(USA) Minute Maid juice adding vitamin D3 (animal derived), not vegan D2

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if you want to contact Minute Maid, go

tohttp://www.minutemaid.com/cgi-bin/contact.cgiMinute Maid juice adding vitamin

D3 (animal derived), not vegan D2SUMMARY: The Food and Drug Administration (FDA)

is amending the food additive regulations to provide for the safe use of

vitaminD3 as a nutrient supplement in calcium-fortified fruit juices and juice

drinks, excluding fruit juices and juice drinksspecially formulated or processed

for infants, at levels not to exceed 100 International Units (IU) per reference

amount customarily consumed(RACC). This action is in response to a petition

filed by The Minute Maid

Co.http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/\

2003/03-4604.htm

 

 

[Federal Register: February 27, 2003 (Volume 68, Number 39)][Rules and

Regulations] [Page 9000-9003]From the Federal Register Online via

GPO Access [wais.access.gpo.gov][DOCID:fr27fe03-9]

=======================================================================---------\

-----------------------------DEPARTMENT OF

HEALTH AND HUMAN SERVICESFood and Drug Administration21 CFR Part 172[Docket No.

02F-0160]Food Additives Permitted for Direct Addition to Food for Human

Consumption; Vitamin D3AGENCY: Food and Drug Administration, HHS.ACTION: Final

rule.-----SUMM\

ARY: The Food and Drug Administration (FDA) is amending the food additive

regulations to provide for the safe use of vitamin D3 as a nutrient supplement

in calcium-fortified fruit juices and juice drinks, excluding fruit juices and

juice drinks specially formulated or processed for infants, at levels not to

exceed 100 International Units (IU) per reference amount customarily consumed

(RACC). This action is in response to a petition filed by The Minute Maid

Co.DATES: This rule is effective February 27, 2003. Submit written objections

and requests for a hearing by March 31, 2003. The Director of the Office of the

Federal Register approves the incorporation by reference of certain publications

in Sec. 172.380 (21 CFR 172.380) as of February 27, 2003.ADDRESSES: Submit

written objections and requests for a hearing to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Submit electronic objections to

http://www.fda.gov/dockets/ecomments.objections to

http://www.fda.gov/dockets/ecomments.FOR FURTHER INFORMATION CONTACT: Judith L.

Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,

202-418-3354.SUPPLEMENTARY INFORMATION:Table of ContentsI. IntroductionII.

Evaluation of Safety A. Acceptable Daily Intake for Vitamin D for Adults,

Children, and Infants B. Estimated Daily Intake for Vitamin D C. Safety

AssessmentIII. ConclusionIV. Environmental EffectsV. Paperwork Reduction Act of

1995VI. ReferencesVII. ObjectionsI. Introduction In a notice published in the

Federal Register of April 25, 2002 (67 FR 20533), FDA announced that a food

additive petition (FAP 2A4734) had been filed by The Minute Maid Co., c/o King

and Spalding, 1700 Pennsylvania Ave. NW., Washington, DC 20006. The petition

proposed that the food additive regulations be amended in 21 CFR part 172 to

provide for the safe use of vitamin D3 in calcium-fortified fruit juices and

juice drinks at levels not to exceed 100 IU per

RACC\1\.------\

--- \1\RACC values represent the amount of food typically consumed per eating

occasion. The RACC for fruit juices and juice drinks intended for the general

population is 240 milliliters (mL) (21 CFR

101.12).------\

--- Vitamin D\2\ is affirmed as generally recognized as safe (GRAS) in Sec.

184.1950©(1) (21 CFR 184.1950©(1)), in accordance with 21 CFR 184.1(b)(2),

for use as a nutrient supplement, as defined in 21 CFR 170.3(o)(20), as the sole

source of added Vitamin D in foods within the limitations specified in the

following

table:--------\

- \2\Vitamin D comprises a group of fat soluble seco-sterols and comes in

many forms. The two major physiologically relevant forms are vitamin D2 and

vitamin D3. Vitamin D without a subscript represents either D2 or D3. As used in

Sec. 184.1950, the meaning of the term vitamin D includes crystalline vitamin

D2, crystalline vitamin D3 and vitamin D2 resin, and vitamin D3 resin.[[Page

9001]] Table

1.------

Category of Food Maximum Levels in Food (As

Served)------B\

reakfast 350 IU/100 grams (g)

cerealsGrain 90 IU/100 g

products and pastasMilk

42 IU/100 gMilk products 89 IU/100

g------

Additionally, vitamin D is affirmed as GRAS for use in infant formula (Sec.

184.1950©(2)) and as an optional ingredient in margarine (Sec.

