Regulations: The regulatory landscape for vitamin E tocotrienol

The vitamin E family​

Tocotrienols are a form of vitamin E that have traditionally been in the shadow of the more popular vitamin E form – tocopherols.

Overall, there are eight forms of vitamin E: four tocopherols (alpha, beta, gamma, delta) and four tocotrienols (alpha, beta, gamma, delta). Alpha-tocopherol (alpha-Toc) is the main source found in supplements and in the European diet, while gamma-tocopherol (gamma-Toc) is the most common form in the American diet.

Tocotrienols (TCT) are only minor components in plants, although several sources with relatively high levels include palm oil, cereal grains, rice bran and annatto.

Use in food and beverages​

All of the tocotrienol ingredients on the market claim to be GRAS (generally recognised as safe), with the determinations being self-affirmed. American River Nutrition, which sources from annatto, said its DeltaGold branded ingredient received self-affirmed GRAS status in July 2010.

The leader in the sector – Malaysia’s Carotech – notes that it achieved self-affirmed GRAS status in January 2010 for both its palm tocotrienol rich fraction (TRF) and palm carotenoids. Speaking to NutraIngredients, WH Leong, VP of Carotech Inc, said that the company is expecting a no objection letter from FDA for the GRAS status around June 2011.

Davos Life Sciences states that self-affirmation was achieved in April 2010 for its palm oil-derived tocotrienols and alpha-tocopherol (the notice was made on behalf of the Malaysian Palm Oil Board).

Claims​

Regarding claims allowed on products, Carotech’s Leong notes that two structure function claims are allowed: One for cardiovascular health, and the other for antioxidants. For American River’s, its president Dr Barrie Tan said that the only claim allowed is that “the ingredient is a potent antioxidant containing only tocotrienols”​.

European health claims​

The situation in Europe is a lot less rosy. The EFSA Journal​ (2010;8(10):1816) recently published a list of opinions on vitamin E (the journal does not discriminate between tocopherols and tocotrienols) for a range of health conditions.

According to the EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), the evidence is conclusive for a cause and effect relationship “between the dietary intake of vitamin E and protection of DNA, protein and lipids from oxidative damage”​.

However, no cause and effect relationships were established for the:

• the maintenance of the normal function of the immune system,
• maintenance of normal bone,
• maintenance of normal teeth,
• maintenance of normal hair,
• maintenance of normal skin,
• maintenance of normal nails,
• maintenance of normal cardiac function,
• maintenance of normal vision by protection of the lens of the eye,
• contribution to normal cognitive function,
• regeneration of the reduced form of vitamin C,
• maintenance of normal blood circulation, nor
• maintenance of a normal scalp.