Source: https://www.global-regulation.com/law/united-states/26335/infant-formula%253a-the-addition-of-minimum-and-maximum-levels-of-selenium-to-infant-formula-and-related-labeling-requirements.html
Timestamp: 2018-11-13 16:18:58
Document Index: 713231640

Matched Legal Cases: ['§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107', '§ 106', '§ 107', '§ 101', '§ 107', '§ 107', '§ 107', '§ 107', '§ 101', '§ 101', '§ 107', '§ 107', '§ 107', '§ 107', '§ 107']

Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements (United States)
Link to law: https://www.federalregister.gov/articles/text/raw_text/201/515/394.txt
Instructions: All submissions received must include the Docket No. FDA-2013-N-0067 for this rulemaking. All objections received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document.
Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient content of infant formulas. Under section 412(i)(2) of the FD&C Act, the Secretary of Health and Human Services (the Secretary) is authorized to revise the list of required nutrients and the required level for any required nutrient. This authority has been delegated to the Commissioner of Food and Drugs (the Commissioner). The table in section 412(i) of the FD&C Act, and in FDA regulations at § 107.100(a) (21 CFR 107.100(a)), specifies that infant formulas must contain 29 nutrients; minimum levels for each nutrient and maximum levels for 9 of the nutrients are also specified. In 1989, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance for selenium for infants 0 to 6 months of age of 10.0 micrograms per day (μg/day), a level extrapolated from adult values on the basis of body weight and with a factor allowed for growth (Ref. 1).
In the Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend the nutrient specifications for infant formula to include selenium as a required nutrient in § 107.100(a). We also proposed to establish minimum and maximum levels for selenium in infant formulas because evidence exists for both deficiency and toxicity of selenium. We proposed 2.0 μg selenium per 100 kilocalories (/100 kcal) as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas.
In addition, we proposed to amend the labeling requirements for infant formula in § 107.10(a)(2) to add selenium to the list of nutrients along with the requirement to list the amount of selenium per 100 kcal in the formula.
Section 412(i) of the FD&C Act contains a table of nutrients (including minimum and, in some cases, maximum levels for nutrients) that are required to be in an infant formula. Section 412(i)(2) of the FD&C Act authorizes the Secretary to revise the statutory table of nutrients and to revise the level of any required nutrient. The Secretary has delegated this authority to the Commissioner. Our regulations establishing the table of nutrients are codified at § 107.100.
The final rule amends § 107.100 to add selenium to the list of nutrients required for infant formula. The legal authority for the amendment to § 107.100 comes from section 412(i)(2) of the FD&C Act.
The final rule also requires adding selenium to the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2). “Infant formula” is defined as a food for “special dietary use” under section 201(z) of the FD&C Act (21 U.S.C. 321(z)). Under sections 403(j) and 701(e) of the FD&C Act (21 U.S.C. 343(j) and 21 U.S.C. 371(e)), the Secretary, and by delegation the Commissioner, may prescribe regulations concerning the vitamin and mineral content of foods for special dietary uses to fully inform purchasers as to the value of the food for such uses. As such, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2) under sections 201(z), 403(j), 412(i), and 701(e) of the FD&C Act.
A. The Addition of Selenium to the Statement of the Amounts of Nutrients (§ 107.10(a)(2))
The proposed rule would amend the infant formula nutrient labeling and nutrient specification regulations at §§ 107.10 and 107.100, respectively. Proposed § 107.10(a)(2) would add selenium to the statement of the amounts of nutrients required for infant formula labeling.
We did not receive any comments on proposed § 107.10(a)(2). However, we note that we have revised § 107.10(a)(2) in this final rule to correspond to changes resulting from an interim final rule that appeared in the Federal Register on February 10, 2014 (79 FR 7934), and later affirmed in a final rule that appeared in the Federal Register on June 10, 2014 (79 FR 33057). In brief, § 107.10(a)(2) was reworded by replacing “A statement of the amount of each of the following nutrients supplied by 100 kilocalories” with “A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer.”
B. Minimum and Maximum Levels of Selenium (§ 107.100)
Proposed § 107.100(a) would add selenium to the list of required nutrients in infant formula. The proposal also would establish minimum and maximum levels for selenium in infant formula because evidence exists for both deficiency and toxicity of selenium, and there is no room for error in production of a food that serves as the sole source of nutrition for infants. We proposed to set 2.0 μg selenium/100 kcal as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas. Since the publication of the proposed rule, we have conducted a search of the scientific literature to identify whether additional studies on selenium requirements of infants were published after we issued our proposal. We did not find any relevant studies in our search.
(Response 1) We decline to lower the minimum level of selenium in infant formula to 1.6 μg/100 kcal to accommodate analytical variability that can occur between laboratories as the comment suggested. The level of any substance (including nutrients, food additives, or contaminants) established for regulatory purposes must be a value that is based on and true to the available scientific evidence. We recognize that analytical variability is always present and manage this matter under our compliance program. We also note that lowering the minimum level of selenium would not change the analytical variability, and the tested level of selenium might fall below whatever minimum level is set, due to analytical variability. For example, if the minimum level was lowered to 1.6 μg/100 kcal, the tested level of selenium might fall below 1.6 μg/100 kcal due to analytical variability. However, on our own initiative we have revised proposed § 107.100(a) to insert the word “level” between the words “minimum” and “specified” in light of an inadvertent omission in the proposed rule.
