Statement on FDA Status of Borates
This certification applies to all grades* of the following products manufactured by U.S. Borax, Inc.
*Grades include: Powder, granular, fine, technical, TG, TP, and NF
1. The FDA has approved boric acid and borax for use under the indirect food additive regulations listed in the table below (X mark indicates approved use).
|CFR Title 21
||Substances for use only as components of adhesives
||Substances for use as components of coatings
||Not to exceed the amount required as a preservative in emulsion defoamer
||Substances for use only as components of paper and paperboard
||For use only as a preservative in coating
||Polymers: Textile and textile fibers
||For use as preservative only
||Adjuvants, production aids, and sanitizers: Antioxidants and/or stabilizers for polymers
||For use only at levels not to exceed 0.16% by weight of ethylene-vinyl acetate-vinyle alcohol copolymers complying with 177.1360(a)(3) and (d)
||Prior-sanctioned food ingredients: Substances for use in the manufacture of paper and paperboard products used in food packaging
||For use in adhesives, sizes, and coatings2
2. U.S. Borax NF grade sodium borate products (e.g. Borax Decahydrate NF, and Optibor Boric Acid NF) are processed to meet the U.S. National Formulary standards for use as excipients, botanical and other “non-drug”3 ingredients used in the drug preparations.
3. The products listed above, as of the date of shipment, are not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetics Act (FFDCA) or any state food and drug laws.
U.S. Borax Inc. 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 labeled as "NOT FOR INTERNAL USE" and thus are not intended for internal related applications nor as an active ingredient. U.S. Borax Inc. is not required to maintain, nor do we maintain a Drug Master File for our NF products. None of our products or facilities are registered with the U.S. FDA.
1CFR Title 21 - parts 175, 176, 177, 178, and 181 refer only to Borax (e.g. does not include CAS Registry Number), and therefore these listings are considered relevant for both sodium tetraborate pentahydrate and sodium tetraborate decahydrate which have the same toxicological profile and are separated only by degrees of hydrations.
2Under the conditions of normal use, these substances would not reasonably be expected to migrate to food, based on available scientific information and data.
3Optibor 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.
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