Document ID: FDA-2012-F-0138-0007
Agency: fda
Document Type: Rule
Title: Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3
Posted Date: 2014-08-12T04:00Z

[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Rules and Regulations]
[Pages 46993-46996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18969]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2012-F-0138]

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulations to provide for the safe use of vitamin 
D3 as a nutrient supplement in meal replacement beverages 
that are not intended for special dietary use in reducing or 
maintaining body weight and for use in foods that are sole sources of 
nutrition for enteral feedings. We are taking this action in response 
to a petition filed by Abbott Laboratories (Abbott).

DATES: This rule is effective August 12, 2014. See section VII 
``Objections'' for further information on the filing of objections. 
Submit either electronic or written objections and requests for a 
hearing by September 11, 2014. The incorporation by reference of 
certain publications listed in the regulations is approved by the 
Director of the Federal Register as of August 12, 2014.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing identified by Docket No. FDA-2012-F-0138, by any 
of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-F-0138 for this rulemaking. All objections 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 6, 2012 (77 FR 13232), FDA 
announced that Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 
43219, had filed a food additive petition (FAP 2A4788). The petition 
proposed that FDA amend the food additive regulations in Sec.  172.380 
(21 CFR 172.380), Vitamin D3, to provide for the safe use of 
vitamin D3 as a nutrient supplement in meal replacement 
beverages and meal replacement bars that are not intended for special 
dietary use in reducing or maintaining body weight and for use in foods 
that are sole sources of nutrition for enteral tube feeding. After the 
document was published, Abbott amended the petition to exclude the 
proposed use of vitamin D3 in meal replacement bars. This 
final rule is a complete response to the petition.
    Abbott has requested that we amend Sec.  172.380 to authorize the 
use of vitamin D3 as a nutrient supplement at levels not to 
exceed 500 International Units (IU) per 240 milliliters (mL) (prepared 
beverage) in meal replacement beverages that are not intended for 
special dietary use in reducing or maintaining body weight and that are 
represented for use such that the total amount of vitamin D3 
provided by the product does not exceed 1,000 IU per day, and at levels 
not to exceed 1.0 IU per kilocalorie (kcal) in food represented for use 
as a sole source of nutrition for enteral feeding.
    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 vitamin D2 or vitamin D3 or 
both. Vitamin D is affirmed as generally recognized as safe (GRAS) for 
use in food as a nutrient supplement in Sec.  184.1950(c)(1) (21 CFR 
184.1950(c)(1)) in accordance with Sec.  184.1(b)(2) (21 CFR 
184.1(b)(2)), with the following specific limitations:

------------------------------------------------------------------------
                                             Maximum levels in food (as
             Category of food                          served)
------------------------------------------------------------------------
Breakfast cereals.........................  350 IU/100 grams (g).
Grain products and pasta..................  90 IU/100 g.
Milk......................................  42 IU/100 g.
Milk products.............................  89 IU/100 g.
------------------------------------------------------------------------

    Additionally, under Sec.  184.1950(c)(2) and (c)(3), vitamin D is 
affirmed as GRAS for use in infant formulas and margarine, 
respectively. Under Sec.  172.380, vitamin D3 is approved 
for use as a food additive as a nutrient supplement in calcium-
fortified fruit juices and fruit juice drinks; meal replacement and 
other type bars, soy protein-based meal replacement beverages 
represented for special dietary use in reducing or maintaining body 
weight; and cheese and cheese products as defined therein. Under Sec.  
172.379, vitamin D2 is approved for use as a food additive 
as a nutrient supplement in soy beverages, soy beverage products, soy-
based butter substitute spreads, and soy-based cheese substitutes and 
soy-based cheese substitute products. Under Sec.  172.381, vitamin 
D2 bakers yeast is approved for use as a food additive as a 
source of vitamin D2 and as a leavening agent in yeast-
leavened baked goods and baking mixes and yeast-leavened baked snack 
foods.
    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 (hypercalcemia) 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 Sec.  184.1950. Under Sec.  
184.1(b)(2), an ingredient affirmed as GRAS with

[[Page 46994]]

specific limitations may be used in food only within such limitations, 
including the category of food, functional use of the ingredient, and 
level of use. Any addition of vitamin D to food beyond those 
limitations set out in Sec.  184.1950 requires either a food additive 
regulation or an amendment of Sec.  184.1950.
    To support the safety of the proposed uses of vitamin 
D3, Abbott submitted dietary exposure estimates of vitamin D 
from the proposed uses of vitamin D3, as well as all current 
dietary sources for four scenarios: (1) Background exposure from 
naturally occurring sources of vitamin D and currently regulated uses 
of vitamin D at levels reported in the U.S. Department of Agriculture 
Food and Nutrient Database for Dietary Studies, which represent typical 
vitamin D levels in foods; (2) background exposure plus exposure from 
yeast-leavened baked goods and baking mixes and yeast-leavened snack 
foods containing 400 IU vitamin D/100 g food as served (at the time 
that Abbott submitted their petition, the petition to amend the food 
additive regulations for the use of vitamin D2 bakers yeast 
was under review); (3) background exposure, exposure from yeast-
containing baked products containing 400 IU vitamin D/100 g food, and 
from dietary supplement use; and (4) background exposure, exposure from 
yeast-containing baked products containing 400 IU vitamin D/100 g food, 
dietary supplements, and the proposed uses in meal replacement 
beverages and bars. They compared these intake estimates to the 
Tolerable Upper Intake Level (UL) for vitamin D established by the 
Institute of Medicine (IOM) of the National Academies. Abbott also 
submitted a number of publications pertaining to human clinical studies 
on vitamin D. Based on this information, which is discussed in section 
II, Abbott concluded that the proposed uses of vitamin D3 in 
meal replacement beverages that are not intended for special dietary 
use in reducing or maintaining body weight and in foods that are sole 
sources of nutrition for enteral feeding are safe.

II. Evaluation of Safety

    To establish with reasonable certainty that a food additive is not 
harmful under its intended conditions of use, we consider the projected 
human dietary exposure to the additive, the additive's toxicological 
data, and other relevant information (such as published literature) 
available to us. We compare 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. We commonly use the EDI for the 90th 
percentile consumer of a food additive as a measure of high chronic 
dietary intake.

A. Acceptable Intake Level for Vitamin D

    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, and a UL of 1,000 
IU/p/d for all infants.
    In 2011, 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 this information, the 
IOM revised the ULs for vitamin D and developed a report on their 
findings (Ref. 1). In their 2011 assessment of vitamin D, the IOM 
established a UL of 1,000 IU/p/d for infants 0 months to 6 months of 
age and a UL of 1,500 IU/p/d for infants 6 months to 12 months of age. 
For children 1 year to 3 years of age, the IOM established a UL of 
2,500 IU/p/d; for children 4 years to 8 years of age, the IOM 
established a UL of 3,000 IU/p/d. For children 9 years to 18 years of 
age and adults, the IOM established a UL of 4,000 IU/p/d.
    The IOM considers the UL as the highest average daily 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

1. Meal Replacement Beverages
    For the proposed use of vitamin D3 in meal replacement 
beverages that are not intended for special dietary use in reducing or 
maintaining body weight, Abbott provided dietary intake estimates for 
vitamin D for seven population groups, assuming typical vitamin D 
levels in food. Although Abbott stated that their proposed uses do not 
include products for infants or children less than 9 years of age, 
Abbott included exposure estimates for children 1 to 3 years of age and 
4 to 8 years of age. Because Abbott's exposure estimates differed in 
several aspects from the way in which we typically calculate dietary 
exposure, we conducted our own exposure estimate for vitamin D from: 
(1) The proposed use of vitamin D3 in meal replacement 
beverages that are not intended for special dietary use in reducing or 
maintaining body weight; (2) current food uses of vitamin D (including 
regulated uses, naturally occurring sources of vitamin D, and dietary 
supplements); and (3) combined current and proposed food uses. We 
estimated the exposure to vitamin D for the overall U.S. population (1 
year of age and older) and 10 population subgroups (including 2 
subgroups for infants less than 12 months of age), assuming that all 
foods that can be fortified with vitamin D will be fortified at the 
maximum level permitted.
    Our estimated exposure to vitamin D from all food sources for the 
overall U.S. population (1 years of age and older), including consumers 
of meal replacement beverages that are not intended for special dietary 
use in reducing or maintaining body weight, was 1,520 IU per person per 
day (IU/p/d) for the 90th percentile consumer, based on food 
consumption data in the 2007-2008 National Health and Nutrition 
Examination Survey (NHANES). Infants are not expected to consume meal 
replacement beverages; however, we included these subpopulations in our 
exposure assessment for completeness. According to the 2007-2008 
NHANES, no meal replacement beverage consumption was reported for 
infants 0 months to 6 months of age, and only very limited consumption 
of meal replacement beverages was reported for infants 6 to 12 months 
of age. The cumulative exposure for infants 0 to 6 months of age and 
infants 6 to 12 months of age from all food sources of vitamin D, 
including the proposed uses and dietary supplements, was estimated to 
be 844

