``healthy'' brand producer that had begun investigating possible reformulation--were well over $1 million, but we do not have detailed reformulation cost estimates for meals and main dishes. Consistent with its estimate for individual foods (see discussion under ``Benefits of Option 2a''), FDA assumes that reformulating a meal or main dish would require 5,000 hours of professional time at $30 per hour, $190,000 for development and pilot plant operating expenses, and $100,000 for market testing per product. Since this reformulation would be undertaken to keep the ``healthy'' claim on an existing product, we assume negligible relabeling or marketing costs. The total reformulation costs are therefore $440,000 per product, or $36,520,000 for the 83 meals assumed to be reformulated if adopting the second-tier sodium levels for meals and main dishes under scenario 6a. Assuming 50 percent of the cost is incurred per year for 2 years, and ignoring the time discount, the cost is $18,260,000 per year.
The agency assumes that a substantial number of market participants would choose to rebrand or relabel their products out of the ``healthy'' category if it becomes too restrictive. As with option 2a, the direct costs of relabeling the product and conducting a marketing campaign would be social costs, since they represent extra investment that will not increase or improve the choice of products for consumers. Although FDA has no information about the costs of this type of rebranding activity, they are probably substantial. As discussed in the analysis of the benefits of option 2a in this document, there will also be a $0.32 per unit premium loss on ``healthy'' products no longer on the market. Sales of the brands still in the market were approximately 1.3 million units per product in 1999 (Ref. 8). Under the assumption of 19 percent loss of ``healthy'' meals and main dishes if the second-tier sodium level goes into effect (scenario 6a), 28 products would be taken off the market, either by rebranding or relabeling them out of the ``healthy'' category or by discontinuing them altogether, with a total lost premium of $11,648,000 per year (28 products x $0.32 premium lost x average sales of 1.3 million units per year).
Adding this cost to the reformulation costs of the 83 products yields a total cost estimate of $29.90 million for years one and two, and a residual of the lost premium of $11.65 million for what would have been the rest of the normal life cycle of the lost ``healthy'' brand. Avoiding these costs represents a large benefit of option 2b.
Option 2c: Retain the First-Tier Sodium Levels for ``Healthy'' Meals and Main Dishes and Individual ``Healthy'' Foods (the Final Rule). The benefits and costs of option 2c are close to the sum of the benefits and costs associated with options 2a and 2b. However, as explained in the discussion of option 2a, retaining the first-tier sodium levels for ``healthy'' individual foods would decrease the consistency, relative to option 2b, between sodium levels in ``healthy'' meals and main dishes and the sodium levels in meals put together by combining ``healthy'' individual foods.
Costs of Option 2c. The cost of this option, as with option 2a for individual foods and option 2b for meals and main dishes, is the increased risk due to higher sodium intake and the diminishing effectiveness of the ``healthy'' claim as a signal to identify products that contain strictly controlled levels of sodium. Since option 2c is essentially combining options 2a and 2b, the costs associated with a higher sodium intake are roughly the sum of the costs associated with options 2a and 2b.
As explained in detail in the discussion of option 2b of this document, the average increase in sodium intake occurring under option 2b relative to option 1 is insubstantial (roughly 22 mg per meal), and the health effects from this low level of sodium increase are negligible. Even under the conservative assumption of a linear dose response, the statistical lives saved by decreasing allowable sodium in ``healthy'' meals and main dishes to second-tier levels would be less than 1.
As discussed in detail under option 2a of this document, the potential change in sodium intake occurring under option 2a (relative to option 1) due to retaining the less restrictive first-tier level of sodium allowable in individual foods labeled as ``healthy,'' is uncertain. Because most individual foods are not restricted in formula under either sodium level, and because consumers may turn to higher sodium alternatives if the sodium level requirement becomes too restrictive for certain products (soups, cheeses, pasta sauces), the net increase in sodium will probably be small. Furthermore, the health costs due to a small increase in sodium intake will be largely mitigated by retaining a greater number of choices of relatively healthy foods (low in fat and saturated fat, controlled in cholesterol and sodium, and a good source of one or more beneficial nutrients).
Therefore, the costs of option 2c resulting from the reduced effectiveness of the ``healthy'' claim as a signal of foods with strictly controlled sodium and the health risks due to a potential increase in total sodium intake, though uncertain, are likely to be small.
Benefits of Option 2c. The benefits of avoiding reformulation, rebranding, and relabeling costs under this option are roughly the sum of the benefits associated with options 2a and 2b.
As discussed in the benefits section of option 2a of this document, the benefits of avoiding reformulation, rebranding, and relabeling costs by retaining first-tier sodium levels for ``healthy'' individual foods are substantial. FDA estimates the total cost avoided under option 2a to be $20.77 million for years one and two, and a residual of the lost premium of $17.47 million for what would have been the rest of the normal life cycle of the lost ``healthy'' products.
The benefits of avoiding reformulation, rebranding, and relabeling costs by retaining first-tier sodium levels for ``healthy'' meals and main dishes are also substantial. FDA estimates the total cost of reformulation and relabeling avoided under option 2b is $29.90 million for years one and two, and $11.65 million per year thereafter.
The total benefits of option 2c from the avoided reformulation and relabeling costs associated with implementing the second-tier sodium levels for both ``healthy'' meal and main dish products and ``healthy'' individual foods are equal to the sum of the benefits of options 2a and 2b: $50.67 million for years one and two, and $29.12 million per year thereafter.
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Net Benefits of Option 2c. The net benefits of option 2c, retaining the first-tier level of sodium for both ``healthy'' meal and main dish products and ``healthy'' individual foods, are roughly the sum of the net benefits of options 2a and 2b.
Since the net benefits of retaining the first-tier sodium level for both ``healthy'' individual foods and ``healthy'' meal and main dish products are substantial and positive, FDA concludes that the net benefits of 2c, roughly the sum of the net benefits associated with 2a and 2b, are substantial and positive, and higher than the net benefits of the other options. Therefore, net benefits are maximized by option 2c, the final rule, which adopts the first-tier sodium levels for both individual foods and for meals and main dishes. 3. Summary of Benefits and Costs
This analysis attempts to use limited data to illustrate in some detail what would take place in the market under this final rule (option 2c) and other regulatory alternatives. The analysis for both ``healthy'' meals and main dishes and ``healthy'' individual foods shows that while the benefits of retaining the first-tier sodium level (the costs foregone) are substantial for companies that would need to reformulate to comply with the second-tier sodium level or rebrand and relabel themselves out of the ``healthy'' market, the health costs associated with retaining the first-tier sodium level are both unquantifiable and most likely insubstantial. The benefits of the foregone reformulation, rebranding, and relabeling costs, and the health benefits of keeping available a greater choice of goods that are simultaneously low in fat and saturated fat, controlled in cholesterol and sodium, and a good source of beneficial nutrients, clearly outweigh the costs due to a small loss in the strength of the ``healthy'' sodium signal and a small increase in average daily sodium intake. Therefore, the net benefits of the rule, which would adopt as permanent the first- tier sodium level for all foods, are positive.
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Small Entity Analysis
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA finds that this final rule would not have a significant economic impact on a substantial number of small entities.
This final rule makes permanent the first-tier sodium level of 600 mg for meals and main dishes and 480 mg for individual foods. Without this final rule, the more restrictive second-tier sodium levels would raise the costs of making a ``healthy'' claim on such products. If a small business were to market a ``healthy'' meal, main dish, or individual food, it would be able to do so at lower cost under the final rule than if FDA left the current rule unmodified. FDA therefore certifies that this final rule will not have a significant impact on a substantial number of small entities.
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Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement that includes an assessment of anticipated costs and benefits before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $115 million, using the most current (2003) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
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Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
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Federalism
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
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References
The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
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U.S. Department of Agriculture and Department of Health and Human Services, ``Dietary Guidelines for Americans'' 5th ed., U.S. Government Printing Office, Washington, DC, 2000.
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Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate, chapter 6, ``Sodium and Chloride'' pp 269- 423. Panel on Dietary Reference Intakes for Electrolytes and Water, Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine of the National Academies, The National Academies Press 2004.
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``Dietary Guidelines for Americans 2005'' U.S. Department of Health and Human Services, U.S. Department of Agriculture http://www.healthierus.gov/dietaryguidelines.
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MyPyramid.gov, U.S. Department of Agriculture first available 2005 at http://www.mypyramid.gov
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Letter from Carl A. Roth, Associate Director for Scientific
Program Operation, to William Kovaks, Vice President Environment, Technology, & Regulatory Affairs, Chamber of Commerce of the United States of America, and Richard Hanneman, President, The Salt Institute, August 19, 2003, http://aspe.hhs.gov/infoquality/request&response/reply_8b.shtml .
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Letter from Barbara Alving, Acting Director to William Kovaks, Vice President Environment, Technology, & Regulatory Affairs, Chamber of Commerce of the United States of America, and Richard Hanneman, President, The Salt Institute, February 11, 2004, http://aspe.hhs.gov/infoquality/request&response/reply_8d.shtml.
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Calories Count Report of the Working Group on Obesity March 12, 2004, http://www.cfsan.fda.gov/~dms/owg-toc.html.
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Anderson, Ellen M., memorandum to file, September 3, 2002.
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Anderson, Ellen M. and Heili Kim, memorandum to file, August 30, 2001.
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``Healthy Choice Total Franchise Sales vs. Total Food Sales (IRI)'' Exhibit 3A to ConAgra Comment C 127 to 91N-384H.
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``Trends in the United States, Consumer Attitudes and the Supermarket 1996,'' Conducted for the Food Marketing Institute By Abt Associates Inc., Published by The Research Department, Food Marketing Institute, Washington, DC.
