Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written objections in the following ways:
In a notice published in the
Additionally, under §§ 184.1950(c)(2) and (c)(3), vitamin D is affirmed as GRAS for use in infant formulas and margarine, respectively. Under § 172.380, vitamin D
Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism such as rickets in children or osteomalacia in adults. Excessive intake of vitamin D elevates blood plasma calcium levels by increased intestinal absorption and/or mobilization from the bone.
To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as GRAS with specific limitations as listed in § 184.1950. Under § 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950.
To support the safety of the proposed uses of vitamin D
To support the safety of UV light-treated bakers yeast, Lallemand performed analyses to demonstrate that UV light treatment of bakers yeast does not produce additional sterols of toxicological concern. Lallemand provided chromatograms of extracts of UV light-treated and non-UV light-treated bakers yeast, and identified the substances present in the yeast extracts. One of the substances identified, tachysterol, is a photoisomer resulting from UV light treatment of the vitamin D precursor, pre-vitamin D. Tachysterol is a biologically inactive pre-vitamin form of vitamin D. Lallemand
A second photoisomer, lumisterol, is also typically formed from UV light treatment of pre-vitamin D. Lallemand reported that they did not detect lumisterol in the UV light-treated samples. Because tachysterol is reported as the predominant photoisomer produced at the UV wavelength used to make vitamin D
Other substances identified from the chromatograms were pre-vitamin D
To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, FDA considers the projected human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to the Agency. FDA compares an individual's estimated daily intake (EDI) of the additive from all food sources to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all food sources of the additive. The Agency commonly uses the EDI for the 90th percentile consumer of a food additive as a measure of high chronic dietary intake.
Lallemand provided mean and 90th percentile vitamin D intake estimates for consumers of yeast-leavened baked products from: (1) The proposed food uses of vitamin D
Lallemand's estimate of intake of vitamin D from all food sources for the overall U.S. population (1 year of age and older), including consumers of the yeast-leavened baked products identified in the petition, was 1,670 IU per person per day (IU/p/d) for the 90th percentile consumer. For the population subgroup of infants less than 12 months of age, including consumers of the yeast-leavened baked products identified in the petition, the dietary intake of vitamin D from all food sources was estimated to be 969 IU/p/d for the 90th percentile consumer. FDA concurs with these intake estimates.
In 1997, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at the IOM conducted an extensive review of toxicology and metabolism studies on vitamin D published through 1996. The IOM published a detailed report that included a UL for vitamin D for infants, children, and adults. At that time, the IOM established a UL for vitamin D of 2,000 IU/per day (p/d) for children 1 to 18 years of age and adults. The UL for all infants was 1,000 IU/p/d.
More recently, the IOM conducted an extensive review of relevant published scientific literature on vitamin D to update current dietary reference intakes and ULs for vitamin D. Based on more recent information, the IOM revised the ULs for vitamin D and developed a report on their findings.
The IOM considers the UL as the highest usual intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients and considers intake from all sources: food, water, nutrient supplements, and pharmacological agents. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and an uncertainty factor.
FDA reviewed and evaluated the information submitted by Lallemand regarding the safety of UV light-treated bakers yeast. FDA concludes that the use of UV light-treated bakers yeast does not pose a safety concern, since the UV light treatment has been shown not to produce any new components of toxicological concern that could be introduced into the diet (see section II.A of this document).
In addition, FDA reviewed and evaluated the information submitted by Lallemand regarding the safety of the dietary intake of vitamin D
FDA considered the ULs established by the IOM relative to the intake estimates provided by Lallemand as the primary basis for assessing the safety of petitioned uses of vitamin D. FDA also reviewed the scientific articles submitted by Lallemand. Finally, FDA reviewed studies on vitamin D that have published since the Agency's evaluation of four previous food additive petitions for fortifying a variety of foods with vitamin D. The most recent petition resulted in FDA's amendment of the food additive regulations in § 172.379 to allow for the safe use of vitamin D
Depending on the age group, the IOM ULs for the U.S. population 1 year of age and older range from 2,500 IU/p/d to 4,000 IU/p/d. The estimated intake of vitamin D from all food sources, including the proposed uses, at the 90th percentile for the overall U.S. population (1 year of age and older) is estimated to be 1,670 IU/p/d, which is below the lowest IOM UL in the range of ULs for the overall U.S. population (1 year of age and older). For infants less
Based on all data relevant to vitamin D
In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see
The Agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 9A4779 (74 FR 66979). No new information or comments have been received that would affect the Agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see
FDA's review of this petition was limited to section 409 of the FD&C Act (21 U.S.C. 348). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.
Food additives, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is amended as follows:
21 U.S.C. 321, 341, 342, 348, 371, 379e.
(a) Vitamin D
(b) Vitamin D
(c) The additive may be used in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at levels not to exceed 400 International Units of vitamin D
(d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the
(e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, “vitamin D