FDA’s new nutrition label regulation for fat-soluble vitamins

FDA’s new nutrition label regulation for fat-soluble vitamins

In 2020, FDA expects fat-soluble vitamins to be measured in metric units rather than international units as was expected in the past.

Bryan See, Diyanah Roslan | Nov 05, 2018

Article Source: Natural Products INSIDER

The international unit (IU) has been used to measure fat-soluble vitamins—vitamin A, D and E—for decades. The IU is an arbitrary amount based on the amount of a given nutrient needed to produce a biological effect. Different than milligram or microgram, the IU measurement describes something that we cannot see; the potency or biological activity of a product. While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

In the new regulation for the nutrition facts label, FDA is replacing the unit “IU” for vitamin A, vitamin D and vitamin E with the metric unit. The unit for vitamin A will be changed to micrograms of retinol activity equivalents (mcg RAE), milligram of alpha-tocopherol (mg) for vitamin E while Vitamin D will be changed to microgram, while the IU reading for Vitamin D could be displayed in parentheses. This regulation will come into effect on Jan. 1, 2020 for companies with US$10 million or more in annual sales; and Jan 1, 2021 for companies with less than $10 million in annual sales. It is expected that other countries will follow this new regulation as well to standardize the labelling system. This new supplement/ nutrition facts label hopefully will help consumers to make a better decision in terms of choosing the right vitamin A and vitamin E for their daily consumption.

Vitamin A

Vitamin A is essential vitamin for healthy vision and cellular communication. There are two main ways to obtain vitamin A in the diet, through:

(1)         retinols from animal sources and dairy products;

(2)         pro-vitamin A carotenoid from plant.

Both retinols and pro-vitamin A carotenoid are metabolized in the body into the active form of vitamin A, retinoic acid. However, retinols and pro-vitamin A carotenoid differ in their bioactivities. As an example, it takes different amount of IU from retinol, beta-carotene from food, beta-carotene from supplement or alpha-carotene to make 1 microgram of retinoic acid.

Therefore, it is vital for consumers to check the source and forms of vitamin A to ensure they get sufficient vitamin A according to the recommended dietary intake (RDI). The RDI of the vitamin A has also changed from 5,000 IU (equivalent to 1,500 mcg RAE) to 900 mcg RAE for males and 700 mcg RAE for females respectively.

The conversion of unit of vitamin A from IU to the metric unit, mcg RAE, will take into account the differences in vitamin A activity between retinols and pro-vitamin A carotenoid. In the new unit, 1 RAE will equal to 1 mcg retinol, 12 mcg beta-carotene, 24 mcg alpha-carotene or 24 mcg beta-cryptoxanthin. Hence, the change of IU to mcg RAE for vitamin A is welcomed as this will reflect the actual or reality of vitamin A activity of its different forms—retinol and pro-vitamin A carotenoid.

Vitamin E

Meanwhile, vitamin E has eight different isoforms; the alpha-, beta-, delta- and gamma-tocopherol; and alpha-, beta-, delta- and gamma-tocotrienol. These vitamin E isoforms share overlapping biological activities such as fat-soluble antioxidant and also have unique health properties. They are naturally found in vegetable oils such as soybean, sunflower and palm, with different composition of tocopherols and/or tocotrienols.

Once the IU unit for vitamin E is obsolete and changed to mg of alpha-tocopherol, natural alpha-tocopherol (or d-alpha-tocopherol) will be worth twice the amount of synthetic alpha-tocopherol (or dl-alpha-tocopherol) as vitamin E.

This change of unit will also provide an even field toward other vitamin E isoforms because for the first time, alpha-tocopherol will have the same unit as other isoforms. Basically, the abolishment of IU removes the privilege of alpha-tocopherol—which has been stealing the limelight of other vitamin E isoforms.

The RDI for vitamin E (d-alpha-tocopherol) is reduced from 30 IU (about 20.2mg of d-alpha-tocopherol) to 15 mg of d-alpha-tocopherol. Hence, the common vitamin E 400 IU products will change to 268.5 mg of d-alpha-tocopherol with almost 18 times more than the daily value.

Change is inevitable

To make progress, change must occur. The unit change will incite questions such as, “What happened to the 400 IU vitamin E supplements?” “Why is the 400 IU now called 268.5 mg of d-alpha-tocopherol? Is it too high for me?” or “Is this 900 mcg RAE of vitamin A enough for me?” and so on, from the consumers whom have become accustomed to the IU system.

