FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB)

TO THE NATIONAL ORGANIC PROGRAM (NOP)

Date: May 6, 2009

Subject: Injectable trace minerals, vitamins and electrolytes

Chair: Jeff Moyer

Recommendation

The NOSB hereby recommends to the NOP the following:

Rulemaking Action: X

Guidance Statement: ________

Other: ________

Summary Statement of the Recommendation (including Recount of Vote):

Recommendation 

PROPOSED RECOMMENDATION TO ADD NEW SECTION TO 7 CFR 205.603:

(g) As nutritive supplements, formulated injectable supplements of trace minerals per 205.603 (d) 

(2), vitamins per 205.603 (d) (3), and electrolytes per 205.603 (a) (8), with excipients per 205.603 

(f), in accordance with FDA and restricted to use by or on the order of a licensed veterinarian.

NOSB Vote: Yes to Recommend to NOP Motion: Hubert Karreman Second: Bea James

Board vote: Yes - 14 No- 0 Abstain- 0 Absent - 1 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP):

Currently there are categories of substances for livestock health care already on the list - 205.603 

(a)(8), 205.603 (electrolytes) (d)(2) (trace minerals) and (d)(3) (vitamins) and (f) (excipients). 

However, it is not specific that these materials can be used via injection – in fact, the trace 

minerals and vitamins are explicitly to be used as feed additives only. This recommendation will 

allow the injectable formulated versions of (a)(8), (d)(2), and (d)(3). Section (f) because there are 

no pure vitamins, trace minerals or electrolytes available without excipients. These injectable 

forms of trace minerals, vitamins and electrolytes are being viewed as nutritive supplements (as 

many of the labels state) rather than as medicines. See the Livestock Committee’s full rationale 

that is attached.

Response by the NOP:
Attach Committee Recommendation here along that includes committee votes and any 

attachments

National Organic Standards Board (NOSB)

March 15, 2009

Recommendation 

PROPOSED RECOMMENDATION TO ADD NEW SECTION TO 

205.603:

(g) As nutritive supplements, formulated injectable supplements of trace minerals per 

205.603 (d) (2), vitamins per 205.603 (d) (3), and electrolytes per 205.603 (a) (8), with 

excipients per 205.603 (f), in accordance with FDA and restricted to use by or on the 

order of a licensed veterinarian.

I. Introduction:

By law, organic livestock rations need to provide a total feed ration composed of 

agricultural products, including pasture and forage, that are organically produced and, if 

applicable organically handled, Except that nonsynthetic substances and synthetic substances 

allowed under 205.603 may be used as feed additives and supplements (7CFR205.237). The goal 

of livestock producers should be to provide a balanced ration to the animals under their care. 

Rations, by definition, are fed to animals and consumed in an oral manner. They can have 

synthetic vitamins and minerals added [205.603 (d) (2) and 205.603(d) (3)]. A balanced ration 

delivers what the average animal in a herd needs on a daily basis. However, there can be times of 

stress when certain individual animals need high amounts of vitamins and minerals delivered to 

target tissues in a rapid manner. Also, animals that are not eating, for whatever reason, are not 

taking in the oral forms of vitamins and minerals and may need nutritive supplementation best 

delivered by injection. With the prohibition of the use of antibiotics in certified organic livestock, 

farmers and veterinarians need as many tools as possible remaining to prioritize animal health.

Currently, the prohibition of injectable vitamin and mineral formulations effectively eliminates a 

common method that works to assist livestock health and well-being. Injectable forms of vitamins 

and minerals provide valuable support to an animal's immune system, and the recommendation is 

brought forth to allow, strictly on an as needed basis, the use of formulations of injectable 

vitamins, minerals and electrolytes as nutritive supplements for organic livestock. The allowance 

use of injectable formulations of vitamins and minerals will enhance the overall health and 

welfare of certified organic livestock.

II. Background:

Rations that deliver the daily needs of vitamins and minerals via feedstuffs for animal 

health are the goal of livestock farmers. However, due to biochemical and physical limitations, 
certain areas of the country can be naturally deficient in soil fertility. For example, the 

northeastern part of the United States is well known to be deficient in soil selenium. Even when 

feed rations are supplemented with the maximum allowable selenium as per FDA, peri-parturient 

animals can lack the right balance of vitamin E and selenium, which can then impact the 

capabilities of the reproductive tract. 

When animals are not eating, they do not consume the right balance of vitamins and 

minerals, whether natural or synthetic (as allowed by 205.603), and these individual animals may 

benefit from nutritive supplementation via injection. Some examples will help describe and 

justify the need for an occasional injectable vitamin and/or mineral. In dairy cows that have low 

blood calcium levels immediately after calving, intravenous delivery of ionic calcium as an 

electrolyte can be of tremendous benefit. To prevent low blood calcium is the goal of course. 

However, in areas where high potassium forages are common (due to decades of manure 

application to land which also receives regular NPK applications) it can be difficult to keep the

correct calcium balance in the expectant mother cow. In this case, a one time injection of vitamin 

D3 may help the animal to assimilate dietary calcium better from the intestine and positively 

affect the calcium to phosphorus ratio in the blood stream. Also, an animal that has a sluggish 

appetite or is anorexic may benefit from a dose of vitamin B complex given in the muscle or 

under the skin. Individual animals also may need vitamin C, sometimes in high doses, for its antioxidant effects. Vitamin E, while found in fresh growing pastures, can be critically depleted in 

stored feeds by the end of winter. Vitamin E in combination with selenium is synergistic for cattle 

reproductive health and is a commonly used vitamin-mineral formulation used in the 

conventional industry. 

In 1995, the NOSB reviewed vitamins and minerals of synthetic sources to be feed additives and 

recommended their inclusion onto the National List. The NOP codified these feed additives and 

they have been in use since promulgation of the Rule in October 2002.

III. Regulatory Framework 

The National Organic Standards Board was established by the Organic Food Production 

Act to assist the Secretary of the USDA in the development of standards for substances to be used 

in organic production and to advise the Secretary on any other aspects of the implementation of 

the title (SEC. 2119. [7 U.S.C. 6518] (a)). The Board is made up of stakeholders representing 

various segments of the industry. Currently there are three members who are directly involved 

with the organic dairy industry – a dairy farmer, a nutritionist and a veterinarian. It has come to 

the attention of the Board that injectable formulations of vitamins and minerals need to be 

allowed (for the reasons stated in the Background and Introduction), just as the feed additive 

versions of vitamins and minerals have already been recommended and codified. Direct impact 

upon animal welfare associated with the allowance or prohibition of formulations of injectable 

vitamins and minerals forms the basis for the Livestock Committee’s recommendation.

Certain sections of the current Rule are germane to the intent and goal of this 

recommendation. Clearly, vitamins, minerals, electrolytes and excipients are already allowed by 

the following regulations. While the regulation allows vitamins and minerals only as feed

additives, it is not as clear that electrolytes and excipients are restricted to only being used as feed 

ingredients.

7CFR205.603(d)(2): (d) As feed additives. (2) Trace minerals, used for enrichment or

fortification when FDA approved.
7CFR205.603(d)(3): (d) As feed additives. (3) Vitamins, used for enrichment or fortification 

when FDA approved.

7CFR205.603(f): (f) Excipients, only for use in the manufacture of drugs used to treat organic 

livestock when the excipient is: Identified by the FDA as Generally Recognized As Safe; 

Approved by the FDA as a food additive; or Included in the FDA review and approval of a New 

Animal Drug Application or New Drug Application.

7CFR205.603(a)(8): (8) Electrolytes--without antibiotics.

IV. Discussion: 

While the original writers of the Rule had the best intentions, many realities of livestock 

production were not necessarily analyzed to accommodate the wide range of livestock operations, 

diverse soil fertility across the country and subsequent feed related issues. While the goal of 

economically minded livestock producers is always to optimize the feed resources available to 

their operation, there are times when supplement via injection is necessary. While it is possible 

that some people would rather say to simply feed the animals the vitamins and minerals they 

need, this is easier said than done. The fact of the matter is that injectable formulations of 

vitamins and minerals as an entire category will serve to complement what have been already 

codified by the Program for the feed additives. The Livestock Committee recognizes that there 

are many injectable formulations of vitamins and minerals that exist in the US market place for 

livestock. There are probably just as many different manufacturers of said products. To review 

each and every vitamin and mineral and proprietary formulation is simply not possible due to the 

following reason - the manufacturer information is not available for disclosure. To the best of our 

knowledge, no manufacturer of vitamins and minerals has petitioned the NOSB for their product. 

Owing to the plethora of available injectable vitamin and mineral formulations, conventional 

farmers and veterinarians simply reach for the most available brand that day. There is no 

incentive for farmers or veterinarians to go through the formal petition process since they are the 

end buyer/user and information that is available in the public domain is only for old 

manufacturing processes. It is important to state that vitamins and minerals as feed additives were 

recommended and each were placed on the National List as a category [205.603 (d)(2) and 

(d)(3)] and not listed individually. 

The Livestock Committee does, however, recognize that the public may, at this point in time, 

want to have an idea of the vitamin and mineral formulations being discussed in this 

recommendation. The Livestock Committee will try its best effort to gather as many of the 

commercial labels as possible for informational purposes only but not as a foundation of this 

recommendation since the recommendation is for a category and not individual items within the 

category [in the exact same manner as .603 (d)(2), .603(d)(3), .603(f), .603(a)(8) are currently 

codified]

The Livestock Committee looks forward to feedback from different stakeholder groups on this 

recommendation. Some groups would likely be: farmers and farmer organizations, NGO’s that 

advocate heightened awareness of health and welfare of farm animals, accredited certifying 

agencies (private and State), pharmacologists, physiologists, nutritionists, veterinarians, and 

consumers of organic products.

We believe that farmers and organic consumers will be pleased that animals needing an 

occasional vitamin and/or mineral injection for nutritive supplementation would be allowed to 

receive such an administration with the proposed recommendation. We believe that nutritionists 
will agree that there are times when vitamins and minerals as feed additives may not be adequate 

to fulfill an animal’s need at certain times of life. We believe that persons trained in the animal 

sciences will concur with the occasional need of an injectable formulation of a vitamin and/or 

mineral. We look forward to hearing how certifiers have addressed the issue of injectable trace 

minerals, vitamins, and electrolytes.

V. Recommendation:

It is proposed to amend the National List to add in a new category, 205.603(g) to read:

As nutritive supplements, formulated injectable supplements of trace minerals per 205.603 

(d) (2), vitamins per 205.603 (d) (3), and electrolytes per 205.603 (a) (8), with excipients per 

205.603 (f), in accordance with FDA and restricted to use by or on the order of a licensed 

veterinarian.

VI. Committee Vote: 

Motion: Hubert Karreman

Seconded: Dan Giacomini

Committee Vote: Yes: 5

No: 0

Abstain: 0

Absent: 2