(Response 3) The level of 1.0 μg/100 kcal as the minimum level for selenium in infant formula was adopted by the Codex Alimentarius in 2007 for its Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981) (Ref. 6) based on recommendation of this level by an International Expert Group (IEG) of the ESPGHAN (Ref. 4). The IEG recommended 1.0 μg selenium/100 kcal for infant formula based on the median selenium content of human milk and an established history of apparent safe use. However, as described in the proposed rule (78 FR 22442 at 22444), no information was provided regarding the details of how such information was used in making the recommendation for 1.0 μg selenium/100 kcal in infant formula. In addition, the recommendation of the IEG was made in 2005 before the dose-response study of Daniels et al. was published in 2008, and data from that study suggest that a level of 1.9 μg selenium/100 kcal in infant formula meets infants' selenium needs. Further, although, as noted in the comment, the level of 1.0 μg/100 kcal was also adopted as the minimum level for selenium by the European Union in 2006 for its Directive on Infant Formulae and Follow-On Formulae (Commission Directive 2006/141/EC), identification of a scientific basis for the selection of 1.0 μg selenium/100 kcal was not included in the European Union Commission Directive.
(Response 6) As noted in the response to comment 4, the maximum level of any substance must be a value that is based on and true to the available scientific evidence. For this reason, we are not setting a higher maximum value that would include an allowance for analytical variability or method bias. We are not aware of method bias (consistent over- or under-measurement of the actual concentration) in the analysis of selenium in infant formula. We acknowledge that analytical variability occurs between laboratories when testing the levels of nutrients in infant formula, and we manage this matter under our compliance program as necessary. Further, we decline to set a 30 percent allowance for analytical variation for the chemical analysis of selenium in infant formula. The comment did not provide a reason for setting such a high allowance for analytical variation, and 30 percent variability is much higher than performance requirements for commonly used methods for chemical analysis of minerals in infant formula, which typically is about 10 to 15 percent.
(Response 7) The final rule will be effective 12 months after publication of this document (see DATES ). This will allow the industry to make any needed reformulations and label changes to their infant formula products in the 12-month period that the comment identified as cost effective and timely for needed changes.
(Response 8) FDA's specifications for infant formula composition in § 107.100 identify nutrients that must be included in the formula. The regulations do not specify ingredients that can serve as sources of the nutrients, except for vitamin K in § 107.100(c). We decline to specify the form of selenium in infant formula because we do not have information that indicates that any specific source of selenium should be used in infant formula. Our recently published current good manufacturing practices for infant formulas require that ingredients used in infant formulas be safe and suitable for use in infant formula. Specifically, under § 106.40(a), the only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the FD&C Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe for such use, or is authorized by a prior sanction.
FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a regulatory impact analysis that presents the benefits and costs of this proposed rule (Ref. 7). We believe that the final rule will not be a significant regulatory action as defined by Executive Order 12866.
Description: The final rule revises § 107.10(a)(2) to require that selenium be listed in the nutrient list on the label for all infant formulas. In particular, in the nutrient list, selenium must be listed between iodine and sodium and the amount per 100 calories declared; and because selenium is a required ingredient in infant formula, selenium is required to be declared in the formula's ingredient statement by its common or usual name and positioned according to the descending order of its predominance in the formula, under § 101.4 (21 CFR 101.4). The present version of § 107.10(a)(2) is approved by OMB in accordance with the PRA and has been assigned OMB control number 0910-0256. This final rule modifies the information collection associated with the present version of § 107.10(a)(2) by adding 23 hours to the burden associated with the collection. A manufacturer not in compliance with the new minimum and maximum levels for selenium in infant formula would be required to make a one-time change to the nutrient list information disclosed to consumers on the label of its infant formula, to account for the required change in the amount of selenium in its products. The nutrient information disclosed by manufacturers on the infant formula label is necessary to inform purchasers of the value of the infant formula. As discussed previously in this document, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2).
Table 1—Estimated Annual Third-Party Disclosure Burden 1
§ 107.10(a)(2)—Nutrient labeling for infant formula
FDA concludes that there will be no additional burden associated with the requirement to disclose selenium in the ingredient statement as required under § 101.4 because all infant formula manufacturers currently add selenium as an ingredient to their infant formula products that are sold in the United States, and all manufacturers currently disclose selenium in the ingredient statement, as specified by § 101.4. Additionally, all manufacturers currently disclose selenium in the nutrient list, as required by § 107.10(b)(5). Under § 107.10(a)(2), only one manufacturer would need to make a one-time labeling change to modify the amount of selenium shown in the nutrient list on the labels of its infant formula.
This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections. You must number each objection separately, and, within each numbered objection, you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, we will consider the absence of such a request as waiving the right to a hearing on that objection. If you request a hearing, your objection should include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held.
It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov . We will publish notice of the objections that we have received or lack thereof in the Federal Register .
The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov .
7. FDA/Center for Food Safety and Applied Nutrition, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements, Final Regulatory Impact Analysis and Regulatory Flexibility Analysis,” 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.
Food labeling, Infants and children, Nutrition, Reporting and recordkeeping requirements, Signs and symbols.
2. In § 107.10, revise paragraph (a)(2) to read as follows:
§ 107.10
3. In § 107.100, revise paragraph (a) to read as follows: