RE: Docket No. FDA 2012 N 1210, RIN 0910 AF22: Food Labeling: Revision of the Nutrition and Supplement Facts Labels

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1 August 1, 2014 Division of Dockets Management (HFA-305) 5630 Fishers Lane Rm Rockville, MD RE: Docket No. FDA 2012 N 1210, RIN 0910 AF22: Food Labeling: Revision of the Nutrition and Supplement Facts Labels Dear Sir or Madam: The Natural Products Association (NPA) is submitting this letter as general comments to Docket No. FDA 2012 N 1210, RIN 0910 AF22 regarding the proposed changes to nutrition and supplement facts labels. Thank you for the opportunity to comment. NPA was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods and natural products. NPA is a non-profit 501(c)(6) association whose mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products. We are the oldest and largest trade association in the natural products industry representing over 1,900 members accounting for almost 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids. Many, if not most, NPA members make or sell food or dietary supplement products and will therefore be impacted by the proposed revisions. NPA applauds the Food and Drug Administration s (FDA) goal of evaluating and revising the nutrients that are required and/or permitted to be declared and their daily values, as applicable; amending requirements for foods specifically for children under the age of 4 years, and pregnant and lactating women; and updating the format of the Nutrition and/or Supplement Facts labels to make the nutrition information on product labels relevant and easy to understand, as well as to ensure the information presented represents current scientific and

2 public health knowledge related to nutrients and human nutrition. For the most part we support these proposed revisions, and in these comments we address several specific proposed changes where we want to express our support, request clarification or with which we disagree or consider unnecessary. Added Sugars 1 FDA has proposed the mandatory declaration of added sugars: 101.9(c)(6)(iii), Added Sugars : A statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content. If a statement of the added sugars content is not required and, as a result, not declared, the statement Not a significant source of added sugars shall be placed at the bottom of the table of nutrient values in the same type size. Added sugars shall be defined as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono and disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated so that sugar is the primary component (e.g., fruit juice concentrates), and other caloric sweeteners. Added sugars content shall be indented under sugars and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement Contains less than 1 gram or less than 1 gram may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When a mixture of naturally occurring and added sugars is present in the food, and for specific foods containing added sugars, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation, the manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of added sugars in the label and labeling of food. NPA would like to know what consumer research was conducted and empirical data collected to support the position that declaring added sugars in labeling would lead to changes in behavior to eat less sugar, weight reduction, and ultimately overall health benefits. NPA wants to know what material fact and which consumer studies were used to compel this change for mandatory labeling. While NPA may not disagree with U.S. consensus and expert groups that support reducing the amount of added sugars in the diet, NPA would like transparency into what studies were used to demonstrate that declaring added sugars on a label will result in firms reducing the amount of added sugars in products, resulting in an overall reduction of sugar 1 79 Federal Register (March 3, 2014)

3 consumption. For example, there is no discussion of a dataset to suggest that mandatory labeling could conceivably cut down sugar intake by a certain percent over the next five years. Sodium 2 FDA is proposing an updated reference value for the declaration of percent DV for sodium from the current value of 2,400 mg (milligrams) to 2,300 mg based on a consideration of current science and IOM s report that set Dietary Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake Level of 2,300 mg/day (d) as a reference intake level not to exceed. The sodium levels FDA is adopting are based upon the IOM Sodium Strategies Report and the findings from its Committee on Strategies to Reduce Sodium Intake in the U.S. That report included recommendations based upon race, age, and those with pre-existing medical conditions. It is not clear how this change in the sodium reference value from 2,400 mg to 2,300 mg will result in consumers eating less sodium. NPA would like to know what dataset was used to suggest that lowering the sodium reference value by 100 mg will result in behavioral change among consumers. Folic Acid/Folate 3 FDA is proposing to modify labeling requirements related to the terms that would be allowed for folic acid/folate for conventional foods and dietary supplements as follows: (vii) When the amount of folate is declared in the labeling of a conventional food, the nutrient name folate shall be listed for products containing either folate alone or a mixture of folate and folic acid. The name of the synthetic form of the nutrient, folic acid shall be used when the nutrient is declared in the labeling of dietary supplements. In the preamble, FDA states: Consistent with the proposed amendments related to the units of measure for folate that take into account the differences between folate and folic acid, we are reconsidering appropriate terms for declaration of folate content in foods and dietary supplements. We are proposing to (1) eliminate the synonym "folacin" specified in 101.9(c)(8)(v) and (b)(2)(B)(2); (2) require, in proposed 101.9(c)(8)(vii), that the term "folate" be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid; and (3) require that the term "folic acid" be used in the labeling of dietary supplements only. As proposed, conventional foods would not be permitted to use the term "folic acid." Federal Register (March 3, 2014) 3 79 Federal Register (March 3, 2014) 4 79 Federal Register (March 3, 2014)

