US FDA to clarify legal requirements for liquid dietary supplements and beverages
Since the growth in the marketplace of liquid food products with novel substances the US FDA has finalized two guidance documents which clarify the legal requirements of beverages and liquid supplements and the ingredients allowed in these products.
Beverage or Liquid Supplement?
The following factors are to be used in order to distinguish whether a liquid food product is a liquid supplement or a beverage:
1. Labeling and Advertising – product labels, advertising, web sites and social media by wording or picture
2. Product Name – conventional food names – water, iced tea, coffee, cider, juice, beverage, soda and drink
3. Product Packaging – size, shape color, design and amount held
4. Serving Size and recommended daily intake – conventional beverage US daily average intake of 1200 ml
5. Recommendations and directions of use – dietary supplements labeled in a manner to provide the specific supplement level (e.g. by taking 1 tablespoon three times a day)
6. Marketing practices – conventional foods are often conveyed by marketing the liquid product with a meal or as refreshment
7. Composition – dietary supplements –value in improving nutrition, promoting long-term health and quality of life, and reducing the risk of chronic diet related diseases
8. Other representations about a product – e.g. filings with other government agencies such as the US Patent and Trademark Office or US Security and Exchange Commission
US FDA to Differentiate Between Liquid Dietary Supplements and Beverages
Powdered premix and liquid concentrate products marketed as dietary supplements will still be considered to be dietary supplements provided that they are not represented as being for beverage use or as alternatives to beverages.
Ingredients in conventional foods are those that are generally recognized as safe (GRAS) and approved food additives used at their traditional levels and/or at the legally prescribed level, function and in the type of products allowed. Dietary ingredients in supplements are those substances per section 201 (ff) (1) of the Food , Drug and Cosmetic Act (21. U.S.C. 321 (ff)(1)) (3) and if not marketed before October 15, 1994 must be approved as new dietary ingredients. Additionally, the non-dietary ingredients in dietary supplements must be GRAS and/or approved food additives to be used as prescribed in the regulation or law.
(1) Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocume...)
(2) Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocume...)
(3) Federal Digital System – 21 U.S.C. - FOOD AND DRUGS (http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCO...)