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FDA divides liquid dietary supplements and beverages

By Shane Starling , 04-Dec-2009
Last updated on 04-Dec-2009 at 18:41 GMT2009-12-04T18:41:49Z

The difference between liquid dietary supplements and beverages bearing novel ingredients is the subject of new guidance from the FDA, which has become concerned about practices occurring in the area.

It highlighted two main concerns: Drinks being marketed as dietary supplements and the use of novel ingredients and high-dose ingredients in beverages and the labeling implications that may follow from that.

“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 FDA guidance states.

“Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement…”

Novel and high dose ingredients

On novel and high-dose ingredients, FDA observes: “FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives.

In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods.

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.”

Drinks versus supplements

FDA highlighted examples such as single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea as examples of consumption occasions as a regular foodstuff and not a dietary supplement.

“Liquid products that suggest through their serving size, packaging, or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the US, are represented as beverages.”

Such products, the FDA said, “may not be marketed as a dietary supplement.”

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