Conjugated Linoleic Acid (CLA) Softgels

Conjugated linoleic acid is not a single compound but a family of positional and geometric isomers of linoleic acid, all sharing the formula C18H32O2 and a molecular weight of 280.4, and distinguished from ordinary linoleic acid by having their two double bonds adjacent rather than separated by a methylene group. Two isomers carry the commercial interest: cis-9,trans-11 CLA, known as rumenic acid, CAS 2540-56-9, which is the dominant form in the milk and meat fat of ruminants, and trans-10,cis-12 CLA, CAS 2420-56-6. Commercial CLA is not recovered from dairy. It is made by alkali isomerisation of a linoleic-rich vegetable oil, in practice high-linoleic safflower oil from Carthamus tinctorius, which carries roughly 71.6 to 83.7% linoleic acid; the reaction shifts the double bonds into the conjugated positions and yields the two active isomers in approximately equal proportion. Thovek's fill oil runs at 78 to 82% total CLA of total fatty acids, in either triglyceride or free fatty acid form to the buyer's choice. The softgel is a 1,000 mg standard fill, which delivers approximately 800 mg of total CLA and supports the two- or three-softgel serving that most brands use; a 1,250 mg fill is available where a brand wants a lower pill count. Fill is nitrogen-flushed and stabilised with mixed tocopherols, and released against a peroxide value of 5.0 meq/kg maximum and an anisidine value of 20 maximum, because an oil this unsaturated is the part of the product that fails first if it is mishandled. Shell choice is a commercial decision as much as a technical one. Bovine gelatin with glycerin is the standard and is available on halal or kosher bovine; fish gelatin is offered where a buyer's supply chain prefers it; and a vegetarian shell built on modified maize starch and carrageenan is what makes a genuinely vegan CLA softgel possible. Shape, size, tint and printing are set by the buyer. Two points come up on nearly every enquiry and both belong on the specification. The first is trans fat. CLA does carry trans double bonds, but conjugated trans fatty acids are excluded from trans fat declaration under United States labelling rules and under the Codex definition, so a CLA softgel does not attract a trans fat declaration on that basis; conjugated linoleic acid has also been treated as generally recognised as safe in the United States since 2008, while novel food status and permitted levels differ by market and must be confirmed for the destination before a launch. The second is diet and allergen status, where the fill and the shell diverge. The fill oil is plant-derived and vegan; safflower is an Asteraceae seed crop and is not a listed allergen under Annex II of the EU food information regulation or under US FALCPA, and the oil is free from milk, egg, soy, peanut, tree nut, sesame and gluten. The shell is what governs the finished claim: bovine gelatin softgels are neither vegetarian nor vegan and ship with a gelatin source declaration and a BSE/TSE statement, fish gelatin softgels carry a fish allergen declaration, and only the starch and carrageenan shell yields a vegan finished product. Thovek supplies composition, specification and manufacture; body-composition and other marketing claims on the finished pack are the buyer's responsibility and must be substantiated and cleared for the destination market. Each batch releases with a certificate of analysis, and the importer file covers the FSSAI manufacturing licence, GMP and HACCP certificates, free sale certificate, certificate of origin, allergen, GMO and BSE/TSE statements, gelatin source declaration, stability data and halal, kosher or vegan certification as required.