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Monday, September 13, 2010

Recent insights from FDA Warning Letters

Once again I’d like to share information about FDA’s recent warning letters. This time several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling.

The first involves the use of the claim “0 grams trans fat”.  In a warning letter to David’s Cookies of Fairfield, NJ, FDA stated that “0 grams trans fat” is a nutrient content claim and is “not made in accordance with the applicable requirements.”  There are no authorized nutrient content claims for trans fat. Many of you will recall our recommendation that the statement, “0 grams trans fat per serving” be used since it is a statement of fact.  You may read the entire warning letter at:

There were two warning letters to large corporations regarding claims relating to green tea.
In their letter to Unilever regarding Lipton’ Green Tea, FDA took exception to claims made on the company website regarding links to green tea and heart health/cholesterol levels. The agency takes the position that Lipton is promoting the product as an unapproved new drug due to these claims.

Both the letter to Unilever and a letter to Cadbury regarding their Green Tea Ginger Ale discuss the agency’s objection to the use of the term “antioxidant” in relation to green tea.  FDA only recognizes Vitamin C, Vitamin A, Vitamin E and Selenium as antioxidants. We typically suggest that our clients discuss the ‘antioxidant activity’ of nutrients other than A, C, E and selenium.  The Cadbury warning letter regarding their Green Tea Ginger Ale can be found at: .

These recent warning letters are interesting because they warn about claims that are really quite common in the US grocery market.  In fact, these claims that are so common that when we have warned our clients about them, they frequently say, “but everybody says that!”  These letters demonstrate that the agency is perhaps catching up with the marketplace. This is most likely because the 600 to 800 new inspectors hired a few years ago have mostly completed their training.

There are many things to consider when writing FDA compliant claims.  Armed with 12 years of experience with FDA regulations, we at Bioscience Translation & Application stand ready to help you understand the many nuances to this task. Visit us at

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