FDA draft document gives guidance to enhanced-beverage industry

The specialty beverage industry has two months to respond to a new draft guidance by the Food and Drug Administration on the labelling and sale of its products. Whatever final draft is implemented will impact energy drinks, energy shots and functional beverages — a category that has grown exponentially in recent years.

The document, which can be downloaded here, strives to help manufacturers distinguish between liquid dietary supplements and beverages. The guidance also "reminds" manufacturers and distributors of products that contain novel ingredients about the requirements of the Federal Food, Drug, and Cosmetic Act (the FFDCA.)

Spurring this latest guidance is the 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 agency says. "Products that are represented as conventional foods do not meet the statutory definition of dietary supplements … and must meet the regulatory requirements that apply to conventional foods."

The FDA reports a growth in beverages containing novel ingredients, such as added botanical ingredients or extracts, which have not been previously used in conventional foods. Therefore, they 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," the document states. "This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use."

FDA guidance documents do not establish legally enforceable responsibilities; rather they describe the agency's "current thinking" on a topic and should be viewed as recommendations, the agency says.

To learn more about the draft document, or get involved in an industry response to the document, contact the LDI Group.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.