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``Healthy Choice Soup 2003 Taste Test Results'' Exhibit 4 to ConAgra Comment C 127 91N-384H.
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``Soup Category Sales Breakdown'' Exhibit 5 to ConAgra Comment C 127 to 91N-384H.
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National Partnership for Reinventing Government, Plain Language Action Network, Presidential Memorandum on Plain Language, http://www.plainlanguage.gov/whatisPL/govmandates/memo.cfm.
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Mancini, Dominic, memorandum to file, May 23, 2002.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
[[Page 56848]]
0 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is amended as follows:
PART 101--FOOD LABELING
0 1. The authority citation for 21 CFR part 101 continues to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
0 2. Section 101.65 is amended by revising paragraph (d) to read as follows:
Sec. 101.65 Implied nutrient content claims and related label statements.
* * * * *
(d) General nutritional claims. (1) This paragraph covers labeling claims that are implied nutrient content claims because they:
(i) Suggest that a food because of its nutrient content may help consumers maintain healthy dietary practices; and
(ii) Are made in connection with an explicit or implicit claim or statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'').
(2) You may use the term ``healthy'' or related terms (e.g., ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if:
(i) The food meets the following conditions for fat, saturated fat, cholesterol, and other nutrients:
The
The If the food The fat saturated cholesterol The food is...
level must fat level level must must be... must be... be... contain...
(A) A raw fruit Low fat as Low
The
N/A or vegetable defined in saturated disclosure Sec.
fat as
level for 101.62(b)( defined in cholesterol 2)
Sec.
specified in 101.62(c)(2 Sec. )
101.13(h) or less
(B) A single- Low fat as Low
The
N/A ingredient or a defined in saturated disclosure mixture of
Sec.
fat as
level for frozen or
101.62(b)( defined in cholesterol canned fruits 2)
Sec.
specified in and
101.62(c)(2 Sec. vegetables\1\
)
101.13(h) or less
(C) An enriched Low fat as Low
The
N/A cereal-grain defined in saturated disclosure product that Sec.
fat as
level for conforms to a 101.62(b)( defined in cholesterol standard of 2)
Sec.
specified in identity in
101.62(c)(2 Sec. part 136, 137
)
101.13(h) or or 139 of this
less chapter
(D) A raw,
Less than 5 Less than 2 Less than 95 At least 10 single-
grams (g) g saturated mg
percent of ingredient
total fat fat per RA cholesterol the RDI\3\ seafood or game per RA\2\ and per 100 per RA and or the meat
and per g
per 100 g DRV\4\ per 100 g
RA of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber
(E) A meal
Low fat as Low
90 mg or less At least 10 product as
defined in saturated cholesterol percent of defined in Sec. Sec.
fat as
per LS\5\ the RDI or 101.13(l) or 101.62(b)( defined in
DRV per LS a main dish 3)
Sec.
of two product as
101.62(c)(3
nutrients defined in Sec.
)
(for a main 101.13(m)
dish product) or of three nutrients (for a meal product) of: vitamin A, vitamin C, calcium, iron, protein, or fiber
(F) A food not Low fat as Low
The
At least 10 specifically defined in saturated disclosure percent of listed in this Sec.
fat as
level for the RDI or table
101.62(b)( defined in cholesterol the DRV per 2)
Sec.
specified in RA of one 101.62(c)(2 Sec.
or more of )
101.13(h) or vitamin A, less
vitamin C, calcium, iron, protein or fiber
\1\ May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable. \2\ RA means Reference Amount Customarily Consumed per Eating Occasion (Sec. 101.12(b)). \3\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)). \4\ DRV means Daily Reference Value (Sec. 101.9(c)(9)). \5\ LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (Sec. 101.9(b)).
[[Page 56849]]
(ii) The food meets the following conditions for sodium:
If the food is...
The sodium level must be...
(A) A food with a RA that is
480 mg or less sodium per RA and greater than 30 g or 2 tablespoons per LS (tbsp.)
(B) A food with a RA that is equal 480 mg or less sodium per 50 g\1\ to or less than 30 g or 2 tbsp.
(C) A meal product as defined in 600 mg or less sodium per LS Sec. 101.13(l) or a main dish product as defined in Sec. 101.13(m)
\1\ For dehydrated food that is typically reconstituted with water or a liquid that contains insignificant amounts per RA of all nutrients (as defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared'' form of the product.
(iii) The food complies with the definition and declaration requirements in this part 101 for any specific nutrient content claim on the label or in labeling, and
(iv) If you add a nutrient to the food specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foods in Sec. 104.20 of this chapter.
Dated: September 23, 2005. Jeffrey Shuren, Assistant Commissioner for Policy.
[FR Doc. 05-19511 Filed 9-28-05; 8:45 am]
BILLING CODE 4160-01-S
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