GRAS approval for supplement tabletting agent

By Mike Stones

- Last updated on GMT

Related tags: Gras status

Cognis, global nutritional ingredients and specialty chemicals supplier, has achieved GRAS (Generally Recognized As Safe) status for its tabletting agent Texapon K 12 P PH, a pharmaceutical grade sodium lauryl sulfate (SLS).

The company’s self-affirmed GRAS status achieved on March 31 provides recognition that Texapon can now be used for dietary supplements in the USA and that it has been shown to be safe under the conditions of intended use.

The GRAS status was attained in consultation with a panel of independent experts. Dietary supplement and food manufacturers can now use SLS in two daily doses of up to 30 mg/day.

Market’s needs

The company’s marketing and business manager, John Giannone, told NutraIngredientsUSA.com: For customers this “Provides a level of regulatory and safety support they have not had previously and should allow a faster "to market" for users​.” It also “Differentiates Cognis as a supplier who understands the market’s needs. Now that we have gained GRAS status, formulators and manufacturers of dietary supplement tablets and capsules can use them in the US and other countries​.”

Texapon, which could be used in any hard tablets or powders that require a surfactant for wetting or processing, is said to help guarantee consistently high quality. It’s small and consistent particle size is particularly efficient in tabletting processes, claims the company.

Wetting agents used in the manufacture of tablets and capsules such as dietary supplements aid water uptake during disintegration, and facilitate the dissolution of active ingredients.

Sodium Lauryl Sulfate is a powerful wetting agent​,” said Giannone. “This status allows users in DS to quickly take advantage of this science.” ​SLS is a frequently used tabletting aid that works as a wetting agent, lubricant or solubilizer.

Double benefit

Thomas Rosen, the company’s global product line manager added: “Texapon K 12 P PH can give manufacturers a double benefit, helping them to improve tablet quality while also ensuring high efficiency. Their excellent wetting capabilities, low particle size and uniform quality that our production processes ensure are key to providing these benefits​.”

In addition to its new self-affirmed GRAS status, Texapon also meets other international regulations, including USP/NF, Ph. Eur. and JP standards, and is kosher certified, said the company.

It is produced in accordance with recognized quality requirements (IPEC-PQG GMP) that ensures product traceability.

Related topics: New ingredient approvals, Suppliers

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