184.1950©(3)). Vitamin D is essential for human health. Humans can

synthesize significant amounts of vitamin D3 in skin from its precursor,

7-dehydrocholesterol, under exposure to ultraviolet B radiation in sunlight.

Other sources of naturally occurring vitamin D are foods such as butter,

buttermilk, cheese, cream, eggs, fish, goat milk, meat fats and organ meats,

mushrooms, and sour cream. 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. The elderly, who have significantly decreased

capacity for the production of vitamin D3 in skin, and patients with intestinal

malabsorption syndromes are especially prone to vitamin D deficiency. At high

levels, vitamin D may be toxic. Because it is metabolized to inactive forms in

the skin, vitamin D does not accumulate significantly in the body as a result of

sun exposure. Excessive dietary intake of vitamin D elevates blood plasma

calcium levels by increased intestinal absorption and/or mobilization from the

bone. Vitamin D3, also known as cholecalciferol, is the chemical

9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in, and is

isolated from fish liver oils. It also is manufactured by ultraviolet

irradiation of 7-dehydrocholesterol that is derived synthetically from natural

cholesterol. In both methods, vitamin D3 is purified by crystallization. To

support the safety of the proposed use of vitamin D3, The Minute Maid Co.

submitted a summary of the metabolism of vitamin D, a number of publications

pertaining to human clinical studies, bioavailability studies, and dietary

intake estimates. Based on these data, the petitioner concludes that the

proposed use of vitamin D3 in calcium-fortified fruit juices and juice drinks is

safe.II. Evaluation of Safety In order to establish, with reasonable

certainty, that a new food additive is not harmful under its intended conditions

of use, FDA considers the projected human dietary exposure to the additive, the

additive's toxicological data, and other relevant information (such as published

literature) available to the agency. In determining whether the proposed use

of an additive is safe, FDA compares an individual's estimated daily intake

(EDI) of the additive 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 consumption

levels of these particular foods. The agency commonly uses the EDI for the 90th

percentile consumer of a food additive as a measure of high chronic dietary

exposure.A. Acceptable Daily Intake for Vitamin D for Adults, Children, and

Infants In 1997, the Standing Committee on the Scientific Evaluation of

Dietary Reference Intakes of the Food and Nutrition Board at the National

Academy of Sciences Institute of Medicine (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 tolerable upper intake level (UL)

for vitamin D (both D2 and D3) for infants, children and adults (Ref. 1). The

IOM UL for vitamin D for children 1 to 18 years of age and adults is 2,000

IU/day and for infants is 1,000 IU/day. 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.B. Estimated Daily Intake

for Vitamin D The petitioner provided average and 90th percentile vitamin D

intake estimates for consumers of fruit juices and juice drinks from: (1) The

proposed use in calcium-fortified fruit juices and juice drinks, (2) current

uses in conventional foods (including naturally occurring sources of vitamin D),

(3) current and proposed uses in conventional foods, and (4) current and

proposed uses in both conventional foods and dietary supplements. The petitioner

presented intake estimates for the general population, 2 years of age and older,

and for 15 population subgroups (including estimates for infants less than 1

year old; children 1 year to 3 years old; and adults). The agency has determined

that the methodology used to calculate these estimates is appropriate (Ref. 2).

For the proposed food use, dietary intake of vitamin D3 for 90th percentile

consumers of fruit juices and juice drinks, 2 years of age and older, was

estimated to be 211 IU per person per day (IU/p/d). The corresponding mean

intake was estimated to be 110 IU/p/d. For currently regulated uses in

conventional foods (including naturally occurring sources), mean dietary

exposure to vitamin D for consumers of fruit juices and juice drinks was

estimated to be 197 IU/p/d for consumers 2 years of age and older. Intake at the

90th percentile was estimated to be 368 IU/p/day. For consumers of fruit juices

and juice drinks 2 years of age and older, average and 90th percentile dietary

intakes from current (including naturally occurring sources) and proposed food

uses of vitamin D were estimated to be 306 IU/p/d and 519 IU/p/d, respectively.

The petitioner also considered the intake of vitamin D from dietary supplements.