4 Additionally, FDA goes on to explain that, We are proposing to only allow the use of the term folic acid for the labeling of dietary supplements. Folate is a nutrient found in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified conventional foods and dietary supplements. As discussed in section II.J.2., folic acid or folacin are identified as synonyms of folate and can be used on the Nutrition Facts label ( 101.9(c)(8)(v)) or in the Supplement Facts label ( (b)(2)(i)(B)(2)). However, because of the difference in bioavailability between naturally occurring folate, and synthetic folic acid, we are proposing to amend 101.9(c)(8)(v) such that the term folate would be used in the labeling of conventional foods that contain either folate alone or a mixture of folate and folic acid. As discussed in section II.J.2.c., we consider only the term folic acid to be appropriate for use in the labeling of dietary supplements. Therefore, we are proposing to amend (b)(2)(i)(B) and (b)(2)(i)(b)(2) to specify that folic acid is the term used to declare folic acid content of dietary supplements; and to remove folate and folacin from the list of synonyms that may be used to declare folic acid on the Supplement Facts label 5 FDA also states that [a]s proposed, conventional foods would not be permitted to use the term folic acid. 6 NPA strongly disagrees with the synonym change, that is mandating that folate be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid and mandating that dietary supplements must use the term folic acid and would be prohibited from using the term folate. Folate and folic acid are synonymous, well-known to consumers and used interchangeably, with minor differences in bioavailability. Allowing use of the term folic acid in the labeling of dietary supplements, a category of food, suggests that there is nothing wrong with the term and that its prohibition in conventional food labeling is arbitrary and capricious. The synonyms have been used interchangeably for years, and the recognized difference in bioavailability between folic acid and folate should be allowed on all labels so as not to be false or misleading. FDA seems to encourage misleading practices with this change. If the conventional food contains mixed folate and folic acid, but the proposed rule requires one to list only folate, it is misleading to consumers and introduces significant confusion for those with labeling experience. Additionally, folacin is a well-recognized synonym and should not be removed from the current codified federal regulations. Tetrahydrofolate, methyltetrahydrofolate, and methyl folate, the biologically active forms of folate, should also be allowed synonyms. Dietary supplements are often developed to deliver the biologically active form, and therefore FDA should allow 5 79 Federal Register (March 3, 2014) 6 79 Federal Register (March 3, 2014)

5 synonyms for these forms of folate. A more balanced, sensible approach for both conventional foods and dietary supplements to promote truth in advertising, is to require companies to label their products with the appropriately used term(s) for the ingredient(s) used in the manufacture of the product. If FDA is looking to provide uniformity in labeling by using the RDV for folate, then this could be handled through consumer education during the finalized rule roll out. If there is such a difference in bioavailability for folate and folic acid, why are there not two different RDVs for each form? NPA believes you would need less folic acid to satisfy the DRV, which is derived for folate. While NPA agrees that there is a difference in bioavailability, the difference between the two forms is not that great because the permitted use of folic acid in dietary supplement labeling would involve use of the folate DRV. A primary goal of nutritional labeling is to inform consumers about the nutrients in their food, including the sources of these nutrients, and to provide labeling that is truthful and not misleading. If a conventional food contains even a mixture of folate and folic acid and the conventional food is not permitted to declare folic acid in the nutrition label, how are consumers not misled? If FDA believes Folacin and the biologically active forms of folate should not be permitted in labeling despite containing those dietary ingredients in the product, what message is FDA sending to consumers about accurately labeled products? Many consumers seek out a specific form of certain nutrients, including but not limited to folate, folic acid, folacin, tetrahydrofolate, methyl tetrahydrofolate, and methyl folate, and FDA s proposal regarding how to list folate and folic acid in conventional foods and supplements is illogical and contrary to consumers interests. Fluoride 7 The proposal states that there is evidence demonstrating that dietary fluoride exposure is beneficial to public health owing to its ability to inhibit the development of dental caries in both children and adults 8 (Ref. 90) 9. Therefore, consistent with the factors we consider for declaration of nonstatutory nutrients discussed in section I.C., we are proposing to amend 101.9(c)(5) to provide for voluntary declaration of fluoride. In addition, consistent with existing provisions for voluntary declaration of other nutrients, we are proposing that the declaration of fluoride would be mandatory when a claim about fluoride is made on the label or in labeling of foods. NPA is requesting clarity in this area as the wording in the proposal seems to suggest that the Agency is proposing to allow fluoride claims for dental caries on all food labels. If so, will 7 79 Federal Register (March 3, 2014) 8 79 Federal Register (March 3, 2014) 9 Institute of Medicine (IOM) of the National Academies. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and fluoride, Chapter 8: Fluoride, Washington, DC: National Academies Press; pp

6 these health claims then be permissible, beyond fluoride in bottled water products, to include conventional foods and dietary supplements of any matrix because FDA has evidence acknowledging Fluoride s benefits here? Will the current qualified health claim for fluoridated water and reduced risk of dental caries be updated? Or will claims for reduction in dental caries on all conventional food products, other than bottled water, and dietary supplements cause them to be regulated under a different category (i.e., as a disease claim and therefore regulated as an unapproved drug)? If FDA s evidence suggests benefits of dietary fluoride exposure in preventing dental caries, it is reasonable to conclude that the qualified health claim should be expanded to allow the claim in all products, conventional foods and dietary supplements, labeled with dietary fluoride and in all matrices (capsule, tablet, liquid). Class I and Class II Nutrients 10 FDA is proposing plain language edits to revise the current language to clarify that when a nutrient or nutrients are not naturally occurring (exogenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to Class I requirements rather than Class II requirements. While we support this clarification, NPA requests/recommends FDA allow an acceptable range for meeting label claim with Class I nutrients. Degradation of dietary ingredients is anticipated and can occur during the shelf life of the product. Degradation can occur faster with some nutrients over others and with certain matrices. While 21 CFR (f) allows for reasonable excesses or planned overages over labeled amounts, NPA is concerned that firms will include large excesses (20% +) to remain in compliance for Class I nutrients and other dietary ingredients over the shelf life of the product. While NPA supports that products should be formulated to meet 100 percent of their label claim, and supports that all nutrients and ingredients that make a strength claim must meet that specification at the time of production, NPA and consumers do not want to see massive overages added to products to remain in compliance. NPA is requesting a reasonable variance allowance for minor loss of strength during the product shelf life for Class I nutrients and other dietary ingredients, similar to that allowed in drug monographs and the 80 percent allowance for Class II nutrients. NPA seeks a change to 21 CFR (f)(1) to say that products will be deemed to be in compliance with this section if the dietary ingredient content is at least equal to 90 percent of the value for that dietary ingredient declared on the label. It is also in compliance if it conforms with the specifications of an official compendium. Reasonable excesses of dietary ingredients over labeled amounts would still be acceptable within current good manufacturing practices Federal Register (March 3, 2014)

7 FDA should allow a lower limit of 90 percent potency as in the U.S. Pharmacopeia (USP). USP has recognized the unique nature of dietary supplements in its monographs and currently sets potency ranges with a lower limit of 90 percent for each class of supplement. FDA should adopt a similar approach and not force the USP to modify its standards to comport with FDA s flawed approach. On this issue, DSHEA makes clear Congress intent that compendial standards should be the guiding influence where compendial standards exist and products are represented as complying with those standards. 21 U.S.C. 343 (s)(2)(d) states that a food shall be deemed misbranded, [i]f (1) it is a dietary supplement and (2)(D) the supplement (i) is covered by the specifications of an official compendium; (ii) is represented as conforming to the specifications of an official compendium; and (iii) fails to so conform. 11 It is illogical for FDA to allow potency ranges for drug products and not for dietary supplements. Drugs contain active ingredients, just as dietary supplements are formulated with dietary ingredients, all of which have an impact on the structure and function of the body. Drugs are relied upon by patients as therapeutically active compounds for the treatment and cure of disease and other health conditions. If FDA is willing to allow products such as drugs to be available at less than 100 percent potency, it should permit the same for dietary supplements. Furthermore, most dietary supplement ingredients degrade naturally over time. To meet the 100 percent potency requirement, manufacturers will need to formulate products with substantial overages so that they meet label claim over the shelf life listed for the product. FDA s policy will incur substantial added expense as manufacturers will reformulate with excess dietary ingredients and pass the costs on to consumers. 12 Conclusions In these comments, NPA has outlined its concerns with changes to nutrition and supplement facts labels. NPA would like FDA to present empirical data from consumer studies to support their changes. The requirement to only list folate and not allow other synonyms is very concerning to NPA, as many dietary supplement manufacturers label products with dietary supplements that supply folate. Given FDA s comments regarding the general health benefits of the ingredient fluoride to prevent dental caries, NPA commented on the extent to which firms could make these claims when the product is not bottled water. NPA also provided recommendations for the Agency to allow for reasonable variance for minor loss of strength during the product shelf life for Class I nutrients and other dietary ingredients. Thank you for the opportunity to comment on this important issue. We appreciate the opportunity to participate in this important regulatory public rule-making process. 11 REF: Citizen Petition: Dietary Supplement Potency, Prepared by Sidley & Austin (May 3, 1999). 12 REF: Citizen Petition: Dietary Supplement Potency, Prepared by Sidley & Austin (May 3, 1999).

8 Respectfully submitted, Lauren R. Cohen VP, Public Relations and Communications Natural Products Association cc: