Statement on U.S. Borax Inc. National Formulary certification
This certification applies to U.S. National Formulary grades of the following products produced by U.S. Borax Inc.
- Borax Decahydrate NF Granular: CAS #1303-96-4
- Borax Decahydrate NF Powder: CAS #1303-96-4
- Optibor® NF boric acid Granular: CAS #10043-35-3
- Optibor NF boric acid Powder: CAS #10043-35-3
The U.S. Borax National Formulary (NF) grade products listed above have been labeled as “Not for internal use” for more than 20 years, per the United States Pharmacopeia and The National Formulary (USP–NF) monograph and are approved only for external applications. These products have only been approved as excipients (inactive ingredients) and shall not be used for internal pharmaceutical or any other related application.
U.S. Borax does not offer any product that we approve nor intend for use as a dietary ingredient, pharmaceutical and/or over-the-counter (OTC) active ingredient, nor food additive or direct additive to foods. Our NF grade products are processed to meet the U.S. National Formulary Official Monographs as an excipient (eg, inactive ingredient), and are labeled as "NOT FOR INTERNAL USE" as prescribed by the National Formulary Official Monographs and thus are not intended for internal related applications nor as an active ingredient.
Borates are starting materials in the pharma production process. Borates themselves do not meet the criteria of an active pharmaceutical ingredient (API), provided below:
- Borates do not produce any kind of biologic effect in the body.
- Borates are not biologically active.
- Borates cannot restore, correct or modify physiological functions in humans.
- Borates have no direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans.
As a result, borax and boric acid are currently listed on the U.S. Food and Drug Administration’s (FDA) Not-Approved Active Ingredient List.
There is no conclusive scientific data available today to disprove the points above.
Distributors and end use customers are encouraged to consult our product label as well as all applicable regulations and standards to ensure compliance with all directions of use, caution statements, product safety and laws governing the use of these products. It is incumbent upon distributors and customers to ensure compliance, dependent upon end use. Neither U.S. Borax will be responsible or liable for any non-compliant or inappropriate use.
ANY SUPPORTING DOCUMENTATION PROVIDED FROM U.S. BORAX INC. REPRESENTS THE CONSTITUENT NATURE OF OUR NF GRADE PRODUCTS AND IS NOT AN ENDORSEMENT OF THE USE OF THESE PRODUCTS IN ANY SPECIFIC APPLICATION OR END-USE.
Allergen statement
The products listed above are derived from naturally occurring mineral and inorganic chemical sources and produced in simple aqueous processes. Whilst we do not test for allergens it is reasonable to assume that they are free from potential intolerance factors including gluten that are likely to cause an allergic reaction.
Animal derivation/product origin
The products listed above are derived from processed natural mineral ore. There are no animal derivatives involved or used in their manufacturing.
BSE/TSE statement
The products listed above have not been contaminated or in contact with bovine spongiform encephalopathy (BSE) nor transmittable spongiform encephalopathy (TSE).
Drug master file
U.S. Borax is not required to maintain, nor do we maintain a drug master file for our NF products.
Federal Food, Drug and Cosmetics Act (FFDCA)
The products listed above, as of the date of shipment, are not adulterated or misbranded within the meaning of the FFDCA or any state food and drug laws.
Generally recognized as safe (GRAS)
The products listed above have not been reviewed for GRAS and are therefore not GRAS compliant, nor have they been approved by the FDA as direct food additives.
Hazardous components
The following chemicals are not used in the manufacturing process of the products listed above and whilst we do not specifically test for their presence, it is reasonable to assume that they are absent from these products:
- Azo compounds
- Chlorine gas or hypochlorites
- Chlorphenolic containing biocide
- Chlorinated paraffin
- Class I or II ozone depleting substances
- Cyanide
- Dioxins including 2,3,7,8-TCDD
- Endocrine distruptors
- Ethylene bis-steramide
- Ethylene oxide (ETO)
- Formaldehyde
- Halogens (Br, Cl, F, and I)
- Melamine
- Natural rubber latex/dry natural rubber
- Organic TIN compounds (tributyl tin or triphenyl tin)
- Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA)
- Persistent Organic Pollutants (POPs)
- Phenol compounds, including alkylphenols (AP) and alkylphenol derivatives (eg, alkylphenol ethoxylates (APE), and bisphenol A (BPA))
- Phosphorous base organic compounds
- Phthalates (ie, DEHP, DBP, BBP, DINP, DIDP, DONP)
- Polyaromatic compounds (PAH)
- Polychlorinated biphenyls (PCB), polychlorinated terphenyls (PCT), polybrominated biphenyls (PBB), or polybrominated diphenyl ethers (PBDE)
- Polychlorinated naphthalene
- Polyfluoroalkyl substances (PFAS)
- Residual flammable volatiles
- Thiones
- Toxaphene, hexachlorobenzene, oxtachlorostyrene, dieldrin, chlordane, and DDT or its metabolites
- Volatile organic compounds (VOC)
- Heavy metals (lead, cadmium, arsenic, mercury, antimony, and chromium-hexavalent) are not intentionally added but may be present at trace levels as impurities.
Kosher and halal status
The products listed above are not kosher or halal certified.
Nutrition statement
Our borate products are inert and provide no known nutritional value.
U.S. FDA registration
None of our products and none of our facilities are registered with the U.S. FDA.
U.S. National Formulary
The products listed above are processed to meet the U.S. National Formulary Official Monographs as an excipient (eg, inactive ingredient), and are labeled as "NOT FOR INTERNAL USE" as prescribed by the National Formulary Official Monographs and thus are not intended for internal related applications nor as an active ingredient.
The products listed above are processed to meet the U.S. National Formulary standards for use as excipients, botanical and other “non-drug" ingredients used in the drug preparations.
Optibor boric acid and borax decahydrate are not active ingredients. There is no evidence supporting drug efficacy as listed in the USP-DI (U.S. Pharmacopoeia Drug Information) database.
Resources
August 2021