TSI bolsters self-affirmed GRAS status of joint health suite

By Shane Starling

- Last updated on GMT

Related tags: Gras status, Dietary supplement, Federal food drug and cosmetic act, Food and drug administration

Montana-based TSI Health Sciences confirmed self-affirmed GRAS status for its chondroitin sulfate sodium offerings, as proposed regulatory changes increase demand for GRAS status for certain ingredients.

TSI in April self-affirmed GRAS (Generally Regarded As Safe) for the glucosamine section of its PUREFLEX joint health range after the ingredients were examined by an independent panel of scientific experts, and now it has done the same for chondroitin.

The Food and Drug Administration issuing guidance in December last year on what it suggests is an increasingly problematic borderline between liquid supplements and beverages. Sellers of ingredients that may possess new or old dietary ingredient status for us in such supplements, may find clients requesting GRAS status as their own products face potential FDA reclassification.

TSI president Larry Kolb acknowledged this potential reclassification when announcing the GRAS status for its chondroitin, as joint health ingredients such as chondroitin and glucosamine are more commonly formulated into beverages that may or may not be marketed as dietary supplements.

“There is tremendous momentum today within the FDA to regulate liquid dietary supplements as foods,”​ Kolb said in a statement.

“This new ingredient status provides TSI customers valuable market protection in the event GRAS-affirmed ingredients ultimately become a requirement for inclusion in liquid supplement products.”

The scientific panel scrutinized information for the ingredient sourced from bovine, avian, marine and porcine sources that included safety and dosage data as well as clinical trials.

Supplement or food?

The FDA’s concern has grown as products have entered the market bearing novel ingredients or ingredients at unprecedented doses.

“We have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods,”​ the FDAguidance​ states.

This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the Federal Food, Drug, and Cosmetic Act.”

Related topics: Suppliers, Bone & joint health

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