The National Health and Nutrition Examination Survey III (NHANES III) data

indicate that approximately 40 percent of the U.S. population 2 months of age

and older take dietary supplements. The NHANES[[Page 9002]]III data also show

that, when vitamin D is taken as a dietary supplement, the most frequent level

is 400 IU/day. The petitioner provided results from two Gallup polls that

concluded that consumers of vitamin D3-fortified fruit juices and fruit drinks

also are likely to take supplemental sources of vitamin D. As a conservative

estimate of intake of vitamin D from dietary supplements and food uses, the

petitioner assumed that all consumers of fruit juices and juice drinks would

take dietary supplements containing 400 IU of vitamin D. They then added this

value to the mean and 90th percentile intake estimates from current and proposed

food uses. For consumers of fruit juices and juice drinks 2 years of age and

older, mean and 90th percentile dietary intake estimates from current and

proposed food uses and dietary supplements were 706 IU/p/d and 919 IU/p/d,

respectively. Although the petitioner has notified FDA that it does not

intend to fortify fruit juices and juice drinks specially formulated or

processed for infants with vitamin D3, the petitioner provided intake estimates

for breastfed and non-breastfed infants, 0 to 6 months of age and 7 to 12 months

of age. These estimates assumed that all fruit juices and juice drinks,

including those specially formulated or processed for infants, would be

fortified with vitamin D3. Of these four infant population groups, intake

estimates were the highest for non-breastfed infants, 0 to 6 months of age. For

non-breastfed infants, 0 to 6 months of age, mean and 90th percentile dietary

intake from current and proposed food uses were 443 IU/p/d and 663 IU/p/d,

respectively. When dietary supplements were considered in the estimates for

these consumers, mean and 90th percentile intakes were 843 IU/p/d and 1,063

IU/p/d, respectively. Intake estimates for the other infant population groups

were below the UL for infants of 1,000 IU/day. Due to the relatively small

sample size of infants consuming fruit juices and juice drinks, the agency does

not consider the intake estimates presented by the petitioner to be

statistically robust enough to make a quantitative safety assessment. For

example, for infants 0 to 6 months of age, non-breastfed, intake estimates were

based on data from 49 consumers of fruit juice or juice drinks; for infants, 0

to 6 months, breastfed, 16 consumers; infants, 7 to 12 months, non-breastfed, 75

consumers; and infants, 7 to 12 months, breastfed, 9 consumers. Intake estimates

from these populations are not considered to be statistically robust when

compared, for example, to the numbers of consumers in the sample populations for

children 4 to 8 years of age (1,194 consumers) and 9 to 13 years of age (717

consumers). Because a quantitative safety assessment cannot be made with the

available data, we consider it appropriate to exclude fruit juices and juice

drinks specially formulated or processed for infants (ages 0 to 12 months) from

the proposed use of vitamin D3. The agency recognizes that some infants may

consume fruit juices and juice drinks that are not specially formulated or

processed for infants (Ref. 3); however, fruit juices and juice drinks are not

major components of the diets of infants. Further, in a May 2001 policy

statement, the American Academy of Pediatrics recommended that fruit juice

should not be given to infants before 6 months of age (Ref. 4).C. Safety

Assessment The petitioner submitted over 80 published articles to support the

safety of the proposed use of vitamin D3 in calcium-fortified fruit juices and

juice drinks. These articles included most of the references considered by IOM

in its evaluation and all of the critical references that were the basis for the

UL. The petitioner also submitted publications on vitamin D that appeared in the

literature subsequent to the 1997 IOM report. New information since 1997

supports that vitamin D intake is without adverse effects at the IOM UL for

adults (Ref. 5). No new studies in children on the effects of vitamin D intake

have been published since 1997. We considered the UL established by IOM for

children (ages 1 year and older) and adults relative to the intake estimates

provided by the petitioner as the primary basis for assessing the safety of the

proposed use of vitamin D3 in calcium-fortified fruit juices and juice drinks.

For all population groups of children and adults evaluated, mean and 90th

percentile intake estimates from current and proposed food uses of vitamin D are

well below the IOM UL of 2,000 IU/p/day. Additionally, when dietary supplements

are included in the calculations, intake estimates remain below the UL. Because

the EDI of vitamin D from all sources is less than the UL, the agency believes

that dietary exposure of vitamin D3 from its use as a nutrient supplement in

calcium-fortified fruit juices and juice drinks, excluding juices and juice

drinks specially formulated or processed for infants, will not pose a safety

concern (Ref. 5)III. Conclusion Based on all data relevant to vitamin D

reviewed by the agency, FDA concludes that there is a reasonable certainty that

no harm will result from the use of vitamin D3 as a nutrient supplement at the

levels specified in calcium-fortified fruit juices and juice drinks, excluding

fruit juices and juice drinks specially formulated or processed for infants.

