National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Inositol

April 1, 2012

Summary of Proposed Action:

Inositol is an important biologic compound that serves numerous biologic functions/roles including but 

not limited to the following: a structural component of cell membranes, messenger molecules in 

reactions/processes, assist in overall muscle function and cell growth. Inositol may be formed 

endogenously using glucose as a substrate or it may be obtained by the human body through dietary 

sources. In addition to the aforementioned roles, inositol has been found to influence fat 

accumulation within the liver/intestines, control triacyglycerol and esterified cholesterol levels, and 

impact insulin resistance. Due to its association with these biologic processes/conditions, inositol is 

often marketed as a dietary supplement for those with these afflictions. The category of dietary 

supplements in the United States are not required to be regulated by the FDA in order to assure the 

validity and safety of using a substance to treat conditions, and as long as no health claims are made 

on the supplement they may be sold to American consumers without restrictions.

Inositol is found naturally in many foods which include fruits, beans, grains, seeds, and nuts. Another 

notable source of inositol is human breast milk which has been found to contain high concentrations 

of inositol (1500- 4000 mM/L) as stated in the March 2012 Tap review. The FDA list inositol as 

Generally Recognized as Safe (GRAS) for human consumption by the under 21 CFR 184.1370 and 

also mandates that all infant formulas sold in the United States must contain a minimum 4mg/ 100 

kilocalories of inositol in order to assure infants fed solely on formula sources acquire adequate 

nutrition to grow as successfully as breast-fed infants. 

Commercial production of inositol is often obtained from hydrolysis and acidification that begins from 

the corn/rice steeping process by using the phytic acid extracted from the corn/rice, and then using 

this phytic acid in one of several different chemical processes that ultimately results in isolating 

inositol. Additional methods also include utilization of microbial byproducts and processes (yeast); 

however these reactions are also dependent on synthetic reactions, or reactions that would not 

normally occur in nature to produce the final product of isolated inositol. Therefore, while inositol is a 

natural compound, the methods by which we can obtain commercial quantities of inositol are 

synthetic. 

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

HC 1 Inositol
Basis for annotation: X To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Move that inositol as petitioned is synthetic.

Motion by: John Foster Seconded by: Joe Dickson 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0 

Listing Motion: 1. Move to add inositol to the National List 205.605(b) for use in infant formula 

labeled organic or made with organic (specified ingredients or food group(s))

Motion by: John Foster Seconded by: Joe Dickson 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0

Listing Motion: 2. Move to add inositol to the National List 205.605(b) for use only in agricultural 

products other than infant formula labeled "made with organic (specified ingredients or food 

group(s))" and prohibited in agricultural products labeled "organic".

Motion by: John Foster Seconded by: Joe Dickson 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0

Crops ☐ Agricultural ☐ Allowed1 X

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic X Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.605 with Annotation (if any): 

As noted above.

2

Substance to be added as “prohibited” on National List to § 205. with Annotation (if any): 

Describe why a prohibited substance: 

3

Substance was rejected by vote for amending National List to § 205. . Describe why material 

was rejected: 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up? 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair April 2, 2012

NOSB Evaluation Criteria for Substances Added To the National List

HC 2 Inositol
Category 1. Adverse impacts on humans or the environment? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, use, 

or disposal?

[§205.600 b.2]

x TR 3/9/12

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TR 3/9/12

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TR 3/9/12 

4. Does the substance contain List 1, 2 

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

x

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

x

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

x

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

x

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

x

10.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

x

11.Is there an adverse effect on human 

health as defined by applicable 

Federal regulations? [205.600 b.3]

x

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

x

13.Does the substance contain residues 

of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

x

HC 3 Inositol
1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

HC 4 Inositol
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

x

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

x May be obtained through yeast 

hydrolysis

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

x Yes, but can also be made 

synthetically

4. Is there a natural source of the 

substance? [§205.600 b.1]

x

5. Is there an organic substitute? 

[§205.600 b.1]

x

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

x Yes, but only for infant formula as req 

in 21 CFR 107.100

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

x Mass production is via synthetic 

pathways. Could be produced using 

organic yeast to provide organic 

inositol

9. Is there any alternative substances? 

[§6518 m.6]

x

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

HC 5 Inositol
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x

2. Is the substance consistent with 

organic farming and handling? [§6517 

c (1)(A)(iii); 6517 c (2)(A)(ii)]

x

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

x

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

x

5. Is the primary use as a preservative? 

[§205.600 b.4]

x

6. Is the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive values lost in processing 

(except when required by law, e.g., 

vitamin D in milk)? [205.600 b.4]

x Nutritive, but not replacing nutrients

7. Is the substance used in production, 

and does it contain an active 

synthetic ingredient in the following 

categories:

a. copper and sulfur compounds;

X

b. toxins derived from bacteria; X

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

HC 6 Inositol
NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or 

potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 

205.600 (c)] Substance: Name

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic 

handling? 

x

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic 

handling? 

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate quality to fulfill an 

essential function in a system of 

organic handling? 

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance cannot 

be obtained organically in the 

appropriate quantity to fulfill an 

essential function in a system of 

organic handling?

X

5. Does the industry information 

provided on material / substance 

non-availability as organic, include ( 

but not limited to) the following:

a. Regions of production (including 

factors such as climate and 

number of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

X

HC 7 Inositol
hurricanes, floods, and droughts 

that may temporarily halt 

production or destroy crops or 

supplies; 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a 

consistent supply?

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

HC 8 Inositol