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Monday, March 21, 2011

Warning Letters: Gelatin and Water as Dietary Ingredients

FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up.

In a February 9, 2011 letter to Ancient Formulas of Wichita, Kansas, FDA declared some products misbranded because they did not include a complete list of ingredients.  Specifically the agency noted that the ingredients that make up the capsules were not listed.  Regulations covering ingredient declaration include 21 CFR 101.4, 101.36 and 101.100.  While there are many details in these listings the highlights are as follows:

Ingredients that must be declared:
101.4 (a)(1) Ingredients required to be declared on the label or labeling of a food…shall be listed by common or usual name in descending order of predominance by weight …
101.4 (g) …Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list.

Section 101.100 lists ingredients which do not have to be listed: “Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food.”

In the letter to Ancient Formulas, FDA listed ‘gelatin’ as an example of an undeclared capsule ingredient but depending upon what the capsule supplier lists, there may be need to declare other ingredients.  Softgels often contain colorants and other excipients and most capsules also list water as an ingredient, which should be declared on the label.  

Speaking of water, another dietary supplement manufacturer, Abba Pharmaceuticals of Tampa, Florida, also received a warning letter with the unique citation that they failed to a) establish specifications for water as an ingredient in the liquid dietary supplement product and b) they failed to determine and keep records demonstrating that water used as a dietary supplement ingredient conformed with local, State and Federal regulations and would not contaminate the dietary supplement. (21 CFR 111.15 & 111.23).

Many of you have heard me say that a product label is really a table of contents of how the product was manufactured.  They way ingredients are declared describes how those ingredients were added and mixed. When reviewing your labels, the team at Bioscience Translation & Application looks beyond the label itself to alert you to the regulatory implications for your manufacturing process.  The warning letters discussed above provide examples of why this is important.  Let us help you ensure that your labels are correct and that your processes are FDA compliant.

To read the warning letters in their entirety, visit and search on the company names.  To read the regulations cited above, search using the section numbers cited at .

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