[[Page 46995]]

IU/p/d and 831 IU/p/d, respectively, for the 90th percentile consumer 
(Ref. 2).
2. Enteral Feeding Products
    For the proposed use of vitamin D3 for food represented 
as the sole source of nutrition for enteral feeding, Abbott indicated 
that there are many different methods available in the scientific 
literature for estimating caloric needs when using fortified enteral 
nutrition products as the sole source of nutrition. Abbott reported 
that the simplest method is to assume that a person requires 25-30 kcal 
per kilogram body weight per day (kcal/kg bw/d). Thus, a 60 kg person 
being fed only an enteral nutrition product would require 1,500 kcal to 
1,800 kcal per day. Assuming the proposed vitamin D3 
fortification level of 1.0 IU/kcal in enteral products represented for 
use as the sole source of nutrition and the highest recommended caloric 
requirement of 30 kcal/kg bw/d, results in an estimated vitamin 
D3 exposure of 1,800 IU/p/d for a 60 kg person (Ref. 3). As 
noted by Abbott, this level is far below the UL of 4,000 IU vitamin D 
for an adult. In addition, any person receiving vitamin D3 
from an enteral feeding product as their sole source of nutrition would 
be under the care of a doctor who would be monitoring the patient's 
vitamin D intake.

C. Safety of the Petitioned Uses of Vitamin D3

    FDA reviewed and evaluated the information submitted by Abbott 
regarding the safety of the dietary intake of vitamin D3 
that would result from the proposed uses in meal replacement beverages 
that are not intended for special dietary use in reducing or 
maintaining body weight and for use in foods that are sole sources of 
nutrition for enteral feeding. Abbott submitted scientific articles 
published subsequent to the 1997 IOM report and issuance of the August 
29, 2012, final rule (77 FR 52228) authorizing the use of vitamin 
D2 bakers yeast in yeast-leavened baked goods and baking 
mixes and yeast-leavened baked snack foods. Abbott concluded that these 
recent publications support the safety of increases in the levels of 
vitamin D supplementation in humans that could result from the proposed 
uses. We concur with Abbott's conclusion (Ref. 4).
    We considered the ULs established by the IOM relative to the intake 
estimates as the primary basis for assessing the safety of petitioned 
uses of vitamin D3. We also reviewed the scientific articles 
on vitamin D intake submitted by Abbott, as well as other relevant 
published studies available to FDA since our previous evaluations of 
five food additive petitions for fortifying a variety of foods with 
vitamin D. The most recent petition resulted in our amendment of the 
food additive regulations in Sec.  172.381 to allow for the safe use of 
vitamin D2 bakers yeast as a source of vitamin D2 
and as a leavening agent in yeast-leavened baked goods and baking mixes 
and yeast-leavened baked snack foods (77 FR 52228, August 29, 2012). 
The four earlier food additive petitions also resulted in amendments of 
the food additive regulations to allow for the safe use of vitamin D as 
a nutrient supplement in certain foods (74 FR 11019, March 16, 2009; 70 
FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, 
June 22, 2005; and 68 FR 9000, February 27, 2003).
1. Meal Replacement Beverages
    Depending on the age group, the IOM UL for vitamin D for the U.S. 
population 1 year of age and older ranges from 2,500 IU/p/d to 4,000 
IU/p/d. The estimated exposure to vitamin D from all food sources, 
including the proposed use in meal replacement beverages that are not 
intended for special dietary use in reducing or maintaining body 
weight, at the 90th percentile for the overall U.S. population (1 years 
of age and older) is estimated to be 1,520 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), 2,500 IU/p/d. The estimated exposure to vitamin 
D from all food sources, including the proposed use in meal replacement 
beverages that are not intended for special dietary use in reducing or 
maintaining body weight, for infants 0 months to 6 months of age at the 
90th percentile is 844 IU/p/d; for infants 6 months to 12 months of 
age, estimated exposure to vitamin D is 831 IU/p/d. Both of these 
estimates are below the respective IOM UL of 1,000 IU/p/d for infants 0 
months to 6 months of age and 1,500 IU/p/d for infants 6 months to 12 
months of age. Because the 90th percentile EDI of vitamin D from all 
current and proposed food sources for each population group is less 
than the corresponding IOM UL for that population group, we conclude 
that dietary intake of vitamin D3 from the proposed use as a 
nutrient supplement in meal replacement beverages that are not intended 
for special dietary use in reducing or maintaining body weight is safe.
2. Enteral Feeding Products
    Based on the proposed use level of 1.0 IU/kcal in enteral feeding 
products, the dietary exposure to vitamin D3 is estimated to 
be 1,800 IU/p/d for a 60 kg person. This estimate is below the IOM UL 
of 4,000 IU/p/d for adults. Because the use of these products are 
intended for individuals under medical supervision and monitoring by a 
physician, we have no safety concerns regarding the proposed use of 
vitamin D3 in enteral feeding products, and we conclude that 
this use is safe.

III. Conclusion

    Based on all data relevant to vitamin D3 that we 
reviewed, we conclude that the petitioned use of vitamin D3 
as a nutrient supplement in meal replacement beverages that are not 
intended for special dietary use in reducing or maintaining body weight 
and for use in foods that are sole sources of nutrition for enteral 
feeding within the limits proposed by Abbott is safe. Consequently, we 
are amending the food additive regulations as set forth in this 
document. Additionally, the current regulation for the use of vitamin 
D3 in food (Sec.  172.380) indicates that the additive must 
meet the specifications in the Food Chemicals Codex, 7th Edition (FCC 
7). The more current FCC is the 8th Edition (FCC 8). Because the 
specifications for vitamin D3 in FCC 8 are identical to 
those in FCC 7, we are amending Sec.  172.380 by adopting the 
specifications for vitamin D3 in FCC 8 in place of FCC 7.

IV. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that we considered and relied upon in reaching our 
decision to approve the petition will be made available for public 
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  
171.1(h), we will delete from the documents any materials that are not 
available for public disclosure.

V. Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the March 6, 2012, Federal Register document of petition for 
FAP 2A4788. We stated that we had determined, under 21 CFR 25.32(k), 
that this action ``is of a type that does not individually or 
cumulatively have a significant effect on the human environment'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. We have not received any new information or 
comments that would affect our previous determination.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget

[[Page 46996]]

under the Paperwork Reduction Act of 1995 is not required.

VII. 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 separately 
number each objection, 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, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must 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. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    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.

VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 409 of the 
Federal Food, Drug, and Cosmetic Act (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) 
of the FD&C Act (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.

IX. References

    The following sources are referred to in this document. References 
marked with an asterisk (*) have been placed on display at the Division 
of Dockets Management (see ADDRESSES), under Docket No. FDA-2012-F-
0138, 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. References without asterisks are not on display; 
they are available as published articles and books.

    1. Committee to Review Dietary Reference Intakes for Vitamin D 
and Calcium, Food and Nutrition Board, Institute of Medicine, 
``Dietary Reference Intakes for Calcium and Vitamin D,'' National 
Academies Press, Washington, DC, 2011.
    *2. Memorandum from D. Folmer, Chemistry Review Group, Division 
of Petition Review, to J. Kidwell, Regulatory Group I, Division of 
Petition Review, December 11, 2013.
    *3. Memorandum from D. Folmer, Chemistry Review Group, Division 
of Petition Review, to J. Kidwell, Regulatory Group I, Division of 
Petition Review, February 7, 2013.
    *4. Memorandum from A. Khan, Toxicology Review Group, Division 
of Petition Review, to J. Kidwell, Regulatory Group I, Division of 
Petition Review, February 11, 2014.

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 and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
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.

0
2. Amend Sec.  172.380 by revising paragraph (b) and by adding 
paragraphs (c)(6) and (c)(7) to read as follows:

Sec.  172.380  Vitamin D3.

* * * * *
    (b) Vitamin D3 meets the specifications of the Food 
Chemicals Codex, 8th ed. (2012), pp. 1186-1187, 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 United States 
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 
(Internet address http://www.usp.org). Copies may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (c) * * *
    (6) At levels not to exceed 500 IU per 240 mL (prepared beverage) 
in meal replacement beverages that are not intended for special dietary 
use in reducing or maintaining body weight and that are represented for 
use such that the total amount of Vitamin D3 provided by the 
product does not exceed 1,000 IU per day.
    (7) At levels not to exceed 1.0 IU per kilocalorie in foods 
represented for use as a sole source of nutrition for enteral feeding.

    Dated: August 6, 2014.
Philip L. Chao,
Acting Director, Office of Regulations, Policy and Social Sciences, 
Center for Food Safety and Applied Nutrition.
[FR Doc. 2014-18969 Filed 8-11-14; 8:45 am]
BILLING CODE 4164-01-P