Industry players can embrace these changes and to anticipate consumer’s questions by reformulating their existing vitamin A and E products with a strategy to make their product continue to be sound, consumer-oriented and effective in terms of science, regulatory as well as marketing standpoint.

The current common vitamin E and vitamin A products are formulated at 400 IU of vitamin E activity and 25,000 IU of Vitamin A activity. These products are normally formulated with alpha-tocopherol or beta-carotene (either natural or synthetic forms).

As the natural alpha-tocopherol will have twice the amount of vitamin E, compare to synthetic alpha-tocopherol, a rise in demands for supplements containing natural alpha-tocopherol is anticipated. Having said that–does one really need high concentration (268.5mg) of standalone alpha-tocopherol daily?

With the new supplement facts labelling system and the rising demand of “natural” from consumers, the future vitamin E product is expected to shift from high standalone vitamin E to a full-spectrum vitamin E product with both tocopherols and tocotrienols.

Please don’t think the price for full-spectrum vitamin E is expensive. The level of alpha-tocopherol has been reduced and the saving is used for the inclusion of other tocopherols and tocotrienols. Hence, the price for these two formulas will be about the same.

While giving a 100 percent of the dietary value of Vitamin E, this supplement will provide other tocopherols and tocotrienols, hence delivering the benefits of vitamin E in terms of Vitamin E activity, antioxidant and other biological activities.

Each isoform of Vitamin E has been shown to have its own health benefits. Therefore, the inclusion of all four tocotrienol isoforms will deliver benefit that are absent in the tocopherol isoforms and vice versa, making this product comprehensive and distinct. In fact, there’s no synthetic tocotrienol are available while synthetic alpha-tocopherol is easily available in the market. With the market moving to go natural and with the new FDA nutrition labelling guidelines, it is best to convince the consumers by formulating a full-spectrum vitamin E product that guarantees to be naturally sourced, rather than a stand-alone vitamin E product based on alpha-tocopherol alone (at 268 mg—equivalent to 400 IU) which might raise dubious questions from the consumers.

Vitamin A

There are two forms of vitamin A—1) preformed-vitamin A and 2) pro-vitamin A carotenoids, which is mainly beta-carotene as it has the highest vitamin A activity. The common vitamin A products are with 25,000 IU are either from synthetic, or are fermentative algae beta-carotene.

With the new labelling system, the 25,000 IU will be equivalent to either 7,500 mcg of RAE from retinol or 15,000 mcg of beta-carotene, at approximately 8.3 times more than the daily value.

Beta-carotene is not the only carotenoid. In fact, more than 600 carotenoids are in nature and the six most common carotenoids found in human plasma are alpha-carotene, beta-carotene, beta-cryptoxanthin, lycopene, lutein and zeaxanthin. Half of them are provitamin A carotenoids—where they will convert to retinol when there is a deficiency—and each of them has its unique biological activities associated to specific health benefits such as immunity, skin health and eye protection.

Dietary supplement companies and formulators can formulate a pro-vitamin A carotenoid supplement or a multi-carotenoid vitamin A product using natural plant derived ingredient. It can be done by combining natural mixed-carotene (alpha- and beta-carotene) from palm (like EVTene™ from Excelvite); natural lycopene from tomato (like Lyco-Mato from Lycored) and natural lutein and zeaxanthin from marigold (like Lutemax from OmniActive Health Technologies/FloraGLO from Kemin).

As most dietary supplement companies have vitamins, either standalone or multivitamin, relabeling of products is a must. The new labelling system and relabeling for vitamins (particularly Vitamin A and E) seemed to be easy. However, if it’s not properly defined, it will create confusion and questions among consumers. Nevertheless, this change of labelling system provides an opportunity for product innovation for manufacturers. A true natural full-spectrum vitamin A carotenoid or a full-spectrum vitamin E containing both tocopherols and tocotrienols would be an excellent new product line to develop—to capture the potential market when the new labelling system becomes fully enforced by Jan 1, 2021.

Bryan See, is business development manager, ExcelVite Inc., and Diyanah Roslan, is a nutritionist at ExcelVite Sdn Bhd.

Visit ExcelVite at Supplyside West at booth 3643.

Disclaimer: The statements in the above article have not been evaluated by the Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any disease.