I found this reference "Because honey is a single ingredient food, you do not need to include an ingredient statement on the label." in a Guidance for Industry document for Honey products. Since it referenced "single ingredient food", I thought other foods might qualify.
http://www.fda.gov/f...n/ucm389501.htm
In this case, it is in the food category.
Hi Jaj478,
That is indeed puzzling based on the guidance document you attached. I can't find it listed anywhere in 21CFR 100 or 21CFR 101 that a single-ingredient item does not need an ingredient statement. We list it on our labels, and I would just say that a safe bet here would be to include an ingredient statement on the label. It's better to do it than not to do it and have issues.
Also as far as the nutritional panel is concerned, I do believe you have to include a nutritional panel on the product even if the nutrients are in small amounts.
Per FDA Guidance Doc:
"A simplified Nutrition Facts label may be used if at least eight of the following nutrients are present in insignificant amounts: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron (slightly different rules for labeling foods intended for children less than 2 years). The five core nutrients, shown in bold in the adjoining example, must always appear on all Nutrition Facts labels regardless of amounts present in the food. In addition, any of the nutrients required on the full Nutrition Facts label that are naturally present or are added to the food must be declared on the simplified Nutrition Facts label. 21 CFR 101.9(f) - List of nutrients; 101.9(f)(1) – “Insignificant” defined; 101.9© – “Insignificant” levels listed for nutrients."
Serving Size, Calories, Total Fat, Sodium, Total Carbohydrates [Including Sugar], and Protein must be listed. I thought that was the case, but if you could tell me where you found that particular exemption you mentioned, that would be great. The link to the guidance document I referenced is below. There are some exemptions to labeling if you are a small company, making an ingredient for further reprocessing downstream, etc. I would try to do a nutritional panel for the label as well, because more work is better in this case. Labeling laws are so dense and confusing, that I wouldn't want to miss something in the process of trying to follow exemptions and simplifications.
QAGB
http://www.fda.gov/F...htm#simplified