Thus, vitamin D3 is safe for its proposed use and the agency concludes that the

food additive regulations should be amended as set forth in this document. To

ensure that only food grade vitamin D3 is used in food, the additive must meet

the specifications of the Food Chemicals Codex, 4\th\ ed. In accordance with

Sec. 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 are

available for inspection at the Center for Food Safety and Applied Nutrition by

appointment with the information contact person listed previously. As provided

in Sec. 171.1(h), the agency will delete from the documents any materials that

are not available for public disclosure before making the documents available

for inspection.IV. Environmental Effects The agency has previously considered

the environmental effects of this rule as announced in the notice of filing for

FAP 2A4734 (67 FR 20533). 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.V. Paperwork Reduction Act of 1995 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.VI. References

The following references have been placed on display in the Dockets Management

Branch (see ADDRESSES) and may be seen by interested persons between 9 a.m. and

4 p.m., Monday through Friday. 1. Standing Committee on the Scientific

Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of

Medicine, ``Dietary Reference Intakes for Calcium, Phosphorus, Magnesium,

Vitamin D, and Fluoride,'' National Academy Press, Washington, DC, 1997. 2.

Memorandum from Folmer, Division of Petition Review, Chemistry Review Group,

to[[Page 9003]]Kidwell, Division of Petition Review, May 21, 2002. 3. Meeting

minutes from August 2 and August 28, 2002, Internal meetings, Division of

Petition Review. 4. American Academy of Pediatrics Policy Statement ``The Use

and Misuse of Fruit Juice in Pediatrics (RE0047),'' Pediatrics, 107(5):

1210-1213, 2001. 5. Memorandum from Park, Division of Petition Review,

Toxicology Review Group, to Kidwell, Division of Petition Review, September 17,

2002.VII. Objections Any person who will be adversely affected by this

regulation may at any time file with the Dockets Management Branch (see

ADDRESSES) written or electronic objections. Each objection shall be separately

numbered, and each numbered objection shall specify with particularity the

provisions of the regulation to which objection is made and the grounds for the

objection. Each numbered objection on which a hearing is requested shall

specifically so state. Failure to request a hearing for any particular objection

shall constitute a waiver of the right to a hearing on that objection. Each

numbered objection for which a hearing is requested shall include a detailed

description and analysis of the specific factual information intended to be

presented in support of the objection in the event that a hearing is held.

Failure to include such a description and analysis for any particular objection

shall constitute a waiver of the right to a hearing on the objection. Three

copies of all documents are to be submitted and are to be identified 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 Dockets Management

Branch between 9 a.m. and 4 p.m., Monday through Friday.List of Subjects in 21

CFR Part 172 Food additives, Incorporation by reference, Reporting and

recordkeeping requirements. Therefore, under the Federal Food, Drug, and

Cosmetic Act and under authority delegated to the Commissioner of Food and

Drugs, 21 CFR part 172 is amended as follows:PART 172--FOOD ADDITIVES PERMITTED

FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation

for 21 CFR part 172 continues to read as follows: Authority: 21 U.S.C. 321,

341, 342, 348, 371, 379e. 2. Section 172.380 is added to subpart D to read as

follows:Sec. 172.380 Vitamin D3. The food additive may be used safely in

foods as a nutrient supplement defined under Sec. 170.3(o)(20) of this chapter

in accordance with the following prescribed conditions: (a) Vitamin D3, also

known as cholecalciferol, is the chemical

9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in and is

isolated from fish liver oils. It also is manufactured by ultraviolet

irradiation of 7-dehydrocholesterol produced from cholesterol and is purified by

crystallization. (b) Vitamin D3 meets the specifications of the Food

Chemicals Codex, 4\th\ ed. (1996), p. 434, which is incorporated by reference.

The Director of the Office of the Federal Register approves this incorporation

by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may

obtain copies from the National Academy Press, 2101 Constitution Ave. NW.,

Washington, DC 20418 (Internet address http://www.nap.edu. Copies may be

examined at the Center for Food http://www.nap.edu. Copies may be examined at

the Center for Food Safety and Applied Nutrition's Library, Food and Drug

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or the Office

of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

© Vitamin D3 may be added, at levels not to exceed 100 International Units

(IU) per serving, to 100 percent fruit juices, as defined under Sec.

170.3(n)(35) of this chapter, excluding fruit juices that are specially

formulated or processed for infants, that are fortified with greater than 33

percent of the Recommended Daily Intake (RDI) of calcium per Reference Amount

Customarily Consumed (RACC). (d) Vitamin D3 may be added, at levels not to

exceed 100 IU per serving, to fruit drinks, as defined under Sec. 170.3(n)(35)

of this chapter, excluding fruit drinks that are specially formulated or

processed for infants, that are fortified with greater than 10 percent of the

RDI of calcium per RACC. Dated: February 21, 2003.William K.

Hubbard,Associate Commissioner for Policy and Planning.[FR Doc. 03-4604 Filed

2-24-03; 11:58 am]BILLING CODE 4160-01-S