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U.S. Department of Health and Human Services

Food

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Concerns About Botanicals and Other Novel Ingredients in Conventional Foods

FDA Letter to Industry on Foods Containing Botanical and Other Novel Ingredients

In January 2001, FDA sent a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel or "new" ingredients, including botanicals.

FDA Sends Warning Letters To Manufacturers Concerning The Addition Of Herbal Ingredients To Beverages, June 4 - 5, 2001.

In a set of warning letters issued June 4, 2001 to Hansen Beverage Company and Fresh Samantha, Inc., and June 5, 2001 to U.S. Mills, Inc., the agency specified that ingredients such as herbs and other novel ingredients, when added to conventional foods, should either be pre-approved as a food additive or, alternatively, meet the requirements of the "Generally Recognized as Safe" (or GRAS) provisions. In doing so, the FDA indicated that its goal was to protect the integrity of the food supply and re-emphasized that food manufacturers have the responsibility to follow the regulatory rules already in place. In the warning letters, FDA requested that within 15 working days, companies share with the agency the basis for their determining that several herbal ingredients currently in certain beverages were GRAS. Failure to do so would make the companies and their products subject to enforcement actions.

  • Warning Letter to Hansen Beverage Company*, June 4, 2001
  • Warning Letter to Fresh Samantha, Inc.*, June 4, 2001
  • Warning Letter to U.S. Mills, Inc.*, June 5, 2001

Recent FDA Warning Letters


*Document is temporarily unavailable online.